Sleuthing Health and more

Transcription

Sleuthing Health and more
Michele Skupp
Sleuthing Health, Deals, Tech &
More
[email protected]
973-369-7490
August 7, 2016
Here are my informal notes for your use only:
August 7, 2016
My Informal takeover notes with attributions *health in green, tech in purple,
energy/basic in blue, retail in maroon, financials in orange, miscellaneous in black
Aug 7 2016 PGNX takeover rumors on Investor Hub in light of the VRX Relistor news
Aug 7 2016 In the jaws of Software M&A Rush, large software leaders and PE firms circle
innovators with weakened valuations. ADBE AMZN PANW GOOGL loom as buyers, and targets
include CSOD HUBS PFPT RP NOW SHOP UTLI WDAY and ZEN, article in IBD
Aug 7 2016 CSOD In the jaws of Software M&A Rush, large software leaders and PE firms
circle innovators with weakened valuations. ADBE AMZN PANW GOOGL loom as buyers, and
article in IBD, CSOD as a one of various targets
Aug 7 2016 HUBS In the jaws of Software M&A Rush, large software leaders and PE firms
circle innovators with weakened valuations. ADBE AMAN PANW GOOGL loom as buyers, and
targets include HUBS article in IBD
Aug 7 2016 PFPT In the jaws of Software M&A Rush, large software leaders and PE firms circle
include PFPT, article in IBD
Aug 7 2016 RP In the jaws of Software M&A Rush, large software leaders and PE firms circle
include RP article in IBD
Aug 7 2016 NOW In the jaws of Software M&A Rush, large software leaders and PE firms circle
include NOW article in IBD
Aug 7 2016 SHOP In the jaws of Software M&A Rush, large software leaders and PE firms
circle innovators with weakened valuations. ADBE AMN PANW GOOGL loom as buyers, and
targets include SHOP article in IBD
Aug 7 2016 ULTI In the jaws of Software M&A Rush, large software leaders and PE firms circle
include UTLI article in IBD
Aug 7 2016 ZEN In the jaws of Software M&A Rush, large software leaders and PE firms circle
include ZEN, article in IBD
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Aug 7 2016 WDAY In the jaws of Software M&A Rush, large software leaders and PE firms
circle innovators with weakened valuations. ADBE AMZN PANW GOOGL loom as buyers, and
targets include WDAY article in IBD
Aug 7 2016 BRCM stays ahead of slowing Iphone sales via mergers, positive overview, BRCM
is expected to make a play for MXIM NXPI or XLNX according to analysts, article in IBD.
Aug 7 2016 MXIM BRCM stays ahead of slowing Iphone sales via mergers, positive overview,
BRCM is expected to make a play for MXIM NXPI or XLNX according to analysts, article in IBD.
Aug 7 2016 NXPI BRCM stays ahead of slowing Iphone sales via mergers, positive overview,
BRCM is expected to make a play for MXIM NXPI or XLNX according to analysts, article in IBD.
Aug 7 2016 XLNX BRCM stays ahead of slowing Iphone sales via mergers, positive overview,
BRCM is expected to make a play for MXIM NXPI or XLNX according to analysts, article in IBD
Aug 6 2016 ATHX vague rumors about some sort of deal on Reddit
Aug 5 2016 GBSN pondered as takeover candidate on Street Register
Aug 5 2016 NFLX as takeover bait for BABA on Benzinga
Aug 5 2016 BABA as potential suitor for NFLX on Benzinga
Aug 5 2016 TWTR on Baystreet for deal noise for PE, MSFT , Saudi Prince Alwaleed and Steve
Ballmer
Aug 5 2016 GILD should buy BMY now on Stock Assassin
Aug 5 2016 BMY GILD should buy BMY now on Stock Assassin
Aug 4 2016 ETSY discussed as takeover bait for AMZN in FT Lex
Aug 4 2016 AMZN as potential suitor for ETSY, buy rather than build in FT Lex
Aug 4 2016 EBIO is buyout candidate posts on Investors Hub
Aug 4 2016 TWTR Sun Trust analyst Robert Pack thinks the potential takeover is just a rumor ,
TWTR may consider bids in the future but not before 2017
IBD Investors Business Weekly
In the jaws of Software M&A Rush, large software leaders and PE firms circle innovators
with weakened valuations. ADBE AMZN PANW GOOGL loom as buyers, and targets
include CSOD HUBS PFPT RP NOW SHOP UTLI WDAY and ZEN
The IPO pipeline is primed, a burst of successful stock debuts hints a stream of offerings ahead,
FASB accounting change the biggest in years, rule FASB 606 will affect many companies but
likely will have the most impact on businesses with multiyear contracts, licensing revenue,
contracts that peg revenue to performance benchmarks or third party sales distribution channels
such as telecom companies.AT&T VZ ADBE and MSFT could be most impacted , others such
as AAPL AMZN CSCO FB INTC CRM and QCOM too. More companies will need to adapt more
than just their financial statements
BRCM stays ahead of slowing Iphone sales via mergers, positive overview, BRCM is expected
to make a play for MXIM NXPI or XLNX according to analysts. Growth could come from
additional content at existing tier one smartphone makers like AAPL and Samsung as more
infrastructure comes on line to support 4G and LTE
Medical clinics are coming to malls article
Fred Hickey latest piece is Titled more more more ( how do you like it?)
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Fred has small put positions on SWKS INTC QRVO TXN CRUS ADI NXPI NFLX TSLA
AAPL IBM and CRM
Precious metals are his largest positions although not as large as in January near the
lows. Largest miner positions include AEM NGD GG AGI DRGDF and HL. He still owns
CEF LEAPS in physical gold and SLV , and various other names
Fred knows why Bill Gross recommends hard assets in his latest letter, those are the a
that outperform the most in a money printing environment,
TECH is an inferior alternative in a massive money printing environment
The Daily Reckoning on Janet Yellen Houdini
http://dailyreckoning.com/janet-yellen-21st-century-houdini/
Investors Hub on PGNX buyout potential
Dr_Thorfin 8/07/16 12:56:32 AM
PGNX 10 bagger buyout underway?
Valeant’s Relistor Said to Draw Interest of Potential Buyers
Sale of Relistor could fetch $400 million to $500 million
Relistor has attracted interest from other drugmakers
Valeant and its partner for Relistor, Progenics Pharmaceuticals Inc., said last month that
the U.S. Food and Drug Administration approved the tablet form of the drug to treat
constipation brought on by taking opioids for chronic, non-cancer pain. Valeant said it
expects to start selling Relistor tablets in the U.S. in the third quarter this year. An
injectable form of the treatment was approved by the FDA in 2008.
Progenics said on July 26 it had received a $50 million payment from Valeant after the
FDA’s approval. Progenics is entitled to receive as much as $200 million of milestone
payments tied to sales of the drug, the company said.
BioCentury Weekend
Better modeling through PDUFA article on improving model informed drug development MIDD
which could help sponsors avoid some of the mistakes that most commonly lead to rejections of
first time drug applications. The FDA will conduct a pilot program for MIDD approaches which
will begin in Oct 2017, at least nine FDA guidances could be up for revision in order to
incorporate MIDD and up to 30 biostaticians may be added. The hope is that you can learn
things before you go into the design of a massive trial
OncoResponse which has I Star Discover platform to screen and sequence antibodies
produced by memory B cells and is working with MD Anderson, the company has identified one
lead candidate that will enter testing this year
FDA gets real article on real world evidence for medical devices, comments on draft guidance
are due Oct 25 2016
Zero Hedge Sell Everything". But Why: What Has The Smartest Investors So Spooked?
Many of the smartest investors out there hate stocks. Since May, we’ve heard negative equity
calls from Stan Druckenmiller, George Soros, Carl Icahn, Jeff Gundlach and Bill Gross. what
do they know?
And while we can only guess at the lynchpins of their negative take on stocks, we do have some
idea of how significant they must be. For example, in 2016 the S&P 500 is up 5.9% on a price
basis after 1) the Brexit “Leave” vote, 2) dramatically disappointing Q1 and Q2 U.S. GDP, 3) a
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correction of 20% in oil prices, 4) a Fed that has incorrectly calibrated its public stance on
monetary policy, 5) Donald Trump as the Republican candidate for president, and 6) the U.S. 10
Year Treasury at near record low yields.
None of that has been enough to spook U.S. equity markets. So whatever the big boys think
they know, it must be really bad. But what is it, and why is it so hidden from view?
So when a cluster of high-profile hedge fund and long-biased managers go out of their way to
give dire warnings about the U.S. equity market with stocks sitting at or near all-time highs, any
sensible investor needs to pay attention. These are people with access to information that most
market participants could only dream of having. Former heads of state and central bankers,
private intelligence operatives, senior government officials, the best consultants in any
industry… It is like having an all access pass to anything, anywhere, any time.
Here’s a partial list of bold faced names that have panned stocks and other financial assets in
recent weeks:
Stan Druckenmiller (May 4th at the Ira Sohn Conference): “Get out of the stock market.”
George Soros (June 9th, as reported in the Wall Street Journal): “The billionaire hedge fund
founder and philanthropist recently directed a series of big, bearish investments, according to
people close to the matter.”
Carl Icahn (June 9th, on CNBC): “I don’t think you can have (near) zero interest rates for
much longer without having these bubbles explode on you” while also saying it’s difficult to
assess when exactly that might occur.
Jeff Gundlach (last Friday, in an interview with Reuters): “Sell everything. Nothing here looks
good.”
Bill Gross (in his monthly investment letter, released last week): “I don’t like bonds. I don’t like
most stocks. I don’t like private equity.”
A bearish call, such as the ones our “Sleuth” has made, must therefore convincingly pull the rug
out from the “Lower rates = higher stocks” paradigm. Don’t tell me that these big-money
investors are just making a valuation call – they all know better than that. Try walking into any
of their offices and saying “U.S. stocks trade at 18x earnings… Time to short em…” Your feet
would barely touch the floor as security escorted you and your white mailroom box out of the
building.
Reddit on ATHX
ATHX I saw a rumor about a buyout on another site, but look at the profiles linked to Lehmann
on linkedin. Wow, it might actually be happening
I assume that's what is meant, yes. I have to say, it is a somewhat interesting speculation
considering if you go to all of the other principles in the Company, the "People also viewed" are
just fellow employees- all except BJ that is. By itself, I wouldn't put too much stock into it, but we
all know this is building to an event, hopefully a very, very good event. We all know it's been
publicly stated by Gil that Athersys and Healios have already agreed in principle to an expanded
partnership. We know that currently they are not attending the partnering forum at the Meeting
on the Mesa. We also know that while they have some cash, they are still burning it, so
something will need to change before they put themselves in a real pickle.
Gil and Co. owe it to shareholders to provide a meaningful update on Tuesday in consideration
of the public statements that were made, but not followed up on.
Well, if they do decide to "tie the knot" with Healios for example, it would explain the "delay" in
their expanded partnership announcement. Hopefully Tuesday will provide some direction.
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The Scientist lead articles
The need for a test for active Lyme, Ceres Nanosciences which has beens working on Nanotrap
since 2009,s collaborating with Alessandra Luccini’s lab on using Nanotrap for Lyme
By looking at genes, neurons and the developing brain, scientists are piecing together a new
understanding of autism
Personalizing autism treatment, more than 800 genes are suspected to be involved in autism
Bacterial riboswitches and their identification by Rotem Sorek of the Weizmann Institute
Uniquely Human, fast evolving regions of the human genome differentiate our species from all
other mammals, understanding human accelerated regions
The continued evolution of the human face
Clyde Hutchinson head of synthetic biology at J Craig Venter Institute continues to piece
together a living cell from scratch
IBD Investors Business Weekly
The IPO pipeline is primed, a burst of successful stock debuts hints a stream of offerings ahead,
AT&T VZ ADBE and MSFT could be most impacted , others such as AAPL AMZN CSCO FB
INTC CRM and QCOM too. More companies will need to adapt more than just their financial
statements
FASB accounting change the biggest in years, rule FASB 606 will affect many companies but
likely will have the most impact on businesses with multiyear contracts, licensing revenue,
contracts that peg revenue to performance benchmarks or third party sales distribution channels
BRCM stays ahead of slowing Iphone sales via mergers, positive overview, BRCM is expected
to make a play for MXIM NXPI or XLNX according to analysts. Growth could come from
additional content at existing tier one smartphone makers like AAPL and Samsung as more
infrastructure comes on line to support 4G and LTE Medical clinics are coming to malls article
In the jaws of Software M&A Rush, large software leaders and PE firms circle innovators with
weakened valuations. ADBE AMZN PANW GOOGL loom as buyers, and targets include CSOD
HUBBS PFPT RP NOW SHOP UTLI WDAY and ZEN
Clusterstock on I Bankers leaving
A rule has been broken on Wall Street, and 'any banker with a brain' is now looking for an exit
Wall Street banking careers have for decades followed a common pattern. Historically, you
would join a firm as an analyst right out of college — if not earlier as an intern — and you'd work
your way up through the ranks of associate, vice president, managing director, and, at some
banks, partner. You'd remain loyal to the firm for 30-odd years and retire in your 50s with a
million dollars in the bank. "That rule is out the window," one veteran dealmaker at a top Wall
Street bank told Business Insider recently. A tough business cycle has made it harder for many
banks to continue paying dealmakers competitive wages. Credit Suisse and Deutsche Bank
slashed their bonus pools in 2015. At Goldman Sachs, employee compensation and benefits
were down 40% in the first quarter this year, as revenues plunged and the firm continued to
replace senior staff members with junior bankers. Additionally, bulge-bracket firms are seeing
increased competition for talent from boutique shops, which are typically smaller and specialize
in mergers and acquisitions. The boutiques are starting to land big business — and they are
poaching top dealmakers to do it. "It's going to put pressure on organizations, without
question," the veteran banker we spoke with said. The big banks are also seeing top
performers leave for the corporate companies they advise. I banking as a whole has become a
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less-attractive career option. A survey last year showed that only 4% of Harvard Business
School students graduating wanted to work in investment banking. And a group of hedge fund
interns told us last summer that they felt "a monkey" could do the job of an investment-banking
summer analyst.
Motley Fool on Health Insurers are now playing hardball with regulators over Obamacare
The health insurance marketplace set up under the Affordable Care Act "Obamacare," has 11.1
million paying customers as of March 31, 2016, based on recently reported data from the
Centers for Medicare and Medicaid Services. These enrollees have helped push the uninsured
rate to its lowest levels on record, according to both Gallup and the Centers for Disease Control
and Prevention.Yet in spite of this apparent success, much is amiss with Obamacare.
Premiums for Obamacare plans could see something close to double-digit-percentage
increases in 2017 if KFF is correct. An analysis of the lowest-cost silver plans in 14 cities
projected a premium raise of 11% next year. Though subsidized enrollees can escape the full
wrath of these premium price hikes, middle-class Americans making more than 400% of the
federal poverty level could be hit head-on.But it's not just middle-class Americans that are
caught in the Obamacare crossfire -- it affects health insurance providers, too.
A number of high-profile health insurers have been losing money on Obamacare's marketplace
exchanges hand-over-fist. UNH could lose nearly $1 billion between 2015 and 2016 from its
Obamacare plans, with competitor HUM delivering equally bad losses from its Obamacare
plans this year.
The first problem insurers ran into was that Obamacare enrollees tend to be a sicker, costlier
group compared to employer-sponsored enrollees. A very large study conducted by the Blue
Cross Blue Shield Association found that Obamacare enrollees cost, on average, 22% more per
month than people enrolled through their workplace. Remember, Obamacare regulations no
longer allow insurers to pick and choose who they'll insure, which insurers could do before
Obamacare was implemented. This means consumers with pre-existing conditions can get
insurance on the spot, which has meant higher-than-expected adverse selection for most
health-benefits providers.
The other issue for insurers is that the risk corridor has proven to be an utter failure. The risk
corridor can best be described as a risk-pooling fund designed to pay money out to insurers
losing excessive amounts of money, and to receive money from overly profitable insurers. The
sheer existence of the risk corridor was expected to encourage new entrants into the
marketplace exchanges, which would boost competition and keep premium inflation to a hopeful
minimum. Unfortunately, of the $2.87 billion requested by insurers, only 12.6% was paid out.
This lack of funding in the risk corridor caused more than two-thirds of Obamacare's healthcare
cooperatives to close up shop, and it's caused insurers on the outside looking in to question
whether they want to risk joining an exchange.
Essentially, losses, or weaker-than-expected margins, from Obamacare have left insurers with
two paths to take: cut expenses or boost revenue. The easiest way health insurers can boost
revenue is by increasing their premiums and signing up more members. Based on KFF's
aforementioned 14-city data, insurers are almost universally choosing to counter higher medical
costs under Obamacare with higher premiums.
In terms of cutting costs, insurers have two approaches. They can either choose to reduce the
number of markets they operate in, or they can seek mergers or acquisitions that would result in
cost synergies. Cost reductions could allow insurers to minimize the impact of premium hikes
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while maintaining or growing their margins. UnitedHealth Group has chosen the first path, with
the company reducing the number of states it plans to offer Obamacare plans in during 2017 to
just three from 34 in 2016. The latter path has been chosen by ANTM, which agreed to buy
Cigna (:CI) for $54 billion, and AET, which announced its intent to acquire HUM for $37 billion.
However, in recent weeks the U.S. Department of Justice announced its own intention to block
the merger between Anthem and Cigna, as well as Aetna and Humana. From the DOJ's
perspective, combining four of the five largest health insurers would have an adverse effect on
competition, and would therefore be likely to result in higher premiums for consumers.
Insurers, though, aren't taking the DOJ's decision lying down. Some, like Humana, have chosen
to "punish" the DOJ's decision to block their merger by pulling out of a number of states and
counties. According to Politico, Humana is reducing the number of states it's offering
Obamacare plans in to 11 in 2017 from 19 in 2016. Yet what's even more telling is that it's
reducing the number of counties it's offering individual plans in by nearly 90% -- to 156 in 2017
from 1,351 in 2016. This decision to cut came almost immediately after the DOJ's
announcement that it would block the Aetna-Humana merger.
Anthem has taken a different approach. Instead of pushing back against the DOJ's attempt to
block its merger with Cigna, Anthem is dangling a carrot to possibly sway the DOJ to its side.
Anthem has suggested that if its merger with Cigna goes through, it would add coverage in nine
new states.
In short, insurers have taken to playing hardball with regulators over Obamacare in an effort to
get to a more level and sustainable playing field.Will playing hardball work?
The big question that no one has the answer to at the moment is whether playing hardball is
going to work out in insurers' favor.
On one hand, it's pretty clear that UnitedHealth and Humana substantially pulling back on their
individual plan offerings in 2017 could have a negative impact on consumers. If not from a
simple price impact from having less competition, we could see hundreds of thousands of
Obamacare enrollees displaced and looking for a new plan. This could mean once again
severing ties with an established primary care provider.
But there are also insurers picking up the slack where UnitedHealth and Humana have left off.
Anthem and Aetna have both announced their intent to expand their Obamacare offerings.
What's unclear is whether the DOJ's actions will stymie their desire to actually take those steps.
Smaller insurers may have difficulty picking up the slack if more national insurers follow
UnitedHealth and Humana's path.Ultimately, Obamacare only comprises a small percentage of
revenue for most national insurers, so whatever these companies do will likely have only a
minimal impact on their top and bottom line.
The same can't be said for the consumer who could be in deep trouble if more national insurers
leave Obamacare. For now, all consumers can do is cross their fingers and wait to see what
happens next.
Health News
ACHC will offload Priory clinics in forced sale -- Acadia Healthcare has told the Competition
and Markets Authority that it will sell 19 of Priory's private hospitals to clear the way for its
buyout of the company. The CMA is considering the offer but could force Acadia to make
further concessions, analysts say. Acadia is expected to be given six months to find a buyer for
the assets.
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Star Ledger
Taj Mahal looms over casino vote, the impending closure of AC Taj Mahal casino may help
bolster the arguments of both sides in a referendum over putting casinos in northern NJ, voter
ins November will decide on whether to add two new casinos near NYC
Investment Advisor
Exploring volatility with the inventor of the VIX, Dr Robert Whaley explains how to use the fear
gauge and how not use it
Is Private Equity IBD’s Savior or Sorcerer, private equity firms have increased purchasing
activity of BD’s but it is a mixed bag for firms being bought
Fuel Fix on WMB “ In wake of troubles, Williams CEO looks to future “
Alan Armstrong survived a failed merger and a board revolt in July to remain the chief executive
of the pipeline giant, the Williams Cos. Now, he’s back on top, working to keep the Williams
name and company alive after a tumultuous courtship, falling out, and bitter breakup with the
Dallas pipeline company, Energy Transfer Partners.
Energy Transfer aggressively pursued and planned to acquire Tulsa-based Williams in a $33
billion deal, but then developed a major case of buyer’s remorse in the depressed energy
market. Energy Transfer backed out of the loveless engagement through a legal loophole.
Williams will remain independent and maintain its large uptown Houston hub in the landmark
Williams Tower. Armstrong emphasized Houston, with one of the world’s largest concentration
of energy companies, is a critically important base for Williams now and in the future.
Armstrong is a company man who joined Williams 30 years ago as an engineer and worked his
way to the top — taking over a CEO in 2011.
He was never a big fan of the Energy Transfer deal; he only agreed to go along when it was
approved by his board, which had grown to 13 members after activist hedge fund investors were
added in recent years.Six of those board directors resigned last month after the board narrowly
voted to keep Armstrong as chief executive. Armstrong’s most vocal critics accused him of
“abysmal” leadership after their resignations.“It’s a board’s job to have difficult debates,”
Armstrong said. “While a lot of people see it as something negative, I see it as a positive.”
Armstrong kept quiet during the merger process except to “campaign for his job,” said Brandon
Blossman, an analyst at the Houston energy investment banking firm Tudor, Pickering, Holt &
Co. The “ironic artifact,” Blossman added, is the company performed well throughout the whole
merger dance with solid cash flow. The company even turned a small profit for the first six
months of the year, no easy task given the ongoing struggles of the oil and gas sector.
Now, Armstrong said, he and the rest of his team are focused on moving forward. Step one is to
bring costs under control by selling assets and reduce payouts to investors to conserve cash.
Williams is planning to sell its Canadian pipelines and processing plants and last week sliced its
dividend to 20 cents from 64 cents. The dividend cut will save $1.7 billion through 2017.
That money will help finance pipeline expansions, including the company’s crown jewel Transco
natural gas pipeline system, which runs 10,200 miles from South Texas to New York City. The
goal is meet the increased demand of a larger customer base.
“It’s a top-tier asset and natural gas demand growth is one of the easiest growth stories to hang
your hat on,” Blossman said. Armstrong emphasized that Williams is less affected by oil and gas
prices because it profits from the volumes of gas it transports and the fees it charges, not the
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spot pricing of natural gas on any given day. “We’re not really focused on price [of gas]” he
said. “We’re focused on growth.”
The other focus is on Williams’ more unified board, which now has 7 members. The plan is to
add more directors, but Armstrong is hesitant to increase it by much. He’s quick to point out
that similar companies average about 9 directors.
“Before we had 13 and that was a really big number,” he said.
Benzinga on the new 3d printing ETF and commentary on valuations
ARK Investment Management launched The 3D Printing ETF in July , the first exchange traded
fund dedicated to once-hot 3D printing equities. PRNT follows the 3D-Printing Index. That index
is “composed of equity securities and depositary receipts of exchange listed companies from the
U.S., non-U.S. developed markets and Taiwan that are engaged in 3D printing related
businesses within the following business lines: (i) 3D printing hardware, (ii) computer aided
design (“CAD”) and 3D printing simulation software, (iii) 3D printing centers, (iv) scanning and
measurement, and (v) 3D printing materials,” according to ARK. Arguably, there has already
been one boom/bust cycle in 3D printing stocks, but the transformative industry is still in its
nascent stages. Overall, that's a positive, but there are some difficulties in valuing some of the
stocks that dwell in this space. “
And like the early Internet, 3D printing comes with a lot of hype. Giddy investors who thought
home 3D printers would be as widespread as dial-up modems in 1999 have been disappointed,
and stocks of companies like 3D Systems Corp. DDD 3.58%, a maker of 3D printers for
personal and commercial use, look like those of a poster child for dot-com hubris,” said
AltaVista Research in a recent note.
As of July 18, PRNT's underlying index allocated nearly 53 percent of its weight to technology
stocks and 32 percent to industrials, according to ARK data. Healthcare, consumer discretionary
and materials are the new ETF's other sector weights.AltaVista initiated coverage of PRNT with
an “avoid” rating, but that doesn't mean the research firm is bearish on the new ETF. Quite the
contrary.
Estimates we’ve seen of the potential size and growth of the 3D printing market are all over the
map, and frankly impossible to evaluate. But it will be huge, not just because it dramatically
lowers barriers to entry into manufacturing, but also because of the new capabilities it brings to
existing manufacturers, including rapid prototyping, mass customization, and novel structures
(i.e., things that could not be fabricated with traditional manufacturing techniques),” said
AltaVista.In fact, AltaVista encourages investors not to read too much into its “avoid” rating on
PRNT. As the research firm notes, the stocks in PRTN compare favorably on valuation to S&P
SmallCap 600 Growth Index and look inexpensive compared to biotechnology names.
Current revenue for the 3D printing industry stands at $4 billion, but that number could swell to a
range of $180 billion to $490 billion by 2025, according to McKinsey data.
Summary of New Health & related events added to our work
DATE
EVENT
Aug 8 2016
Aug 8 2016
Aug 8 2016
Aug 8 2016
BEAT - LAKE STREET-SAN FRANCISCO, CA
CROX - PIPER JAFFRAY-NEW YORK, NY
CYTK - NEEDHAM-DETROIT, MI
DONALD TRUMP UNVEILS POLICY AGENDA AT DETROIT
9
ECONOMIC CLUB
Aug 8 2016
Aug 8 2016
Aug 8 2016
Aug 8 2016
Aug 8 2016
Aug 8 2016
Aug 8 2016
Aug 8 2016
Aug 8 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
EVHC - OPPENHEIMER -SAN FRANCISCO, CA
HILLARY CLINTON AND TIM KAIN Q&A
ITCI - LEERINK-BOSTON, MA
MDSO AT PAC CREST TECH LEADERS
NEOG - ROTH CAPITAL-PHILADELPHIA, PA
OFIX - JEFFERIES-MID ATLANTIC
TVPT - JEFFERIES-UNITED STATES
WMGI - JEFFERIES-BOSTON, MA
XNCR - LEERINK-NEW YORK, NY
ADRO - WILLIAM BLAIR- NEW YORK, NY
ATHN AT PAC CREST TECH LEADERS
ATRC - CANACCORD-BOSTON, MA
BEAT - LAKE STREET-SAN DIEGO , CA
COSMO BIO ANALYST MEETING
ENTL - PIPER JAFFRAY-NEW YORK, NY
EXAS - CANACCORD-BOSTON, MA
FLML - JEFFERIES-DENVER/SAN FRANCISCO
Aug 9 2016
HOUSE VETERANS’ AFFAIRS CMTE PANEL HOLDS HEARING ON
“TECHNOLOGY AND TREATMENT: TELEMEDICINE IN THE VA
HEALTHCARE SYSTEM
Aug 9 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
Aug 9 2016
MDRX ANALYST DAY
MTFB MOTIF BIO IPO DUE
NEOG - ROTH CAPITAL-BOSTON, MA
NPTN - CRAIGHALLUM-TORONTO, CANADA
OFIX - JEFFERIES-NEW YORK, NY
SENS - CANACCORD-BOSTON, MA
VRX - JEFFERIES-NEW YORK, NY
VWR - WILLIAM BLAIR-KANSAS CITY, MO
XNCR - LEERINK-BOSTON, MA
Aug 9-14 2016
CLSD DATA FROM PHASE 2 (DOGWOOD) CLINICAL TRIAL FOR
THE TREATMENT OF MACULAR EDEMA ASSOCIATED WITH NONINFECTIOUS UVEITIS AT THE 2016 ASRS
Aug 10 2016
Aug 10 2016
ATRS - JEFFERIES-BOSTON, MA
AVONDALE PARTNERS HEALTH CARE CONFERENCE - BOSTON,
MA AAC, AHS, AMSG, CCRN, CPIX, CYH, LPNT, MDRX, QSII, TMH,
UHS
Aug 10 2016
CANACCORD GENUITY GROWTH CONFERENCE BOSTON: AERI,
AGIO, ALNY, ANGO, ATHN, ATRA, ATRC, CRY, DGX, DXCM, ELGX,
EXAS, FCSC, IMGN, KITE, KPTI, MDVN, NXTM, OFIX, OSUR, QDEL,
SAGE, STAA, TBRA, VASC, VIVO, ZFGN
Aug 10 2016
Aug 10 2016
Aug 10 2016
CPHD - CRAIGHALLUM-MINNEAPOLIS, MN
EGRX - WILLIAM BLAIR- NEW YORK, NY
FLML - JEFFERIES-DENVER/SAN FRANCISCO
10
Aug 10 2016
Aug 10 2016
Aug 10 2016
Aug 10 2016
Aug 10 2016
FLR - CANACCORD-TORONTO, CANADA
LGND - STEPHENS-DALLAS / HOUSTON, TX
LH - CRAIGHALLUM-BOSTON, MA
PG - B. RILEY-CINCINNATI, OH
ZLTQ - LEERINK-MID ATLANTIC
Aug 10-11 2016
CREDIT SUISSE GAMING, LODGING, LEISURE & RESTAURANT
CONFERENCE - NEW YORK, NY
Aug 11 2016
Aug 11 2016
Aug 11 2016
AET - LEERINK-HARTFORD, CT
AHS - WILLIAM BLAIR-MINNEAPOLIS, MN
BNFT - JEFFERIES-NEW YORK, NY
Aug 11 2016
CANACCORD GENUITY GROWTH CONFERENCE: ABAX, APRI,
BSX, CPHD, ENZY, HOLX, KMPH, MMSI, REGN, SGYP, TMH, TRUP,
VSAR
Aug 11 2016
Aug 11 2016
Aug 11 2016
Aug 11 2016
Aug 11 2016
Aug 11 2016
Aug 11 2016
Aug 11 2016
Aug 11 2016
Aug 11 2016
Aug 11 2016
Aug 12 2016
Aug 12 2016
Aug 12 2016
Aug 12 2016
Aug 13 2016
Aug 15 2016
Aug 15 2016
Aug 15 2016
Aug 15-16 2016
Aug 15-16 2016
Aug 16 2016
Aug 16 2016
Aug 16 2016
Aug 16 2016
Aug 16 2016
Aug 16 2016
Aug 16-17 2016
Aug 16-17 2016
CRL CHARLES RIVER LABORATORIES INTERNATIONAL INC
INVESTOR DAY
NVCR - EVERCORE ISI-NEW YORK, NY
NVO - JEFFERIES-CHICAGO, IL
PFE - PIPER JAFFRAY-LONDON, ENGLAND
QUOT - WILLIAM BLAIR- NEW YORK, NY
SFM - OPPENHEIMER -WEST COAST
SNH - JEFFERIES-LOS ANGELES/SAN FRANCISCO, CA
SYNT - NEEDHAM-CHICAGO, IL
THE COVERAGE CONUNDRUM - WHY WON'T PAYERS COVER MY
DEVICE - AND WHAT CAN WE DO
ABOUT IT?
UA - WILLIAM BLAIR-CHICAGO, IL
WOOF - CL KING-CHICAGO, IL
ADXS - JEFFERIES-BOSTON, MA
AHS - WILLIAM BLAIR-MILWAUKEE, WI
IONS - NEEDHAM-NEW YORK, NY
SNH - JEFFERIES-LOS ANGELES/SAN FRANCISCO, CA
WOCKHARDT ANNUAL MEETING
AQXP AT TROUT IN BOSTON
FLML AT JMP IN BOSTON
IART WITH PIPER JAFFRAY IN MIDWEST
AXGN AT TROUT IN NY
BLCM AT TROUT IN NY
BIIB IONS ANALYSIS OF PH III ENDEAR STUDY NEWS
IART WITH PIPER JAFFRAY IN MIDWEST
INCR INC RESEARCH HOLDINGS INC 2016 ANALYST AND
INVESTOR DAY
IONS BIIB ANALYSIS OF PH III ENDEAR STUDY NEWS
NHI AT JMP MIDATLANTIC
QGEN CEO AND IR WITH BERENBERG IN TORONTO
AKTX AT TROUT IN NY
ENTEROME AT TROUT IN NY
11
Aug 17 2016
Aug 17 2016
Aug 17 2016
Aug 17 2016
Aug 17 2016
Aug 17 2016
Aug 17-21 2016
Aug 18 2016
Aug 18 2016
ACHN AT JMP IN TEXAS
BLCM AT SUNTRUST
IMUN IMMUNE THERAPEUTICS SHAREHOLDERS MEETING
NOVOZYMES AT BOF A CHICAGO
PARTNERING WITH IDN BIOPHARMA STRATEGY BAYER SNY
TBPH AT TROUT IN NY
NVDA IS EXPECTED TO ANNOUNCED PASCAL GPUS FOR
NOTEBOOKS AT GAMESCOM NVIDIA'S PASCAL-BASED
DISCRETE GRAPHICS CARDS FOR NOTEBOOKS ARE EXPECTED
TO BE UNVEILED DURING GAMESCOM IN EUROPE, HOSTED
FROM
BLCM AT SUNTRUST IN MIDATLANTIC
ESRX AT SUNTRUST IN NY
Aug 18 2016
FDA WEBINAR TO ADDRESS QUESTIONS ASSOCIATED WITH
THE DRAFT FOR COMPANION DIAGNOSTICS
Aug 18 2016
FOUNDERS FORUM: HOW TO PLAY THE SERIES FEATURING
BRIAN LEE- LOS ANGELES
Aug 18 2016
Aug 23 2016
LXRX AT STIFEL IN SAN FRAN
TROUT GROUP'S 6TH ANNUAL HAMPTONS CEO ROUNDTABLE:
ADVERUM, AFFIMED, AMARIN, AQUINOX, CARIBOU, CELLECTIS,
CIBUS, CIPHER, CYTOMX, DBV, ENTEROME, GENFIT, INTELLIA,
LOXO, MOLOGEN, PAION, PIEIRS, REPROS, THERAVANCE,
VERICEL, VTV
AXON ANNUAL MEETING
GENFIT AT TROUT IN NY
MEDP MEDPACE HOLDINGS IPO DUE
SRDX AT BARRINGTON IN CANADA
3S BIO BOARD MEETING
BANK AM BELLEVUE HEALTHCARE DAY: SANTHERA NVS
COSMO
THE 23RD ANNUAL NAPA PAIN CONFERENCE
Aug 23-24 2016
Aug 25 2016
Aug 25 2016
Aug 26 2016
Aug 26 2016
Aug 29 2016
Aug 30 2016
Aug 30 2016
Aug 30 2016
Aug 30 2016
DAIWA KOREA CORPORATE DAY - HK - HK, HK
DAIWA KOREA CORPORATE DAY - SINGAPORE - SINGAPORE
MEDA EGM TO APPLY FOR DELISTING
SGNT NICHKI-IKO TENDER OFFER EXPIRY
SPIRE HEALTH GROUP AT BERENBERG IN DUBLIN
CSL WITH UBS IN VARIOUS PLACES
CSL WITH UBS IN VARIOUS PLACES
HSBC INDIA DISCOVERY FORUM - HK - HK, HK
PRIMARY HEALTH CARE CEO AT UBS IN CHICAGO
STEPHENS BOSTON SOFTWARE BUS TOUR - BOSTON, MA
Aug 30 2016
THE MOONSHOT SPEAKER NVCA INNOVATION POLICY
ROUNDUP- AUSTIN, TX
Aug 30 2016
UBS INVESTOR CLUB - ZURICH, CH
Aug 30-31 2016
COMMERZBANK SECTOR CONFERENCE-FRANKFURT DE:
SARTORIUS STEDIM, FMS NVO STRATEC
Aug 18 2016
Aug 19 2016
Aug 19 2016
Aug 19 2016
Aug 19 2016
Aug 22 2016
Aug 23 2016
12
Aug 31 2016
Sep 6 2016
Sep 6 2016
Sep 6 2016
Sep 6-7 2016
HSBC INDIA DISCOVERY FORUM - SINGAPORE - SINGAPORE
NOMURA INDIA CORPORATE DAY - LONDON, GB
RENEURON GROUP ANNUAL MEETING
SOCALBIO WORKSHOP ON ACCESSING GOVERNMENT FUNDING
FOR LIFE SCIENCE RESEARCH WEST LOS ANGELES 10:00 AM
TO 3:00 PM
UBS CHINA A-SHARE CONFERENCE - SHENZHEN, CN
Sep 7-8 2016
GOLDMAN SACHS MEDTECH CONFERENCE - LONDON, GB
GERRESHEIMER, STRATEC, SARTORIUS STEDIM
Sep 7-8 2016
ROBERT W BAIRD GLOBAL HEALTHCARE CONFERENCE - NEW
YORK, NY ABC CPHD FMS MDRX OMI PODD
Sep 7-9 2016
Sep 8 2016
MORNINGSTAR ETF CONFERENCE - CHICAGO, IL
BMRN DINNER AT ISI
Sep 8 2016
DAIWA PAN-ASIA INNOVATIVE COMPANIES CONFERENCE TORONTO - TORONTO, CA
Sep 8 2016
STRAUMANN HOLDING AG INVESTOR MEETING
Sep 11 2016
RODMAN & RENSHAW GLOBAL INVESTMENT CONF: 4SC
GENEURO, INO , NICOX QUANTUM GENOMICS
Sep 12 2016
MORGAN STANLEY GLOBAL HEALTH CONFERENCE: HOLX
INNATE PHARMA MACK NTLA NVO SNY
Sep 12 2016
PDCO ANNUAL MEETING
Sep 12 2016
RODMAN & RENSHAW GLOBAL INVESTMENT CONF : FLXS,
PROPANC HEALTH
Sep 13 2016
CL KING & ASSOCIATES BEST IDEAS CONFERENCE - NEW
YORK, NY ABAX HSKA IVC MMSI OSUR TTOO WOOF VIVO
Sep 13 2016
MORGAN STANLEY GLOBAL HEALTH CONFERENCE: ABC FMS
SARTORIUS, SARTORIUS STEDIM BIOTECH
Sep 13-15 2016
LUKE TIMMERMAN MODERATING SERIAL ENTREPRENEUR
PANEL AT BIOPHARMA AMERICA
Sep 16 2016
RHHBY AT UBS BEST OF SWITZERLAND CONF
Sep 19-20 2016
BERENBERG GOLDMAN SACHS GERMAN CORPORATE CONF:
EVOTEC, FMSSARTORIUS STEDIM, STRATEC
Sep 20 2016
Sep 21-24 2016
Sep 21-24 2016
Sep 21-24 2016
Sep 21-24 2016
Sep 21-24 2016
Sep 22 2016
Sep 22-25 2016
Sep 22-25 2016
Sep 22-25 2016
Sep 22-25 2016
Sep 22-25 2016
THE INC. STARTUP ACCELERATOR
ASMB AT INTERNATIONAL HBV MEETING
GILD AT INTERNATIONAL HBV MEETING
NVS AT INTERNATIONAL HBV MEETING
RHHBY AT INTERNATIONAL HBV MEETING
SNY AT INTERNATIONAL HBV MEETING
ICONIC BOSTON
ALR AT AMERICAN ACADEMY OF PAIN MANAGEMENT
AZN AT AMERICAN ACADEMY OF PAIN MANAGEMENT
COLL AT AMERICAN ACADEMY OF PAIN MANAGEMENT
INSY AMERICAN ACADEMY OF PAIN MANAGEMENT
PTX AMERICAN ACADEMY OF PAIN MANAGEMENT
13
Sep 22-25 2016
Sep 22-25 2016
Sep 22-25 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 23-27 2016
Sep 25 2016
Sep 25 2016
PURDUE AT AMERICAN ACADEMY OF PAIN MANAGEMENT
TAKEDA AT AMERICAN ACADEMY OF PAIN MANAGEMENT
TEVA AMERICAN ACADEMY OF PAIN MANAGEMENT
AGN AT AMERICAN SOCIETY OF PLASTIC SURGERY
ALPHAEON AT AMERICAN SOCIETY OF PLASTIC SURGERY
AT AMERICAN SOCIETY OF PLASTIC SURGERY
COHERA MEDICAL AT AMERICAN SOCIETY OF PLASTIC
SURGERY
CUTR AT AMERICAN SOCIETY OF PLASTIC SURGERY
CYNO AT AMERICAN SOCIETY OF PLASTIC SURGERY
ELOS AT AMERICAN SOCIETY OF PLASTIC SURGERY
HNSN AMERICAN SOCIETY OF PLASTIC SURGERY
HOLX AT AMERICAN SOCIETY OF PLASTIC SURGERY
HSIC AT AMERICAN SOCIETY OF PLASTIC SURGERY
IART AT AMERICAN SOCIETY OF PLASTIC SURGERY
IVTY AT AMERICAN SOCIETY OF PLASTIC SURGERY
MASI AT AMERICAN SOCIETY OF PLASTIC SURGERY
MDT AT AMERICAN SOCIETY OF PLASTIC SURGERY
MDXG AT AMERICAN SOCIETY OF PLASTIC SURGERY
NEOGRAFT AT AMERICAN SOCIETY OF PLASTIC SURGERY
NEXTECH AT AMERICAN SOCIETY OF PLASTIC SURGERY
NSRGY GALDERMA AT AMERICAN SOCIETY OF PLASTIC
SURGERY
OSIR AMERICAN SOCIETY OF PLASTIC SURGERY
PIERRE FABRE AT AMERICAN SOCIETY OF PLASTIC SURGERY
SNN AT AMERICAN SOCIETY OF PLASTIC SURGERY
SYK AT AMERICAN SOCIETY OF PLASTIC SURGERY
VRX AT AMERICAN SOCIETY OF PLASTIC SURGERY
ZBH AT AMERICAN SOCIETY OF PLASTIC SURGERY
ABBV AMGN’S BSUFA FOR BIOSIMILIAR BP 501
AMGN BSUFA FOR BIOSIMILIAR ABP 501
Sep 25-28 2016
A AGILENT DAKO PATHOLOGY AT COLLEGE OF AMERICAN
PATHOLOGISTS CAP
Sep 25-28 2016
Sep 25-28 2016
Sep 25-28 2016
Sep 25-28 2016
Sep 25-28 2016
Sep 25-28 2016
Sep 25-28 2016
Sep 25-28 2016
Sep 25-28 2016
Sep 25-28 2016
Sep 25-28 2016
Sep 25-28 2016
EXAS AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
HAE AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
HOLX AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
ILMN AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
MCK AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
MYGN AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
NGNM AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
QGEN AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
RHHBY AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
SGEN AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
TMO AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
VCYT AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
14
Sep 25-28 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 26-30 2016
Sep 27 2016
Sep 27 2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
WGBS AT COLLEGE OF AMERICAN PATHOLOGISTS CAP
ACRX AT WORLD CONGRESS ON PAIN
AGN AT WORLD CONGRESS ON PAIN
AMGN AT WORLD CONGRESS ON PAIN
ASTELLAS AT WORLD CONGRESS ON PAIN
AZN AT WORLD CONGRESS ON PAIN
BSX AT WORLD CONGRESS ON PAIN
ENDP AT WORLD CONGRESS ON PAIN
FUJIFILM AT WORLD CONGRESS ON PAIN
GRUNENTHAL AT WORLD CONGRESS ON PAIN
KMB AT WORLD CONGRESS ON PAIN
LINDE AT WORLD CONGRESS ON PAIN
LLY AT WORLD CONGRESS ON PAIN
MDT AT WORLD CONGRESS ON PAIN
MRK AT WORLD CONGRESS ON PAIN
MUNDIPHARMA AT WORLD CONGRESS ON PAIN
PFE AT WORLD CONGRESS ON PAIN
PHG AT WORLD CONGRESS ON PAIN
PROSTRAKAN AT WORLD CONGRESS ON PAIN
PURDUE AT WORLD CONGRESS ON PAIN
QRXPY QRXPHARMA AT WORLD CONGRESS ON PAIN
SNN AT WORLD CONGRESS ON PAIN
SNY AT WORLD CONGRESS ON PAIN
STJ AT WORLD CONGRESS ON PAIN
TEVA AT WORLD CONGRESS ON PAIN
UCB AT WORLD CONGRESS ON PAIN
VAR VARIAN MEDICAL SYSTEMS INC INVESTOR MEETING AT
ASTRO 2016
NVCA CFO BOOT CAMP WASHINGTON DC SEP 27-29 2016
ABBV AT EADV
AMGN AT EADV
BAYER AT
BI AT EADV
BIIB AT EADV
CELG AT EADV
CUTR AT EADV
CYNO AT EADV
ELOS AT EADV
15
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 28 -Oct 2
2016
Sep 29-30 2016
Sep 29-Oct 1
2016
Sep 29-Oct 1
2016
Sep 29-Oct 1
2016
Sep 29-Oct 1
2016
Sep 29-Oct 1
2016
Sep 29-Oct 1
2016
Sep 29-Oct 1
2016
Sep 29-Oct 1
2016
Sep 29-Oct 1
2016
Oct 5-6 2016
GALENICA AT EADV
GSK AT EADV
JNJ AT EADV
MEDA AT EADV
NSRGY GALDERMA AT EADV
PFE AT EADV
PHG AT EADV
REGN SNY AT EADV
SNY REGN AT EADV
SSKN AT EADV
ZBH AT EADV
ZLTQ AT EADV
LATIN AMERICA REGULATORY COMPLIANCE REQUIREMENTS
ACROSS THE LIFE SCIENCE INDUSTRY - SAN DIEGO
ARTHREX AT ASSH SURGERY OF THE HAND
AXGN AT ASSH SURGERY OF THE HAND
BIOVENTUS AT ASSH SURGERY OF THE HAND
IART AT ASSH SURGERY OF THE HAND
MEDARTIS AT ASSH SURGERY OF THE HAND
OSTEOMED AT ASSH SURGERY OF THE HAND
SNN AT ASSH SURGERY OF THE HAND
SYK AT ASSH SURGERY OF THE HAND
ZBH AT ASSH SURGERY OF THE HAND
NOMURA TAIWAN CORPORATE DAY - HK, HK
Oct 6 2016
NUS HEARING ON SETTLEMENT SCHEDULED F IN FEDERAL
COURT IN SALT LAKE CITY
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
AMGN AT ESMO
ARIA AT ESMO
ASTELLAS AT ESMO
BAYER AT ESMO
16
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 7-11 2016
Oct 13 2016
Oct 20 2016
Oct 21 2016
Oct 22-26 2016
Oct 25 2016
Oct 26 2016
BI AT ESMO
BMY AT ESMO
CELG AT ESMO
CLVS AT ESMO
DAIICHI SANKO AT ESMO
EXEL AT ESMO
GHDX AT ESMO
HELSINN AT ESMO
IMS AT ESMO
INCY AT ESMO
IPSEN AT ESMO
JNJ AT ESMO
LLY AT ESMO
MDVN AT ESMO
MOLECULAR HEALTH AT ESMO
MRKAT ESMO
MRK-KG AT ESMO
MYGN AT ESMO
NSTG AT ESMO
NVS AT ESMO
ONCOTHERM GMBH AT ESMO
OSE IMMUNOTHERAPIES AT ESMO
PFE AT ESMO
PHARMAMAR AT ESMO
PIERRE FABRE AT ESMO
PPHM AT ESMO
PRIME ONCOLOGY AT ESMO
Q NOVELLA CLINICAL AT ESMO
QGEN AT ESMO
SERVIER AT ESMO
SHPG AT ESMO
SIRTEX MEDICAL AT ESMO
SNY AT ESMO
TEVA AT ESMO
TSRO AT ESMO
VAR AT ESMO
DEUTSCHE BANK ASIAN MANAGERS FORUM - HK, HK
4TH WORLD CONTROVERSIES DEBATES & CONSENSUS IN
BONE MUSCLE & JOINT DISEASE BMJD
MDCO ABP-700 PH I DATA AT INTL SOCIETY FOR
ANESTHESIOLOGISTS
MDCO ABP-700 DATA AT AMERICAN SOCIETY
ANESTHESIOLOGISTS
NLNK ANALYST DAY
LONZA CAPITAL MARKETS DAY
17
Oct 26-27 2016
Oct 28 2016
JEFFERIES GREATER CHINA SUMMIT - HK, HK
SUMITOMO DAINIPPON PHARMA ANALYST MEETING
Nov 6-9 2016
PHARMA EXPO PROCESSING AND PACKAGING CONFERENCE &
TRADESHOW- CHICAGO
Nov 9-13 2016
Nov 9-13 2016
Nov 9-13 2016
Nov 9-13 2016
Nov 9-13 2016
Nov 10 2016
Nov 11-16 2016
Nov 11-16 2016
Nov 12 2016
Nov 14 2016
Nov 15 2016
Nov 15 2016
Nov 16 2016
Nov 16 2016
Nov 16-17 2016
Nov 21 2016
Nov 24 2016
Nov 25 -27 2016
Nov 28-Dec 2
2016
ADXS AZN ADXS-HPV MEDI14736 DURVALUMAB PH I DATA AT
SITC
AZN ADXS ADXS-HPV MEDI14736 DURVALUMAB PH I DATA AT
SITC
BMY BMS-9860106 PK/PD PH I DATA AT SITC
BMY INNATE PHARMA NIVO LIIRILUMAB PH I DATA FOR SOLID
TUMORS AND NSCLC, RCC MELANOMA COLORECTAL CANCER
OVARIAN CARCINOMA AT SITC
BMY NIVO + BMS 936558/ BMS 986016 AT SITC
SRCL STERICYCLE INC INVESTOR DAY
ANTH CHABLIS-SC1 PHASE 3 CLINICAL STUDY OF BLISIBIMOD
EXPECTS TOPLINE EFFICACY AND SAFETY DATA WILL BE
AVAILABLE PRIOR TO THE ANNUAL AMERICAN COLLEGE OF
RHEUMATOLOGY ANNUAL MEETING IN
MESO MPC300 IVS REVASCOR PH II IV DATA AT ACR
22ND SCHLESWIGER PAIN CONGRESS UPDATE CANCER PAIN
INVESTEC CONFERENCE - LONDON, GB
QGEN ANALYST DAY
RAYMOND JAMES BOSTON FALL INVESTORS CONFERENCE BOSTON, MA
DVAX VACCINES AND RELATED BIOLOGICAL PRODUCTS
ADVISORY COMMITTEE (VBRPAC) WILL REVIEW THE BLA FOR
HEPLISAV-B
ROTH TECHNOLOGY CORPORATE ACCESS DAY - NEW YORK,
NY
JEFFERIES GLOBAL HEALTHCARE CONFERENCE - LONDON LONDON, UK COSMO NVS RHHBY
DEUTSCHES EIGENKAPITALFORUM: PAION, STRATEC,
SARTORIUS STEDIM BIOTECH, SARTORIUS AG
CARNEGIE IT SEMINAR - HELSINKI, FI
ESMO RARE ADULT SOLID CANCERS CONF - MILAN
NOMURA INVESTMENT FORUM - TOKYO, JP
Nov 29-30 2016
BIA SEPARATIONS AT CELL THERAPY MANUFACTURING &
GENE THERAPY CONFERENCE
Nov 29-30 2016
BIO-TECHNE TMO AT CELL THERAPY MANUFACTURING & GENE
THERAPY CONFERENCE
Nov 29-30 2016
Nov 29-30 2016
Nov 29-30 2016
CELLGENIX AT CELL THERAPY MANUFACTURING & GENE
THERAPY CONFERENCE
FMS AT CELL THERAPY MANUFACTURING & GENE THERAPY
CONFERENCE
GLW AT CELL THERAPY MANUFACTURING & GENE THERAPY
CONFERENCE
18
Nov 29-30 2016
Nov 29-30 2016
MACOPHARMA AT CELL THERAPY MANUFACTURING & GENE
THERAPY CONFERENCE
PLL AT CELL THERAPY MANUFACTURING & GENE THERAPY
CONFERENCE
Nov 29-30 2016
RHHBY AT CELL THERAPY MANUFACTURING & GENE THERAPY
CONFERENCE
Nov 29-30 2016
SARTORIUS STEDIM AT CELL THERAPY MANUFACTURING &
GENE THERAPY CONFERENCE
Nov 29-30 2016
TRAKCEL AT CELL THERAPY MANUFACTURING & GENE
THERAPY CONFERENCE
Dec 2 2016
GOODBODY EQUITY CONFERENCE - LONDON, GB
Dec 3-6 2016
SGEN AND TAKEDA ANNOUNCED THAT THE PHASE 3 ALCANZA
DATA PRESENTATION AT ASH
Dec 3-6 2016
TAKEDA AND SGEN ANNOUNCED THAT THE PHASE 3 ALCANZA
DATA PRESENTATION AT ASH
Dec 6 2016
THE SCIENCE OF PAIN AND ITS MANAGEMENT 2016
Dec 6-7 2016
CREDIT SUISSE EUROPEAN BUSINESS SERVICES CONFERENCE
- SAN FRANCISCO, CA
Dec 8 2016
Dec 12-16 2016
Dec 16 2016
Mar 3 2017
Mar 23 2017
Apr 13-14 2017
EMA A WORKSHOP TO GAIN MORE INPUT FROM
STAKEHOLDERS ON THE ADAPTIVE PATHWAY, INCLUDING
REAL-WORLD EVIDENCE COLLECTION, THE CURRENT
DEFINITION OF UNMET NEED AND APPROPRIATE
PRESCRIPTION CONTROLS
TERUMO CORP MEDIUM- AND LONG-TERM GROWTH STRATEGY
MEETING
ALNY R& D DAY
11TH INTERNATIONAL SYMPOSIUM ON ADVANCED OVARIAN
CANCER OPTIMAL THERAPY – VALENCIA
WCO-IOF -ESCEO WORLD CONGRESS ON OSTEOPOROSIS
OSTEO ARTHRITIS AND MUSOLOSKELETAL
DISEASESFLORENCE ITALY
6TH GLOBAL EXPERTS MEETING ON CARDIOVASCULAR
PHARMACOLOGY AND CARDIAC MEDICATIONS- DUBAI
May 3 2017
SEFID INTL CONFERENCE ON PAIN MIND & MOVEMENT
VALENCIA – SPAIN
May 4-6 2017
May 5-8 2017
IMPAKT 2017 BREAST CANCER CONF- BELGIUM
ELCC EUROLUNG CANCER CONF GENEVA
May 18 2017
EAPC 2017 15TH WORLD CONGRESS OF THE EUROPEAN
ASSOCIATION FOR PALLIATIVE CARE- MADRID
Sep 7-9 2017
72ND ANNUAL MEETING OF THE ASSH -SAN FRAN
August 6, 2016
Bronte Capital which position will Mr Ackman exit: HLF Herbalife or VRX Valeant?
Bill Ackman just exited his large position in Canadian Pacific. This was a stunningly successful
position: genuinely I wish I had done it. It also produces a very large taxable gain. Mr Ackman
19
however has been producing less-than-stellar performance for his Pershing Square fund. So at
the moment he is leaving his clients with large losses plus a large tax bill. I can't imagine they
would be thrilled with that. Logically then Bill Ackman will wipe his taxable gain by reducing or
exiting one of his large losing positions - either the short on Herbalife or the long on Valeant. I
really don't have any insight into which - but he is on the board of Valeant and that makes
moving the Valeant position more problematic. Thoughts anyone?
Barron's
Safe Yields of Up to 5%: Barron's Fixed-Income Panel A panel of fixed-income pros identifies
opportunities for safe yields above 5% Positive stock mentions for NSRGY UN VOD EPD HCN
CXW
A reviving fracking industry should boost demand for sand, lifting shares of Fairmount Santrol
Holdings (FMSA) and U.S. Silica Holdings (SLCA).
BLK BlackRock's Steady Money Machine
FIS: Banking's Best Stock Play Isn't a Bank Barron's is positive on FIS, Its services are made
even more popular by its ability to facilitate the shift to digital consumer services, such as check
deposits from smartphones. The stock is up 30% this year, but could climb another 25% over
the next 12 months as revenue climbs, debt is paid off, and last year's $5.1B acquisition of
SunGard bares fruit
How TIAA-CREF Bond Fund Beats the Competition
ISBC Investors Bancorp (ISBC) and HarborOne Bancorp (HONE): "Sizing Up Small Caps" is
positive on these two small banks. New Jersey-based Investors Bancorp looks like an attractive,
low-risk investment given its discount to peers, commitment to share buybacks, and history of
growing through smart acquisitions. Boston-based HarborOne is a recent thrift conversion that
came partially public just over a month ago. Shares trade at 1.4 times tangible book, which isn't
noteworthy, but that figure could fall dramatically if the bank were to dissolve its mutual holding
company’s stake via a "second-step conversion," though this could be years away (link).
Infrastructure Stocks Look Overheated
LG Display Is Up 46%: Take Profits
MNRO Monro: A Muffled Outlook cautious on Monro, shares of which have risen at a 12%
annual pace over the last five years even as same-store sales have fallen. The slowing sales
growth and increasing competition from expanded maintenance services at dealerships make
the company's stated goals of 15% annual sales gains and 20% profit growth look overly
ambitious. Shares could fall from a recent $62 into the mid-$40
PG Morgan Stanley Likes Procter & Gamble's Positive Outlook
RCL Royal Caribbean Could Cruise Ahead share have fallen 27% this year, but concerns about
Chinese demand appear to be overblown; Bookings are solid, and the stock trades for just 10.5
times 2017 earnings estimates
Six solid companies that have statistical profiles similar to utilities or consumer staples, but
boast more room for earnings growth, solid dividends, and valuations that make them even
better than pricey safety stocks: AMGN BRCM HBI IR PPG RHI
Speaking of Dividends: Many large materials companies in the S&P 500 feature attractive
yields, but investors have to be wary of their strong cyclicality and vulnerability to commodities
prices; LyondellBasell Industries (LYB), Avery Dennison (AVY), Praxair (PX), and Air Products
& Chemicals (APD) look to have the safest payouts of the group.
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Stock Buybacks Driving Companies Into Debt
TRIP cautious write up the company is in the middle of a transition that could hold back
earnings for several quarters, and shares look overvalued at 29 times expected 2017 earnings.
TSM Taiwan Semiconductor Shares Will Outperform Taiwan
Vanguard's Climate-Change Dismissal
Zika Creates a Pandemic Pandemonium
BioCentury
FDA releases guidance on colitis endpoints In draft guidance released Friday, FDA said ideal
efficacy endpoints for studies of ulcerative colitis (UC) therapies should include both a patientreported assessment of signs and symptoms and a physician-reported endoscopic and
histological assessment. FDA also recommended a clinical remission primary endpoint that
incorporates "well-defined" patient-assessed outcomes such as stool frequency and rectal
bleeding, as well as endoscopy scores. It said sponsors should discuss endpoints evaluating
mucosal healing with FDA before conducting a study because existing scoring systems do not
yet provide sufficient histological criteria to assess mucosal healing. The agency did not
recommend using Mayo Score and Ulcerative Colitis Disease Activity Index (UCDAI)
measurements to support approval, noting that they rely on physicians' assessments of signs
and symptoms of disease rather than patients' assessments.
CFDA has issued new proposals to revamp China's Drug Registration Rules (DRR) that offer a
mixed bag of updated policies that could stymie or promote innovation, according to life
sciences legal specialists in China.The revisions, which are tantamount to revising the Food,
Drug and Cosmetic Act in the U.S., are based on State Council reforms released last year that
offered the prospect of eliminating a backlog of drug reviews, updating China's drug
classification system and reforming clinical trial rules to allow parallel drug development in and
outside of China . According to law firm Ropes and Gray, the revised rules would alter innovator
exclusivity by eliminating the linkage between patent protection and drug approvals, allowing
CFDA to approve products that infringe on active patents. Sponsors of competing applications
would be required to provide a statement to CFDA stating that the product does not infringe.
The revision also would allow CFDA to review clinical trial authorization applications for
products identical to innovator compounds during an innovator drug's post-approval monitoring
period. Under the current rules, CFDA is not allowed to accept applications during the
monitoring period. The agency reviews applications within two years of any relevant patents'
expiration, and cannot approve follow-on products before the patents expire. The changes
would represent a weakening of IP protection in the country, adding that statements on
infringement provided by competing applicants would not be reviewed critically by CFDA and
could cause China to fall behind other countries -- notably Korea, which has stronger IP
protection -- in innovative development. On clinical trials, the proposed revision would allow
companies to include China in international trials during Phase I development, rather than
Phase II, by doing away with the distinction between international multi-center clinical studies
and drug registration studies. The studies must be conducted explicitly for the purpose of
regulatory approval. The modified rules also would eliminate statutory timelines for CFDA to
review applications and prohibit sponsors from marketing APIs without an approved drug
product marketing application. Ropes Partner Katherine Wang said the revision would
effectively force API manufacturers to seek marketing approval of drugs, and in the longer term
would likely reduce the number of API manufacturers. The revisions also would obligate
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application sponsors to review the performance of any third-party service providers and appoint
dedicated regulatory specialists to handle communications with CFDA.
Health News
Chengdu Olymvax Biopharma in-licensed greater China rights to a novel Group A
Streptococcus (GAS) vaccine developed by Australia's Griffith University Olymvax will
manufacture the vaccine for Phase I clinical trials that will be conducted concurrently in China
and Australia. The needle-free vaccine is delivered in a single dose through the nose, which
facilitates access to lung lining tissue, the location for most strep infections.Olymvax will pay
Griffith royalties on sales and also make milestone payments.
LGND recent news that Ligand formed a new company, Nucorion Pharma, that will develop
three preclinical Ligand programs in China . Each of the programs use Ligand’s LTP (Liver
Targeting Prodrug) technology. Nucorion, which is backed by Silver River Investors of Hong
Kong, will also develop drug candidates licensed directly from Ohio State University. The
company will develop anti-cancer and anti-viral products with an initial target of the China
market. Nucorion raised $5 million in a Series A led by Silver River; Ligand invested $1 million
and will own less than 20% of Nucorion.
MRK FDA approves Merck’s KEYTRUDA for patients with recurrent or metastatic head and
neck squamous cell carcinoma with disease progression on or after platinum-containing
chemotherapy
Nucorion Pharm recent news that LGND formed a new company, Nucorion Pharma, that will
develop three preclinical Ligand programs in China . Each of the programs use Ligand’s LTP
(Liver Targeting Prodrug) technology. Nucorion, which is backed by Silver River Investors of
Hong Kong, will also develop drug candidates licensed directly from Ohio State University. The
company will develop anti-cancer and anti-viral products with an initial target of the China
market. Nucorion raised $5 million in a Series A led by Silver River; Ligand invested $1 million
and will own less than 20% of Nucorion.
POP Medical (formerly Pro Access) has obtained FDA approval for marketing of its medical
device for treatment of pelvic floor prolapse. 20% of the women in the world suffer from this
condition at any given moment, and 30% at some time in their lives. The condition causes
internal organs to exert pressure on the pelvic floor, which can lead to repeat urinary tract
infections, vaginal bleeding, pain, discomfort in sexual relations, etc. The accepted treatment
was formerly a hysterectomy. In recent years, solutions involving anchoring through an
alternative artificial pelvic floor have been developed, but these do not last, and feature bleeding
and other side effects.The newest methods for treating the problem are based on anchoring the
existing pelvic floor tissue to the tendons above it. POP Medical's products is a new method of
anchoring the pelvic floor to tendons that significantly shortens the duration of treatment (15
minutes, compared with an hour or more in the current methods), reduces pain, and simplifies
the treatment, thereby substantially reducing the risk incurred.
Ossen Innovation plans to transform itself into a glucose monitoring medical device maker
Ossen has struck a deal to acquire the Americas-Asia Diabetes Research Foundation, whose
San MediTech (Huzhou) subsidiary offers a continuous glucose monitoring device in China.
Ossen will spin off its present business -- the manufacture of prestressed steel materials for
bridges -- to a buyer group led by its current Chairman, Dr. Liang Tang. No financial details of
the two transactions were disclosed. Board approval for the two deals is required.
22
Shandong Luoxin Pharma recent news that they in-licensed exclusive China rights to a lung
cancer drug candidate from Yuhan Corp In a deal potentially worth $120 million in milestones
The drug, YH25448, targets EGFR-mutation positive non-small cell lung cancer in patients
resistant to existing therapies. The two pharmas will develop the drug simultaneously in Asia:
Luoxin in greater China; Yuhan in Korea and Taiwan. Yuhan received $6 million upfront and is
also eligible for double-digit royalties on revenues from Luoxin.
ViroMed obtained IND approval for VM202, its lead gene therapy drug candidate, from Korea's
Ministry of Food and Drug Safety (MFDS) ViroMed will conduct a Phase II trial of the drug in
108 Korean patients with ischemic heart disease (IHD); the goal is to increase heart function by
forming new blood vessels. VM202 has already started two Phase III trials: one in patients with
diabetic peripheral neuropathy (DPN) and the other for ischemic diabetic foot ulcers.
Yuhan Corp recent news that Shandong Luoxin Pharma in-licensed exclusive China rights to a
lung cancer drug candidate from Yuhan Corp in a deal potentially worth $120 million in
milestones The drug, YH25448, targets EGFR-mutation positive non-small cell lung cancer in
patients resistant to existing therapies. The two pharmas will develop the drug simultaneously in
Asia: Luoxin in greater China; Yuhan in Korea and Taiwan. Yuhan received $6 million upfront
and is also eligible for double-digit royalties on revenues from Luoxin.
Diabetes in Control
Probiotics for the Management of Diabetes Can probiotics improve A1c’s, plus much more?
Is Liraglutide A Wonder Drug Against Cardiovascular Death?LEADER showed liraglutide
reduces risk of cardiovascular death, but latest study shows no benefit to high-risk patients.
Sleep Pattern and Diabetes Risk Does sleep matter when it comes to diabetes?
Obesity and Its Effects on Mortality Rate Does obesity increase or decrease death rate?
Diabetes and Its Effect on Cancer Does diabetes cause cancer, or vice versa?
Head Scratching Days with Insulin Action Changes The topic of insulin action (resistance
and sensitivity) has come up multiple times over the years in my articles, but it is admittedly
much more complex than I often make it out to be. In a DIC article last summer, you can find a
short list of all the factors that can potentially improve insulin action (basically insulin sensitivity).
In reality, though, sometimes it is impossible to know exactly what is causing your reduced
insulin action from day to day and how to easily and consistently manage it.
Medcity Recent article on IBM
IBM in the Aug. 1 issue of Nature Nanotechnology, researchers from IBM highlighted dramatic
improvements in a technology called nanoscale deterministic lateral displacement. The end
result is a biochip that can sift 20 nanometer (a billionth of a meter) samples of DNA, RNA,
exosomes and possibly viruses away from larger structures.“We’ve created a structure in silicon
that contains nanoposts — pillars that are about 100 to 200 nanometers,” said Gustavo
Stolovitzky, program director of Translational Systems Biology and Nanobiotechnology, IBM
Research and the paper’s co-author. “When biological structures are put into solution in the
chip, they zigzag through the pillars. Smaller particles go straight, while the larger pieces veer
off, following the natural angle of the chip’s pillar structure. It’s kind of like a Pachinko machine,
where the larger particles are bumping off the pillars and going in their natural direction while
the smaller particles are not bumping and go straight.”The chip is the first step towards
developing a liquid biopsy, and exosomes may be the greatest prize. These vesicles — small
structures within a cell made of fluid and enclosed by two layers of lipid — have been linked to
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cell signaling, garbage disposal and other functions. They run between 30 and 100 nanometer
in size and carry DNA, RNA, surface proteins and other molecules that might deliver a snapshot
of cellular health. “Traditionally, exosomes were viewed as garbage cans that excrete anything
that’s not wanted,” said Stolovitzky. “But now we are realizing they exchange information
between cells. Exosomes contain mutations that are known to be present in particular types of
cancer.”
For IBM, this is a high profile entry into the race for a fast and accurate liquid biopsy. These
diagnostics could detect cancer early, track a therapy’s effectiveness in real time and accelerate
drug development. Liquid biopsy represents a multi-billion dollar market and dozens of
companies have entered the ring, including sequencing giant Illumina.The study is a first step
for IBM, proving they can sort by size. The next phase will improve the system’s efficiency,
collecting enough exosomes to determine if they come from cancer cells. Eventually, disease
information won’t be limited to cancer. Exosomes could provide important clues about
neurodegenerative, metabolic and other conditions. The chip could also separate viruses – at
least in principle – though that has yet to be tested systematically. While some have expressed
surprise that IBM has entered the liquid biopsy space, Stolovitzky and Smith believe it’s a
natural extension of their existing skills.
“IBM is the perfect place to do what we’re doing because of the deep expertise in
microelectronics and nanotechnology,” Stolovitzky said. The group was given a mandate to
separate, detect and manipulate single molecules on a chip. Now that they’ve achieved the
separation piece, the team wants to create a modular platform that can perform multiple jobs.
“We have taken down what can be done on a chip significantly,” said Smith, “Now we have to
build a standardized platform, where we can interchange building blocks. It would be like Lego
bricks, where we can arrange them in different ways to perform a variety of diagnostic
applications.” The first target will be prostate cancer. Exosomes should contain a potential
marker called prostate specific membrane antigen, which could advance early detection. “The
goal is to do a non-invasive analysis from urine to detect exosomes that indicate the presence
of prostate cancer,” says Stolovitzky. “This study is the first proof-of-concept.”
Real Clear Health stories
IBM Enters the Liquid Biopsy Sweepstakes
Josh Baxt, MedCityNews
Hormone Therapy For Prostate Cancer May Be Risky For Black Men
Beachum, WP
Vexing Question: Did We Ease Your Pain?
Sabrina Tavernise & Jan Hoffman, NYT
A Memo to Trump on Healthcare
Joel Zinberg, American Enterprise Institute
Zika in the United States, Explained in Nine Maps
Brian Resnick, Vox
Philip Morris Gets Its Ash Kicked in Uruguay
S. Glantz & E. Crosbie, Conversation
Health Reform Russian Style: A Brief Primer on Putincare
Robert Field, Philly.com
Zika Threat Is Changing Americans’ Minds About Late-Term Abortion
Zielinski, TP
24
Treating Infectious Diseases With Network Medicine
Brian Anderson, HAB
Pennsylvania Medicaid Now Covers Gender Transition Services
Gordon, Philly.com
Right to Shop: The Next Big Thing in Healthcare
N. Horton & J. Archambault, Forbes
Mobile System Could Make Biotech Drugs On-Demand in Remote Areas Reuters
New pain related conferences to add
The 23rd Annual Napa Pain Conference Aug 23 2016
Neuroscience of Pain Early Life Adversity Mechanism and Treatment Oct 15 2016
4th World Controversies Debates & Consensus in Bone Muscle & Joint Disease BMJD
Oct 20 2016
WCO-IOF -ESCEO World Congress on Osteoporosis Osteoarthritis and Musculoskeletal
diseases- Florence Italy Mar 23 2017
SEFID Intl Conference on Pain Mind & movement Valencia – Spain May 3 2017
EAPC 2017 15th World Congress of the European Association for Palliative Care- Madrid
May 18 2017
ESMO conferences to add
ESMO Rare Adult Solid cancers conf - Milan Nov 25 -27 2016
11th International Symposium on Advanced Ovarian Cancer Optimal Therapy – Valencia
Mar 3 2017
ELCC Eurolung Cancer Conf Geneva May 5-8 2017
IMPAKT 2017 Breast cancer conf- Belgium May 4-6 2017
August 5, 2016
Aug 5 2016 GBSN pondered as takeover candidate on Street Register
Aug 5 2016 NFLX as takeover bait for BABA on Benzinga
Aug 5 2016 BABA as potential suitor for NFLX on Benzinga
Aug 5 2016 TWTR on Baystreet for deal noise for PE, MSFT , Saudi Prince Alwaleed and Steve
Ballmer
Aug 5 2016 GILD should buy BMY now on Stock Assassin
Aug 5 2016 BMY GILD should buy BMY now on Stock Assassin
Aug 4 2016 TWTR Sun Trust analyst Robert Pack thinks the potential takeover is just a rumor ,
TWTR may consider bids in the future but not before 2017
New health events to add to work
MDSO at Pac Crest Tech Leaders Aug 8 2016
ATHN at Pac Crest Tech Leaders Aug 9 2016
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MTFB Motif Bio IPO due Aug 9 2016
MDRX analyst day Aug 9 2016
Cosmo Bio analyst meeting Aug 9 2016
Wockhardt annual meeting Aug 13 2016
AQXP at Trout in Boston Aug 15 2016
AXGN at Trout in NY Aug 15-16 2016
BLCM at Trout in NY Aug 15-16 2016
AKTX at Trout in NY Aug 16-17 2016
Enterome at Trout in NY Aug 16-17 2016
IMUN Immune Therapeutics shareholders meeting Aug 17 2016
TBPH at Trout in NY Aug 17 2016
MEDP Medpace Holdings IPO due Aug 19 2016
Genfit at Trout in NY Aug 19 2016
AXON annual meeting Aug 19 2016
3S BIO board meeting Aug 22 2016
SGNT Nichki-Iko tender offer expiry Aug 26 2016
ReNeuron Group annual meeting Sep 6 2016
BMRN dinner at ISI Sep 8 2016
Straumann Holding AG Investor Meeting Sep 8 2016
PDCO annual meeting Sep 12 2016
RHHBY at UBS Best of Switzerland Conf Sep 16 2016
AMGN BsUFA for biosimiliar ABP 501 is Sep 25 2016
ABBV AMGN’s BsUFA for biosimiliar BP 501 is Sep 25 2016
NLNK analyst day Oct 25 2016
Lonza Capital Markets Day Oct 26 2016
Sumitomo Dainippon Pharma Analyst meeting Oct 28 2016
QGEN analyst day Nov 15 2016
DVAX Vaccines and Related Biological Products Advisory Committee (VBRPAC) will
review the BLA for HEPLISAV-B Nov 16 2016
ALNY R& D day Dec 16 2016
Donald Trump unveils policy agenda at Detroit Economic Club Aug 8 2016
Hillary Clinton and Tim Kain Q&A Aug 8 2016
House Veterans’ Affairs cmte panel holds hearing on “Technology and Treatment:
Telemedicine in the VA Healthcare System Aug 9 2016
Trout Group's 6th Annual Hamptons CEO Roundtable: Adverum, Affimed, Amarin,
Aquinox, Caribou, Cellectis, Cibus, Cipher, CytomX, DBV, Enterome, Genfit, Intellia,
Loxo, Mologen, Paion, Pieirs, Repros, Theravance, Vericel, vTv Aug 18 2016
Partnering with IDN BioPharma Strategy BAYER SNY Aug 17 2016
Latin America Regulatory Compliance Requirements across the Life Science Industry San Diego, Sep 29-30 2016
Pharma Expo Processing and Packaging Conference & Tradeshow- Chicago Nov 6-9
2016
List of Attendees at upcoming Sell side conferences:
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Canaccord Genuity Growth Conference Boston: AERI, AGIO, ALNY, ANGO, ATHN, ATRA,
ATRC, CRY, DGX, DXCM, ELGX, EXAS, FCSC, IMGN, KITE, KPTI, MDVN, NXTM, OFIX,
OSUR, QDEL, SAGE, STAA, TBRA, VASC, VIVO, ZFGN Aug 10 2016
Avondale Partners - Healthcare 1-1 Conference, Boston: AAC, AHS, AMSG, CCRN, CPIX,
CYH, LPNT, MDRX, QSII, TMH, UHS Aug 10 2016
Canaccord Genuity Growth Conference: ABAX, APRI, BSX, CPHD, ENZY, HOLX, KMPH,
MMSI, REGN, SGYP, TMH, TRUP, VSAR Aug 11 2016
Wedbush Pac Grow Healthcare Conf : ACHN BSX BMPC DXCM EPZM MGNX ICPT
PODD PRTA SYROS TNDM Aug 16 2016
Wedbush Pac Grow Healthcare Conf : DXTR HRC KPTI MMSI NTLA HRC KPTI NVDQ
PTCT XNCR Aug 17 2016
Bank AM Bellevue Healthcare : SANTHERA NVS COSMO Aug 23 2016
Commerzbank Sector Conf: Sartorius Stedim, FMS, NVO, Stratec Aug 30-31 2016
Robert Baird Global Health conf: ABC CPHD FMS MDRX OMI PODD Sep 7 2016
Goldman Sachs European Medtech conf : Gerresheimer, Stratec, Sartorius Stedim Sep 7
2016
Rodman & Renshaw Global Investment Conf: 4SC GeNeuro, INO , Nicox Quantum
Genomics Sep 11 2016
Rodman & Renshaw Global Investment Conf : FLXS, Propanc Health Sep 12 2016
Morgan Stanley Global Health Conference: HOLX Innate Pharma MACK NTLA NVO SNY
Sep 12 2016
CL King Best Ideas Conf : ABAX HSKA IVC MMSI OSUR TTOO WOOF VIVO Sep 13 2016
Morgan Stanley Global Health Conference: ABC FMS Sartorius, Sartorius Stedim Biotech
Sep 13 2016
Berenberg Goldman Sachs German Corporate Conf: Evotec, FMS Sartorius Stedim,
Stratec Sep 19-20 2016
Jefferies London Health Care Conf: Cosmo, NVS RHHBY Nov 16-17 2016
Deutsches Eigenkapitalforum: Paion, Stratec, Sartorius Stedim Biotech, Sartorius AG
Nov 21 2016
FT Lex
WMT needed to buy AMZN back in the 1990’s, WMT needs a fix and whether or not they
buy Jet they will have to make painful investments to keep up
SI looking sharp positive commentary , despite global challenges orders are flowing
faster than revenue gets booked, the SI Vision 2020 plan is looking good so far
NKE with competitors likes UA Under Armour on its heel it is wise to avoid wasting resources in
a fringe division, ie golf equipment
FT
The decline of the startup nation, despite headline grabbing tales of Silicon Valley unicorns, new
business formation in the US is waning, can the US get its capitalist mojo back?
Cyber security groups vulnerable to M&A attacks, boom in dealmaking as private equity groups
circle and industry consolidates
US credit push stokes fear of house of cards
Bloomberg Businessweek
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IRM the treasure of Iron Mountain, MTV with the help of the document storage company Iron
Mountain, is bringing old hits back to life
The interview issue: Satya Nadella MSFT,IBM Ginni Rometty on how she does not worry about
declining revenue, Carlos Slim, Marissa Mayer, Stacy Brown Philpot of Task Rabbit, Claudio
Descalzi CEO of ENI, Ed Bastian of DAL
NY Times
PharmaCielo discussed in an article that Colombians see a future in pot, a new legal kind of
drug baron eyes the medical marijuana market, the Rio Negro region in the Colombian Andes
verdant territory
BBJ on Duchennes and SRPT and others Duchenne advocates’ wait for an FDA decision
nears the six-month mark
SRPT It’s been nearly six months since the FDA original Feb. 26 deadline to make a decision
whether to approve the SRPT eteplirsen. That date has been pushed back repeatedly — first
due to a snowstorm, then due to the FDA’s “continuing review and internal discussions” of the
scientific data surrounding the drug, called eteplirsen.
Currently, no one appears to know when a decision will be forthcoming. Rumors that SRPT may
be presenting at the Morgan Stanley Global Healthcare Conference 2016 next month — which
would suggest the company is expecting its “quiet period” pending the FDA’s decision could end
soon — are as yet unconfirmed (the company isn’t commenting). Likewise, speculation that the
holdup at the FDA is due to disagreement between higher-ups at the agency and the specific
division that conducted the review of the drug are also just that — speculation.
Asked about the ongoing delay and the effect it’s having on patients and their families, the
FDA’s head of drug approvals, Janet Woodcock, said she’s bound by law not to comment. But
patient advocates themselves have told me in recent days that the wait is taking a toll. Beyond
the hundreds of boys with Duchenne who have died, been forced to use wheelchairs or lost
their ability to feed themselves in the past few months, Christine McSherry, head of the
Massachusetts-based advocacy group, the Jett Foundation, said that many patients are
refusing to enroll in other drug studies until a decision on eteplirsen has been rendered. “There
are lots of kids out there who could start another trial,” said McSherry, a Pembroke resident. But
many aren’t, she said, for fear that they’d have drop out if the drug is approved, and then may
need to wait additional weeks for any other drug to flush out of their system before being eligible
to take eteplirsen. “What would happen if they should enroll their child in another trial?”
McSherry — whose 19-year-old son, Jett, has the disease — said local companies like
Catabasis Pharmaceuticals (Nasdaq: CATB) are currently enrolling in Duchenne trials, as are
San Francisco--based FibroGen and Beverly Hills, California-based Capricor Therapeutics.
“We’ve been doing due diligence on these trials to make sure people know about them,” she
said. Cath Jayasuriya, founder and executive director of Newport Beach, California-based
Coalition Duchenne and the mother of a 23-year-old with Duchenne, said in an email, “The
delay in making a decision ignores the tremendous cost to boys and young men with Duchenne
and their families.”
But Debra Miller, the founder of another disease foundation that also happens to be in
Newport Beach called CureDuchenne, says she’s choosing to take the glass-half-full
approach.“Every single day that we don’t have a denial is a good day,” she said. She
believes that “there’s a lot going on behind the scenes” at the FDA, and says, “I think
28
they really want to approve the drug.”Still, she said the lack of a specific timeline is
frustrating. “It’s wearing on the community for sure,” she said.
Baystreet on TWTR
TWTR shares have performed pretty well, increasing more than 10% on rumors former
Microsoft head Steve Ballmer and Saudi Prince Alwaleed bin Talal were thinking about
partnering and taking the company private.The deal makes sense on the surface. Many think
Twitter is undervalued after falling more than 50% from its 2013 IPO. Both Ballmer and the
Prince already own big chunks of stock. And it’s often much nicer to try and turn a company
around when it’s privately held, rather than having the eyes of Wall Street watching your every
move.
But this isn’t the only viable Twitter buyout rumor. Microsoft is often mentioned as a potential
acquiror. It has plenty of capital, and it could use the same infrastructure it uses to sell Bing ads
to increase Twitter’s use as an advertising portal.
FB Facebook is less likely, but the possibility still exists Mark Zuckerberg will make the decision
to acquire Twitter. Many people feel Twitter’s management team is somewhat lacking. Having
Zuckerberg in charge of Twitter instantly adds credibility.
Finally, there’s private equity potential, which seems like the most likely outcome. Venture
capitalists like Marc Andreessen and Carl Icahn’s names have both been linked to Twitter, as
well as Ballmer and the Saudi Prince. Each of these people have the ability to get the $17-$20
billion it would likely take for a Twitter buyout.
Street Register on GBSN
GBSN Great Basin makes its money from test cartridges for various diseases. It installs a
testing machine at a facility, and then sells the facility disposable cartridges that the facility in
question uses to identify disease in patients. It’s a rapid process and – fundamentally – a great
bit of equipment. Potentially game changing, in the right hands.Last month, the company picked
up CE marking for its Shiga Toxin Direct Test, and just this week management announced the
commercial launch of the product. It believes the test will penetrate 50% of its customer base
before the close of the first quarter next year. A host of clinical trials are underway right now in
the US, designed to expand the test base that Great Basin Scientific can offer to its customers.
Essentially, the more tests it can get approved, the more it can sell to the facilities that house its
technology, and the more money it can make. Here’s our take, however. The company that
underpins Great Basin Scientific, and its technology/business model, is worth more than the
current $3 million or so market cap. There has to be a point where the shorts realize this and
start to cover, and at this point, we could see a small but significant bounce. This bounce should
draw speculative momentum attention, and could be a nice near term play. Beyond that, a
strong management team should be able to help the company recover, or at least dress up
Great Basin for a buyout.
Barron's on BMY All is not lost for Bristol-Myers Squibb (BMY) following today’s surprise
clinical trial failure
BMY has a strong balance sheet, which gives it the strength to regroup, Secondly, Opdivo isn’t
necessarily out in the cold. Bristol-Myers has many trials underway studying how to best use its
immunotherapies, including a late-stage study called CheckMate-227 that is testing Opdivo in
combination with an older immunotherapy called Yervoy as a first-line lung cancer therapy.But
perhaps most important of all, both Bristol-Myers and analysts need to dig into trial data to
29
determine what went wrong with the CheckMate-026 study, and why Merck’s Keytruda
succeeded.Opdivo was shown to be active as a first-line lung cancer treatment, just not good
enough. Evercore ISI analyst Mark Schoenebaum speculates it could be that the BMY included
a much broader patient population in its study, while Merck focused on a narrower group of
patients. As he writes:We will be eagerly anticipating more details of the trial data in order to tell
what exactly went wrong – at the moment, our only lead is the much-broader patient population
in BMY’s trial: their high-expresser cutoff was 5% PD-L1 expression, a much lower bar than
MRK’s 50%. While PD-L1 expression isn’t a perfect biomarker, looking for access to this
broader market may have been too much of a reach for BMY.
The question that analysts now want answered is how did patients in the Bristol-Myers study
with PD-L1 expression of 50% or higher fare using Opdivo.
As Leerink analyst Seamus Fernandez wrote in a recent note:
Whether or not high expressing patients would have shown a positive result in the study in not
known, although BMY has commented that given their data, they are equally surprised by the
success of MRK’s study. We appear to have misinterpreted this to mean that Opdivo did not
separate in patients with PDL1 biomarker tumor proportion scores > 50%
In our follow up conversation with mgmt., they emphasized that they have no expectations for a
filing based on CM-026. In all of our evaluations of Keytruda vs. Opdivo, the products appear to
perform very similarly overall – regardless of the PDL1 biomarker cutoff used. BMY further
noted that responses still appear to be very important for patients treated in the 1L setting and
noted that Opdivo clearly is active in this setting, but simply didn’t best chemotherapy on either
PFS or OS on either the primary endpoints of PFS of the secondary endpoints of OS. Our views
on the importance of -227 to Opdivo’s and Yervoy’s future success are unchanged, but we view
this feedback as more encouraging than our initial conversation implied.
All eyes will be on Opdivo at higher expression thresholds to confirm the market’s view that
there isn’t a difference between the two products.
That said, perception that there isn’t a difference between Opdivo and Keytruda is likely to
broaden within the physician community and doesn’t change our views of how the CM-026
impacts how we model this result
Politico Drug lobby plans counterattack on prices
Washington’s powerful drug lobby is gearing up to spend hundreds of millions of dollars on a
post-election ad war pushing back against politicians from both parties who have savaged its
members over drug prices.The massive campaign by the Pharmaceutical Research and
Manufacturers of America — expected to start positive by highlighting drugs that save or
prolong lives — will dwarf the $20 million that health insurers spent on the iconic "Harry and
Louise" campaign credited with sinking Hillary Clinton's health reform plan in the early 1990s.
Targeting politicians is not part of the initial plan, but lobbyists say the organization is prepared
to do so if members of Congress or the executive branch push agendas that are seen as
detrimental to the industry.And that’s just one part of a larger effort by the K Street lobbying
powerhouse to seize control of the public narrative over drug prices and to reassert its
dominance in Washington after several years in which it has taken a public shellacking over
prices, with even reliable political allies in Congress questioning its pricing strategies. Both
Clinton and Donald Trump, for instance, are urging changes in the law that would allow the
government to negotiate drug prices for Medicare beneficiaries.
30
PhRMA wants to drive a broader discussion on health costs, emphasizing that other players
must play a role in tamping down costs and offering to work with insurers and others to find
solutions, senior company officials and lobbyists said.
"The reality and the message and the playbook used for a number of years is over," said Bill
Pierce, senior director of the public affairs firm APCO Worldwide, which represents several drug
companies, and a former HHS official under President George W. Bush.
The industry can no longer defend high drug prices by pointing to the pricey research and
development that goes into innovative medicines. "They have to move on," he said.
ADVERTISING
Benzinga
BABA Benzinga Pro reported in its Market-Moving Exclusive newsfeed that Alibaba Group
Holding Ltd BABA may be making a bid for NFLX According to the story, Alibaba has been
trying to build a service similar to Netflix in China via Tmall Box Office. In June 2015 Liu
Chunning, President of Alibaba’s Digital Entertainment unit said, "Our mission, the mission of all
of Alibaba, is to redefine home entertainment."
Street Sweeper
BWEN TheStreetSweeper releases a brand-new report on Broadwind Energy (BWEN)! This
Illinois-based wind tower component builder has been embroiled in seven years of expensive
drama. But the stock has risen and is now precariously positioned for a drama-queen swoon.
Issues include: *Miserable margins *Unprofitable at near-peak production *Institutional holders
have been selling *Single analyst rating is a hold *Production issues, creating cost overruns and
customer penalties. *Historical issues have included SEC charges, an inflated-stock lawsuit
settlement and a Clean Water Act violation.
Health news
ABBV Elliot Mgmt has sued ABBV alleging they committed fraud in their bid to acquire SHPG .
In the June suit, ABBV made false and misleading statements about the merits of the deal and
ABBV played down the tax rationale according to Elliot. The deal died in Oct 2014 and of
course Elliot lost a lot of money. ( NY Post article)
ABBV filed suit against AMGN in the U.S. District Court for the District of Delaware alleging that
Amgen's ABP 501, a biosimilar version of AbbVie's Humira adalimumab, infringes 10 patents
covering Humira. AbbVie is seeking an injunction to prevent Amgen from launching ABP 501.
Once Amgen provides 180-day notice that it plans to market the biosimilar, AbbVie said it plans
to assert another 51 patents it believes Amgen infringes. Last month, FDA's Arthritis Advisory
Committee voted unanimously to recommend ABP 501's approval for all of the indications on
Humira's label except those covered by Orphan drug exclusivity AbbVie said it thinks its Humira
patent portfolio is strong enough to keep biosimilars off the U.S. market until 2022. Amgen has
stated that it could launch its biosimilar Humira "as soon as 2017,"
AET news that the Judge orders ANTM-CI case reassigned to new judge in order to expedite
trials Judge writes: "After hearing from all parties both in writing and orally, the Court has
decided to refer the Anthem-Cigna case back to the calendar committee for random
reassignment to a new judge. "The Court acknowledges the parties' need for expedition and is
inclined to accommodate their contractual deadlines to the extent reasonable. But doing so
would require a decision on the merits in Aetna’s case before the year’s end and another in
31
Anthem’s case not long thereafter. Given the complexity and importance of these cases, the
Court cannot feasibly try and decide both in that timeframe. "Ultimately, it will be fairer to the
parties and better for the public if one of the cases is randomly reassigned to another judge in
this district, who can give it prompt and full attention while this judge does the same with the
other. "In the Court’s view, Anthem’s case is the better candidate for reassignment. If both
mergers’ contractual deadlines are given equal consideration, it is apparent that Aetna’s case
must proceed on the shorter timeline. That counsels in favor of this judge retaining the Aetna
matter— both in order to avoid further delay and out of consideration for the transferee judge
AET & HUM shares have moved higher following the order
AGN and Gedeon Richter provide update on cariprazine program MD-72 Adjunctive MDD Trial
Topline results from the MD-72 trial indicate that flexible doses of cariprazine did not separate
significantly from placebo as an add-on treatment in this trial. In a previously conducted trial
(MD-75), flexible doses of cariprazine (2-4 mg) were significantly more effective than placebo as
an adjunctive treatment to antidepressant therapy in adults with major depressive disorder
(MDD) who failed to adequately respond to antidepressant monotherapy. It is not uncommon
that clinical trials in MDD fail to show a separation from placebo even with effective drugs.
Allergan (AGN) and Gedeon Richter remain committed to developing cariprazine as a potential
treatment option for patients suffering from this serious illness and will continue to work on a
subsequent Phase 3 trial. Patient enrollment underway for bipolar depression trials Allergan
and Gedeon Richter have started the patient enrollment in their Phase 3 clinical trial program
investigating the use of cariprazine as a treatment for bipolar depression. Two parallel studies
will be conducted at approximately 85 sites across the US and Europe. Additional development
programs in prevention of schizophrenia relapse and predominant negative symptoms of
schizophrenia In January 2015 Gedeon Richter and Allergan announced positive phase 3 trial
results for cariprazine in the prevention of relapse of schizophrenia symptoms in adult patients.
The companies are planning to submit an efficacy supplement that will provide for the
maintenance of efficacy in schizophrenia patients. In January 2015, Gedeon Richter
announced a positive Phase 3 study that evaluated cariprazine for the treatment of predominant
negative symptoms (PNS) of schizophrenia. Both companies are in active discussions with FDA
regarding the submission of an efficacy supplement to provide for the treatment of PNS. Based
on our current regulatory interactions we intend to file in H1/17.
AMGN ABBV filed suit against AMGN in the U.S. District Court for the District of Delaware
alleging that Amgen's ABP 501, a biosimilar version of AbbVie's Humira adalimumab, infringes
10 patents covering Humira. AbbVie is seeking an injunction to prevent Amgen from launching
ABP 501. Once Amgen provides 180-day notice that it plans to market the biosimilar, AbbVie
said it plans to assert another 51 patents it believes Amgen infringes. Last month, FDA's
Arthritis Advisory Committee voted unanimously to recommend ABP 501's approval for all of the
indications on Humira's label except those covered by Orphan drug exclusivity AbbVie said it
thinks its Humira patent portfolio is strong enough to keep biosimilars off the U.S. market until
2022. Amgen has stated that it could launch its biosimilar Humira "as soon as 2017,"
ANTM Judge orders ANTM-CI case reassigned to new judge in order to expedite trials Judge
writes: "After hearing from all parties both in writing and orally, the Court has decided to refer
the Anthem-Cigna case back to the calendar committee for random reassignment to a new
judge. "The Court acknowledges the parties' need for expedition and is inclined to
accommodate their contractual deadlines to the extent reasonable. But doing so would require a
32
decision on the merits in Aetna’s case before the year’s end and another in Anthem’s case not
long thereafter. Given the complexity and importance of these cases, the Court cannot feasibly
try and decide both in that timeframe. "Ultimately, it will be fairer to the parties and better for the
public if one of the cases is randomly reassigned to another judge in this district, who can give it
prompt and full attention while this judge does the same with the other. "In the Court’s view,
Anthem’s case is the better candidate for reassignment. If both mergers’ contractual deadlines
are given equal consideration, it is apparent that Aetna’s case must proceed on the shorter
timeline. That counsels in favor of this judge retaining the Aetna matter— both in order to avoid
further delay and out of consideration for the transferee judge AET & HUM shares have moved
higher following the order
ATOS to receive $1.76M from settlement with Besins Healthcare. Atossa and Besins have
further agreed, pursuant to and as set forth in the Termination agreement, that Besins will
assume, and Atossa shall have no further rights to, all clinical, regulatory, manufacturing, and all
other development and commercialization of 4-hydroxy tamoxifen and Afimoxifene Topical Gel .
Besins will reimburse Atossa for out-of-pocket expenses incurred by Atossa to pursue the AfTG
Program and will make a termination payment in the total amount of $1,762,931.
AZN news that BMY announced that CheckMate -026, a trial investigating the use of Opdivo
(nivolumab) as monotherapy, did not meet its primary endpoint of progression-free survival in patients
with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1
at ≥ 5% AZN AstraZeneca expects data next half from the Phase III MYSTIC study of durvalumab as
monotherapy and in combination with its CTLA-4 mAb tremelimumab (CP-675206) vs. chemotherapy as
a first-line therapy for NSCLC. The pharma is still enrolling patients in the Phase III NEPTUNE study,
which is also evaluating durvalumab plus tremelimumab vs. standard of care in first-line NSCLC. Neither
MYSTIC nor NEPTUNE specifies whether patients must express PD-L1. Durvalumab also is in Phase III
testing for PD-L1-positive bladder cancer.
Bayer is examining Monsanto Co.’s financial accounts, people familiar with the matter said, a
crucial step that could pave the way for the German company to raise its $55 billion takeover
offer for the U.S. agrochemicals giant.Bayer has signed confidentiality agreements to conduct
due diligence on Monsanto, a process that is expected to last a few more weeks, as it weighs
the size and timing of a new bid, the people said, asking not to be identified because the
deliberations are private. No final decision on whether to improve the offer has been made, they
said.
BIIB Samsung Bioepsis and MRK news that the FDA accepted for filing an NDA for MK-1293 to
treat Type 1 and Type 2 diabetes. The candidate is a follow-on biologic of Lantus insulin
glargine from SNY. MRK is partnered with Samsung Bioepis, a JV between BIIB and Samsung
Group (Seoul, South Korea), to commercialize MK-1293. Merck said FDA will review MK-1293
through its 505(b)(2) pathway, which allows it to reference previous safety and efficiency data
for Lantus. It will not be reviewed as a biosimilar. MRK expects a decision from FDA in 2017,
but did not disclose a PDUFA date.
BIIB SGMO disclosed delays for multiple clinical programs. The company now plans to begin
Phase I/II studies next year of SB-318 to treat mucopolysaccharidosis I (MPS I, Hurler
syndrome) and SB-913 for MPS II (Hunter syndrome). It previously planned to start the MPS I
study in mid-2016, and the MPS II trial in 2H16. President and CEO Sandy Macrae attributed
the delay to a reagent error that will require Sangamo to repeat some preclinical work.
Sangamo said it and partner Biogen Inc would submit INDs next year for SB-BCLmr-HSPC to
33
treat beta-thalassemia and the partners' therapy for sickle cell disease, and would conduct
"additional preclinical work" for both programs. In May, then-President and CEO Edward
Lanphier said Sangamo expected to submit an IND during 2Q16 for the beta-thalassemia
program, and expected Biogen to file an IND in 2H16 for the sickle cell program. Sangamo
intends to begin a Phase I/II study of its SB-FIX-1501 (SB-FIX) for hemophilia B this year, but
acknowledged a delay in that program as well. In May, Lanphier had said the company hoped to
dose the first patient in June.’
BMRN dinner at ISI Sep 8 2016
BMY announced that CheckMate -026, a trial investigating the use of Opdivo (nivolumab) as
monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously
untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at ≥ 5% The
results reflected a risky but potentially lucrative bet by Bristol-Myers, highlighting a difference in strategy
with Merck. By designing its study to include patients with lower levels of a key biomarker thought to
predict response to the drug, Bristol-Myers was aiming at a far larger market for Opdivo. Merck’s
Keytruda trial, meanwhile, focused on a smaller subset with high levels of the biomarker, called PD-L1 -fewer patients, but a better chance of success.The stock fell the most in 14 years after.The drug failure as
a first-line treatment is a blow to Bristol-Myers, which has pegged its growth on immune-based therapies
such as Opdivo for cancers. Lung cancer is a significant opportunity for these treatments, which have thus
far been largely approved for cancers that affect fewer patients. Opdivo is approved in lung cancer,
though not as a first-line therapy, a large growth opportunity for cancer drugs.“This is a major surprise -possibly the biggest clinical surprise of my career,” Evercore ISI analyst Mark Schoenebaum, who
recommends holding Bristol-Myers stock, wrote in a note. “Investors had high expectations for this
trial.”The company will complete a full evaluation of the CheckMate -026 data and work with
investigators on the future presentation of the results Management comments: “Opdivo has become a
foundational treatment that is transforming cancer care across multiple tumor types. While we are
disappointed CheckMate -026 did not meet its primary endpoint in this broad patient population, we
remain committed to improving patient outcomes through our comprehensive development program,
including the ongoing Phase 3 CheckMate -227 study exploring the potential of the combination of
Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy,or Opdivo plus chemotherapy
in PD-L1 negative patients.” BMY did not disclose detailed data from CheckMate -026, which enrolled
541 patients. The pharma said it will evaluate the data and work with investigators on presenting the
results. Secondary endpoints in the study included overall survival (OS) and objective response rate
(ORR). BMY pharma has "not had the data long enough to conduct a comprehensive analysis," including
evaluating the data in a subgroup of patients with high PD-L1 expression.The ongoing Phase III
CheckMate -227 study is evaluating Opdivo in combination with BMS's Yervoy ipilimumab in PD-L1positive NSCLC patients, or Opdivo plus chemotherapy in PD-L1-negative NSCLC patients. Yervoy is a
human mAb against CTLA-4 (CD152). Abernathy said BMS expects data from the study in early 2018,
and said the ability to perform an interim analysis is built into the study's design. BMY has worldwide
rights to Opdivo from Ono Pharmaceutical.except in Japan, South Korea and Taiwan, where the
companies are partnered for the product .MRK is now likely to enjoy the benefit of the only
immunotherapy to be approved in first line cancer and will enjoy this exclusivity for at least 12
months
CI Judge orders ANTM-CI case reassigned to new judge in order to expedite trials Judge
writes: "After hearing from all parties both in writing and orally, the Court has decided to refer
the Anthem-Cigna case back to the calendar committee for random reassignment to a new
34
judge. "The Court acknowledges the parties' need for expedition and is inclined to
accommodate their contractual deadlines to the extent reasonable. But doing so would require a
decision on the merits in Aetna’s case before the year’s end and another in Anthem’s case not
long thereafter. Given the complexity and importance of these cases, the Court cannot feasibly
try and decide both in that timeframe. "Ultimately, it will be fairer to the parties and better for the
public if one of the cases is randomly reassigned to another judge in this district, who can give it
prompt and full attention while this judge does the same with the other. "In the Court’s view,
Anthem’s case is the better candidate for reassignment. If both mergers’ contractual deadlines
are given equal consideration, it is apparent that Aetna’s case must proceed on the shorter
timeline. That counsels in favor of this judge retaining the Aetna matter— both in order to avoid
further delay and out of consideration for the transferee judge AET & HUM shares have moved
higher following the order
DVAX Vaccines and Related Biological Products Advisory Committee (VBRPAC) will DVAX
review the Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine,
Recombinant Adjuvanted Nov 16 2016, the pdufa remains Dec 15 2016
EBIO ThromboGenics terminates collaboration and license agreement with Eleven
Biotherapeutics - 8-K On 1-Aug-16, Eleven Biotherapeutics received notice from
ThromboGenics N.V. of ThromboGenics’s termination, effective as of 31-Oct-16, of the
Collaboration and License agreement between the company and ThromboGenics , dated 28May-13. Under the Collaboration, the company and ThromboGenics collaborated to seek to
identify protein or peptide therapeutics that directly modulate any of a specified set of targets in
a novel pathway in retinal disease. In connection with the Collaboration, ThromboGenics paid
the company an upfront technology licensing fee of $1,750,000 and paid the company to
perform activities under the Collaboration at a set rate per full-time equivalent person working
on Collaboration activities. The initial research term concluded in November 2015. There have
not been any collaboration products identified whose modulation of any of the targets has been
confirmed in the course of the Collaboration. The Collaboration also provided for potential
future payments to the company by ThromboGenics of up to an aggregate of $10,000,000 if
ThromboGenics were to achieve specified preclinical and clinical milestones with respect to
collaboration products and up to an aggregate of $15,000,000 if ThromboGenics were to
achieve specified regulatory milestones with respect to collaboration products. In addition,
ThromboGenics would have been obligated to pay the company a low single digit royalty on
sales of collaboration products by ThromboGenics, its affiliates or sublicensees. None of these
milestones or royalties are expected to be payable following termination of the Collaboration.
EBS PIP filed a formal protest against the Department of HHS challenging its solicitation for a
next-generation Anthrax vaccine provider. According to the protest, filed with the U.S.
Government Accountability Office, the government's "Request for Proposals" was written in a
way that eliminates competition and assures a sole source award to EBS Emergent
BioSolutions Inc., the company that has long been the sole-source provider of the vaccine. The
protest requests the GAO suspend the award under the solicitation while it reviews
PharmAthene's complaint. Under federal procurement regulations, GAO has 100 days to
review the complaint
Eureka Therapeutics Inc and Memorial Sloan Kettering granted Juno Therapeutics Inc.
(exclusive, worldwide rights to binding domains against three multiple myeloma (MM) targets.
Juno will incorporate the targets into chimeric antigen receptor (CAR) T cell therapies to treat
35
MM. The deal includes a binding domain targeting tumor necrosis factor (TNF) receptor
superfamily member 17 (BCMA; TNFRSF17; CD269). Juno said its CAR T therapy against
BCMA could enter the clinic as early as 1H17. The deal's other two targets are undisclosed.
MSKCC and Eureka are eligible for an undisclosed upfront payment and milestones, plus
royalties.
Gedeon Richter and AGN provide update on cariprazine program MD-72 Adjunctive MDD Trial
Topline results from the MD-72 trial indicate that flexible doses of cariprazine did not separate
significantly from placebo as an add-on treatment in this trial. In a previously conducted trial
(MD-75), flexible doses of cariprazine (2-4 mg) were significantly more effective than placebo as
an adjunctive treatment to antidepressant therapy in adults with major depressive disorder
(MDD) who failed to adequately respond to antidepressant monotherapy. It is not uncommon
that clinical trials in MDD fail to show a separation from placebo even with effective drugs.
Allergan (AGN) and Gedeon Richter remain committed to developing cariprazine as a potential
treatment option for patients suffering from this serious illness and will continue to work on a
subsequent Phase 3 trial. Patient enrollment underway for bipolar depression trials Allergan
and Gedeon Richter have started the patient enrollment in their Phase 3 clinical trial program
investigating the use of cariprazine as a treatment for bipolar depression. Two parallel studies
will be conducted at approximately 85 sites across the US and Europe. Additional development
programs in prevention of schizophrenia relapse and predominant negative symptoms of
schizophrenia In January 2015 Gedeon Richter and Allergan announced positive phase 3 trial
results for cariprazine in the prevention of relapse of schizophrenia symptoms in adult patients.
The companies are planning to submit an efficacy supplement that will provide for the
maintenance of efficacy in schizophrenia patients. In January 2015, Gedeon Richter
announced a positive Phase 3 study that evaluated cariprazine for the treatment of predominant
negative symptoms (PNS) of schizophrenia. Both companies are in active discussions with FDA
regarding the submission of an efficacy supplement to provide for the treatment of PNS. Based
on our current regulatory interactions we intend to file in H1/17.
GEMP Gemphire Therapeutics IPO trades today
GSK priced gene therapy Strimvelis at EUR 594,000 ($663,679), spokesperson Anna Padula
told BioCentury. In May, the European Commission approved Strimvelis to treat severe
combined immunodeficiency due to adenosine demainase deficiency (ADA-SCID) for whom no
suitable HLA-matched related stem cell donor is available. The Italian Medicines Agency (AIFA)
agreed to reimburse for the treatment, Padula said. She added that the price compares
favorably with long-term enzyme replacement therapy, which she said can cost EUR 3-EUR 4.2
million ($3.4- $4.7 million) over a 10-year period.
HUM AET news that the Judge orders ANTM-CI case reassigned to new judge in order to
expedite trials Judge writes: "After hearing from all parties both in writing and orally, the Court
has decided to refer the Anthem-Cigna case back to the calendar committee for random
reassignment to a new judge. "The Court acknowledges the parties' need for expedition and is
inclined to accommodate their contractual deadlines to the extent reasonable. But doing so
would require a decision on the merits in Aetna’s case before the year’s end and another in
Anthem’s case not long thereafter. Given the complexity and importance of these cases, the
Court cannot feasibly try and decide both in that timeframe. "Ultimately, it will be fairer to the
parties and better for the public if one of the cases is randomly reassigned to another judge in
this district, who can give it prompt and full attention while this judge does the same with the
36
other. "In the Court’s view, Anthem’s case is the better candidate for reassignment. If both
mergers’ contractual deadlines are given equal consideration, it is apparent that Aetna’s case
must proceed on the shorter timeline. That counsels in favor of this judge retaining the Aetna
matter— both in order to avoid further delay and out of consideration for the transferee judge
AET & HUM shares have moved higher following the order
ICPT Upcoming events: Ocaliva CHMP opinion by YE16 Ocaliva Ph2 CONTROL data in
NASH in 2H17; and completion of the INT-767 Phase I study.
JUNO news that Eureka Therapeutics Inc and Memorial Sloan Kettering granted Juno
Therapeutics Inc. (exclusive, worldwide rights to binding domains against three multiple
myeloma (MM) targets. Juno will incorporate the targets into chimeric antigen receptor (CAR) T
cell therapies to treat MM. The deal includes a binding domain targeting tumor necrosis factor
(TNF) receptor superfamily member 17 (BCMA; TNFRSF17; CD269). Juno said its CAR T
therapy against BCMA could enter the clinic as early as 1H17. The deal's other two targets are
undisclosed. MSKCC and Eureka are eligible for an undisclosed upfront payment and
milestones, plus royalties.As expected, Juno delayed its regulatory timeline for JCAR015, an
autologous CD19-directed CAR T therapy in development to treat hematologic malignancies.
Juno now hopes JCAR015 will be approved in 1H18. It had previously hoped to gain approval
as early as 2017.Last month, FDA placed a clinical hold on the Phase II ROCKET trial of
JCAR015 to treat relapsed or refractory acute lymphoblastic leukemia (ALL) after Juno reported
two patient deaths from cerebral edema in the trial. FDA lifted the hold on July 12 after Juno
revised ROCKET's protocol
MNTA and NVS Sandoz are awaiting approval for the 40-milligram dose of Glatopa with
tentative approval expected this year. Approval is expected to progress more quickly than for
the 20-mg dose, which was more challenging because it reviewed the active pharmaceutical
ingredient. The 40-mg ANDA references the master file for the 20-mg dose. Momenta may have
an edge against other generic makers targeting the 40-mg dose since it's currently the only
approved API.The 20-mg dose has only captured 38% of the glatiramer acetate market, which
may bode well for the 40-mg copy since Glatopa didn't erode much of the 40-mg market.
Copaxone 40 mg/mL holds 82% of the total U.S. market.
MNTA will discontinue enrollment in the Phase II portion of a Phase I/II study of necuparanib
(M402) to treat metastatic pancreatic cancer. A DSMB's planned interim futility analysis showed
that a combination including necuparanib "did not show a sufficient level of efficacy to warrant
continued enrollment."Momenta's next most advanced innovative candidate is M281, a mAb
against the Fc fragment of IgG receptor transporter alpha (FCRN; FCGRT). It is in Phase I
testing for autoimmune diseases. Momenta has two approved complex generics and a pipeline
that includes biosimilars
MNTA enrollment in Phase I Portion of M281 Trial for Auto Antibody Driven Disease Nears
Completion M230 -Recombinant Homogeneous Fc Primer to Enter Clinic 2017
Momenta's R&D spending, which has on average been almost twice as high as revenue, is
likely to increase as the company advances its novel drug candidates. These include
autoimmune candidates such as M281, which is an anti-FcRn monoclonal antibody. The
company is also considering collaborations for its hyper-sialylated IVIg (hsIVIg), a high potency
alternative to IVIg, which would lower R&D spending and may allow for faster development
timelines.
37
MRK the FDA has accepted for review the NDA for MK-1293, an investigational follow-on
biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes,
which is being developed by MRK with partial funding from Samsung Bioepis. The candidate is
a follow-on biologic of Lantus insulin glargine from SNY. MRK is partnered with Samsung
Bioepis, a JV between BIIB and Samsung Group to commercialize MK-1293. Merck said FDA
will review MK-1293 through its 505(b)(2) pathway, which allows it to reference previous safety
and efficiency data for Lantus. It will not be reviewed as a biosimilar. Spokesperson Kristen
Drake told BioCentury the company expects a decision from FDA in 2017, but did not disclose a
PDUFA date. Merck said EMA is reviewing an application for MK-1293. The candidate is
considered a biosimilar outside the U.S. Lantus is a synthetic sustained-release subcutaneous
insulin analog
MRK BMY announced that CheckMate -026, a trial investigating the use of Opdivo (nivolumab) as
monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously
untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at ≥ 5% The
results reflected a risky but potentially lucrative bet by Bristol-Myers, highlighting a difference in strategy
with Merck BMS shed $20.1 billion in market cap for a closing valuation of $105.7 billion. Investors
rewarded MRK , which markets rival PD-1 mAb Keytruda pembrolizumab, In June, Keytruda met the
primary PFS endpoint and significantly improved overall survival (OS) vs. platinum-based therapies in
the Phase III KEYNOTE-024 trial as a first-line therapy for NSCLC. That study evaluated Keytruda in
metastatic NSCLC patients with high expression of PD-L1, defined as ≥50% Both Opdivo and Keytruda
are approved to treat NSCLC that has progressed on or after platinum-based chemotherapy, and to treat
melanoma. Keytruda's label for NSCLC is limited to patients who express PD-L1, while Opdivo's label is
not restricted to PD-L1 expressers. BMY did not disclose detailed data from CheckMate -026, which
enrolled 541 patients. The pharma said it will evaluate the data and work with investigators on presenting
the results. Secondary endpoints in the study included overall survival (OS) and objective response rate
(ORR). BMY pharma has "not had the data long enough to conduct a comprehensive analysis," including
CheckMate -227 study is evaluating Opdivo in combination with BMS's Yervoy ipilimumab in PD-L1positive NSCLC patients, or Opdivo plus chemotherapy in PD-L1-negative NSCLC patients. Yervoy is a
human mAb against CTLA-4 (CD152). Abernathy said BMS expects data from the study in early 2018,
and said the ability to perform an interim analysis is built into the study's design. Also MRK and PFE
and Pfizer's avelumab is in the Phase III JAVELIN Lung 100 trial vs. chemotherapy as a first-line
treatment for metastatic or recurrent PD-L1 positive NSCLC.MRK is now likely to enjoy the
benefit of the only immunotherapy to be approved in first line cancer and will enjoy this
exclusivity for at least 12 months
Quantum Pharma announces Colonis has launched Mucodis Vaginal Cream The cream is part
of the Mucodis range of in-licensed patented medical devices, which focus on treating some of
the side effects experienced by patients undergoing the treatment of cancer. The Mucodis
range provides the NHS with prescribable products to address a number of the side effects
associated with cancer treatments including mucositis, radiation-induced dermatitis,
vulvovaginitis and proctitis. Colonis has been granted an exclusive distribution licence for these
products for five years, with an option to extend beyond this initial period.
OMCL board authorizes stock repurchase program for up to $50M ,m this is in addition to the
Nov 4 2014 stock repo plan in place
38
ONO news that BMY announced that CheckMate -026, a trial investigating the use of Opdivo
at ≥ 5% Bristol-Myers has worldwide rights to Opdivo from Ono Pharmaceutical Co.except in
Japan, South Korea and Taiwan, where the companies are partnered for the product The
results reflected a risky but potentially lucrative bet by Bristol-Myers, highlighting a difference in
strategy with Merck. By designing its study to include patients with lower levels of a key
biomarker thought to predict response to the drug, Bristol-Myers was aiming at a far larger
market for Opdivo. Merck’s Keytruda trial, meanwhile, focused on a smaller subset with high
levels of the biomarker, called PD-L1 -- fewer patients, but a better chance of success.The stock
fell the most in 14 years after.The drug failure as a first-line treatment is a blow to Bristol-Myers,
which has pegged its growth on immune-based therapies such as Opdivo for cancers. Lung
cancer is a significant opportunity for these treatments, which have thus far been largely
approved for cancers that affect fewer patients. Opdivo is approved in lung cancer, though not
as a first-line therapy, a large growth opportunity for cancer drugs.“This is a major surprise -possibly the biggest clinical surprise of my career,” Evercore ISI analyst Mark Schoenebaum,
who recommends holding Bristol-Myers stock, wrote in a note. “Investors had high expectations
for this trial.”The company will complete a full evaluation of the CheckMate -026 data and work
with investigators on the future presentation of the results Management comments: “Opdivo
has become a foundational treatment that is transforming cancer care across multiple tumor
types. While we are disappointed CheckMate -026 did not meet its primary endpoint in this
broad patient population, we remain committed to improving patient outcomes through our
comprehensive development program, including the ongoing Phase 3 CheckMate -227 study
exploring the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and
Opdivo plus Yervoy,or Opdivo plus chemotherapy in PD-L1 negative patients.” BMY did not
disclose detailed data from CheckMate -026, which enrolled 541 patients. The pharma said it
will evaluate the data and work with investigators on presenting the results. Secondary
endpoints in the study included overall survival (OS) and objective response rate (ORR). BMY
pharma has "not had the data long enough to conduct a comprehensive analysis," including
CheckMate -227 study is evaluating Opdivo in combination with BMS's Yervoy ipilimumab in
PD-L1-positive NSCLC patients, or Opdivo plus chemotherapy in PD-L1-negative NSCLC
patients. Yervoy is a human mAb against CTLA-4 (CD152). Abernathy said BMS expects data
from the study in early 2018, and said the ability to perform an interim analysis is built into the
study's design. MRK is now likely to enjoy the benefit of the only immunotherapy to be approved
in first line cancer and will enjoy this exclusivity for at least 12 months
PGNX news for VRX that Relistor drug has attracted interest from other companies as VRX
works to reduce its debt load, people familiar with the matter said.A potential sale could value
the constipation treatment at $400 million to $500 million, the people said, asking not to be
identified because the deliberations are private. Valeant could still choose not to sell the drug,
the people said. A representative for Valeant declined to comment. Chief Executive Officer Joe
Papa is seeking to ease a debt burden that ballooned to more than $30 billion as he also works
to help the business recover from criticism of its business practices and drug pricing. The
company, whose investors include Bill Ackman’s Pershing Square Capital Management, is also
considering other asset sales, including smaller cosmetic and pharmaceutical assets, to raise
39
cash, people familiar with the matter have said previously. Valeant and its partner for Relistor,
Progenics Pharmaceuticals Inc., said last month that the FDA approved the tablet form of the
drug to treat constipation brought on by taking opioids for chronic, non-cancer pain. Valeant said
it expects to start selling Relistor tablets in the U.S. in the third quarter this year. An injectable
form of the treatment was approved by the FDA in 2008.Progenics said on July 26 it had
received a $50 million payment from Valeant after the FDA’s approval. Progenics is entitled to
receive as much as $200 million of milestone payments tied to sales of the drug, the company
said.
PIP filed a formal protest against the Department of HHS challenging its solicitation for a nextgeneration Anthrax vaccine provider. According to the protest, filed with the U.S. Government
Accountability Office, the government's "Request for Proposals" was written in a way that
eliminates competition and assures a sole source award to EBS Emergent BioSolutions Inc., the
company that has long been the sole-source provider of the vaccine. The protest requests the
GAO suspend the award under the solicitation while it reviews PharmAthene's complaint.
Under federal procurement regulations, GAO has 100 days to review the complaint.
RAX Apollo Said in Talks to Buy Rackspace for More Than $3.5b
ReliantHeart has announced that its aVAD intraventricular heart pump won approval in the
European union, allowing the company to begin implants in the coming months. The device,
while only 2.5 centimeters in diameter, still has a 1.2 cm main channel for the blood to flow
through.
RMD discloses subpoena in 10-K, earlier in July 2016, RMD received a federal administrative
subpoena from the OIG of the Department of Health and Human Services.subpoena contains a
request for documents and other materials that relate primarily to industry offerings of patient
resupply software to home medical equipment
RHHBY FDA Approves First Generic of Roche’s Tamiflu
RHHBY French Health Authorities Limit Use of Roche’s Avastin: Echos Roche’s anti-cancer
drug Avastin has been found by French regulators to have insufficient benefit in some cases
and will therefore lose special funding status, French daily Les Echos reports, citing the Journal
Officiel.
RHHBY news that BMY announced that CheckMate -026, a trial investigating the use of Opdivo
at ≥ 5% Clinical trials.gov reports RHHBY expects data in 2H17 from the Phase III IMpower111 study
comparing Tecentriq monotherapy vs. chemotherapy as first-line treatment for squamous NSCLC patients
whose tumors express PD-L1. Genentech spokesperson Austine Graff said the company has not disclosed
when it expects data from the study, and declined to disclose its cut-off PD-L1 expression level. She said
Roche is in the process of consolidating two trials -- IMpower111 and the Phase III IMpower110 trial in
non-squamous NSCLC -- into a single study, with PFS and OS as primary endpoints. Roche is still
enrolling patients in other Phase III studies of Tecentriq as first-line therapy in non-squamous NSCLC
patients. Tecentriq is under review for second-line NSCLC in PD-L1 expressers. Its PDUFA date is Oct
19 2016. The drug also has accelerated approval from FDA for bladder cancer.
Samsung Bioepsis and MRK news that the FDA accepted for filing an NDA for MK-1293 to
treat Type 1 and Type 2 diabetes. The candidate is a follow-on biologic of Lantus insulin
40
for Lantus. It will not be reviewed as a biosimilar. The company expects a decision from FDA in
2017, but did not disclose a PDUFA date.
SGMO disclosed delays for multiple clinical programs. The company now plans to begin Phase
I/II studies next year of SB-318 to treat mucopolysaccharidosis I (MPS I, Hurler syndrome) and
SB-913 for MPS II (Hunter syndrome). It previously planned to start the MPS I study in mid2016, and the MPS II trial in 2H16. President and CEO Sandy Macrae attributed the delay to a
reagent error that will require Sangamo to repeat some preclinical work. Sangamo said it and
partner Biogen Inc would submit INDs next year for SB-BCLmr-HSPC to treat beta-thalassemia
and the partners' therapy for sickle cell disease, and would conduct "additional preclinical work"
for both programs. In May, then-President and CEO Edward Lanphier said Sangamo expected
to submit an IND during 2Q16 for the beta-thalassemia program, and expected Biogen to file an
IND in 2H16 for the sickle cell program. Sangamo intends to begin a Phase I/II study of its SBFIX-1501 (SB-FIX) for hemophilia B this year, but acknowledged a delay in that program as
well. In May, Lanphier had said the company hoped to dose the first patient in June.’
SNY Samsung Bioepsis and MRK news that the FDA accepted for filing an NDA for MK-1293
to treat Type 1 and Type 2 diabetes. The candidate is a follow-on biologic of Lantus insulin
for Lantus. It will not be reviewed as a biosimilar. The company expects a decision from FDA in
2017, but did not disclose a PDUFA date.
TEVA announces launch of generic Gleevec tablets in the United States Teva Pharmaceutical
announced the launch of the generic equivalent to Gleevec (imatinib mesylate) tablets,100 mg
and 400 mg, in the United States for multiple indications approved by the FDA.
TEVA bberg has story that one Could Expect Treanda Generics in Three Waves Post Trial
The trial decision finding Teva's four Treanda patents valid could mean three waves of generic
copies are likely. Glenmark has publicly said its Treanda settlement allows it to launch in 2019.
Due to a successful dismissal bid, Sagent and InnoPharma were able to sidestep Teva's 2031
patent, allowing them to launch in 2026, the date of Teva's second-latest Treanda patent
expiration. Accord and Sagent are likely settling to launch earlier than 2026. Remaining
defendants would have to wait until 2031.
ThromboGenics terminates collaboration and license agreement with Eleven Biotherapeutics 8-K Eleven Biotherapeutics received notice from ThromboGenics N.V. of ThromboGenics’s
termination, effective as of 31-Oct-16, of the Collaboration and License agreement between the
company and ThromboGenics , dated 28-May-13. Under the Collaboration, the company and
ThromboGenics collaborated to seek to identify protein or peptide therapeutics that directly
modulate any of a specified set of targets in a novel pathway in retinal disease. In connection
with the Collaboration, ThromboGenics paid the company an upfront technology licensing fee of
$1,750,000 and paid the company to perform activities under the Collaboration at a set rate per
full-time equivalent person working on Collaboration activities. The initial research term
concluded in November 2015. There have not been any collaboration products identified whose
modulation of any of the targets has been confirmed in the course of the Collaboration. The
Collaboration also provided for potential future payments to the company by ThromboGenics of
up to an aggregate of $10,000,000 if ThromboGenics were to achieve specified preclinical and
41
clinical milestones with respect to collaboration products and up to an aggregate of $15,000,000
if ThromboGenics were to achieve specified regulatory milestones with respect to collaboration
products. In addition, ThromboGenics would have been obligated to pay the company a low
single digit royalty on sales of collaboration products by ThromboGenics, its affiliates or
sublicensees. None of these milestones or royalties are expected to be payable following
termination of the Collaboration
VRSN US DOJ may take a look at VeriSign's purchase of .web domain -- VRSN recent
purchase of the .web domain for $135M, as well as the deal with ICANN for an 8-year extension
of its .com contract, could attract the attention from the DOJ, according to the report. The price
that was paid as well as antitrust concerns given that .web could be considered competitive to
the .com and .net domains that VRSN already owns, may be grounds for the DOJ to take a
look, according to Capitol Forum.
VRX Relistor drug has attracted interest from other companies as VRX works to reduce its debt
load, people familiar with the matter said.A potential sale could value the constipation treatment
at $400 million to $500 million, the people said, asking not to be identified because the
deliberations are private. Valeant could still choose not to sell the drug, the people said. A
representative for Valeant declined to comment. Chief Executive Officer Joe Papa is seeking to
ease a debt burden that ballooned to more than $30 billion as he also works to help the
business recover from criticism of its business practices and drug pricing. The company, whose
investors include Bill Ackman’s Pershing Square Capital Management, is also considering other
asset sales, including smaller cosmetic and pharmaceutical assets, to raise cash, people
familiar with the matter have said previously. Valeant and its partner for Relistor, Progenics
Pharmaceuticals Inc., said last month that the FDA approved the tablet form of the drug to treat
constipation brought on by taking opioids for chronic, non-cancer pain. Valeant said it expects to
start selling Relistor tablets in the U.S. in the third quarter this year. An injectable form of the
treatment was approved by the FDA in 2008.Progenics said on July 26 it had received a $50
million payment from Valeant after the FDA’s approval. Progenics is entitled to receive as much
as $200 million of milestone payments tied to sales of the drug, the company said.
XON FDA releases final environmental assessment for genetically engineered mosquito Today,
the FDA has published a final environmental assessment (EA) and finding of no significant
impact (FONSI) that agrees with the EA’s conclusion that the proposed field trial will not have
significant impacts on the environment. The field trial is designed to assess whether the release
of Oxitec Ltd.’s (Intrexon, XON) genetically engineered (GE) mosquitoes (OX513A) will
suppress the local Aedes aegypti mosquito population in the release area at Key Haven,
Florida. Ae. aegypti is known to transmit potentially debilitating human viral diseases, including
Zika, dengue, yellow fever and chikungunya.
Broker meetings in health
Aug 8
BEAT - Lake Street-San Francisco, CA
CROX - Piper Jaffray-New York, NY
CYTK - Needham-Detroit, MI
EVHC - Oppenheimer -San Francisco, CA
ITCI - Leerink-Boston, MA
NEOG - Roth Capital-Philadelphia, PA
OFIX - Jefferies-Mid Atlantic
42
TVPT - Jefferies-United States
WMGI - Jefferies-Boston, MA
XNCR - Leerink-New York, NY
Aug 9
ADRO - William Blair- New York, NY
ATRC - Canaccord-Boston, MA
BEAT - Lake Street-San Diego , CA
ENTL - Piper Jaffray-New York, NY
EXAS - Canaccord-Boston, MA
FLML - Jefferies-Denver/San Francisco
NEOG - Roth Capital-Boston, MA
NPTN - CraigHallum-Toronto, Canada
OFIX - Jefferies-New York, NY
SENS - Canaccord-Boston, MA
VRX - Jefferies-New York, NY
VWR - William Blair-Kansas City, MO
XNCR - Leerink-Boston, MA
Aug 10
ATRS - Jefferies-Boston, MA
CPHD - CraigHallum-Minneapolis, MN
EGRX - William Blair- New York, NY
FLML - Jefferies-Denver/San Francisco
FLR - Canaccord-Toronto, Canada
LGND - Stephens-Dallas / Houston, TX
LH - CraigHallum-Boston, MA
PG - B. Riley-Cincinnati, OH
ZLTQ - Leerink-Mid Atlantic
Aug 11
AET - Leerink-Hartford, CT
AHS - William Blair-Minneapolis, MN
BNFT - Jefferies-New York, NY
NVCR - Evercore ISI-New York, NY
NVO - Jefferies-Chicago, IL
PFE - Piper Jaffray-London, England
QUOT - William Blair- New York, NY
SFM - Oppenheimer -West Coast
SNH - Jefferies-Los Angeles/San Francisco, CA
SYNT - Needham-Chicago, IL
UA - William Blair-Chicago, IL
WOOF - CL King-Chicago, IL
Aug 12
ADXS - Jefferies-Boston, MA
AHS - William Blair-Milwaukee, WI
IONS - Needham-New York, NY
SNH - Jefferies-Los Angeles/San Francisco, CA
43
Aug 15
FLML at JMP in Boston
IART with Piper Jaffray in Midwest
Aug 16
IART with Piper Jaffray in Midwest
NHI at JMP Midatlantic Aug 16 2016
QGEN CEO and IR with Berenberg in Toronto Aug 16 2016
Aug 17
ACHN at JMP in Texas
BLCM at Suntrust in Midatlantic
Novozymes at Bof A Chicago
Aug 18
BLCM at Suntrust in Midatlantic
ESRX at Suntrust in NY
LXRX at Stifel in San Fran
Aug 19
SRDX at Barrington in Canada
Aug 26 2016
Spire Health Group at Berenberg in Dublin
Aug 29 2016
CSL with UBS in various places
Aug 30 2016
CSL with UBS in various places
Primary Health Care CEO at UBS in Chicago
Bionap on RDHL
RDHL there are some very important catalysts on the horizon, including a DSMB interim look at
the Phase 3 MAP-US trial with RHB-104 for Crohn's disease, as well as final data from the
Phase 2a exploratory trial with RHB-104 in multiple sclerosis. Phase 3 data from Bekinda® in
gastroenteritis is expected before the end of the year; and, the confirmatory Phase 3 RHB-105
trial in patients with active H. pylori infection is expected to be initiated in the coming
months.These important catalysts certainly make RedHill a name to watch over the next few
months; moreover, earlier-stage assets in the pipeline, including Yeliva™™ and Mesupron, are
also interesting and present RedHill the opportunity to expand its business into oncology.
Mesupron targets a validated cancer biomarker of high significance and Phase 2 data points to
clear utility in both pancreatic and metastatic breast cancer. These assets provide diversification
and upside to the story as RedHill enters a pivotal period over the next year.
FDA Law Blog
FDA Law Blog highlighted in Food and Drug Law Journal, titled "FDA’s Flexibility in Subpart H
Approvals: Assessing Quantum of Effectiveness Evidence”. "The paper examines the strength
of scientific and clinical evidence for FDA’s 19 non-AIDS, non-cancer Subpart H approval
determinations over the accelerated approval program’s 24-year existence. The authors
conclude that, despite the agency’s infrequent use of accelerated approval for non-AIDS, noncancer therapies, FDA exercises extraordinary regulatory flexibility in its Subpart H approvals—
much more than is expressly provided for" by FDA regulations. Authors note the three key
44
factors in FDA’s Expedited Programs Guidance are 1. Understanding of the disease; 2.
Understanding of the relationship between drug effect and disease process; and 3. Clinical
evidence for (a) the unvalidated surrogate, and (b) the clinical benefit. They write however, “you
don’t need to knock it out of the park” on all 3 factors.(source Factset)
August 4, 2016
Aug 4 2016 TWTR Sun Trust analyst Robert Pack thinks the potential takeover is just a
rumor , TWTR may consider bids in the future but not before 2017
New health events to add
CRL Charles River Laboratories International Inc Investor Day Aug 11 2016
INCR INC Research Holdings Inc 2016 Analyst and Investor Day Aug 16 2016
BIIB IONS analysis of PH III ENDEAR Study news Aug 16 2016
IONS BIIB analysis of PH III ENDEAR Study news Aug 16 2016
VAR Varian Medical Systems Inc Investor Meeting at ASTRO 2016 Sep 27 2016
SRCL Stericycle Inc Investor Day Nov 10 2016
Terumo Corp Medium- and Long-Term Growth Strategy Meeting Dec 12-16 2016
New co specific events to add non health
SNC State National Gas analyst meeting Aug 9 2016
EXC Exelon Corp Corporate Analyst Meeting Aug 10 2016
EICHERMOT.NSE Eicher Motors Ltd Institutional Investor Meeting Aug 11-12 2016
JEN.DE Jenoptik AG Analyst Conference Aug 11 2016
EE El Paso Electric Co Investor Meeting Aug 12 2016
ZURN.VX Zurich Insurance Group AG Non Life Reserve Triangles And Other Exhibits For
The Full Year 2015 Corporate Call Aug 12 2016
Cummins India Ltd Institutional Investor Meeting Aug 17 2016
Cott Corp Conference Call to Provide Financial Modeling information on Eden Springs
and S&D Acquisition Aug 17 2016
UHAL Amerco 10(th) Annual Virtual Analyst and Investor Meeting Aug 25 2016
CTS Investor Day Sep 8 2016
LEG Leggett & Platt Inc Investor Day Sep 14 2016
INTU Intuit Inc Corporate Analyst Meeting Sep 21 2016
NIC Inc Investor Meetings Hosted by Maxim Group Sep 22 2016
DEQ.DE Deutsche Euroshop AG Supervisory Board Meeting - Hamburg Sep 23 2016
DANSKE.CO Tieto Oyj Investor Breakfast Hosted by Danske Bank Sep 30 2016
LUK Leucadia National Corp and Jefferies Group LLC Combined Investor Day Oct 5 2016
INF.L Informa PLC Investor Day 2016 Oct 6 2016
ISAT.L Inmarsat PLC Capital Markets Day Oct 7 2016
PAL.VA Palfinger AG Investors Conference Oct 10 2016
SRCL Stericycle Inc Investor Day Nov 10 2016
45
PRO PROS Holdings Inc Analyst Day Nov 10 2016
TDC Teradata Corp Analyst Day Nov 17 2016
HEIA.AS Heineken NV What's Brewing Seminar Nov 25 2016
DG.PA Vinci SA Investor Day Dec 2 2016
BSFT BroadSoft Inc 2016 Analyst Day Dec 5 2016
New broker conferences to add
Cowen Industrial Innovation & Technology Summit - Chicago, IL Aug 4 2016
Credit Suisse Gaming, Lodging, Leisure & Restaurant Conference - New York, NY
Aug 10-11 2016
Daiwa Korea Corporate Day - HK - HK, HK
Aug 23-24 2016
Daiwa Korea Corporate Day - SINGAPORE - SINGAPORE Aug 25 2016
Piper Jaffray Texas Regional Bank Bus Tour - Dallas, TX Aug 29-30 2016
Stephens Boston Software Bus Tour - Boston, MA
Aug 30 2016
HSBC India Discovery Forum - HK - HK, HK Aug 30 2016
UBS Investor Club - Zurich, CH Aug 30 2016
HSBC India Discovery Forum - SINGAPORE - SINGAPORE Aug 31 2016
Nomura India Corporate Day - London, GB Sep 6 2016
Deutsche Bank Aircraft Finance & Leasing Conference - New York, NY Sep 6-7 2016
UBS China A-Share Conference - Shenzhen, CN Sep 6-7 2016
Morningstar ETF Conference - Chicago, IL Sep 7-9 2016
Daiwa Pan-Asia Innovative Companies Conference - Toronto - Toronto, CA Sep 8 2016
Canaccord Genuity Online Gaming Conference - London, GB Sep 20 2016
Piper Jaffray Midwest Bank CEO Roundtable - New Buffalo, MI Sep 29 2016
Nomura Taiwan Corporate Day - HK, HK
Oct 5-6 2016
Deutsche Bank Asian Managers Forum - HK, HK Oct 13 2016
Nomura HK China Transportation and Logistics Corporate Day - HK, HK Oct 14 2016
Jefferies Greater China Summit - HK, HK Oct 26-27 2016
Deutsche Bank dbAccess Indonesia Conference - Jakarta, ID Nov 1-3 2016
Piper Jaffray West Coast Bank Symposium - CA Nov 2 2016
Investec Conference - London, GB Nov 14 2016
Raymond James Boston Fall Investors Conference - Boston, MA Nov 15 2016
ROTH Technology Corporate Access Day - New York, NY Nov 16 2016
Carnegie IT Seminar - Helsinki, FI Nov 24 2016
Nomura Investment Forum - Tokyo, JP Nov 28-Dec 2 2016
JPMorgan Fintech & Specialty Finance Forum - New York, NY Nov 30 2016
Goodbody Equity Conference - London, GB
Dec 2 2016
Credit Suisse European Business Services Conference - San Francisco, CA
Dec 6-7
2016
Other events to add
The India International Gold Convention Aug 11 2016
Game of Business Tribeca Rooftop | New York, NY Aug 9 2016
NVCA Innovation Policy Roundup- Austin, TX Aug 30 2016
NVCA CFO Boot Camp Washington DC Sep 27-29 2016
Founders Forum: How to Play the Series Featuring Brian Lee- Los Angeles Aug 18 2016
46
The Inc. Startup Accelerator Sep 20 2016
Iconic Boston Sep 22 2016
5th Annual Global Crowdfunding Convention Oct 15-17 2016
The Country Caller on TWTR
TWTR SunTrust analyst Robert Peck thinks the chatter regarding a potential takeover is
just a rumor and a deal is unlikely to happen and that TWTR is very unlikely to consider a
buyout offer because of two reasons. First being the less-than-a-year role of CEO Jack
Dorsey in the company. Secondly he believes that the recently reconstituted board,
highly supportive of the CEO, would want time to decide whether a turnaround plan
would be successful or not.According to SunTrust analyst, private equity bids do not
make sense for the Tweeting platform at this point in time. The several reasons he
provided include, “1) they would need an operator to run it; 2) it would be a large check
@ ~$19bn; 3) PE bids leverage cash flow to generate ROE and Twitter has de minimis
FCF; 4) there would be no overlapping synergies to take out costs; and 5) employees are
highly compensated in stock (100% of TTM EBITDA) and they would need to be
compensated in cash going forward, making the deal more expensive.”However, Twitter
may consider strategic bids in future but not any time soon before 2017, said Mr. Peck.
FT Lex
ETSY Getting craftier, the alternative is that AMZN decides it is simpler to pay $ 2 billion
or so to acquire ETSY, AMZN makes few big acquisitions, but it bought Zappos, the shoe
retailer, for $ 1.1 billion in 2209, Homemade is not always best
Motley Fool Biogen's risky pipeline and one-sided portfolio could be a deal-killer
BIIB risky pipeline and MS-focused portfolio could wind up pushing away most, if not all,
possible suitors for the company, despite its healthy profits. The two biggest cogs in Biogen's
portfolio are Anti-LINGO-1 and aducanumab. Unfortunately, Anti-LINGO-1, which was designed
to reverse underlying nerve damage suffered by MS patients, failed a pivotal midstage study in
June. Long story short, anti-LINGO's future is extremely uncertain. On the other hand,
aducanumab, an experimental treatment for Alzheimer's disease, has been largely successful,
albeit in early stage studies. Although the mid-range dose flopped in clinical studies, the 3 mg
dose and 10 mg dose demonstrated positive results, pushing Biogen into later-stage studies
with the drug. Data from this late-stage study is expected by 2018. If approved, aducanumab
could easily hit $5 billion to $10 billion in sales depending on its efficacy.
Last year, Celgene acquired Receptos for $7.2 billion in order to get its hands on ozanimod, a
next-generation MS drug. Currently in late-stage trials with top-line data expected next year,
ozanimod has shown plenty of clinical promise. Its phase 3 study is a head-to-head against
Biogen's Avonex, and if it outperforms, Avonex's roughly $2.4 billion in sales could be chipped
away quickly. RHHBY MS drug, Ocrevus, which is currently under priority review looks to be on
its way to approval for primary progressive multiple sclerosis, a form of the disease that has no
approved medications and targets 10%-15% of the MS population. However, Ocrevus is also
being pointed at relapsing MS, which could put it in direct competition with Biogen. In short, a
Biogen buyer would have to accept that its stranglehold on MS could be waning, and that its
pipeline is growing riskier than ever.
47
Not exactly a great formula if you're looking to sell. It's unclear what direction Biogen will take
with Scangos looking to step aside, but I'd surmise that Biogen putting itself on the auction block
seems like something that's unlikely to happen.
BBJ Don Seiffert on Five reasons it would) stink for Massachusetts if Biogen is acquired
BIIB but from the point of view of Greater Boston’s non-investor community, the prospect of
Biogen being purchased by a big pharma company deserves to be viewed with a lot skepticism.
MRK rumored to be the most likely buyer — or some other giant drug company, an acquisition
of Biogen would be bad news for the area for the following five reasons:
Layoffs. Safe to say that any company that acquires Biogen is going to be looking to cut some
of the 2,900 local staff. While Biogen’s research scientists are probably the safest of the bunch
— presumably any buyer will be interested in maintaining at least some of the company’s R&D
operations — administrative and sales positions that overlap with that of the acquiring firm
would likely be slashed. That said, local researchers would not necessarily be immune, as we
saw when Merck bought Cubist in 2015 and then cut about a quarter of that company’s local
headcount— 120 scientists in all — a couple months later.
BIIB support of local nonprofits and charitable causes. The company’s philanthropic arm, the
Biogen Foundation, gave $35 million in contributions, grants and gifts in 2014, according to tax
forms. A lot of that went to local causes such as the Greater Boston Food Bank, the Museum of
Science and to promoting education in and around Cambridge. While any would-be acquirer will
probably have its own charitable foundation, companies tend to give most generously to the
communities around their headquarters, and almost any scenario would move Biogen’s
headquarters out of state.
BIIB leadership in being a good corporate citizen. The company leads the region by example in
its commitment to anti-discrimination, humanitarian and ecological causes. A few examples:
Three of the 11 members of its board are women, much higher than the industry standard of 10
percent. The company achieved carbon neutrality last year by investing in sustainable
technologies and working with its suppliers to reduce carbon emissions. It also has a perfect
score on the Human Rights Campaign’s Corporate Equality Index. Those achievements are rare
in any industry, and it’s likely that they would be much less a priority under a new corporate
entity.
Loss of its name. Like Genzyme and Millennium before it, the name “Biogen” is associated with
Greater Boston’s crucial role in the growth of the biotech industry over the past four decades.
Founded in Switzerland by Nobel Prize-winning chemist Walter Gilbert, the company has been
based in Massachusetts since 1982. Its 1996 drug, Avonex, was one of the first in the world to
treat multiple sclerosis, and it has since developed five others. Sure, an acquirer may decide to
keep the name “Biogen” for a while after it’s acquisition, but as in the cases of both Millennium
Pharmaceuticals (bought by Takeda in 2008) and Genzyme (bought by Sanofi in 2011), the
days when the name Biogen will be associated with this region's world-class life sciences sector
will be numbered.
The Kendall Square culture. Granted, Biogen is a far ways from being a startup company,
having been publicly traded since 1983. Its executives wear suits and ties, not T-shirts. But what
has made Biogen great for all these years is its attitude — the same attitude that’s made
Kendall Square great, which comes down to a willingness to tackle big challenges that could
change the world. Despite its success in developing drugs for multiple sclerosis and hemophilia,
the company made a risky decision last year to bet its reputation on trying to develop the first
48
drug for Alzheimer’s disease, universally recognized as one of the biggest health care
challenges of our time. Sure, Merck and other big pharmas are working on Alzheimer's as well,
but the risk of failure for those big pharma companies is simply not as great. I would argue that
Biogen — despite its steps toward corporatization — still has the heart of a scrappy biotech. To
be acquired by a big pharma firm would be one big step away from that.
Health news
ABEO announces European regulatory approval for phase 1/2 trial utilizing ABO-102 in patients
with MPS IIIA ABEO announced European regulatory approval for a Phase 1/2 Gene Therapy
Clinical Trial utilizing ABO-102 (AAV-SGSH) for patients with Sanfilippo syndrome type A (MPS
IIIA). The clinical study was approved by the Agencia Espanola de Medicamentos y Productos
Sanitarios, and the Company is conducting the Phase 1/2 clinical study at Cruces University
Hospital (Bilbao, Spain).
ABBV BAYER seek new treatment avenues for Endometriosis- Bayer has two experimental
therapies in human testing, focuses early research away from hormonal approaches, Joachim
Marr, Bayer’s head of medical affairs for women’s health, says in interview. AbbVie has
developed elagolix, which may be submitted for approval this year, says industry needs
something effective but minimally invasive Endometriosis costs $78 billion a year in lost
productivity and medical expenses in U.S.
ADAP announces partial clinical hold of planned pivotal study of NY-ESO spear T-cell therapy
ADAP has received notice from the FDA that a partial clinical hold has been placed on its
planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma
(MRCLS). This trial is not yet active at any investigational sites, and has not recruited any
patients. This notification of partial clinical hold does not apply to any other Adaptimmune
study. The FDA notification is not based on safety concerns. In its correspondence, the FDA
requested additional CMC information and answers to certain trial design questions prior to the
trial start.
AKRX board authorized a stock repurchase program pursuant to which the company may
repurchase up to $200M of the company’s common stock.
AMPH wholly owned UK subsidiary, Amphastar UK Limited, acquired a UK based corporation,
International Medication Systems (UK) Limited, including its product trademarks, and other
related product assets, as well as Marketing Authorizations for thirty-three products in the UK,
Ireland, Australia, and New Zealand, representing eleven different injectable chemical entities,
from UCB PHARMA GmbH for $7.7M. The products are generic injectables containing the
following active ingredients; Adrenaline, Amiodarone, Atropine, Calcium Chloride, Furosemide,
Glucose, Lidocaine, Magnesium Sulphate, Morphine, Naloxone and Sodium Bicarbonate.
Amphastar plans to transfer the products to its facilities in California. The transfer will require
UK MHRA and other related regulatory agency approval before the products can be relaunched.
AMRN FDA agrees to Amend SPA on Trial .Amarin says amendment to Reduce-It
cardiovascular outcomes study keeps primary endpoint and overall study timing and size
unchanged, adds a second interim efficacy analysis and additional pre-specified endpoints. Co.
sees top-line data in 2018 Secondary, tertiary trial endpoints expanded; statistical analysis plan
now includes more than 30 pre-specified secondary and tertiary endpoints Trial will test whether
treatment with AMRN’s Vascepa reduces cardiovascular events in patients who have
persistently elevated triglyceride levels despite stabilized statin therapy
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AMRN and FDA reaffirm concurrence on REDUCE-IT through SPA agreement amendment
The company announced that the FDA agreed to an amendment of the company's special
protocol assessment (SPA) agreement for the REDUCE-IT cardiovascular outcomes study
reaffirming concurrence on critical components of the revised study protocol and analysis plans
and incorporating recommendations from the trial's independent oversight committees Key new
elements reflected in the company's amendment include: Finalized details of the statistical
analysis plan covering both final and interim efficacy analyses Added a second pre-specified
interim efficacy analysis at approximately 80% of the 1,612 primary cardiovascular events
targeted for completion of the study Expanded to over 30 the number of pre-specified
secondary and tertiary endpoints in an effort to more fully capture the broad potential clinical
effects of Vascepa (icosapent ethyl) and the diversity of the patient population being studied
The amendment does not change the primary endpoint or the overall size of the REDUCE-IT
study or the company's prior guidance on timing. Prospective study of additional endpoints
could lead to improved patient care for specific groups within the diverse population studied in
REDUCE-IT. The addition of a second interim efficacy analysis at approximately 80%
completion is expected to facilitate the compilation of the final locked dataset at study end and
potentially shorten the time needed to complete final analysis and final result reporting.
ANTH announces completion of dosing in CHABLIS-SC1 Phase 3 clinical study of blisibimod
The company announced that the last patient in the Phase 3 CHABLIS-SC1 clinical study,
evaluating blisibimod for the treatment of systemic lupus erythematosus, received their final
study dose on July 27th Due to timing of this final visit, the company expects topline efficacy
and safety data will be available prior to the annual American College of Rheumatology Annual
Meeting in November
ANTM CI New York to hold hearing to address ANTM/CI deal - Bloomberg Citing a letter sent
to an ANTM attorney, article reports that the state's Department of Financial Services believes
the planned purchase would reduce competition in the state's insurance markets and hurt the
financial health of the companies. Department has confirmed the letter and indicates that no
date has been set, but a notice will be sent in the near future. Notes that the deal would give the
combined firm a third of the state's commercial insurance market and would control almost half
of the state's market for providing administrative services to self-insured firms.
APHB granted Japanese patent covering the use of phage therapy to resensitize Pseudomonas
aeruginosa infections to antibiotics AmpliPhi Biosciences announced that the Japanese Patent
Office has granted AmpliPhi a patent for the “Beneficial effects of bacteriophage treatments”
targeting Pseudomonas aeruginosa (Pseudomonas)infections. A corresponding patent has
been granted in the United States and is currently being prosecuted in Canada. Additional
patents with broader bacterial species claims have been granted in the European Union and
Australia. The patent covers the treatment of Pseudomonas infections through the sequential
use of a bacteriophage (phage) therapeutic followed by an antibiotic to which the bacteria were
formerly resistant. AB-PA01 is currently being manufactured in AmpliPhi’s cGMP facility and is
in nonclinical studies at the Royal Brompton Hospital, London, UK. AmpliPhi anticipates
initiating a Phase 1 clinical trial in 2017 of AB-PA01 for the treatment of CF using a nebulized
formulation of the phage cocktail.
APRI in 2016 we will continue to pursue out-licensing opportunities for Vitaros in Japan and
China. Apricus’ expenditures will include minimal costs for the preparatory Phase 2B clinical
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development of RayVa, as well as costs for activities associated with supporting the regulatory
approval of Vitaros in the U.S. and the commercialization of Vitaros in Europe.
ATNM issues mid-year letter; notes positive outlook Iomab-B pivotal phase 3 trial initiation
signals transformation of company profile to later-stage development Actimab-A progressing
into phase 2 clinical trial with impetus from phase I results and peripheral blast burden
hypothesis directing to competitively higher response rates
AVEO Q4 of 2017. AVEO expects that its cash resources, its borrowing capacity under its
amended loan agreement, together with certain anticipated operational milestone payments
from its collaboration partners, could allow the company to fund its U.S. tivozanib development
strategy through at least pivotal Phase 3 TIVO-3 top-line data as well as a tivozanib-PD-1
inhibitor combination trial.
BASI Bioanalytical Systems elects Larry Boulet Chairman On 28-Jul-16, the company’s board
voted unanimously to elect Larry S. Boulet as Chairman of the board. Boulet has served as a
director and Chairman of the Audit Committee of the company since 2007.
Bayer Evotec has reached a milestone from Bayer for progression of a program from the
alliance portfolio into Phase 1 clinical development for treatment of endometriosis, triggering a
milestone payment to Evotec. Milestone achieved under strategic alliance between Evotec and
Bayer entered in Oct. 2012; goal of collaboration is to develop 3 clinical candidates within the 5year alliance in the disease area of endometriosis
BAYER examining Monsanto financial accounts, people familiar with the matter said, a crucial
step that could pave the way for the German company to raise its $55 billion takeover offer for
the U.S. agrochemicals giant.Bayer has signed confidentiality agreements to conduct due
diligence on Monsanto, a process that is expected to last a few more weeks, as it weighs the
size and timing of a new bid, the people said, asking not to be identified because the
said.
BAYER Evotec reaches milestone from BAYER triggering payment to Evotec Evotec AG
announces that it has reached a milestone from Bayer for the progression of a programme from
the alliance portfolio into Phase I clinical development for the treatment of endometriosis,
triggering a milestone payment to Evotec. This milestone was achieved under the strategic
alliance between Evotec and Bayer entered in Oct-12. Bayer will be responsible for subsequent
clinical development and commercialisation while Evotec is eligible for clinical and sales
milestones as well as royalties on net sales depending on the successful development and
approval of a potential drug candidate.
BDSI announces randomization target reached in clinical trial of Clonidine topical gel BDSI has
reached its target number of subjects to be randomized in its multi-center, double-blind,
placebo-controlled Phase 2B study assessing the efficacy and safety of Clonidine Topical Gel in
the treatment of pain associated with painful diabetic neuropathy. Based on the timing of
randomization of the last patient, BDSI now expects topline results of the study will be available
by the end of this year, which puts it six to eight weeks ahead of schedule.
BIIB hasn’t received any formal expressions of interest and isn’t actively soliciting takeover
offers, Reuters said, citing person familiar. While peers have spoken with individual BIIB board
members over time, nothing has been submitted to board recently
BIIB WSJ's Heard on the Street column says buying Biogen would be big gamble for big
pharma The column says that the shares are pricey, even if they were trading at a multiple
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almost twice as high 18 months ago, and if Biogen's pipeline doesn't deliver a winner, any
purchaser might not get a decent return on its investment.
CALA announces enrollment of first patient in CB-839 in combination with checkpoint modulator
Calithera Biosciences announces that the first patient has been enrolled in a Phase 1/2 clinical
trial assessing the safety and efficacy of CB-839, a first-in-class glutaminase inhibitor, in
combination with nivolumab for the treatment of renal cell carcinoma, malignant melanoma and
non-small cell lung cancer. The Phase 1/2 study will assess the safety, pharmacokinetics and
pharmacodynamics of CB-839 and nivolumab. The study will enroll patients with clear cell renal
cell carcinoma who are either naïve to checkpoint inhibitors, or were recently treated with
nivolumab without tumor response, as well as melanoma and non-small cell lung cancer
patients who have received anti-PD-1 monotherapy as their most recent line of therapy without
tumor response.
CERU Reports Q2: “Since our last quarterly call, we made significant progress advancing both
of our clinical candidates, CRLX101 and CRLX301,” said Christopher D. T. Guiffre, President
and CEO of Cerulean. “We reached the 70 events needed to lock the database for our
randomized Phase 2 trial in 3rd and 4th line renal cell carcinoma (RCC). Therefore, we remain
on track to report top-line data this quarter. In addition, we presented compelling data from our
Phase 1B/2 trial of CRLX101 with weekly paclitaxel in relapsed ovarian cancer, and subsequent
to the end of the quarter, the FDA granted Fast Track designation for this promising
combination. We believe CRLX101 has broad clinical utility as both monotherapy and in
combination with other anti-cancer agents against a broad range of tumor types, and we look
forward to providing updates on our continued clinical progress in the months ahead.” Cash
Position - The company had $47.2M in cash and cash equivalents at 30-Jun-16. The company
believes its cash and cash equivalents are sufficient to fund its planned operations into Q2 of
2017 and that the company has the ability to reduce or defer operating expenses as may be
needed to fund its operations into Q3 of 2017.
CFRX receives designation as a small and medium enterprise by the European Medicines
Agency Companies with small and medium enterprise status are eligible to receive financial
incentives as well as administrative and regulatory support through national and regional level
programs as well as being eligible for early application (prior to proof of concept) to the priority
medicines (PRIME) scheme CEO comments ''This strengthens our drive toward bringing our
new lysin technology, and especially our lead compound CF-301, to a global population of
patients.''
Chengdu Olymvax Biopharma has in-licensed greater China rights to a novel Group A
Streptococcus (GAS) vaccine developed by Australia's Griffith University. Olymvax will
manufacture the vaccine for Phase I clinical trials that will be conducted concurrently in China
and Australia. The needle-free vaccine is delivered in a single dose through the nose, which
facilitates access to lung lining tissue, the location for most strep infections.Olymvax will pay
Griffith royalties on sales and also make milestone payments.
CI ANTM New York to hold hearing to address ANTM/CI deal - Bloomberg Citing a letter sent
to an ANTM attorney, article reports that the state's Department of Financial Services believes
the planned purchase would reduce competition in the state's insurance markets and hurt the
financial health of the companies. Department has confirmed the letter and indicates that no
date has been set, but a notice will be sent in the near future. Notes that the deal would give the
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combined firm a third of the state's commercial insurance market and would control almost half
of the state's market for providing administrative services to self-insured firms.
CognitiveScale, an artificial intelligence/cognitive computing startup, announced it has raised
$21.8 million in venture funding to promote global sales. The two-year-old startup has
developed software to create a cloud-computing platform that uses machine learning to mine
very large databases. Most delivery startups have focused on bringing us lunch or fetching our
dry cleaning. Dropoff wants to leverage software and GPS to digitize business-to-business
courier services. Two years after launching in Austin, the startup has expanded service to Los
Angeles.
.
DPRX "In Q2 we completed enrollment in the OneStep-1 and OneStep-2 pivotal Phase 3 clinical
trials of Locilex in patients with mild infections of diabetic foot ulcers (Mild DFI) and expect to
have top-line data in September. Pending the results of these trials, we anticipate submitting a
New Drug Application to the FDA and a Marketing Authorization Application to the European
Medicines Agency in H1 of 2017." StreetAccount reported results from the 10-Q after the close
yesterday.
EGLT FDA panel votes to support approval of Arymo ER for pain management ($7.62) Talk To
EGLT FDA panel votes to support abuse-deterrence labeling for Egalet's Arymo ER by the oral,
nasal, and intravenous routes of abuse
Emperra GmbH based in Germany is launching the world's first Bluetooth insulin pen on the
market and therefore expanding its ESYSTA product system's function. The new ESYSTA BT
pen is equipped with a Bluetooth interface and transfers the injected insulin doses directly to the
patient's digital blood glucose diary. The smart insulin pens automatically connected via the 868
MHz interface (similar to the ISM band) are already being successfully used in medicine in
combination with a wireless transmission blood glucose meter as an integrated diabetes
management system, ESYSTA. Both the hardware components and software solutions
(ESYSTA portal, ESYSTA app) have been certified as CE-compliant medical products. Patients
and doctors can achieve a new quality of medical care for Type 1 and Type 2 diabetics using
the patented ESYSTA solution. On the basis of the available scientific data and reimbursement
by statutory health insurance companies on the complex German healthcare market, Emperra is
striving to use this smart insulin pen based ESYSTA telemonitoring solution with an FDA filing
process for the US market. FDA clearance is expected in 2016.
Evotec reaches milestone from BAYER triggering payment to Evotec Evotec AG announces
that it has reached a milestone from Bayer for the progression of a programme from the alliance
portfolio into Phase I clinical development for the treatment of endometriosis, triggering a
milestone payment to Evotec. . Bayer will be responsible for subsequent clinical development
and commercialisation while Evotec is eligible for clinical and sales milestones as well as
royalties on net sales depending on the successful development and approval of a potential
drug candidate.
Fibrostatin SL reported preclinical data for lead candidate T12, which targets the extracellular
GPBP kinase that regulates the assembly of a previously unrecognized mesenchymal collagen
IV network, significantly reduced fibrosis and extended survival in animal models of idiopathic
pulmonary fibrosis. T12 treatment was also effective in slowing the growth and spread of tumors
(lung and breast) in animal studies.
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Galenica subsidiary Vifor Pharma USA Inc. is starting today its previously announced tender
offer for any and all outstanding shares of common stock of Relypsa, at a price of $32.00/share
in cash, without interest and less applicable withholding taxes.
GNCA Outlook On the basis of Genocea’s current operating plans, including the planned
commencement of Phase 3 trials for GEN-003 in the second half of 2017, Genocea expects that
cash, cash equivalents, and investments will be sufficient to fund its operating expenses and
capital expenditure requirements into the second half of 2017, assuming no receipt of proceeds
from potential business development partnerships, equity financings or debt drawdowns
Anticipated upcoming clinical and regulatory milestones for GEN-003 Phase 2B viral shedding
data expected in September Phase 2B 6-month clinical efficacy data expected around the end
of 2016 End-of-Phase 2 meeting with the FDA expected in Q1 2017 Initiation of Phase 2
antiviral combination study in Q4 of 2016
ICPT Anticipated Upcoming Development Milestones: Primary Biliary Cholangitis [PBC]
Program Planned submission of updated COBALT Phase 4 clinical trial protocol to regulatory
authorities by YE16 EU marketing approval decision anticipated by YE 2016 NASH Program
Phase 2 CONTROL trial enrollment completion expected by YE 2016 Phase 3 REGENERATE
trial enrollment completion for interim analysis expected in 1H 2017 Primary Sclerosing
Cholangitis (PSC) Program Phase 2 AESOP trial enrollment completion expected by YE 2016
INT-767 Program Phase 1 trial completion expected by YE 2016
IMGN Pipeline Updates: Mirvetuximab soravtansine is a well-differentiated experimental
therapy for the treatment of ovarian cancer and potentially other tumor types that express its
target, folate receptor alpha (FRα). This ADC is being evaluated in clinical trials as a singleagent therapy for platinum-resistant ovarian cancer and in combination regimens for both
platinum-resistant and platinum-sensitive disease. Single-Agent Therapy: Held Type B meeting
with the FDA to review the path to registration for mirvetuximab soravtansine and the proposed
FORWARD I study protocol. With the benefit of the agency’s guidance, ImmunoGen is moving
forward with initiating this Phase 3 trial as previously outlined, including with the primary
endpoint of progression-free survival (PFS). Strategic Combination Regimens: Initiated the 35patient Phase 2 assessment in FORWARD II of mirvetuximab soravtansine in combination with
Avastin following successful completion of dose finding. Continued enrollment in the
FORWARD II cohorts assessing the ADC used with pegylated liposomal doxorubicin (PLD) and,
separately, with carboplatin, with the cohort assessing the combination with Keytruda on track to
open this summer. Exploring Additional Opportunities Through ImmunoGen’s collaboration
with the National Comprehensive Cancer Network (NCCN), grants were awarded for clinical
assessment of mirvetuximab soravtansine in combination with gemcitabine and as a treatment
of triple negative breast cancer as well as for preclinical studies on mechanisms of resistance,
sensitivity, and biomarkers.
IMGN update : IMGN779 / IMGN632 IMGN779 and IMGN632 deploy ImmunoGen’s new ultrapotent, DNA-acting payload agents that alkylate DNA without crosslinking it. In preclinical
studies, these agents have been found to avoid the sustained toxicity seen with DNAcrosslinking agents. Initiated Phase 1 clinical testing of IMGN779, a CD33-targeting ADC, for
the treatment of AML. Initial clinical data from this trial are expected to be presented in 2017.
Advanced CD123-targeting IMGN632 into IND-enabling testing. The first preclinical findings with
this novel ADC were presented at the European Hematology Association annual meeting, with
additional data on its distinctive activity and tolerability expected to be presented in late 2016.
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IMGN529 IMGN529 deploys ImmunoGen’s validated maytansinoid payload technology and
recently gained orphan drug status in diffuse large B-cell lymphoma (DLBCL). Initiated Phase 2
clinical testing of IMGN529 used in combination with Rituxan for patients with B-cell
malignancies including DLBCL based on marked synergy in preclinical testing.
INSM Continues to expect patient enrollment in its phase 3 CONVERT study of ARIKAYCE
(liposomal amikacin for inhalation) to conclude in 2016
ITM Isotopen Technologien Munchen AG, of Garching, Germany, said the EMA granted
marketing authorization for Endolucinbeta, following a positive recommendation earlier this year
by the Committee for Medicinal Products for Human Use. Endolucinbeta is a
radiopharmaceutical precursor used for radiolabeling of disease-specific carrier molecules such
as antibodies or peptides.
JNP Outlook: Based on year-to date revenues and expectations for the second half of the year,
Juniper now anticipates full-year 2016 revenue growth in the low- to mid-teen percentage range
over 2015 results.
JUNO announces multiple myeloma The company has entered into an exclusive license
agreement with Memorial Sloan Kettering Cancer Center (MSK) and Eureka Therapeutics, Inc.
for a novel, fully-human binding domain targeting B-cell maturation antigen (BCMA), along with
binding domains against two additional undisclosed multiple myeloma targets to be used for the
potential development and commercialization of chimeric antigen receptor (CAR) cell therapies
for patients with multiple myeloma. The binding domains were developed under a collaboration
agreement between Eureka Therapeutics and MSK.
KDMN Daniel Loeb increases stake in Kadmon Loeb, who already owns 10% of Kadmon,
bought 1.4m shares at between $9.34-$12 a share in co.
MASI announces CE marking for pediatric O3 regional Oximetry
MAYNE following its $652 million deal for 42 drug products from Teva Pharmaceutical (TEVA)
and Allergan (AGN), Australia-based Mayne Pharma has increased the scope of a planned
expansion of a manufacturing facility in eastern North Carolina.The deal with Teva and Allergan
brought 37 approved drugs and five products that have been filed with the U.S. Food and Drug
Administration under the Mayne Pharma brand. The deal thrust Mayne into the 25 generic
companies in the United States. At least 11 of the products will be shifted to Mayne Pharma’s
manufacturing plants in Greenville, N.C. and Salisbury, South Australia. With the added number
of products in its pipeline, Mayne said it will commit an additional $15 million to the expansion of
its manufacturing facility in Greenville, N.C. Last year, the company broke ground on what was
a planned $65 million expansion that includes a 126,000 square-foot expansion to support
space for use in large-scale oral and solid-dose manufacturing. The additional $15 million will
introduce new capabilities to the facility, including multi-particulate layering and bead-coating
fluid bed technology, WNCT reported.Mayne develops and manufactures branded and generic
products globally.
Microbion Corp FDA granted MBN-101 fast track designation for adjunctive treatment of mild
and moderate diabetic foot ulcer infections. The drug, a broadspectrum antimicrobial, previously
received FDA qualified infectious disease product designation for that indication. A safety and
efficacy study of MBN-101 in moderate to severe diabetic foot ulcers is set to start in the fourth
quarter.
MNTA announced that the company has discontinued further accrual in its Phase 2 trial
evaluating necuparanib in combination with Abraxane and gemcitabine in patients with
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advanced metastatic pancreatic cancer. The decision to discontinue enrollment into the study
was based on the recommendation from the independent Data Safety Monitoring board (DSMB)
following a planned interim futility analysis conducted once 57 deaths (50% of the target number
of 114 events required for trial completion) had occurred. Management comments: “We are
extremely disappointed with the outcome of the futility analysis – in particular, for those patients
with pancreatic cancer where there is still so much unmet need for safe and effective therapy,”
“We agree with the DSMB recommendations and plan to confirm the futility analysis and
determine next steps for the necuparanib program.” MNTA heeded the recommendation of an
independent data safety monitoring board (DSMB) and stopped enrollment in the phase II trial
of necuparanib in patients with advanced metastatic pancreatic cancer following the trial’s
planned interim futility analysis. While no new safety signals were observed and the DSMB
deemed the toxicity profile manageable, the Cambridge, Mass.-based company said data
assessed from 120 randomized patients concluded that necuparanib, in combination with
Abraxane (nab-paclitaxel, Celgene Corp.) and gemcitabine, did not show a sufficient level of
efficacy to warrant continued enrollment.
MON BAYER examining Monsanto financial accounts, people familiar with the matter said, a
crucial step that could pave the way for the German company to raise its $55 billion takeover
offer for the U.S. agrochemicals giant.Bayer has signed confidentiality agreements to conduct
due diligence on Monsanto, a process that is expected to last a few more weeks, as it weighs
the size and timing of a new bid, the people said, asking not to be identified because the
said.
NTEC Intech Pharma initiated a new clinical development program for its Accordion Pill
platform with the two primary cannabinoids contained in Cannabis sativa. The company plans to
formulate and test cannabidiol (CBD) and tetrahydrocannabinol (THC), or AP-CBD/THC, for the
treatment of various indications, including pain management. A phase I trial with AP-CBD/THC
is expected to begin during the first quarter of next year.
NUVA secures CMS add-on payment for MAGEC system NuVasive announced that the U.S.
Centers for Medicare and Medicaid Services (CMS) has granted a new technology add-on
payment (NTAP) for magnetically controlled growth rods. The company's MAGEC system is the
only magnetically controlled growth modulation system cleared by the FDA for pediatric spinal
deformity, helping surgeons reduce the number of surgeries required to treat patients with Early
Onset Scoliosis (EOS).
NVS draft guidance, NICE recommends secukinumab for treating ankylosing spondylitis (CHF
79.95 -CHF 0.05) In draft guidance, the National Institute for Health and Care Excellence
(NICE) has recommended secukinumab for treating ankylosing spondylitis The draft guidance
recommends the drug for treating active ankylosing spondylitis in adults when non-steroidal
anti-inflammatory drugs or TNF-alpha inhibitors haven’t worked or aren’t suitable The drug is
recommended only if the company provides it with the discount agreed in the confidential
patient access scheme
OCUL one Item Remains in FDA Letter Ocular Therapeutix up 22.6% post-market after FDA
issued recent letter, says one outstanding item remains regarding manufacturing process and
controls. Letter says “corrective actions” appear to address 10 inspectional observations raised
in Form FDA 483, except for one FDA requested OCUL provide evidence when “migration to
automatic integration of analytical testing is complete,” anticipated during 3Q On July 25, OCUL
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got FDA complete response letter regarding Dextenza NDA identifying deficiencies in
manufacturing process, controls
OMER announces results from OMS906 complement program OMS906 significantly reduced
both incidence and severity of disease in a well-established animal model of arthritis mediated
by the APC
Ornim Inc., an Israeli medical device company, raised $20 million in an initial closing of a Series
C funding, led by LongTec HongTao China Ventures LP, a medical device specialist. Ornim has
developed the c-FLOW™ platform, a non-invasive device that provides real-time blood flow or
perfusion measurement in the brain and other vital tissues. c-FLOW is already approved in the
US. Ornim has begun the China registration process for the device, which is planned for 2017
completion. OrbiMed, GE Ventures, and other existing investors also participated in the
financing.
PARN Management comments: “Our R&D team is making excellent progress on our lead
projects; in H1 we commenced several investigational studies into PAR121, our osteogenic drug
candidate, and PAR122, our dermatotrophic drug candidate. We expect to report results from
these studies in H2 of 2016. We have commenced studies into the potential use of Zydax for
osteoarthritis in cats, and expect to commence investigational studies into applicability of Zydax
for interstitial cystitis in cats "We previously provided full year 2016 revenue guidance of A$14 –
A$16M. Given our significant outperformance in H1, we now increase full year 2016 guidance to
A$17 – A$18M. For our current business operations, we expect 2017 revenues to grow to
~A$25M which we estimate will make the company profitable in H2 of 2017
PRTK based on current assumptions, Paratek’s cash, cash equivalents and marketable
securities, as well as the $20.0M available to us under the Loan agreement with Hercules, will
enable the company to fund operating expenses and capital expenditure requirements through
the submission of a new drug application for omadacycline for the treatment of ABSSSI and
CABP, which the company currently expects to occur in H1 of 2018.
PTN completes patient visits in ph. 3 trials of bremelanotide for HSDD PTN announced that the
last patient visits in the company's reconnect studies, consisting of two pivotal Phase 3 clinical
trials of bremelanotide for the treatment of female hypoactive sexual desire disorder (HSDD),
have been completed. "We now look forward to data verification and database lock, which we
anticipate occurring in late September, with topline data announced shortly thereafter."
ReNeuron Group announces long term follow up Phase I data from PISCES I study published in
The lancet The study was designed primarily to determine the safety of the CTX cell therapy
candidate in patients with stable motor disability following their stroke. A number of secondary
endpoints were also monitored to investigate possible signals of efficacy in the participants
taking part in the study. Patients in the study were treated from twelve to fifty one months after
stroke onset Improvements in the National Institutes of Health Stroke Scale ("NIHSS") were
seen in all dose groups.
RDHL Bionap who follows the company closely has a writeup that there are some very
important catalysts on the horizon, including a DSMB interim look at the Phase 3 MAP-US trial
with RHB-104 for Crohn's disease, as well as final data from the Phase 2a exploratory trial with
RHB-104 in multiple sclerosis. Phase 3 data from Bekinda® in gastroenteritis is expected before
the end of the year; and, the confirmatory Phase 3 RHB-105 trial in patients with active H. pylori
infection is expected to be initiated in the coming months.These important catalysts certainly
make RedHill a name to watch over the next few months; moreover, earlier-stage assets in the
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pipeline, including Yeliva™™ and Mesupron, are also interesting and present RedHill the
opportunity to expand its business into oncology. Mesupron targets a validated cancer
biomarker of high significance and Phase 2 data points to clear utility in both pancreatic and
metastatic breast cancer. These assets provide diversification and upside to the story as RedHill
enters a pivotal period over the next year.
RHHBY FDA grants orphan drug designation to Genentech for vemurafenib to treat ErdheimChester disease According to the FDA's Orphan Drug product website, Genentech has been
granted Orphan drug designation for vemurafenib for the treatment of Erdheim-Chester
Disease.
RHHBY FDA approves first generic version of Tamiflu the FDA approved the first generic
version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu
(influenza A and B) in patients two weeks of age and older who have had flu symptoms for no
more than 48 hours; and prevention of the flu in patients one year of age and older.
.
RLYP Galenica subsidiary Vifor Pharma USA Inc. is starting today its previously announced
tender offer for any and all outstanding shares of common stock of Relypsa, at a price of
$32.00/share in cash, without interest and less applicable withholding taxes.
RLYP CEO Orwin informed the Relypsa board believed an offer closer to $34.00 per Share
was more reflective of the value of the company and the Relypsa board was not interested in
exploring a reduced up-front cash offer coupled with a contingent value right.
RWLK reports German social court ruling deems ReWalk exoskeleton medically necessary
(earlier) RWLK announced the first ruling by the Social Welfare Court of Speyer declaring the
ReWalk exoskeleton system was medically necessary and should be covered by insurance for
an individual with spinal cord injury (SCI). The ruling, which was delivered in late July,
overturned the original denial of the claim by the payor, a statutory health insurance entity.
SNY conditionally clears Sanofi's acquisition of Boehringer Ingelheim's consumer health
business The decision is conditional upon the divestment of a number of Sanofi's and
Boehringer Ingelheim's businesses in the Czech Republic, Estonia, France, Hungary, Greece,
Ireland, Latvia, Poland and Slovakia Sanofi offered to divest either its own or Böhringer
Ingelheim's local businesses in the markets concerned Czech Republic, Estonia, Hungary,
Latvia, Poland and Slovakia - antispasmodic product(s) Czech Republic - anti-constipation
product(s) Greece (OTC), Ireland (on prescription) - chesty cough product(s) France - headache
product(s)
Stada Arzneimittel plans to lift restrictions on transfer of its stock, opening company up to
possible takeover -- Handelsblatt Without citing sources, Handelsblatt reports that Stada and
investor Active Ownership Capital have already agreed that restrictions on transferring stock
should be lifted at the company’s shareholders meeting on 26-Aug. According to Handelsblatt
PE firms such as CVC Capital Partners, EQT, Permira, Apax, Blackstone, Advent and BC
Partners have expressed interest in Stada.
STML Management comments: We are making substantial progress across our entire clinical
pipeline this year. A key highlight of the quarter was the high profile oral presentations of
positive results from our ongoing Phase 2 potentially pivotal trial of SL-401 in BPDCN at both
the ASCO and EHA annual meetings.” “The efficacy and safety data from this trial continue to
be strong with increasing treatment duration and patient exposure. We look forward to additional
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clinical and regulatory updates this year, including more clarity around our registration pathway
and timeline.”
TRVN for the remainder of 2016, the company anticipates that research and development
expenses will increase as compared to H1 of 2016, primarily as a result of the initiation of the
APOLLO efficacy studies in June and the expected acceleration of the ATHENA safety study
recruitment. Pipeline update: Oliceridine Phase 3 pivotal efficacy trials enrolling on schedule for
top-line data in 1Q17
TTPH discussion. During Q2, we finalized the protocol for IGNITE4 our upcoming phase 3
clinical trial evaluating IV eravacycline in patients with complicated intra-abdominal infections
(cIAI), and remain on track to initiate this trial early in Q4 of 2016,” “Based on discussions with
the FDA, we have designed IGNITE4 using a 12.5% non-inferiority margin and a trial population
of approximately 450 patients. We currently anticipate reporting top-line results from IGNITE4
as early as Q4 of 2017. In parallel, we are also working to finalize the trial design for IGNITE3,
our phase 3 clinical trial evaluating once-daily IV eravacycline in complicated urinary tract
infections (cUTI), and we look forward to providing details regarding the design and timing of
IGNITE3 once the protocol is completed.” We continue to advance development work on the
oral formulation of eravacycline. Early data from this phase 1 program indicate that the oral
dosing regimen used in IGNITE2 leads to lower systemic levels of eravacycline than expected.
These data also suggest that administration of oral eravacycline in a fasted state results in
increased drug exposure. With this information now in hand, we have commenced further
clinical testing designed to evaluate several additional variables associated with optimizing the
oral eravacycline dosing regimen.”
VTAE Management comments: "We are on track to report top-line results for the ongoing
Phase 2a proof-of-concept study for VTP-38543, our wholly owned, potential first-in-class LXRβ
selective agonist being developed for atopic dermatitis, in Q4 of 2016. Second, we continue to
finalize plans for the next clinical trial, expected to initiate in Q4 of 2016, of VTP-43742, our
wholly owned, first-in-class RORyt inhibitor, in psoriasis patients."
ZIOP announced the publication of data highlighting the benefits of using the non-viral Sleeping
Beauty (SB) system to genetically modify T-cells to express a chimeric antigen receptor (CAR)
for use against leukemias and lymphomas. In the paper, 26 patients with multiply relapsed Blineage acute lymphoblastic leukemia (ALL, n=17) or B-cell non-Hodgkin lymphoma, (NHL, n=9)
were enrolled in two investigator-initiated clinical trials at the University of Texas MD Anderson
Cancer Center infusing SB-modified T cells after autologous (n=7) or allogeneic (n=19)
hematopoietic stem-cell transplantation (HSCT). Autologous CAR-T: Seven patients with
advanced NHL were treated with autologous HSCT followed by administration of patient-derived
CAR T cells. Six of the seven patients remain in complete remission (CR) and the 30-month
progression-free survival (PFS) and overall survival (OS) rates were 83.3% and 100%,
respectively. Allogeneic CAR-T: Nineteen patients (ALL n=17, NHL n=2) received donor-derived
CAR T cells. The patients had advanced disease at the time of HSCT and CAR T cells were
administered without additional lymphodepletion. Eleven of 19 patients remain in remission with
1-year PFS and OS rates of 53% and 63%, respectively. HLA partially-matched allogeneic
CAR-T: When the subset of allogeneic recipients of HSCT receiving haplo-identical CAR T cells
were examined, eight patients had 1-year PFS and OS rates of 75% and 100%, respectively.
SB-mediated gene transfer and stimulation resulted in large ex vivo expansion of T cells while
retaining CAR expression and without integration hotspots. Autologous and allogeneic T cells
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survived after infusion an average of 201 and 51 days, respectively. No unexpected acute
infusion or delayed toxicities were noted in the autologous or allogeneic recipients. Mild
elevations in cytokines were observed without cytokine storm.
TEVA and state AGs reach $125M settlement over delay of generic Provigil; to be paid out of
$1.2B escrow fund set up as part of 2015 settlement with FTC NY State Attorney General Eric
Schneiderman today announced a $125M, 48-state settlement with drug manufacturer
Cephalon, now part of Teva Pharmaceutical Industries, ending multistate investigation into
anticompetitive conduct by Cephalon to protect the profits it earned from having a patentprotected monopoly on the sale of its landmark drug, Provigil.
Zytosevice chemotherapy compound maker Zytoservice has attracted offers in a second bidding
round from several buyout groups, people familiar with the situation said. Private equity firms
including IK - the former owner of Zytoservice peer GHD - and PAI have submitted bids valuing
Hamburg-based Zytoservice at roughly 250 million euros ($278 million), they added. Compared
with initial offers, valuations have come down in the second round of bidding as recent changes
to the regulatory regime weighed on prices, one of the people said. To reduce the cost of
cancer treatment, leading German health insurers earlier this year put in place tender processes
to procure chemotherapeutic agents, curbing drug suppliers' margins. Zytoservice majority
owner Capiton earlier this year mandated healthcare advisory firm Ferber to find a buyer for
Zytoservice, which was founded in 2002 and employs 200 staff.
FT Lex
ETSY Getting craftier, the alternative is that AMZN decides it is simpler to pay $ 2 billion
or so to acquire ETSY, AMZN makes few big acquisitions, but it bought Zappos, the shoe
retailer, for $ 1.1 billion in 2209, Homemade is not always best
FT
FB Whats App, the Facebook app has emerged as an alternative internet infrastructure in many
emerging markets, allowing companies and governments to connect directly with citizens, but
can it make a profit? What’s App is a value added perk Mexicans have embraced, Latin America
number two economy is the world’s second biggest behind South Africa. The article discusses
the Whats app has a presence in Kenya, India and its importance around the world
Bioworld
When Congress returns to Washington Sept. 6 following its August recess, lawmakers will face
two looming deadlines – for passage of fiscal 2017 spending authorizations and more funding to
battle the Zika virus. Congress will have only a few weeks to agree to spending bills or a
continuing resolution to keep the government running after the new fiscal year begins Oct. 1.
While emergency funding for the Zika wars could be rolled into the spending bills, pressure is
mounting for that debate to be settled sooner than later. Health and Human Services Secretary
Sylvia Burwell added her voice to the growing groundswell yesterday in a letter to Republican
lawmakers who have been urging the government to spend the money already set aside to fight
the virus. That money will be gone by the end of September, Burwell said.
Real Clear Health
The Fiscal Challenges of the Post-Obama Era
James C. Capretta, RealClearPolicy
No Shame: Marketers of Anti-Zika Repellents Given Warning Letters
60
Robbins, Stat
The DEA Warns Pot Grow Spots Are the "New Meth Houses"
C. Ingraham, WP
What's Really Making Your Insurance Premiums Go Up
Sy Mukherjee, Fortune
Governors Have Powerful Influence on Medicaid Expansion
Drew Altman, WSJ
Humana to Abandon Obamacare Patients in 1,200 Counties
Bruce Japsen, Forbes
Deadly Medical Errors Less Common Than You Think
Richard Gunderman, Convers.
Retirement Healthcare May Be Budget Buster
Robert C. Pozen, Financial Times
NIH Launches First Clinical Trial of Zika Vaccine
Liz Szabo, USA Today
How to Improve the Prescription Drug Market
Rodney L. Whitlock, Morning Consult
The FDA's Dueling Priorities
Jessa Gamble, The Atlantic
Average American 15 Pounds Heavier Than 20 Years Ago
Randy Dotinga, HealthDay
Aetna Is Notifying Docs About Their Drug-Dispensing Habits
Lenny Bernstein, WP
Dirt May Be Good for Your Immune System, Studies Show
Lindzi Wessel, Stat
CMS Finalizes Controversial Hospital Overpayment Cut
Virgil Dickson, MH
"Little Ninja": Zika-Spreading Mosquito Puts Up Tough Fight
Jennifer Kay, AP
New Electronic Skin Patch Is Powered by a Cell Phone
Katherine Bourzac, Tech. Rev.
Nearly 1 in 4 U.S. Seniors Has Some Form of Disability
Robert Preidt, HealthDay
August 3, 2016
New health events to add
NERV Expert Interview @ 5PM EDT (Thursday 8/4) - Could Minerva’s MIN-101 Be the First
Drug for Negative Schizophrenia Symptoms to Hit the Market? Featured by the Excellent
Slingshot Insights the cutting edge venue
CLSD data from Phase 2 (DOGWOOD) Clinical Trial for the Treatment of Macular Edema
Associated with Non-Infectious Uveitis at the 2016 ASRS Aug 9-14 2016
ANTH CHABLIS-SC1 Phase 3 clinical study of blisibimod expects topline efficacy and
safety data will be available prior to the annual American College of Rheumatology
Annual Meeting in Nov 11-16 2016
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EMA a workshop to gain more input from stakeholders on the adaptive pathway,
including real-world evidence collection, the current definition of unmet need and
appropriate prescription controls Dec 8 2016.
Luke Timmerman moderating serial entrepreneur panel at BioParm America Sep 13-15
2016
Aug 3 2016 The BIIB news “reinforces our view that large cap biotech may have gotten too
cheap and big pharma companies are ready and poised to do more deals as they are flush with
cash, in a low interest rate environment and need pipeline[s],” RBC’s Yee wrote. “This is
positive for other large caps as well,” including CELG BMRN and VRTX , according to Piper
Jaffray Joshua Schimmer
Aug 3 2016 VRTX the BIIB news “reinforces our view that large cap biotech may have gotten
too cheap and big pharma companies are ready and poised to do more deals as they are flush
with cash, in a low interest rate environment and need pipeline[s],” RBC’s Yee wrote. “This is
Aug 3 2016 TWTR all over social media and websites and WSJ for renewed takeover noise
Aug 3 2016 BMRN the BIIB news “reinforces our view that large cap biotech may have gotten
Aug 3 2016 CELG the BIIB news “reinforces our view that large cap biotech may have gotten
Aug 3 2016 SHPG in regards to whether they to deal making Ornskov was clear that Shire
would take a very measured, “step-by-step” approach to building a new franchise. “I think that
this is not a commitment at this stage for Shire to be spending significant resources on research
or commercially
Aug 3 2016 TEVA will target “attractive specialty assets, or branded drug assets or pipeline
assets,” CEO Erez Vigodman says in interview.Teva business isn’t just generics, vision is much
broader
Aug 3 2016 ENT HNA owner of China's fourth largest airline Hainan Airlines, is said to be
working with corporate finance advisers from Moelis and accountants at Ernst & Young on the
deal. One reliable source said HNA had already approached Global Eagle Entertainment with a
potential offer of around $11 a share.
NEJM
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Strengthening research thru data sharing, data sharing has the incredible potential to strengthen
academic research
The Yale Open Data Access YODA project
Toward Fairness in Data Sharing
Sharing Data from Cardiovascular Clinical Trials
Innate Immunity and Asthma Risk in Amish and Hutterite Farm Children, the Amish
environment provides protection against asthma by engaging and shaping the innate
immune response
ABBV Two Phase 3 trials of Adalimumab for Hidradenitis Suppurativa, treatment as
compared to placebo resulted in significantly higher clinical response rate in boths trials
at 12 weeks
Sickle Cell Trait, Rhabdomyolysis and Mortality among US Army Soldiers
Inherited DNA Repair Mutations in Men with Metastatic Prostate Cancer
Editorial on Innate Immunity in Asthma
Bill Gross
In this high risk/low return world, the obvious answer is to reduce risk and accept lower
than historical returns. But don’t you have to put your money somewhere? Yes, of course,
except markets offer little in the way of double digit returns. Negative returns and principal
losses in many asset categories are increasingly possible unless nominal growth rates
reach acceptable levels. I don’t like bonds; I don’t like most stocks; I don’t like private
equity.Real assets such as land, gold, and tangible plant and equipment at a discount are
favored asset categories. But those are hard for an individual to buy because wealth has been
“financialized”.
Pharmaceutical Manufacturing
China to lead biologics boom
Worldwide orphan drug sales forecast to total $ 178 billion
2016 Pharmaceutical Equipment buying trends
SHPG Shawn Fitzpatrick interview with their associate director of manufacturing bioreactor
operations of SHPG
The expanding role of XRAY analysis, new techniques are expanding the role of Xray analytical
technologies to range from drug discovery to quality control
Bioworld
BIIB Piper Jaffray analyst Joshua Schimmer, the rumor of acquisition talks “makes
sense, mostly.” He acknowledged that timing “of the announcement relative to the CEO
departure is a bit awkward as one wouldn’t want to switch horses in midstream of a
potential acquisition, but we assume the interest emerged in response to the SMA data in
the broader context of a frustrated investor base. Trying to gauge the company’s
valuation is difficult, mostly due to the high-risk Alzheimer’s program. Biogen is in phase
III testing with beta-amyloid-targeting antibody aducanumab. Given the difficulty of
getting an Alzheimer’s drug through phase III, it’s hardly a sure bet. “Pending phase III
results, [aducanumab] could either be worth nothing or billions of dollars (we suspect
the former),” Schimmer wrote in a research note. “Structuring a transaction around this
uncertainty might require some fairly unprecedented [contingent value rights] or may be
so impossible as to prevent a deal from transpiring.” It’s not the first time Biogen has
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endured takeout speculation. In 2007. BIIB confirmed month long buzz that it was talking
to potential buyers. The news “reinforces our view that large cap biotech may have
gotten too cheap and big pharma companies are ready and poised to do more deals as
they are flush with cash, in a low interest rate environment and need pipeline[s],” RBC’s
Yee wrote. “This is positive for other large caps as well,” including CELG BMRN and
VRTX
The FDA this week launched the first phase of a pilot of its intercenter consult request (ICCR)
process for products that combine drugs, devices or biological products. During the two month
phase 1, the ICCR pilot will start in select offices in the agency’s three medical products centers.
Additional offices in each center will be rolled into the pilot in subsequent phases. The agency
aims to implement the program in all the offices by the end of the second quarter of 2017.
During each phase, the FDA will collect quantitative and qualitative data that will allow it to
refine processes, procedures and training for the subsequent phases. The intent is to develop a
robust process that enables efficient, effective collaboration
The U.S. Government Accountability Office (GAO) is recommending that Congress consider
requiring all manufacturers of drugs paid at average sales price (ASP) to submit pricing data to
CMS. It also urged CMS to periodically request source documentation from a sample of drug
manufacturers to verify the ASP data they submit. The recommendations, released this week,
stem from a GAO study of expenditures for the Medicare Part B drug program in 2014.
Medicare and its beneficiaries spent about $21 billion in 2014 on about 46 million
administrations of 551 Part B drugs covered based on ASP. The GAO found that six drugs,
each exceeding $1 billion in expenditures, accounted for 36 percent of all expenditures on Part
B ASP drugs. However, 10 different drugs, each administered more than 1 million times that
year, accounted for 37 percent of all administrations. Looking at the numbers another way, the
GAO said that multisource drugs were used in 74 percent of the administrations, but single
source drugs accounted for 81 percent of the expenditures.
STAT Pharmalot on GILD
GILD after getting beaten up last week over the pricing of its hepatitis C treatments in the United
Kingdom, GILD is s going on the offensive. GILDas sustained intense criticism over complaints
that its prices have strained payer budgets, fired back at a report in an influential medical journal
and declared that “we stand behind our pricing.”Although Gilead has never been entirely mute
when confronted with criticism, the drug maker is generally circumspect about addressing
specific developments. But the report in BMJ seems to have hit a nerve, since the journal wrote
that England’s National Health Service was forced to take several controversial steps to delay
coverage of Gilead’s medicines, and it came at the expense of patients.
Gilead set a price in the United Kingdom that met a threshold set by the government’s costeffectiveness watchdog, and the firm is willing to continue talks with the National Health Service.
The NHS, by the way, called the BMJ report “naive” for suggesting it had the ability to handle a
large volume of hepatitis C patients quickly.“However, drug pricing cannot be looked at in
isolation, but rather must be placed in the context of a country’s health care system, the cost
incurred to the healthcare systems with no treatment or inferior treatment, and how countries
successfully incentivize and allocate research and development costs to spur pharmaceutical
innovation,”
Barron's Potential Biogen Buyout May Not Roil Quintiles
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Wells Fargo Securities In short, a Biogen acquisition could either be a modest positive or a
modest negative for Quintiles Transnational Holdings -- it is simply too early to know.
In 2014, Quintiles ( Q) entered a five-year strategic deal with Biogen for Phases 2-4 and select
Phase 1 studies. We believe Biogen is likely a top-five client for Quintiles, generating a couple
hundred million in annual revenue.
Luke Timmerman 12 Entrepreneurs who have repeatedly created value and note the
very well regarded Timmerman will be speaking Sep 13-15 2016 at BioPharm America
Michael Gilman was most recently the co-founder and CEO of Cambridge, Mass.-based
Padlock Therapeutics. It was sold to Bristol-Myers Squibb for $225 million upfront, and total
value of up to $600 million with milestones. That sale, in March, came after just $18 million of
venture capital, and about two years of work on a PAD enzyme drug discovery program for
autoimmune diseases. Gilman’s previous company, Stromedix, was acquired by Biogen for $75
million upfront and a total deal value of $562 million, milestones included.
Nancy Stagliano learned the biotech business, like many other entrepreneurs, at Millennium
Pharmaceuticals, starting in the late 1990s. She was a first-time co-founder and CEO at South
San Francisco-based CytomX Therapeutics. A co-inventor of the company’s underlying
technology, she left in 2011. The company, now led by Sean McCarthy, went public last year
and has a market value of $350 million.Stagliano entered a different situation next. She was
CEO of South San Francisco-based iPierian, an induced pluripotent stem cell company that had
endured several waves of management turnover. It needed what she calls a “re-start.” Ipierian
got focused on diseases related to Tau-protein aggregation. Less than three years later, BristolMyers Squibb acquired it for $175 million upfront and total deal consideration of $550 million.
But that deal didn’t give away everything from the iPierian platform. Before the sale, Stagliano
and the iPierian board had split off assets directed at the classic complement pathway for the
treatment of rare diseases. Those assets became True North Therapeutics. The company
released some preliminary, but quite encouraging data from the first five patients at a scientific
meeting in June.
Rich Heyman: Aragon and Seragon,the San Diego-based entrepreneur sold Aragon
Pharmaceuticals and its prostate cancer drug for up to $1 billion to Johnson & Johnson in July
2013. Before that hand-off, Heyman was thinking a step ahead, splitting off a breast cancer
asset into a second company, Seragon Pharmaceuticals. The same team stayed intact, kept
working, and sold Seragon a year later to Roche/Genentech for up to $1.7 billion. Heyman is
working with the renowned cancer researcher Charles Sawyers to build another company,
South San Francisco-based ORIC Pharmaceuticals. In his late 50s, Heyman keeps going in
startups because he enjoys taking relatively raw concepts and giving them direction.“
Kathleen Sereda Glaub. Glaub worked her way up on the finance side of the house at
Genentech and Cell Genesys. Her first big hit as an entrepreneur came at Berkeley, Calif.based Plexxikon. As president of that small drug developer, she teamed up with scientific
entrepreneur Peter Hirth for more than a decade. They created the melanoma drug Zelboraf for
melanoma, and sold the company to Daiichi Sankyo for up to $935 million in 2011. Then she
started over in another startup, San Mateo, Calif.-based Afferent Pharmaceuticals. That
company, with a drug for chronic cough and cough related to idiopathic pulmonary fibrosis,
navigated into Phase II clinical trials. Merck came along last month and snapped it up for $500
million upfront and $750 million more in milestone payments.
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Peter Van Vlasselaer is an immunologist by training got his first startup experience at Dendreon.
He worked there six years as an early employee and vice president in the 1990s, when the die
for its prostate cancer immunotherapy was cast. He moved on to senior vice president level at
another small company, ITMN InterMune. When given the chance to be a first-time CEO
Avidia, he took it and then sold that company, the developer of an IL-6 inhibitor for autoimmune
diseases, to Amgen for $380 million in 2006. Proving that wasn’t a fluke, he created value in his
next stop. Arresto Biosciences, the developer of an antibody for fibrosis, was acquired by Gilead
Sciences for $225 million upfront.After a brief stint to stabilize iPierian during its upheaval, he
jumped into another startup, Redwood City, Calif.-based Armo Biosciences. Before cancer
immunotherapy asset values skyrocketed, he and the Armo team were at work developing a
recombinant IL-10 molecule from Merck that researchers think has potential to activate killer Tcells. When I interviewed Van Vlasselaer in November 2013 about getting back into cancer
immunotherapy, he showed he understood the moment in time: “The whole immunotherapy field
has come and gone so many times, and now it’s back. I think it’s back for good,” he said.
Prescient words.
Katrine Bosley Bosley comes from a family of entrepreneurs, so and worked her way around the
Boston biotech community in stints at a then-small company ALKS in venture capital (Highland
Capital Partners), and then at a mid-sized biotech becoming a bigger, more diversified
enterprise (Biogen).Eager to grow, she took a job as vice president of business development at
Adnexus Therapeutics, staying through its acquisition by Bristol-Myers Squibb. Her first CEO
job was with Avila Therapeutics in April 2009. The company had raised a $21 million Series A
venture round two years earlier, and had about 30 employees. During the post-financial crisis
time, she helped wrap up the Series B investment. She then tirelessly told the story of a
covalent-binding small molecule aimed at the Bruton’s tyrosine kinase (BTK). She led the
company through key external validations from the Leukemia & Lymphoma Society, Clovis
Oncology, and Sanofi. Avila ended up acquired by Celgene in January 2012 for $350 million
upfront, plus up to $575 million in milestone payments. She carefully evaluated her next step
through board work, and as an entrepreneur-in-residence at the Broad Institute. Then the right
opportunity knocked. Editas Medicine, an aspiring drugmaker using CRISPR-Cas9 genome
editing technology, needed a CEO. The company had raised a $43 million Series A, had 14
employees, and was about six months old. Bosley leaped. Two years later, she led its IPO.
Editas, even though it’s still in preclinical development, now has a market value of more than $1
billion.
Randy Scott who is the co-founder of Incyte INCY, GHDX Genomic Health, and Invitae is one
of the most respected entrepreneurs in the genomics and genomic diagnostics business. Incyte
morphed into a drug developer in later years, and is now a completely different company worth
more than $16 billion. But he was in position to do so because of the value created from its
genomics work. Scott’s next act, Redwood City, Calif.-based Genomic Health, blazed a trail with
its molecular diagnostic test for breast cancer. His latest venture, San Francisco-based Invitae,
is casting a wide net with genomic tests for rare diseases, cancer and cardiovascular disease.
Tillman Gerngross. professor at Dartmouth College, got his first taste of entrepreneurial
success with GlycoFi. That company, which made engineered antibody drug candidates in
yeast, was sold to Merck for $400 million in 2006. Determined to do things differently on the
next go-round, to make sure antibody technology didn’t get sold and put on ice inside one
company (as had happened several times in the past), Gerngross co-founded Lebanon, NH-
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based Adimab. The idea was to create a free standing, independent antibody discovery shop
that could thrive on licensing its technology to multiple partners. It has done that in spades, with
more than 35 partnerships and a reported market valuation of more than $1 billion. Gerngross
also likes to keep multiple plates spinning at once. He co-founded Arsanis; oversees tech
transfer at Dartmouth; maintains an academic lab; and has a part-time gig as a venture partner
with SV Life Sciences.
Troy Wilson. A chemist and lawyer by training, He got his first entrepreneurial taste as a cofounder of San Diego-based Ambrx in 2002. He stayed there about four years, and moved on to
co-found and lead San Diego-based Intellikine, an early mover in the world of PI3 kinase
biology. That company was sold to Takeda Pharmaceuticals for $190 million upfront and $120
million in milestones in 2011. Now he’s the CEO of Kura Oncology, a cancer drug developer
that he took public (albeit at a lesser price than hoped).Wilson also co-founded and leads two
other small companies—Wellspring Biosciences, and Avidity Biosciences. Wellspring, a
company that includes a few key people Wilson worked with before at Intellikine, is working on a
drug aimed at the KRAS gene that has stymied so many companies over the years. It operates
largely through a partnership with Johnson & Johnson. Avidity is an antibody-siRNA conjugate
technology company that leans heavily on the talents of two senior managers Wilson works with
there—Kent Hawryluk and Art Levin.
Bruce Montgomery. A pulmonologist by training, Montgomery has made a career out of
developing drugs for cystic fibrosis. At Genentech, he worked on developing Pulmozyme. As an
entrepreneur, he went on to spearhead development of the inhalable antibiotic, tobramycin, at
Seattle-based Pathogenesis. That company was acquired by Chiron (now part of Novartis) for
$700 million in 2000. His next act was as co-founder and CEO of Corus Pharma, another
developer of an inhalable antibiotic for cystic fibrosis. That was acquired by Gilead Sciences for
$365 million in 2006. After a few years in senior management at Gilead, Montgomery started
Cardeas Pharma to develop a novel antibiotic for ventilator-associated pneumonia. Clay Siegall,
the co-founder and longtime CEO of Seattle Genetics, once called Montgomery “the top biotech
entrepreneur in Seattle.”
Philippe Dro has built a track record as one of the strongest serial biotech entrepreneurs in
Europe. He as CFO at Switzerland-based Axovan, a developer of an endothelin receptor
antagonist acquired by Actelion for $191 million in 2003. Then came Endoart, a developer of
remote-control implants for treatment of morbid obesity. Dro, as chairman and CEO, sold that
company to Allergan for $97 million in 2007. He followed that up with an even bigger success at
Glycovaxyn, a conjugated vaccine company sold for $190 million last year to GSK. Now he’s
working at Austria-based Themis Bioscience, a biotech startup aimed at vaccines for infectious
tropical diseases. “
Craig Venter ng made a lot of enemies in academia when he aimed at dagger at the heart of
NIH-funded science in the 1990s, claiming the private sector could sequence the genome
better, faster, and cheaper than a government-supported project. At Celera Genomics, Venter
rode the go-go wave of the first genomics bubble, creating a lot of paper wealth, for a time.
When that company shifted gears into drug development and Venter needed something else to
do, he started his own research institute, the J. Craig Venter Institute in San Diego. It now has
250 scientists and staff. That’s a startup of a different kind, but Venter wasn’t done with the
corporate world. He co-founded Human Longevity, Inc., which has audacious goals for a new
age of genome sequencing and its application to longevity and wellness. HLI raised a $220
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million Series B financing in April. If nothing else, that’s proof that Venter, pushing 70, can rally
people and money to pursue lofty dreams.
Motley Fool Seven stocks that could make big moves this year due to anticipated
“regulatory of clinical catalysts” expected within the next year.
AGEN ALNY CLVS EXEL KITE NVAX TRVN
AGEN has several checkpoint inhibitors enter the clinic in 2017. Fool analysts said the
company’s checkpoint inhibitors, including AGEN2041 and AGEN1884, each have the potential
to capture hundreds of millions in sales if they pass regulatory hurdles.
ALNY is expected to release top line results from its Phase III lead candidate Patisiran for
familial amyloidotic polyneuropathy form of transthyretin-mediated amyloidosis at a small lab in
Cambridge. The Boston-based company anticipates Patisiran to clear Phase III development by
next year, with an NDA filing in late 2017. By the end of 2020, Alnylam expects to achieve a
profile of three marketed products and 10 RNAi therapeutic clinical programs.
CLVS has had a rough year, particularly with the failure to gain regulatory approval for its
experimental drug rociletinib. However, the company that was forced to lay off about 35 percent
of its workforce earlier this year is hoping for positive Phase III results for rucaparib, a PARP
inhibitor developed for the treatment of patients with platinum-sensitive, high-grade serous or
endometrioid epithelial ovarian, primary peritoneal or fallopian tube cancer. If the results are
good, Clovis hopes to overcome its disappointing first half of 2016 and begin 2017 with a New
Drug Approval application to the US FDA
EXEL is expecting data from its Phase III live cancer drug, cabozantinib, later this year.
Cabozantinib, a kinase inhibitor, is designed for a late-line of therapy, but if approved, could
prove to be a strong revenue generator
KITE is gearing up for results from its lead CAR T-cell product candidate, KTE-C19. KTE-C19 is
currently in a mid-stage study for the treatment of chemorefractory diffuse large B-cell
lymphoma (DLBCL). If results from the trial are good, the company could look at 2017 as the
year to file its NDA with the FDA. Analysts are predicting sales of $1.7 billion for KTE-C19 if the
drug is approved. KTE-C19 is designed to genetically modify a patient’s T cells to express a
Chimeric Antigen Receptor (CAR) designed to target the antigen CD19, a protein expressed on
the cell surface of B-cell lymphomas and leukemias.
NVAX is expected to provide an update on its RSV (respiratory syncytial virus) F vaccine during
the third quarter. The drug has been fast-tracked by the FDA. If the treatment passes regulatory
hurdles, the company anticipates the drug could become a blockbuster and generate up to $8
billion in annual revenue.
TRVN is anticipating data from two Phase III trials for its pain treatment, oliceridine, in 2017.
The drug could be a viable option to morphine, which would certainly mean revenue for the
company.
Health news
ACOR enters settlement agreement with Alkem regarding Ampyra extended-release tablets
Acorda Therapeutics entered into a settlement agreement with Alkem Laboratories Ltd. and
Ascend Laboratories, LLC to resolve pending patent litigation brought by the company against
Alkem involving Ampyra (dalfampridine) Extended-Release Tablets. The pending patent
litigation was filed by the company in the U.S. District Court for the District of Delaware in
response to Alkem's submission of an Abbreviated New Drug Application to the FDA, seeking
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marketing approval for a generic version of Ampyra. As a result of the settlement agreement,
Alkem will be permitted to market a generic version of Ampyra in the United States at a
specified date in 2027, or potentially earlier under certain circumstances. The parties will
request that the Court enter a Consent Order, in which it will dismiss the company's litigation
against Alkem referred to above. Details of the settlement are confidential, and the parties will
submit the agreement to the Federal Trade Commission and the Department of Justice, as
required by federal law. The settlement with Alkem does not resolve pending patent litigation
brought by the company against other parties who have submitted ANDAs to the FDA seeking
marketing approval for generic versions of Ampyra. The expiration date for the company's latest
expiring Ampyra patent listed in the FDA's Orange Book is May 2027
ADAP has received notice from the FDA that a partial clinical hold has been placed on its
planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma
(MRCLS). This trial is not yet active at any investigational sites, and has not recruited any
patients. This notification of partial clinical hold does not apply to any other Adaptimmune
study. The FDA notification is not based on safety concerns. In its correspondence, the FDA
requested additional CMC information and answers to certain trial design questions prior to the
trial start. Adaptimmune intends to provide a full response to the FDA shortly
ADMP announces new patents for its dry powder inhaler Adamis Pharmaceuticals announced it
recently received a notice of allowance that one of its patent applications for its proprietary dry
powder inhaler, Taper DPI, will issue in the US (U.S. Patent Application No. 14/622,617). The
approved claims describe the device and components that are important for its drug delivery
functions. In addition, the company was recently granted a European patent for one of its
patent applications for its proprietary dry powder inhaler, Taper DPI (European Patent
EP1996173 “Powder Filling Processes”)
AGN comments on sale of Anda to Teva (TEVA) Until the transaction is completed, Allergan will
continue to operate Anda in a business-as-usual mode, provide full support to manage the
business, introduce new products and maximize its partnerships with customers. Beginning
with its Q2 2016 earnings report, Allergan will report its Anda business as discontinued
operations. For Q2 of 2016, Anda is expected to contribute approximately $375M in net
revenues excluding sales of Allergan's branded products and approximately $0.05 in EPS For
the full year 2016, Anda is expected to contribute approximately $1.5B in third-party net revenue
and approximately $0.15 in EPS.
AMED reports receipt of civil investigative demand from DoJ related to federal False Claims Act
AMED received a CID issued by the U.S. Department of Justice pursuant to the federal False
Claims Act relating to claims submitted to Medicare and/or Medicaid for hospice services
provided through designated facilities in the Parkersburg, West Virginia area. The CID requests
the delivery of information to the United States Attorney’s Office for the Southern District of
West Virginia regarding 68 identified hospice patients, as well as documents relating to our
hospice clinical and business operations in the Parkersburg area. Based on the information
currently available to us, we cannot predict the timing or outcome of this investigation or
reasonably
AMPE provides regulatory update on AMPION Ampio Pharmaceuticals announced that it has
filed a meeting request and Briefing Document with the FDA to seek guidance on the filing of
the company's BLA for Ampion to treat patients suffering from pain caused by severe
Osteoarthritis (OA) of the knee. The agency has discretion with regard to the type and
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scheduling of such a meeting, however, the company anticipates the meeting will take place in
the 3rd quarter of this year. In Q2 of this year, Ampio submitted their Chemistry Manufacturing
and Controls (CMC) documents for Ampion with the FDA, and requested the Agency provide
any related guidance. The company recently received the Agency's comments and believes
there are no issues that will prevent the filing of an Ampion BLA. Ampio also announced that
the STRUT Study that treated pain due to OA of the knee with multiple injections of Ampion,
authored by Dr. John Schwappach, the trial's Principal Investigator, was accepted for
publication in the peer-reviewed journal "Orthopedics." As soon as the journal is in print, the
article will be posted on Ampio's website. The STRUT Study demonstrated a 64% reduction in
pain compared to baseline.
AMRS enters partnership with BIIB the partnership will explore the use of Amyris’s advanced
microbe engineering technology to evaluate and develop multiple host microorganisms as
alternatives to mammalian cell lines for the production of therapeutic recombinant proteins.
Terms were not disclosed.
AMRS has entered into a funded partnership with BIIB to explore the use of Amyris’s advanced
microbe engineering technology to evaluate and develop multiple host microorganisms as
alternatives to mammalian cell lines for the production of therapeutic recombinant proteins.
ANDA TEVA announces acquisition of Anda for $500M., the 4th largest distributor of generic
pharmaceuticals in the U.S. for $500M. Anda distributes generic, brand, specialty and over-thecounter pharmaceutical products from more than 300 manufacturers to retail independent and
chain pharmacies, nursing homes, mail order pharmacies, hospitals, clinics and physician
offices across the United States. For the full year 2016, Anda is expected to generate more
than $1B in third-party net revenue. As part of the deal, Teva will acquire three distribution
centers in Olive Branch, MS; Weston, FL; and Groveport, OH, with a total of over 650
employees. The closing of this transaction is subject to antitrust clearance and satisfaction of
other conditions. The transaction is expected to close in H2 of 2016.
ANTH completes of dosing in CHABLIS-SC1 Phase 3 clinical study of blisibimod The company
announced that the last patient in the Phase 3 CHABLIS-SC1 clinical study, evaluating
blisibimod for the treatment of systemic lupus erythematosus, received their final study dose on
July 27th Due to timing of this final visit, the company expects topline efficacy and safety data
will be available prior to the annual American College of Rheumatology Annual Meeting in
November 11-16 2016
APHB completes enrollment of its investigational phage therapy trial targeting Staphylococcus
aureus AmpliPhi Biosciences announced it has completed enrollment of its Phase 1 clinical trial
to evaluate the safety of AB-SA01, its proprietary phage cocktail targeting Staphylococcus
aureus (S. aureus) infections. AmpliPhi expects to report topline results by the end of Q3 of
2016.
Assurex Health news that MYGN signs definitive agreement to acquire Assurex Health for
$225M upfront with potential $185M in milestones Assurex Health provides genetic testing for
psychotropic medicine selection, and generated revenue of more than $60M and tested more
than 150,000 patients in Myriad’s fiscal year 2016. The transaction is expected to close at the
end of Myriad’s Q1 of fiscal year 2017.
Avrobio lands $25M series A for ex-vivo gene therapy After seeding gene therapy start-up
Avrobio Inc. earlier this year, Atlas Venture stepped back up to the plate, joined by Clarus and
SV Life Sciences, to fund the company’s $25 million series A. The round will accelerate
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development of Avrobio’s initial programs in Fabry disease and acute myeloid leukemia (AML),
both expected to enter the clinic this year, and allow the company to expand its pipeline in rare
diseases and solid and liquid cancers. ‘AVR-01 is designed as an immunotherapy that triggers
the immune system to detect and eradicate tumor cells. The process begins with the extraction
of a patient’s cancer cells, which are genetically modified to express the cytokine interleukin-12
(IL-12) and then infused back into the patient through a single procedure. With AVR-02 in Fabry
disease, the company is seeking to modify a patient’s cells by adding a functional copy of the
faulty gene, so CD34+ hematopoietic stem cells are modified to express the enzyme alphagalactosidase A (alpha-gal A), then infused back into the patient. The goal is to deliver longlasting or permanent continuous elevation of the endogenous enzyme to improve patient
outcomes and, potentially, eliminate biweekly intravenous infusions of enzyme replacement
therapy over a lifetime. Avrobio is presently “executing” a phase I study of AVR-01 in AML, with
the primary goals of demonstrating the safety and tolerability of infusing into patients autologous
AML cells transduced to express IL-12, according to MacKay. The trial also will seek to
determine the maximum tolerated dose. A second phase I study of AVR-02 in Fabry disease will
evaluate the safety and toxicity of autologous stem cell transplantation with mobilized CD34+
cells transduced to express alpha-gal A. Both trials are expected to begin this year in Canada,
where clinical trial applications (CTAs) already are approved, and run through 2017.
BIIB AMRS is trading up over 17% after announcing that the Company has entered into a
funded partnership with Biogen (BIIB) (trading down over 4%), to explore the use of Amyris’s
advanced microbe engineering technology to evaluate and develop multiple host
microorganisms as alternatives to mammalian cell lines for the production of therapeutic
recombinant proteins.
BIIB BBERG Gadfly some analysts have called for upwards of $400 a share in a takeover, but
it's unlikely any buyer would pay such a premium, given the uncertainty. The stock closed at
$330.11 on Tuesday. Biogen shares have already rallied since the start of July, partly on
takeover speculation -- which only intensified after the company said on July 21 that CEO
George Scangos will be leaving and that it didn't yet have a replacement.If Biogen has any
confidence in its experimental Alzheimer's disease treatment and other therapies in its pipeline,
and if it thinks its best-selling multiple sclerosis drug Tecfidera will keep market exclusivity, then
this might not be the right time to sell.But those are big "ifs," with big implications for Biogen's
future value.As for Tecfidera, some time this year a patent review board could knock out patents
that would put the drug's $3.6 billion in annual sales at risk. Or not. t all adds up to a potential
M&A standoff. Acquirers probably can't afford to risk a big premium for the company, given the
amount of debt they'd have to raise. But unless they're bigger pessimists than they seem,
Biogen's board members may not be able to accept much less
BIIB BMO Ian Somaiya, Alex Arfaei .BIIB may get near $337/share A sale depends on BIIB
accepting a CVR for Alzheimer’s assets, Alzheimer’s may be worth an added $57/share
Aducanumab risk adjusted value is “greatest source of uncertainty” MRK “bullish” on BIIB’s
amyloid hypothesis, could combine future BIIB product with its BACE inhibitor, would be a
strategic fit LLY’s sola may also be complementary in Alzheimer’s
Biohit an initial study investigating the simultaneous determination of Biohit GastroPanel
biomarkers using Randox Biochip Array Technology (BAT) has now been completed.
According to preliminary study results, BAT simultaneously detects three key GastroPanel
biomarkers from a single patient sample. This multi-analytical approach would result in
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GastroPanel becoming a more cost-effective, user-friendly test for diagnosis of dyspeptic
symptoms and the screening of gastric cancer risk.
BIOTRONIK is touting the first implantation of a pacemaker from the newly EU-approved ESeries of the company's devices. The Enitra 8 HF-T QP is now pacing a woman with a history of
failure and complete heart block who received the device at the Great Western Hospital in
Swindon, UK, according to the company. The pacemaker has an expected 14 year battery
lifetime
CELG NICE in draft guidance recommends Celgene's apremilast as an option for treating
severe chronic plaque psoriasis that has not responded to systemic therapy NICE now
recommends apremilast as an option for treating severe chronic plaque psoriasis that has not
responded to systemic therapy, or systemic therapy is contraindicated or not tolerated, only
when the company provides it with the discount agreed in the patient access scheme. Taken
orally twice a day, apremilast is thought by clinicians to be a preferred treatment option for those
patients who do not wish to receive alternative treatments by injection.
Clinuvel Pharmaceuticals completes pre-clinical study of SCENESSE (A$5.09) Highlights: FDA
requirement for combination therapy model replicating clinical studies protocol in vitiligo fulfilled.
Clinuvel has completed one US Phase II clinical trial of SCENESSE in vitiligo patients
(CUV102), with a second study (CUV103) underway in Singapore. Safety of the combination
therapy confirms observations in clinical trials CUV102 and CUV103. Clinuvel will request a
guidance meeting with the FDA to discuss the upcoming vitiligo trial in North America. Safety
data add to the New Drug Application package to be submitted to the FDA for erythropoietic
protoporphyria.
CLRB announces $2M NCI SBIR contract for a Phase 2 clinical study to support funding of a
Phase 2 clinical study of the company’s lead product candidate, CLR 131, for the potential
treatment of hematologic malignancies, including multiple myeloma. The first phase of the NCI
SBIR contract was focused on the pre-clinical development of CLR 125. However, following a
comprehensive data review and product development and commercialization analysis, the
company determined that the superior strategic approach would be to redeploy the contract to
CLR 131, its lead product candidate. Following a review of all the data, both the NCI and the
company determined that the second phase of the contract would be optimized through a multicenter, open label, study of CLR 131 in patients with hematologic malignancies.
CLSD to to Present Data from Phase 2 (DOGWOOD) Clinical Trial for the Treatment of
Macular Edema Associated with Non-Infectious Uveitis at the 2016 ASRS Annual Meeting
Clearside Biomedical announced that results from their Phase 2 clinical trial (DOGWOOD) and
Phase 1/2 clinical trial for the treatment of macular edema associated with non-infectious uveitis
will be presented at the 2016 Annual Meeting of the American Society of Retina Specialists
(ASRS), August 9-14, 2016, in San Francisco, CA
Companion Medical, a startup out of San Diego, CA, has come up with an insulin pen that also
connects to smartphones to help track intake, calculate dosage, and manage how much is in
reserve. The InPen uses standard Bluetooth wireless to connect to a smartphone app that
handles all the calculations, display of data, and management of reminders. Automatically
calculating dosage, article in Medgadget
Concordia again confirms strategic review ongoing, reports Nilandron and Dutoprol excluded
from CVS formulary, and provides business update Concordia International today confirmed
that its review of strategic alternatives is ongoing (Note Concordia had previously confirmed the
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strategic review was ongoing on 2-Jun) Concordia also confirmed that there was one formulary
change affecting two products in its North America portfolio. CVS Health confirmed this week
that Nilandron and Dutoprol will be removed from CVS Health's formulary. Concordia believes
this exclusion is immaterial to its business. The company today also provided an update on its
business: "We remain highly confident in our business prospects going forward.We have a
strong team across the world who help provide patients with important medicines. The team is
supported by durable company fundamentals; Concordia has no liquidity or debt issues, a
strong free cash profile, and sales channels in more than 100 countries. We remain optimistic
about our long-term future."
CTIX reports topline data from phase 1 trial of Kevetrin in advanced solid tumors The Phase 1
dose-escalation study of Kevetrin, with dosing amounts ranging from 10mg/m2 to 750mg/m2,
met its primary endpoint in showing no clinically significant adverse effects of Kevetrin in
patients based on clinical laboratory parameters through all dosing levels and across the
duration of treatment. With regards to secondary endpoints, it was determined that Kevetrin has
a relatively short apparent biological half-life (less than 2 hr) in plasma. Plasma half-life (T1/2)
clearance (CL) and volume of distribution (Vd) suggest that drug elimination predominantly
involves hepatic mechanisms and Kevetrin undergoes rapid extensive distribution from systemic
circulation into tissues. PK data, as measured by AUC and Cmax levels, further revealed that
Kevetrin exhibited a dose-dependent response, has as stated a relatively short half-life and
clears the body within one day -- on average between 8 and 10 hours -- though the drug can
remain in the body up to approximately 24 hours Based on these findings, the company
believes the impact of Kevetrin when administered to patients with repeated dosing (3x per
week), as planned in the upcoming ovarian cancer trial, will achieve fairly steady levels of
Kevetrin above the minimum effective concentration
CVRS J. Aaron Grantham, MD, Joins Corindus Vascular Robotics as Chief Medical Officer
Corindus Vascular Robotics announces that J. Aaron Grantham, MD, a leading interventional
cardiologist, and an innovator in the treatment of chronic total occlusions (CTOs), has joined the
company as Chief Medical Officer (CMO)
CVS raised its annual forecast and released second-quarter earnings that beat analysts’
estimates, as deals to add pharmacies and a nursing home drugs business helped raise
revenue.
CVS will add 35 products to its lists of excluded drugs in 2017, no longer covering some
treatments for cancer and diabetes, in an aggressive move to favor lower-priced treatments.
Benefit manager to exclude some cancer, diabetes treatments Company cites ‘hyperinflationary’
increases on 10 drugs CVS will remove coverage for NVS leukemia drug Tasigna, MDVN
Xtandi, and SNY insulin Lantus, expanding the company’s strategy of excluding expensive
products when alternatives are available. The total number of excluded drugs for 2017 will be
131, It’s the first time that brand-name cancer drugs have been taken off CVS’s standard
formulary, The excluded drugs list also includes 10 that have had “hyperinflationary” price
increases, the company said in a statement on its website. CVS specifically targeted drugs with
greater than 200 percent cumulative price increases in three years, Executive Vice President
Jonathan Roberts said on a conference call. “Our goal is either we are not going to cover them,
or we’re going to get the economics back” to negate big price increases, he said on the call.
EDIT announces exclusive license for CRISPR genome editing technology from Mass General
Hospital Editas Medicine has entered into an exclusive license agreement with Massachusetts
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General Hospital (MGH) to access intellectual property and technology related to high-fidelity
Cas9 nucleases and Cas9 PAM variants that will enable the company to address an expanded
range of genetically-defined diseases with the potential for enhanced specificity. As published
in the January 28, 2016 issue of Nature, MGH researchers led by Dr. Joung described their
high-fidelity Cas9 variant – Streptococcus pyogenes Cas9-HF1 – designed to reduce nonspecific DNA contacts. SpCas9-HF1 rendered all or nearly all off-target events undetectable by
genome-wide break capture and targeted sequencing methods. The MGH team has also
identified and characterized a series of novel S. pyogenes and S. aureus Cas9 PAM variants
that substantially increase the range of sites in the genome that can be targeted for genome
editing. Financial details of the agreement were not disclosed
ENDP will continue to face price pressure in its generic unit in 2Q and may also report
sequential volume declines, based on an analysis of top drugs by revenue in the unit. Generic
volume is up about 3.2% on a pro forma basis, including products from Par Pharma. Continued
growth of Xiaflex in approved indications will be a key focus in the quarter. The launch of
Belbuca will likely continue to see a negative effect from the pushback on opioids.
Evelo Biosciences Inc is an exclusive collaboration with Mayo Clinic investigators to advance
immuno-microbiome-based therapies for cancer. The company will work with Mayo to isolate
and characterize cancer-associated bacteria from patient stool samples and tumor biopsies in
service of contributing to Evelo’s cancer associated bacteria library. The company will then
advance specific cancer-associated bacteria as therapeutics based on their ability to activate
the immune system against tumors.
FOLD plans to submit a Japanese new drug application (J-NDA) to request marketing
authorization for migalastat, an oral precision medicine for Fabry disease, in the first half of
2017. Following a meeting with and written correspondence from the Pharmaceuticals and
Medical Devices Agency (PMDA) in Japan, the J-NDA will be based upon data from completed
clinical studies with migalastat, including two pivotal Phase 3 studies, as well as a Phase 1
study that previously evaluated the pharmacokinetics (PK) of migalastat in Japanese volunteers.
Taking into account data from Japanese patients included in the Phase 3 program and the
similar PK properties in Japanese and non-Japanese individuals, the PMDA confirmed that
these completed studies meet J-NDA submission requirements without the need to conduct an
additional clinical study in Japan.
GILD news that HHS England plans to appeal a U.K. High Court ruling giving it authority to
cover the use of HIV therapy Truvada emtricitabine/tenofovir disoproxil fumarate from Gilead
Sciences Inc. for pre-exposure prophylaxis (PrEP) to prevent sexually acquired HIV. NHS
England had chosen not to cover PrEP therapy because it did not believe it had the legal power
to do so.NHS England had argued that local authorities should assume responsibility for
preventative medicine related to sexually transmitted diseases, and that under its governing
legislation, NHS England may not perform "public health functions" carried out by local
authorities.In the ruling, the judge wrote that "the expression 'public health function' is not
synonymous with or a proxy for preventative medicine," and that it was not Parliament's intent
"to construe 'public health functions' as a factor limiting the duty and neatly excluding
preventative medicines, but including curative treatments." The case was brought by the nonprofit National Aids Trust after NHS England said in March that it could not cover PrEP because
it would be subjected to legal challenge. On Tuesday, NHS England said it intends to publish as
soon as possible a draft policy proposition concerning its PrEP coverage.Last month, EMA's
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CHMP recommended expanding Truvada's label to include PrEP to reduce the risk of sexually
acquired HIV-1 in adults at high risk.
GLMD Management comments on ARREST Study: As of 31-Jul-16, we had randomized 132
patients and have another 27 subjects that are eligible to be randomized. In addition, 41
subjects are currently in the screening process, which normally takes between 6-8 weeks.
Based on this we continue to expect to complete the full recruitment of 240 patients by the end
of Q4, 2016.
GNSZ Genspera changed its name to Inspyr Therapeutics Inc. and began trading on under the
symbol NSPX on Aug 2 2016. The company said the change reflects “the significant potential
we see with the novel prodrug mipsagargin and our company’s future potential.”
INO will continue to develop its hepatitis B DNA immunotherapy (INO-1800) independently
following RHHBY notice that it will discontinue its collaboration with Inovio and its development
of INO-1800.
GSK developed what looks like a cure for a rare and deadly disease, and it’s going to cost
$665,000 for a single dose.GSK’s drug, called Strimvelis, is a gene therapy for severe combined
immune deficiency, an inborn illness that leaves children unable to protect themselves against
infection. It’s the same condition that forced David Vetter to live his life in a protective plastic
sphere, depicted in the documentary “The Boy in the Bubble.”Without treatment, children with
the disease die before the age of 2. But a single administration of GSK’s therapy kept 100
percent of patients alive after three years in a small clinical trial, and that was enough to
convince European regulators to approve it in May.And those results are worth $665,000,
according to the Italian Medicines Agency, which agreed to reimburse for GSK’s drug. Severe
combined immune deficiency is otherwise treated with risky bone marrow transplants or enzyme
replacement therapies that must be taken for life and can cost more than $4 million over the
course of a decade, GSK said. Strimvelis, by contrast, could be a bargain
InClinica news that Velocity Fund Partners, a Pittsburgh private equity company, has
announced the acquisition of the Philadelphia clinical contract research organization (CRO)
Indipharm and is relaunching the CRO as InClinica. Financial terms were not disclosed.
Velocity Fund Partners targets promising life sciences opportunities and believes InClinica is
well-positioned for growth.“InClinica’s existing global footprint and experience in early drug and
device development and clinical trials, combined with Velocity’s unique experience and contacts
in both healthcare and life sciences, will enable InClinica to provide companies with significant
value in all clinical phases,” said Ken Melani, Managing Partner of Velocity Fund Partners and
Chairman of InClinica.InClinica specializes in leading companies through clinical trials. It works
across all phases of clinical development, with a particular strength in assisting small to midsized companies entering first in man and phase 2 studies.
INO will independently develop hepatitis B immunotherapy as RHHBY discontinues
collaboration Inovio announced the company will continue to develop its hepatitis B DNA
immunotherapy (INO-1800) independently following Roche’s notice that it will discontinue its
collaboration with Inovio and its development of INO-1800. INO-1800 was licensed to Roche
from Inovio in 2013. All of Roche's rights to INO-1800, including the right to license the product
to other parties, will be returned. Inovio will continue to advance its current phase I study of
INO-1800, which is enrolling as planned in 30 clinical sites in the U.S. and Asia-Pacific regions.
Inovio anticipates completing enrollment in H1 of 2017 and expects results in H2 of 2017.
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Ipsen Telesta Therapeutics is terminating future expenditures on MCNA, ending its deal with
Ipsen SA, of Paris. Since the type A meeting with the FDA in April, Telesta has determined that
there is no reasonable assurance that a development partner in any region of the world can be
found for MCNA in the short term, the company said. The firm also has implemented a
workforce reduction that will decrease its operational staffing to 15 full-time employees from 50
people at March 31, 2016, and 32 as at June 30, 2016. Late last year, citing insufficient data, a
too-small study and a patient population that was not clearly defined, an FDA advisory panel
recommended the FDA reject the BLA for the bladder
JAZZ Defitelio receives approval for New Technology Add-on Payment Centers for Medicare
and Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for
Defitelio.
LIVN Management comments: André-Michel Ballester, CEO: "We are also seeing double digit
growth, both in our Neuromodulation franchise overall and importantly in our high voltage device
Platinium across Europe, as well as encouraging penetration of our low voltage device KORA
250 in Japan. At the same time, we have seen margin improvements across the income
statement and made meaningful advances in our restructuring activities and in capturing
synergies. With accelerating top line growth in H2 of the year and good expense discipline, we
are on plan to deliver on our financial commitments in 2016, while making exciting progress
toward building sustainable long-term growth."
LMNX announced that it has received FDA clearance for the ARIES Flu A/B & RSV Assay. This
is the second assay the FDA has cleared for use on the Luminex ARIES System. The ARIES
Flu A/B & RSV Assay is a rapid, accurate method for the detection and differentiation of
influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) from nasopharyngeal
swab (NPS) specimens using the ARIES System. The ARIES Flu A/B & RSV Assay delivers
results in less than 2 hours for the detection and differentiation of three key respiratory
pathogens: influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) using a
sample to answer platform. This new assay also allows for panel customization with the unique
ability to only report the results of interest.
MDVN CVS will remove coverage for expanding the company’s Xtandi strategy of excluding
expensive products when alternatives are available. The total number of excluded drugs for
2017 will be 131, spokeswoman Carolyn Castel said Tuesday
Morphosys completes safety run-in phase of phase 2 study of MOR208 in combination with
lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma MorphoSys
announces that it has successfully completed the safety run-in phase of its clinical phase 2
study of MOR208 in combination with lenalidomide in patients with relapsed or refractory diffuse
large B cell lymphoma ("DLBCL"). Six patients have been administered MOR208 at the
recommended dose (12mg/kg) in combination with lenalidomide during the safety run-in part of
the L-MIND study. No unexpected safety signals were detected, and the study will continue as
planned. Management expects to present first efficacy data in 2017.
Morphosys says no unexpected safety signals detected in safety run-in of MOR208 in
combination with lenalidomide in patients with relapsed or refractory diffuse large B cell
lymphoma.Says no unexpected safety signals were detect
MRK Keytruda gets EU approval for PD-L1 Lung Cancer advanced non-small cell lung cancer
whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.
MSTX announces the issuance of United States Patent No. 9,403,941 for "Poloxamer
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Composition Free of Long Circulating Material and Methods for Production and Uses Thereof"
by the United States Patent and Trademark Office (USPTO). The patent includes claims
covering composition of matter, methods of use, and methods of making certain purified forms
of poloxamer 188, including vepoloxamer, and should provide key intellectual property
protection in the U.S. for the company's vepoloxamer programs. The '941 patent will expire no
earlier than July 2035. The company also has filed corresponding patent applications that will
allow it to seek similar patent protection for vepoloxamer in key markets throughout the world,
including Europe and Japan. The company believes that the '941 patent will be eligible for
listing in the FDA's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations,
commonly known as the Orange Book, should vepoloxamer receive FDA approval for the
treatment of patients with sickle cell disease or heart failure.
MYGN signs definitive agreement to acquire Assurex Health for $225M upfront with potential
$185M in milestones Assurex Health provides genetic testing for psychotropic medicine
selection, and generated revenue of more than $60M and tested more than 150,000 patients in
Myriad’s fiscal year 2016. The transaction is expected to close at the end of Myriad’s Q1 of
fiscal year 2017.
NBIX Management commentary : Our R&D team has been carefully compiling the extensive
data from our 20 clinical trials of valbenazine along with the preclinical and drug manufacturing
data into an NDA that we anticipate will be submitted to the FDA soon. We have fully deployed
our medical affairs team and continue to build the capabilities to introduce valbenazine to
patients and a treatment community in need of new medicines for a serious disorder." Essential
Tremor Program (NBI-640756) Update Based on the results of this initial study, the company
has initiated a second Phase I, single site, randomized, double-blind, placebo-controlled,
multiple-dose, sequential dose-escalation study to evaluate the safety, tolerability and
pharmacokinetics of NBI-640756 in up to 30 healthy volunteers over a week of continuous
dosing. The study is being conducted in multiple sequential cohorts of ten subjects per cohort;
data from this second Phase I study is expected later in 2016. The data from this study, in
conjunction with the single dose Phase I study and preclinical studies, will be evaluated and
utilized in the design of the anticipated Phase II program for NBI-640756.
NSPX Genspera changed its name to Inspyr Therapeutics Inc. and began trading under symbol
NSPX on Aug 2 2016. The company said the change reflects “the significant potential we see
with the novel prodrug mipsagargin and our company’s future potential.”
NVS CVS will remove coverage for NVS leukemia drug Tasigna, , expanding the company’s
strategy of excluding expensive products when alternatives are available. The total number of
excluded drugs for 2017 will be 131
NVS LEE011 inhibitor gets FDA Breakthrough Therapy designation as first-line treatment for
HER+R+/HER2- advanced breast cancer.
OCUL has an update on the status of its New Drug Application (NDA) for DEXTENZA for
intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery. OCUL
got a CRL on Jul 25 2016 regarding its NDA for DEXTENZA that identified issues pertaining to
deficiencies in the manufacturing process and controls identified during a pre-NDA approval
inspection of the company’s manufacturing facility. The CRL for DEXTENZA did not identify any
efficacy or safety concerns with respect to the clinical data provided in the NDA nor any need for
additional clinical trials for the approval of the NDA. Recently, the FDA issued a letter to Ocular
Therapeutix noting that corrective actions detailed in its responses as a whole appear to
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address the ten inspectional observations raised in the Form FDA 483 with one exception which
relates to the proposed process for identity testing of an incoming inert gas component used in
the manufacturing process. In this letter, the FDA also requested that the company provide
evidence when migration to automatic integration of analytical testing is complete, which is
anticipated during Q3 of 2016. “We are working closely with the FDA to address the one
remaining item and are planning for a resubmission to our NDA as soon as possible,” said Amar
Sawhney, Ph.D., President, CEO and Chairman. “We remain committed to bringing DEXTENZA
to market as rapidly as possible.”
OPHT Program Updates Continues to expect initial, topline data from both pivotal Phase 3 trials
of Fovista in combination with Lucentis in wet age-related macular degeneration (AMD) in Q4
Continues to enroll patients in its Phase 2/3 trial of Zimura in patients with geographic atrophy In
addition, its Phase 2 trial evaluating the potential role of Zimura when administered in
combination with anti-VEGF drugs for the treatment of wet AMD has been activated.
PG calls for splitting up the company have “already dissipated greatly,” CEO David Taylor said
in an interview following the company’s 4th-quarter earnings report, according to the Financial
Times.
PSDV appoints Dario Paggiarino as Chief Medical Officer Paggiarino joined pSivida from Lpath
(LPTN), a company focused on the discovery and development of lipid-targeted therapeutics,
where he served as SVP and chief development officer.
QCOM new licensing deal with Oppo extends a recent upbeat trend for the company in China
after a yearlong retrenchment, and will be followed by more similar deals through the rest of this
year. Qualcomm in licensing deal with Oppo Following a difficult year in China that saw it fined a
record amount for anti-competitive behavior, global telecoms chip leader Qualcomm (QCOM)
appears to be slowing regaining its footing in the world’s largest smartphone market. That’s my
interpretation of the latest headline, which has the company announcing a new chip licensing
deal with Oppo, one of the market’s fastest growing smartphone makers. Word of this latest
deal almost certainly came from Qualcomm itself, which is eager to show its days of trouble in
China are in the past.The deal is quite significant, since Oppo has risen rapidly over the last
year to become China’s second largest smartphone brand, behind only the similarly surging
Huawei. In this year’s first quarter, Oppo’s China sales, which account for the vast majority of its
business, nearly tripled to 15.8 million units, giving it 15.4 percent of the Chinese market,
according to IDC.It’s a bit unclear how many of China’s major smartphone brands still need to
sign new agreements with Qualcomm, since the company doesn’t make big announcements for
each such deal. I expect Qualcomm may have already reached a deal with Huawei or feel it is
close to such a deal, since Huawei is generally one of the industry’s more mature players and is
less likely to use stalling tactics like Meizu’s.
QURE has positive news in regards to SHPG announcement that SHPG is ending
development of hemophilia B gene therapy BAX-355 removes near-term competitor to QURE’s
AMT-060, Leerink analyst Michael Schmidt says in note Says increasing competition in
hemophilia B development has been major overhang on QURE shares; current market cap
reflects little to no value for AMT-060 or gene therapy platform Says Shire’s Baxalta had
previously said it may start Phase 3 studies of BAX-355 in the near term; Shire now shifting
focus to a preclinical program given inconsistent data
RDUS reaffirms it will present data from abaloparatide transdermal patch studies in women with
postmenopausal osteoporosis on Sept. 19 at the American Society for Bone and Mineral
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Research (ASBMR), spokeswoman Barbara Ryan said in a phone interview. RDUS shares up
as much as 16%, most intraday since March 9 on volume 2.7x 3-month average, on
anticipation of data being presented tomorrow along with 2Q results and running M&A
speculation, 2 investors said Ryan said RDUS data has “been accepted for an oral late breaker
at ASBMR. The whole purpose about having a late breaker is that data is being presented
there” Ryan had no comment on takeover speculation on current healthcare M&A environment
REVA Medical submits application for CE Marking of its Fantom scaffold) The company
expects it would receive CE Mark approval, or notice of any issues with the application, prior to
Dec 31 2016. This regulatory approval would allow commercial sales in Europe and other
countries that recognize the CE Mark.
Resverlogix the Life Sciences Report has article , they interview with Marcel Wijma, CEO and
managing director of Van Leeuwenhoeck Research"Resverlogix announced that it started a
new Phase 1 trial with its lead drug apabetalone in patients with severe kidney disease. If
successful, the clinical results will allow for more advanced kidney impairment and dialysis trials
to proceed. The results are expected before the end of the year. This new trial is part of the
company's strategy to expand its clinical program with apabetalone (RVX-208) into new
indications and orphan diseases." Resverlogix's epigenetic approach to the treatment of
cardiovascular and other diseases represents "a novel and important new area of focus for the
pharmaceutical industry," according to the analyst. "With a successful Phase 3 trial, and
considering the market potential for RVX-208, we feel that a very significant upside potential for
RVX-208 and Resverlogix is attainable," Wijma wrote. They also interview John Vandermosten
of Zacks Small-Cap Research noted he expects top-line data in the BETonMACE trial to read
out in 2018. "The Phase 1 study for renal indications, "is being conducted in New Zealand and
[the company] expects to post results in the second half of 2016, after which additional renal
impairment and dialysis trials will proceed if positive data is seen. We hope to see a Phase 2
trial begin shortly after the completion of the data analysis and [Resverlogix] could potentially
obtain approval in a renal indication under an orphan designation prior to an approval for highrisk cardiovascular disease" Apabetalone's ability to selectively inhibit a specific BET domain
"produces a specific set of biological effects with potentially important benefits for patients with
diseases such as high-risk cardiovascular disease (CVD), diabetes mellitus (DM), chronic
kidney disease, Alzheimer's disease, orphan diseases, and peripheral artery disease, while
maintaining a well-described safety profile," according to the company. RVX-208 is intended to
inhibit bromodomain and extra terminal domain (BET) proteins. The Phase 3 trial, known as
BETonMACE, is focused on patients with chronic kidney disease, DM, and low HDL (highdensity lipoprotein). The Phase 3 study is currently "enrolling as planned," the company stated.
RHHBY INO will independently develop hepatitis B immunotherapy as RHHBY discontinues
collaboration Inovio announced the company will continue to develop its hepatitis B DNA
immunotherapy (INO-1800) independently following Roche’s notice that it will discontinue its
collaboration with Inovio and its development of INO-1800. INO-1800 was licensed to Roche
from Inovio in 2013. All of Roche's rights to INO-1800, including the right to license the product
to other parties, will be returned. Inovio will continue to advance its current phase I study of
INO-1800, which is enrolling as planned in 30 clinical sites in the U.S. and Asia-Pacific regions.
Inovio anticipates completing enrollment in H1 of 2017 and expects results in H2 of 2017.
SNY CVS will remove coverage for SNY insulin Lantus, expanding the company’s strategy of
excluding expensive products when alternatives are available. The total number of excluded
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drugs for 2017 will be 131, SNY is disappointed by CVS Decision on Lantus, Toujeo-- Sanofi to
continue talks with other insurers for Lantus, Toujeo.Sanofi spokesman Jack Cox says
“disappointing that a plan would make a decision that makes it difficult for patients to benefit
from the gold standard of basal insulin treatment”
SRPT Janney says Sarepta accelerated approval could come this m Janney says Sarepta
accelerated approval could come this month Janney Capital analyst Debjit Chattopadhyay said
he believes that the fact that Sarepta's ESSENCE study has been formally activated implies that
IRB approvals from one or more sites is available. Noting that the FDA has not yet given a CRL
to the company for eteplirsen, Chattopadhyay said he assumes the 48-week biopsies from the
PROMOVI study point to a mechanistic validation and he "would not be surprised" by an
accelerated approval for eteplirsen during August. The analyst keeps a Neutral rating on
Sarepta shares.
Telesta Therapeutics is terminating future expenditures on MCNA, ending its deal with Ipsen
SA, of Paris. Since the type A meeting with the FDA in April, Telesta has determined that there
is no reasonable assurance that a development partner in any region of the world can be found
for MCNA in the short term, the company said. The firm also has implemented a workforce
reduction that will decrease its operational staffing to 15 full-time employees from 50 people at
March 31, 2016, and 32 as at June 30, 2016. Late last year, citing insufficient data, a too-small
study and a patient population that was not clearly defined, an FDA advisory panel
recommended the FDA reject the BLA for the bladder
TEVA announces acquisition of Anda for $500M the 4th largest distributor of generic
pharmaceuticals in the U.S. for $500M. Anda distributes generic, brand, specialty and over-thecounter pharmaceutical products from more than 300 manufacturers to retail independent and
chain pharmacies, nursing homes, mail order pharmacies, hospitals, clinics and physician
offices across the United States. For the full year 2016, Anda is expected to generate more
than $1B in third-party net revenue. As part of the deal, Teva will acquire three distribution
centers in Olive Branch, MS; Weston, FL; and Groveport, OH, with a total of over 650
employees. The closing of this transaction is subject to antitrust clearance and satisfaction of
other conditions. The transaction is expected to close in H2 of 2016.
TEVA will target “attractive specialty assets, or branded drug assets or pipeline assets,” CEO
Erez Vigodman says in interview.Teva business isn’t just generics, vision is much broader:
VigodmanIntegrating Allergan is Teva’s No. 1 priority to meet goals at moment
Viromed Co. obtained IND approval from the Korean Ministry of Food and Drug Safety for a
phase II trial of gene therapy candidate VM202 for ischemic heart disease (IHD). The trial will
assess 108 participants with IHD who have received a percutaneous coronary intervention for
acute myocardial infarction 30 days prior to study enrollment. The objective is to test doserelated safety and tolerability, with secondary efficacy endpoints including cardiac function and
output.
Viromed news that VM Biopharma the U.S. division of Korean firm
VTAE "We are on track to report top-line results for the ongoing Phase 2a proof-of-concept
study for VTP-38543, our wholly owned, potential first-in-class LXRβ selective agonist being
developed for atopic dermatitis, in Q4 of 2016. Second, we continue to finalize plans for the next
clinical trial, expected to initiate in Q4 of 2016, of VTP-43742, our wholly owned, first-in-class
RORyt inhibitor, in psoriasis patients."
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WMT is supposedly in talks to acquire discount online shopping company Jet.com Jet.com is a
privately owned company headquartered in Hoboken, NJ and was co-founded by Marc
Lore.Marc Lore was formerly the CEO and co-founder of Quidsi, which ran Diapers.com and
Soap.com, which was a part of Amazon.com (AMZN). Therefore, "we know" Lore has
experience "under a very formidable competitor to Walmart," which is Amazon, she explained.
Xiamen Origin Biotech Co. FDA sent warning letter to the company two months after placing the
company on import alert. The letter, posted to the agency website this week, claimed the
company fabricated an employee name that was used to sign certificates of analysis issued to
customers. The certificates omitted the name and address of the API manufacturer and didn’t
include the required copy of the original batch certificate. During a January inspection, an
employee at the company told the FDA investigator that there were no drugs at the site and that
the company had stopped relabeling drugs in January 2015.
Zenith Epigenetics Corp changed its name to Zenith Capital Corp., concurrent with an internal
corporate reorganization, effective Aug. 1, which transfers the company’s principal operating
assets to Zenith Epigenetics Ltd., a wholly owned subsidiary of Zenith Capital, in exchange for
additional common shares of Zenith Epigenetics. Zenith Capital will own all the securities of
Zenith Epigenetics and retains its investment in the royalty preferred shares of Resverlogix
Corp., also of Calgary. Zenith Epigenetics is developing bromodomain inhibitors, with lead
candidate ZEN-3694 in clinical development for metastatic castration-resistant prostate cancer
YCBB on QCOM
QCOM new licensing deal with Oppo extends a recent upbeat trend for the company in China
after a yearlong retrenchment, and will be followed by more similar deals through the rest of this
year. Qualcomm in licensing deal with Oppo Following a difficult year in China that saw it fined a
record amount for anti-competitive behavior, global telecoms chip leader Qualcomm (QCOM)
appears to be slowing regaining its footing in the world’s largest smartphone market. That’s my
interpretation of the latest headline, which has the company announcing a new chip licensing
deal with Oppo, one of the market’s fastest growing smartphone makers. Word of this latest
deal almost certainly came from Qualcomm itself, which is eager to show its days of trouble in
China are in the past.The deal is quite significant, since Oppo has risen rapidly over the last
year to become China’s second largest smartphone brand, behind only the similarly surging
Huawei. In this year’s first quarter, Oppo’s China sales, which account for the vast majority of its
business, nearly tripled to 15.8 million units, giving it 15.4 percent of the Chinese market,
according to IDC.It’s a bit unclear how many of China’s major smartphone brands still need to
sign new agreements with Qualcomm, since the company doesn’t make big announcements for
each such deal. I expect Qualcomm may have already reached a deal with Huawei or feel it is
close to such a deal, since Huawei is generally one of the industry’s more mature players and is
less likely to use stalling tactics like Meizu’s.
One result of Qualcomm’s new confidence will be rising costs for China’s smartphone makers,
many of them already losing money due to the stiff competition. That could force many
companies to look for cheaper alternatives from Qualcomm rivals like Taiwan’s MediaTek or
China’s own Spreadtrum. It could even finally prompt some of the smaller players like OnePlus
or Smartisan to finally call it quits, sparking a much-needed round of consolidation in the
overheated market.
Real Clear Health
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CVS Ends Coverage of Two Biotechs in Favor of Biosimilars
Walker & Ziobro, WSJ
More Than Half of Hospitals to be Penalized for Excess Readmissions
Rau, KHN
Aetna’s ACA Reversal Is Latest Blow to US Health Law
Zachary Tracer, Bloomberg
Does Flossing Help or Not? The Evidence is Mixed at Best
Rae Ellen Bichell, NPR
Anti-Abortion Group Pressuring Kaine
Jonathan Swan, The Hill
Scientists Get Closer to Harnessing the Health Benefits of Red Wine
Roland, WSJ
A Bed Shortage for the Mentally Ill and Long Waits for Help
Ollove, Stateline
CMS Chronic Care Management Program and Patient Engagement
Findlay, MCN
Biogen Shares Spiking On Rumors of a Mega-Deal With Rivals
Mukherjee, Fortune
Healthcare Inequality on the Rise
D. Himmelstein & S. Woolhandler, The Hill
27 Overnight Shifts: Lessons Learned From Indian Health Providers
Eicken, NEJM
I Wish the Candidates Would Stop Talking About Vaccines
Carroll, Incidental Econ
What Banned Drugs Do Cheating Athletes Take?
Bonnie Berkowitz, WP
NY Times
Cutting edge in mobile China tech innovations are spurring imitators in Silicon Valley even
among behemoths, China’s mobile business is way ahead of the West
Fortune on PFE split
PFE Splitting itself up could depend on the next President’s tax plan.For Pfizer, breaking up is
hard to do—but it might be easier depending on who wins the presidential election in November,
the company said Tuesday.
But Read apparently is no longer confident that a breakup would be best for Pfizer, or that it
would come with the tax advantages he has long sought.But Read admitted that Pfizer might
wait for the outcome of the presidential election before making a decision, as Donald Trump and
Hillary Clinton’s tax plans are likely to impact the tax savings the company could achieve
through various deals.“Hopefully if we have a new administration, whichever administration is in,
there will be a need to look at tax reform, and tax reform has implications for what you want to
do and what kind of taxes you want to pay,” Read said. “So it is an influence in our thinking.”
Trump has promised a tax reform plan that would lower businesses’ tax rate to a maximum of
15%, rendering “corporate inversions unnecessary by making America’s tax rate one of the best
in the world.” Clinton, meanwhile, singled out Pfizer in outlining ways she would prevent deals
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like its Allergan merger and other inversions and tax-saving maneuvers, but pledged reform that
would make the U.S. a more competitive place for businesses to operate.
But dividing the business would also limit the cash each would have access to as well, limiting
their abilities to invest in R&D, pay dividends, or spend in other areas, Read said. “If you’re one
company you have more choices,” he said. “Once you split you permanently divide those cash
flows and you basically lose flexibility.”Pfizer said it even compared the market performance of
the S&P 500 and the Guggenheim S&P Spin-Off ETF, which tracks companies that have been
spun or split off from a parent corporation, but that there was no clear winner over the longer
term.
“The real question is what can be done if the divisions were split versus what can be done if
they’re inside Pfizer?” Read said. “Is there some material obstacle inside the company in either
of these divisions if they remain inside Pfizer?”
The company still plans to decide whether or not to split by the end of this year, but even if the
answer is no, Read said it could still decide to do so in the future, as the option doesn’t have “an
expiration date.”
August 2, 2016
Aug 2 2016 GILD and pondering a breakup of the company in Biospace
Aug 2 2016 GILD another article in Biospace postulating who they could buy : INCY VRTX
MDVN DVAX and KITE
Aug 2 2016 KITE in Biospace as takeover bait for GILD . Hagopian suggested Gilead acquire
Kite. “Due to Juno’s stumble,” Hagopian said, “Kite is poised to be the first CAR-T competitor to
the market, potentially years in front of its next competitor, which will allow them to become the
Gilead of this particular aggressive new oncology market. Kite would likely cost just over $3
billion to acquire.”
Aug 1 2016 MSFT on Talking Points postulating who they could buy:Vidyo, Genesys maybe,
PLCM unlikely
Aug 1 2016 PLCM on Talking Points, sees an acquisition by MSFT as unlikely
Aug 1 2016 Vidyo MSFT on Talking Points postulating who they could buy:Vidyo which makes
sense
Aug 1 2016 Genesys discussed on Talking Points and sees a MSFT buyout possible but Vidyo
makes more sense
Aug 1 2016 TWTR why TWTR should buy Nuzzel on WSJ
Aug 1 2016 FMC is in good position to scoop up assets, article in BBERG Gadfly
New events to add to the work
Meda EGM to apply for delisting Aug 25 2016
Belkin
Has had an amazing call in gold & silver miners, the YTD percentage is +248% in his special
table of names. Belkin continues to see upside in this sector and long gold and silver miners
remain favorite trade.
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Adds healthcare service providers, industrial conglomerates, commercial services , energy
services and oil & gas to weaker industry groups
Biospace pondering GILD breakup/acquisition strategy
GILD one idea floated recently is that the company spin off its hepatitis C division. In the
second quarter of this year, it showed an 18 percent drop in sales year-over-year,
primarily from its three HCV drugs, Harvoni, Sovaldi and Epclusa. “We find that spinning
off HCV would help Gilead’s long-term growth profile—which could improve sentiment—
though there would still be earnings lumpiness in the underlying HIV business, which
could weigh on the multiple,” wrote Brian Abrahams, an analyst with Jefferies LLC, in a
note to clients.
Abrahams suggests INCY and VRTX as acquisition targets for GILD
Some have mentioned San Francisco’s Medivation (MDVN), which has booming prostate
cancer drug, Xtandi, and several very promising pipeline drugs, including talazoparib for
advanced breast cancer patients who have BRCA mutations. Medivation is currently the target
of a hostile takeover bid by Paris-based Sanofi (SNY). “I don’t think that Gilead is the best for
Medivation,” said Michael Yee, an analyst at RBC Capital, in an interview with The Street. “They
don’t have a solid tumor presence to make that work. They would be better suited to look to
build better oncology assets elsewhere.”
Bret Jenson, writing for Seeking Alpha back in March suggested DVAX KITE as bait
Hagopian also suggested Gilead acquire Kite. Particularly when the stock recently
dropped after competitor Juno Therapeutics (JUNO) had a clinical hold placed on its own
CAR-T trial after three patient deaths, which cast a shadow over Kite. “Due to Juno’s
stumble,” Hagopian said, “Kite is poised to be the first CAR-T competitor to the market,
potentially years in front of its next competitor, which will allow them to become the
Gilead of this particular aggressive new oncology market. Kite would likely cost just over
$3 billion to acquire.”
Quartz negative on YHOO VZ different cultures article and THIS CANNOT END well
Carriers’ fear of commoditization is alive and bad; how else could we explain Verizon’s
necrophiliac acquisitions of AOL and now Yahoo? For the acquired companies, it makes sense.
If AOL had been a viable entity instead of walking its user base to the grave, or if Yahoo’s
revenues and profits had been on a growth curve, shareholders wouldn’t have clamored for an
end to their suffering. For them, an assisted living home was their best choice.
But what about the acquirer? Does Verizon sincerely want to get richer? Will it try to increase its
ARPU by piling up media properties and finding ways to decrease choices for its customers,
somehow forcing them into paying for content bundles?
And yet, boards of directors, CEOs, bankers, and industry analyst keep telling themselves and
the investing public the same stories. Here, for Verizon, buying two failing properties will make
the resulting conglomerate better.Both AOL and Yahoo bring their own acquisition disaster
stories. In 1999, just as Internet Explorer shot past Navigator as the most popular web browser,
AOL acquired Netscape for about $10 billion. That was nothing compared to the disastrous
$160 billion merger of Time Warner and AOL in 2000, only to see AOL pawned off to Verizon for
$4.4 billion in 2015. With Yahoo we have a litany of failed acquisitions: Broadcast.com for $5.7
billion, Geocities for $3.6 billion, Tumblr for $1.1 billion.
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Marissa Mayer may have made mistakes in her four years as Yahoo CEO—she has her own list
of poor-to-middling acquisitions—but does Verizon management actually believe they can
succeed where Mayer failed?When Mayer came to Yahoo, she brought her Google credentials
and credibility. She had a (good) reputation and industry knowledge, and yet she couldn’t turn
the company around. Some argue that the patient was gone before the surgeon entered the
operating room.
Indeed, I believe it was a succession of mistakes made by Yahoo’s board, including bad CEO
hires before Mayer, that made a turnaround impossible. How can any company survive such a
succession of CEOs:
Timothy Koogle (1995–2001)
Terry Semel (2001–2007)
Jerry Yang (2007–2009)
Carol Bartz (2009–2011)
Tim Morse (interim; 2011–2012)
Scott Thompson (2012)
Ross Levinsohn (interim; 2012)
Marissa Mayer (2012–)
If Verizon’s Board of Directors wants us to believe that Yahoo will not only improve but form a
synergy with its older business, they need to give us more than CEO Lowell McAdam’s bland
testament: “By acquiring Yahoo’s operating business, we are scaling up to be a major
competitor in mobile media…”
McAdam is an experienced executive. Does he really believe he can sell formerly unsuccessful
Yahoo services to Verizon subscribers? Or cause existing Verizon subscribers to suddenly
generate more advertising revenue for Yahoo properties? And let’s not forget to throw AOL
properties and customers into the brew. Yahoo was criticized, fairly, for being hard to define.
How does the compounded Verizon explain itself to employees, customers, shareholders?
Without a clear explanation, there can be no successful execution.
This cannot end well
Biowatch News on CORT
CORT he also expressed continued sales growth. As a rule of thumb, it takes about 9 to 12
months after hiring before we begin to see a significant sales impact. Corcept is finally reaping
fruits from its 2015 additions to its sales and marketing staff.The Cushing’s program has this
“peculiar dynamic”. Let’s assume a conservative average wholesale price for Korlym: $150K per
patient per year. It’s higher but we want to present a robust argument.Corcept’s liaisons are well
trained, being “semi-privately” tutored for about two months. They have generous marketing and
budgetary supports.
How many new prescriptions does the new liaison need to produce to reach breakeven on their
new position over the next 10 months? Answer: about two.Of course, there are caveats to this
math, but you get the idea. You need a ridiculously low number of new sales wins to support the
acquisition of new staff.Many of the Cushing’s patients are being served in the “wild”, in less
densely populated areas. Furthermore, patients with much less severe Cushing’s appear to
benefit from Korlym. On the other hand, the market size is clearly larger than previous estimates
from industry wags.When Belanoff and Corcept began the Cushing’s program, it was thought
that the vast majority of patients were being served at medical centers inside large urban cities.
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Corcept still won’t need a large sales team for Korlym, but additional liaisons will slowly be
added in the near future.Decoding the Cushings vs. Metabolic Programs
If you have been closely reading our material on Corcept, then you are aware of a concern that
the metabolic syndrome program could cannibalize the Cushing’s program. We have been
carefully following CORT118335 in the published and conference literature for the past couple
years. CORT118335 is a different animal from all of Corcept’s other known drugs.
Our Thoughts As we have said before, there’s a slow train coming and it’s Corcept moving
ahead with clinical trials in cancer and Cushing’s disease in 2016. In early 2017, Corcept will
introduce three new drugs in the clinic with the intent of opening two new indications plus an
additional drug for cancer. To many investors, CORT looks like a cancer company. That
apparent story may become deafening if CORT125134 has robust synergy with checkpoint
inhibitors. Trials to Watch Although it looks like 2017 will be Corcept’s year, there are a few
trial results to watch in 2016. Q3-2016
MIFCOG Trial – Cognitive Impairment & Depression
in Alcoholics Q3-2016
Korlym + Eribulin - Breast Cancer – Top-line Results June 2016
SABCS Presentations (Dec 6-10) The MIFCOG trial results are due from the UK but it’s hard to
guesstimate its arrival. The rumor is that the investigators might be moving slowly with the
summer doldrums. With 120 serious alcoholics, it should yield some valuable information
regarding Korlym as a potential treatment. There might also be some University of Chicago
cancer trial results that may arrive at the end of 2016. We aren’t holding our breath.
Nevertheless, we expect it to arrive in 2016 or 2017 at the latest. Lastly, there should be some
PTSD results arriving in second half of this year. (
STAT
New US hospital rankings are out this morning, and Mayo Clinic has booted Massachusetts
General Hospital from the top spot on the list. The switch-up might be in part due to new
methods implemented by US News and World Report this year. The hospital rankings are a
composite of how a hospital scores in 25 specialties, like oncology and gynecology.
A high BMI doesn’t translate to a higher risk of heart attack or death, finds new research. The
finding comes from a study of around 4,000 pairs of genetically identical twins. Researchers
followed the twins — each set of whom had different levels of body fat — for an average of 12
years. The twins with the higher BMIs didn’t have an increased risk of heart attack or mortality
compared to their thinner siblings. The study did, however, note an association between obesity
and risk of developing type 2 diabetes.
Health news
AAAP National Cancer Institute will sponsor and conduct a study of Lutathera The company
announced a clinical trial agreement with the National Cancer Institute ('NCI') whereby NCI will
sponsor and conduct a study of Lutathera in patients with inoperable pheochromocytoma and
paraganglioma
ABEO has an update on its ongoing Ph 1/2 trial for ABO-102, a single treatment gene therapy
strategy for patients with MPS IIIA (Sanfilippo syndrome type A). Following a review of safety
data by independent Data Safety and Monitoring Board on the initial patient enrolled, the trial
enrolled and treated a second patient. Additionally, preliminary measures of clinically relevant
biomarkers provide promising signals of potential systemic and CNS clinical benefits for patients
suffering with MPS IIIA.
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Adicet Bio news that REGN is jumping into CAR-Ts and TCR tech and has selected the startup
Adicet Bio for its collaboration. Both companies emphasize that they’re concentrating on off-theshelf drugs that will be primarily focused on solid tumors, the new new thing in immunooncology where first-gen hematological immunotherapies have encountered hard barriers. The
pact with Regeneron covers a “broad pipeline,” emphasizing that the key to creating a safe,
effective immune cell therapy is being “specific to the tumor target.”
ADXS AMGN news : AMGN is paying $65 million upfront to get the deal kickstarted, with $25
million reserved for an equity stake in the company. Amgen is also adding $475 million in
milestones for the deal as it picks up development responsibilities after Advaxis ADXS is done
with its proof-of-concept work for the still preclinical program for ADXS-NEO. Advaxis work is
based on engineering live attenuated Listeria monocytogenes. By sequencing a patient’s cancer
cells, along with normal cells, investigators will search for neo-antigens in cancer cells that can
be targeted with specifically designed vectors. “After the ADXS-NEO infusion, neoepitope
peptides corresponding to each patient’s cancer-associated mutations are delivered directly into
their antigen presenting cells by Lm-LLO, where they can stimulate cellular immune responses
against multiple neoepitopes simultaneously,” notes Advaxis’ statement on the deal. Clinical
trials for ADXS-NEO are expected to begin in 2017.
AET HUM in separate agreements to sell some Medicare Advantage assets to Molina
Healthcare for ~$117m in cash for both deals. MOH to gain ~290,000 Medicare Advantage
members in 21 states mgen has joined the immunotherapy partnering frenzy. The Big Biotech is
signing up with the little biotech Advaxis, collaborating on its technology using bioengineered
bacteria to recruit a T cell attack on cancer.
AET “While we are pleased with our overall results, in light of updated 2016 projections for our
individual products and the significant structural challenges facing the public exchanges, we
intend to withdraw all of our 2017 public exchange expansion plans, and are undertaking a
complete evaluation of future participation in our current 15-state footprint,” Mark Bertolini,
Aetna’s chairman and CEO, said in a statement. “These people need these procedures and
they need these drugs and they need to be covered,” he said. “But when you couple that with a
risk-adjustment mechanism for high-risk people, that really is limited by virtue of the legislation,
it causes everyone in the system to lose money.”Bertolini said the exchanges could work if
adjustments were made to the health-care law. In its current form, though, it’s nearly impossible.
AET facing more than $300 million in losses from Affordable Care Act health plans this year,
may exit Obamacare markets in some states as challenges to the health-care overhaul pile up.
While the health insurer has yet to leave any states in which it now sells Obamacare programs,
Chief Executive Officer Mark Bertolini said Aetna is evaluating its participation by market and
will start making decisions in coming weeks. The company, which covers 838,000 people
through Obamacare, is halting a planned expansion of those offerings in new states for next
year. Mark Bertolini “We’ve got to be able to cover the costs associated with providing the
care,” Bertolini said in an interview.
Agilis Biotherapeutics LLC said it became the first company to gain an FDA orphan drug
designation for a gene therapy for Friedreich’s ataxia. The company’s candidate, AGIL-FA, is
focused on delivering corrective DNA to specific CNS cells to restore frataxin protein levels
AGN unlikely to pursue deal for Biogen -- CNBC's Meg Tirrell, citing a source
AMGN ADXS news : AMGN is paying $65 million upfront to get the deal kickstarted, with $25
million reserved for an equity stake in the company. Amgen is also adding $475 million in
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milestones for the deal as it picks up development responsibilities after Advaxis ADXS is done
with its proof-of-concept work for the still preclinical program for ADXS-NEO. Advaxis work is
based on engineering live attenuated Listeria monocytogenes. By sequencing a patient’s cancer
cells, along with normal cells, investigators will search for neo-antigens in cancer cells that can
be targeted with specifically designed vectors. “After the ADXS-NEO infusion, neoepitope
peptides corresponding to each patient’s cancer-associated mutations are delivered directly into
their antigen presenting cells by Lm-LLO, where they can stimulate cellular immune responses
against multiple neoepitopes simultaneously,” notes Advaxis’ statement on the deal. Clinical
trials for ADXS-NEO are expected to begin in 2017.
AvroBio discussed in Endpoints,earlier this year, AvroBio got seed financing from Atlas Venture
after zeroing in on the work of a pair of scientists in Toronto. And today he landed a $25 million
A round to get his two lead programs into the clinic later this year.MacKay believes that this is
exactly the right time to get into gene therapy, after pioneers like Bluebird have established how
the technology can work safely. And he’s putting that to the test with a new gene therapy aimed
at rare cases of Fabry disease.For the Fabry program, which will look to substitute enzyme
replacement therapies with a once-and-done curative treatment, investigators are using an ex
vivo approach: extracting CD34+ hematopoietic stem cells from patients and then using a
lentiviral vector to reengineer them to express the normal gene before infusing them back into
the patient.AvroBio also has an entry in the fast-growing immunotherapy arena for acute
myeloid leukemia. It’s extracting cancer cells and engineering them to express IL-12 in order to
spur a durable T cell assault on the cancer. The AvroBio team is working with two scientific cofounders, Jeffrey Medin, who until recently was a professor at the University of Toronto along
with Christopher Paige. AvroBio is based in Cambridge, home turf to MacKay, with a facility in
Toronto where it can remain close to its scientific home. Atlas Venture, Clarus and SV Life
Sciences co-led the A-round, contributing their partners to the board. Bruce Booth at Atlas is
signing on as chairman while Scott Requadt, a managing director at Clarus, and Josh Resnick
at SV Life Sciences join the board. Right now, the team consists of a core group of 8, which
MacKay says is set to grow.
Bigfoot Biomedical is a company working on introducing an "artificial pancreas" for Type 1
diabetics who are on insulin therapy. The company has developed its own algorithms that
control the delivery of insulin by a pump based on readings from a continuous glucose monitor
(CGM). Now these algorithms are about to be tested in a clinical trial
bioMerieux submits 510(k) application to FDA for VIRTUO blood culture system the next
generation of BacT/ALERT automated blood culturing system
Biotica Pharmaceuticals Inc. (Biotica), a biopharmaceutical company and subsidiary of
FutureWorld Corp., which engages in discovering, developing, and commercializing
cannabinoid-based medicines for Neuropathic pain, Cancer, Alzheimer's, Parkinson's,
Esophagitis, and Immune Enhancement, announces today that it has elected Dr. P.C. Sundar
as its President & CEO effective July 19, 2016. Dr. Sundar, through his years of experience
working for fortune 100 pharmaceutical companies will lead the Company in discovering,
developing, and commercializing cannabinoid-based medicines for Neuropathic pain, Cancer,
Alzheimer's, Parkinson's and Esophagitis.
BIIB AGN unlikely to pursue deal for Biogen -- CNBC's Meg Tirrell, citing a source
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BIIB draws takeover interest from AGN MRK- WSJ, citing sources AGN and MRK have
informally sounded out BIIB, according to sources, and the preliminary expressions of interest
may not lead to a deal, according to the repo
BTG has obtained European Conformity (CE) Mark from the Notified Body British Standards
Institution following completion of the reclassification of DC Bead and DC Bead M1 TM as Class
III medical devices.
CAPR discussed in Biowatch news, Capricor has major results arriving in early 2017 HOPEDuchenne Muscular Dystrophy Cardiomyopathy treatment – Results, Q1-2017 ALLSTAR Trial
on Heart Attack Patients – Results, Q1-2017, JNJ Janssen (J&J) Option to License CAP-1002
– Decision, Q2-2017
Cartiva out of Alpharetta, Georgia news that the newly FDA approved Cartiva Synthetic
Cartilage Implant (SCI) is the first man-made cartilage replacement device to become available
in the U.S.
CBIO announces that it has entered into a definitive agreement to sell to Attenua, Inc. certain
oral Neuronal Nicotinic Receptor (NNR) assets that were under development by Targacept prior
to its 2015 merger with Catalyst. The divestiture provides an upfront payment to Catalyst and
may also allow Catalyst to receive up to a total of $105M in development, regulatory and
commercial milestone payments as well as royalties on net sales from Attenua. Under the
terms of the agreement, Attenua will acquire certain oral NNR assets including related
intellectual property rights and materials. The assets sold to Attenua include three molecules
that have aggregate clinical experience in over 1200 patients with depression, ADHD and
Alzheimer’s disease in Phase 1 and 2 clinical trials.
CHA Biotech news that SRNE has entered into a binding term sheet to create a joint venture
("JV") with CHA Biotech Co. LTD,(of South Korea to develop and commercialize proprietary
Chimeric Antigen Receptor ("CAR") modified cellular therapies based on CBT's Activated Killer
Cell ("AKC") technology and five of Sorrento's CARs for all disease conditions, including
oncology and infectious diseases. The JV covers products on a global basis with the exception
of the Greater Chinese market. Sorrento Therapeutics, Inc. In addition, Sorrento will obtain an
exclusive license to develop and commercialize CBT's novel investigator-initiated trial stage
AKC technology in major territories, including the United States, Europe, and with a coexclusive license in China. The AKC technology utilizes proprietary methodologies for the
generation of highly activated, patient-derived Natural Killer (NK) Cells from 60 mL (60 cc or
less than 3 fl. oz.) of peripheral blood. The expansion and activation process takes less than 3
weeks and yields sufficient cells for several treatment cycles. Notably, the resulting AKC product
can be cryopreserved as efficient freeze-thaw protocols have been established. Thus far, more
than 1,000 AKC batches have been produced and used in ongoing clinical studies in Japan.
The treatment protocol does not require lympho-depleting preconditioning of the patients prior to
administration of the AKC. Both CBT and Sorrento will make contributions of $2 million to the
JV. In addition, Sorrento will grant the JV an exclusive license to five CARs solely for
combination with the AKC technology, while CBT will contribute its AKC technology. CBT will
initially own 51% of the JV while Sorrento will initially hold the remaining 49%. Sorrento, under a
royalty bearing license, will also gain access to the AKC technology for use outside the JV alone
or with any other Sorrento products. "CHA Biotech is dedicated to discovering and developing
innovative medical technologies with AKC being a leading example of our research and
development excellence in the cellular therapy field. Our AKC technology requires only a small
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amount of patient blood to generate highly activated NK cells. The AKC can be frozen, stored,
and shipped to the clinical sites where the cells are thawed and administered without loss of
anti-cancer activity. Together we will be able to expedite the clinical product development as
well as utilize Sorrento's CAR technology to enhance AKC's anti-cancer activity. The JV will be
headquartered at our CHA Bio Complex, which is Korea's largest biomedical research center.
We look forward to joining forces with Sorrento to deliver effective cellular immunotherapies to
cancer patients worldwide," commented Jong-soo Choi, CEO of CHA Biotech.
CMS issued a final rule to update fiscal year (FY) 2017 Medicare payment policies and rates
under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital
(LTCH) Prospective Payment System (PPS). The final rule, which would apply to approximately
3,330 acute care hospitals and approximately 430 LTCHs, would affect discharges occurring on
or after Oct 1 2016. The final increase in operating payment rates for general acute care
hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality
Reporting (IQR) Program and are meaningful EHR users is approximately 0.95%. CMS
projects that the rate increase, together with other final changes to IPPS payment policies, will
increase IPPS operating payments by approximately 1.0% and that changes in uncompensated
care payments will decrease IPPS operating payments by 0.4%.
CMS is updating the LTCH PPS standard Federal payment rate by 1.75% for FY 2017 for
LTCHs that successfully participate in the LTCH Quality Reporting Program (LTCH QRP). This
update is based on the most recent estimate of the revised and rebased LTCH PPS market
basket (which is being adopted in this final rule) of 2.8% adjusted by 0.3 percentage point for
multi-factor productivity and an additional adjustment of 0.75 percentage point in accordance
with the Affordable Care Act. CMS projects that LTCH PPS payments will decrease by 7.1%, or
approximately $363M in FY 2017 CMS.
CORT Biowatch news:although it looks like 2017 will be Corcept’s year, there are a few trial
results to watch in 2016. Q3-2016
MIFCOG Trial – Cognitive Impairment & Depression in
Alcoholics Q3-2016
Korlym + Eribulin - Breast Cancer – Top-line Results June 2016
SABCS Presentations (Dec 6-10) The MIFCOG trial results are due from the UK but it’s hard to
guesstimate its arrival. The rumor is that the investigators might be moving slowly with the
summer doldrums. With 120 serious alcoholics, it should yield some valuable information
regarding Korlym as a potential treatment. There might also be some University of Chicago
cancer trial results that may arrive at the end of 2016. We aren’t holding our breath.
Nevertheless, we expect it to arrive in 2016 or 2017 at the latest. Lastly, there should be some
PTSD results arriving in second half of this year.
CTRV announced positive Phase 1b results from a clinical safety study of CMX157, a hepatitis
B (HBV) infection treatment. Phase 2a trial will enroll 60 treatment-naive patients with chronic
HBV infection
CYCC announced the publication of a paper by researchers at Yale University with promising
preclinical data related to CYC065, Cyclacel’s second generation cyclin-dependent kinase
CDK2/9 inhibitor. The paper, titled “Dual CCNE1/PIK3CA targeting is synergistic in CCNE1amplified/PIK3CA-mutated uterine serous carcinomas in vitro and in vivo” is published in the
July 2016 issue of the British Journal of Cancer
DBVT said it’s starting REAL LIfe Use and Safety of EPIT (REALISE) Study of its Viaskin
Peanut treatment for peanut allergic children ages 4 to 11 years old. Says Phase 3 trial
designed to assess the use and safety of Viaskin Peanut in routine clinical practice, including
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patients with history of severe anaphylaxis, without oral food challenges required for entry Study
will also evaluate the evolution of peanut-specific immunological markers over time Results from
the PEPITES trial as well as the safety results from the six-month blinded period of the
REALISE study are expected to be part of the core regulatory filings for the approval of Viaskin
Peanut; topline results from both trials are expected in 2H17
DVA DaVita Clinical Research, a wholly-owned subsidiary of DaVita HealthCare Partners Inc.,
announced a global strategic alliance with Quintiles Q The alliance combines DaVita’s worldclass clinical care and expansive footprint of research sites with Quintiles’ industry-leading
operational delivery and therapeutic expertise in clinical trials.
FMI FDA and CMS have accepted FoundationOne for Parallel Review as an innovative
technology most likely to benefit from the efficiencies of this program. The FDA also accepted
Foundation Medicine’s request for review as part of its Expedited Access Pathway (EAP) for
breakthrough devices. If approved, FoundationOne could be the first FDA-approved
comprehensive genomic profiling (CGP) assay to incorporate multiple companion diagnostics
(CDx) to support precision medicine in oncology, including an indication for use as a companion
diagnostic across a diverse range of solid tumors. Obtaining a Medicare National Coverage
Determination (NCD) from CMS concurrently with FDA approval will allow FoundationOne to be
offered as a covered benefit under Medicare and avoid the significant time interval and
uncertainty that often occurs between FDA approval and an NCD. Based on discussions with
FDA and CMS, Foundation Medicine believes the Parallel Review will conclude in H2 of 2017.
Future World news that Biotica Pharmaceuticals Inc. (Biotica), a biopharmaceutical company
and subsidiary of FutureWorld Corp., which engages in discovering, developing, and
commercializing cannabinoid-based medicines for Neuropathic pain, Cancer, Alzheimer's,
Parkinson's, Esophagitis, and Immune Enhancement, announces today that it has elected Dr.
P.C. Sundar as its President & CEO effective July 19, 2016. Dr. Sundar, through his years of
experience working for fortune 100 pharmaceutical companies will lead the Company in
discovering, developing, and commercializing cannabinoid-based medicines for Neuropathic
pain, Cancer, Alzheimer's, Parkinson's and Esophagitis.
GALT announces the completion of patient recruitment in its Phase 2 clinical trial with GR-MD02 in patients with non-alcoholic steatohepatitis (NASH) with cirrhosis (the NASH-CX trial). The
Company expects to report the topline results of this trial in December 2017, as previously
planned
Gedeon Richter signs exclusive license agreement with Recordati for distribution of Cariprazine
in western Europe, Algeria, Tunisia and Turkey, Budapest-based drugmaker says in statement
on Budapest Bourse website. Richter to receive milestone payment at signing of deal, w/ further
payments conditional on regulatory approval process, starting sales Richter will also receive
royalty on sales volume
GILD top-selling hepatitis C drug, Harvoni, will be covered by pharmacy benefits manager
Express Scripts Holding Co. next year, a move that will help the drugmaker gain more patients.
ESRX Scripts has removed Harvoni from its list of formulary exclusions for 2017, according to a
document published Monday. It will continue to exclude Merck’s drug Zepatier and Gilead’s
other hepatitis C treatment, Sovaldi. Since Harvoni can be used for only eight weeks in some
patients, compared with 12 weeks on Sovaldi, many doctors in the U.S. are already opting for
the shorter-duration therapy.
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GILD ESRX hasn’t made a final assessment regarding the formulary status of either Harvoni or
Epclusa for 2017, company spokesman David Whitrap wrote in an e-mail. As noted in the
exclusion list published yesterday, ESRX said it will be providing an “update later this year
regarding the hepatitis C class” "At this point, those two products may still be excluded, nonpreferred, or preferred in 2017,’’ Whitrap wrote
Hikma ESRX 2017 formulary exclusion list says colchicine is excluded from coverage and
Takeda Colcrys and Hikma’s Mitigare are both preferred alternatives to treat gout.
HUM and AET in separate agreements to sell some Medicare Advantage assets to Molina
Healthcare for ~$117m in cash for both deals. MOH to gain ~290,000 Medicare Advantage
members in 21 states
HZNP has secured covered status for DUEXIS and VIMOVO with CVS/Caremark (CVS). CVS
informed the company that beginning 1-Jan-17, DUEXIS and VIMOVO will be removed from the
CVS/Caremark exclusion list.
IDRA Management comments: As a result of the efforts of the team to continue driving our
programs forward, we are rapidly approaching critical data readouts for Idera. During H2 of this
year, we expect to be in position to share important data from our melanoma trial with IMO2125, as well as the next steps in the program. We also expect to be in a position to select a
recommended Phase 2 dose for our B-cell lymphoma program with IMO-8400. Lastly, we plan
to begin elucidating the path forward for the 3GA (third generation antisense) platform, which we
believe represents a pillar in the foundation of the company we are building.”
Jupiter Orphan Therapeutics discussed today in the WSJ which is working on a , resveratrol,
aside from ever proving that it could do what some scientists believed it could, was finding a
safe concentration of the drug. As an ingredient in wine, you’d have to drink an ocean of it in
order to get any kind of therapeutic effect.
Knight Therapeutics announce Canadian license agreement for NETILDEX The companies
have entered into an agreement whereby Knight received the exclusive rights to commercialize
NETILDEX in Canada. Under the terms of this agreement, Knight will also handle all ongoing
regulatory and commercial activities for NETILDEX in Canada. Destum Partners acted as the
advisor for SIFI on this agreement. .
KOOL Cesca Therapeutics announced that data for its proprietary technology was published in
the Herald Scholarly Open Access (HSOA) Journal of Stem Cells Research, In the study, the
bone marrow aspirate was processed at the point of care (surgical suite) with Cesca
Therapeutics’ proprietary technology for bone marrow concentration. Of the 17 patients treated
with BMC for non-union fracture, 14 displayed signs of bone regeneration and healing of the
fracture. Furthermore, no adverse reactions were observed during or after the procedure.
Kyowa Pharmaceutical Industry has entered into a strategic asset purchase agreement with
Shionogi & Co., Ltd. on August 1, 2016, to acquire 21 long-listed products from the Japanese
pharma major, effective December 1, 2016, subject to certain closing conditions and regulatory
approvals including the transfer of marketing authorization of the products to Kyowa. With the
vision of growing globally as a drug discovery-based pharmaceutical company, Shionogi is
focusing its resources on its core therapeutic and marketing areas, while continuing to create
innovative medicines to support future growth and to strengthen its business operations. As a
part of this growth strategy, Shionogi would transfer 21 long-listed products to Kyowa, the
Japanese subsidiary of Lupin Limited. Kyowa is amongst the top 10 Generic companies in
Japan and a market leader in Central Nervous System (CNS) space well known for its "AMEL"
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brand, in addition to other generic pharmaceutical products in its portfolio. With this acquisition,
Kyowa will rank 6th amongst generic companies in Japan. The 21 products cover therapy areas
such as Central Nervous System (CNS), Oncology, Cardiovascular and Anti-infectives. These
21 products had sales of JPY 9, 400 million (USD 90 million) collectively on NHI price basis.
Commenting on the acquisition, Mr. Nilesh Gupta, Managing Director of Lupin Limited said,
"This acquisition marks Lupin's foray into the Japanese Branded market in-line with our
aspirations to build and strengthen our specialty business globally. The new Branded product
portfolio has a strong fit with Lupin's Kyowa business,
LIVN authorizes $150M share repurchase program
Martindale Pharma a closely held U.K. drug makers is exploring a sale, according to people
familiar with the matter. Martindale, which is being advised by Rothschild & Co., may fetch more
than 200 million pounds ($263 million) in a sale, and attract interest from other companies in the
industry, as well as private equity firms, said the people, who asked not to be named because
the deliberations are private.
Medpace CRO today released the pricing for its initial public offering, looking to float 7 million
shares at between $20 and $23 per share, which will bring in between $140 and $161 million.
Private equity shop Cinven paid CCMP Capital Advisors $921.3 million for Cincinnati-based
Medpace in 2014. The company originally registered for the $150 million IPO in late June,
saying it plans to use to pay down some of its debt.
Meda EGM to apply for delisting Aug 25 2016
MOH AET and HUM agree to sell some Medicare Advantage assets to MOH for est $117m in
cash for both deals. MOH to gain ~290,000 Medicare Advantage members in 21 states
Morningside Pharmaceuticals a closely held UK co is exploring a sale, according to.
Morningside, which is working with Goldman Sachs Group Inc., may be valued at 300 million
pounds. Discussions about the sales are at an early stage, and no final decisions have been
made, the people said.
MRK BIIB draws takeover interest from AGN MRK- WSJ, citing sources AGN and MRK have
informally sounded out BIIB, according to sources, and the preliminary expressions of interest
may not lead to a deal, according to the repo
MYL announced that its recommended public offer to the shareholders of Meda Aktiebolag to
tender all their shares in Meda to Mylan has been accepted by shareholders holding an
aggregate of 342.6M shares, corresponding to approximately 94% of the total number of
outstanding shares and votes in Meda as of Jul 29 2016 Meda EGM to apply for delisting Aug
25 2016 post MYL deal
NVS Alcon division CyPass Micro-Stent gets FDA approval to treat glaucoma.
Stent is designed to reduce intraocular pressure in patients with mild to moderate primary openangle glaucoma , the Stent developed by Transcend Medical, which Alcon purchased in Feb
2016.
ORMP receives additional $4M milestone payment from HTIT This milestone, part of a
previously-announced license and investment agreement between Oramed and HTIT, follows
Oramed's report of additional positive efficacy and safety data from its recently completed
Phase IIb trial of its oral insulin product
PFE settles Celebrex, Bextra litigation for $486M
PFE still mulling a split into two separate companies, Read said Tuesday that there’s no “wrong
answer” in what’s ultimately chosen and it’s not a “make-or-break” decision. Pfizer could also re-
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examine a split later on if it initially decides against separating the New York-based company,
which has a market valuation of $220 billion.“We continue to have very robust dialogue in the
company, preparing for this decision,” Read said on a conference call discussing secondquarter financial results. Pfizer beat analysts’ predictions, though sales of its biggest product,
the vaccine Prevnar, dropped.
Pharma Mar starts phase III Atlantis study with PM1183 in combination with doxorubicin
.
Photocure published data from a meta-analysis of its Blue Light Cystoscopy (BLC) with Cysview
for the treatment of bladder cancer in the August issue of Bladder Cancer. Data showed the rate
of progression was significantly lower in patients treated with BLC with Hexvix versus White
Light Cystoscopy alone.
PSTI the FDA sent positive feedback to the company on the proposed Ph 3 trial of its PLX-PAD
cells in the treatment of critical limb ischemia. The company is gearing up for the trial currently.
Q Quintiles and DaVita Clinical Research, a wholly-owned subsidiary of DaVita HealthCare
Partners Inc., (DVA) announced a global strategic alliance. The alliance combines DaVita’s
world-class clinical care and expansive footprint of research sites with Quintiles’ industry-leading
operational delivery and therapeutic expertise in clinical trials.
Recordati SpA Bberg reports that the company is exploring strategic options that may lead to a
sale amid potential interest from Asian buyers, according to people with knowledge of the
matter.The Milan-based company, which is run by Chief Executive Officer Giovanni Recordati
and Chief Operating Officer Andrea Recordati, is informally speaking with advisers who are
gauging interest among possible bidders, the people said, asking not to be identified because
the deliberations are private. A spokeswoman for Recordati said the owners aren’t planning a
sale of their controlling stake.The Recordati family owns a 51 percent stake in the company,
which has a market value of 6.1 billion euros ($6.9 billion.The business has attracted interest
from Chinese buyers, one of the people said. If the family proceeds with a sale, it would also
likely draw Asian, European and U.S. drugmakers, the people said. Recordati’s size will limit the
number of buyers who can take on the business, they said. There is no formal process
underway and the family may decide against a sale, they said.
Recordati news that Gedeon Richter signs exclusive license agreement with Recordati for
distribution of Cariprazine in western Europe, Algeria, Tunisia and Turkey, Budapest-based
drugmaker says in statement on Budapest Bourse website. Richter to receive milestone
payment at signing of deal, w/ further payments conditional on regulatory approval process,
starting sales Richter will also receive royalty on sales volume
REGN is jumping into CAR-Ts and TCR tech and has selected the startup Adicet Bio for its
collaboration. Both companies emphasize that they’re concentrating on off-the-shelf drugs that
will be primarily focused on solid tumors, the new new thing in immuno-oncology where first-gen
hematological immunotherapies have encountered hard barriers. The pact with Regeneron
covers a “broad pipeline,” emphasizing that the key to creating a safe, effective immune cell
therapy is being “specific to the tumor target.”
RGNX the FDA has granted Rare Pediatric Disease Designation to RGX-121, REGENXBIO’s
investigational gene therapy product candidate for the treatment of Mucopolysaccharidosis Type
II (MPS II)."Along with RGX-111 for the treatment of MPS I, this is our second MPS program to
achieve a Rare Pediatric Disease Designation and builds upon the Orphan Drug Designation
granted to RGX-121 at the end of 2015 by the FDA, underscoring the therapy’s potential to
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provide meaningful benefit to children struggling with this severely debilitating disease,” said
Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “Both of these
programs use our NAV AAV9 vector and we plan to file Investigational New Drug applications
for RGX-111 and RGX-121 in the first half of 2017. We look forward to working with the FDA to
advance this platform of gene therapies for MPS to patients in need.
ROSG announces a new participation agreement with Preferred Provider Organization (PPO),
Galaxy Health Network, as a preferred laboratory provider. This new agreement, which covers
more than 3.5M members, increases Rosetta’s participation as a preferred provider to more
than 166M eligible contracted lives. CEO Kenneth Berlin: “We are particularly pleased that this
agreement will expand patient access for RosettaGX Reveal, our first-of-its-kind microRNA
classifier for indeterminate thyroid nodules. This new patient access should enhance our
commercial and our reimbursement efforts both of which continue to gain significant traction in
the fast-growing molecular classification market for indeterminate thyroid FNAs."
RWLK announced the initiation of its FDA Section 522 post-market study with the Stanford
University School of Medicine listed as the lead study center. Dr. Matthew Smuck, associate
professor of orthopaedic surgery and medical director of rehabilitation services for Stanford
Health Care, will serve as lead investigator. The trial has already enrolled two patients
Shionogi news that Kyowa Pharmaceutical Industry has entered into a strategic asset purchase
agreement with Shionogi & Co., Ltd. on August 1, 2016, to acquire 21 long-listed products from
the Japanese pharma major, effective December 1, 2016, subject to certain closing conditions
and regulatory approvals including the transfer of marketing authorization of the products to
Kyowa. With the vision of growing globally as a drug discovery-based pharmaceutical company,
Shionogi is focusing its resources on its core therapeutic and marketing areas, while continuing
to create innovative medicines to support future growth and to strengthen its business
operations. As a part of this growth strategy, Shionogi would transfer 21 long-listed products to
Kyowa, the Japanese subsidiary of Lupin Limited. Kyowa is amongst the top 10 Generic
companies in Japan and a market leader in Central Nervous System (CNS) space well known
for its "AMEL" brand, in addition to other generic pharmaceutical products in its portfolio. With
this acquisition, Kyowa will rank 6th amongst generic companies in Japan. The 21 products
cover therapy areas such as Central Nervous System (CNS), Oncology, Cardiovascular and
Anti-infectives. These 21 products had sales of JPY 9, 400 million (USD 90 million) collectively
on NHI price basis. Commenting on the acquisition, Mr. Nilesh Gupta, Managing Director of
Lupin Limited said, "This acquisition marks Lupin's foray into the Japanese Branded market inline with our aspirations to build and strengthen our specialty business globally. The new
Branded product portfolio has a strong fit with Lupin's Kyowa business,
SHPG CEO Flemming Ornskov reviewed new, bigger target for cutting costs, upping the ante
from the $500 million in “synergies” pegged at the time the deal was announced to $700 million
now that they’ve had a chance to consider all the prospects. And 30% of that — roughly $210
million – is coming straight out of research.Speaking to analysts on Tuesday morning, the
executive team talked up the combined pipeline of 40 programs as Ornskov highlighted “the
gems in the pipeline” that would continue to get close attention.Those gems included three latestage programs: SHP643 for HAE; SHP620 for CMV, which starts in H2; and SHP647, an IBD
drug recently in-licensed from Pfizer, which dubbed it PF-00547659.heir pipeline review
unveiled 8 programs for the chopping block. Most of those are in early stage development, he
added, but Shire spotlighted three Phase II programs that were cut out, including one for
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SHP625 (the old LUM001) in adults. 625 has won breakthrough drug status at the FDA, but
Shire has had to contend with discouraging data from the drug and will focus on the pediatric
population.Shire is also cutting the gene therapy program for hemophilia B inherited from the
Baxalta acquisition. And that will come as welcome news to Spark (ONCE) and its rivals as they
hustle along their own hemophilia B drugs. BioMarin announced stellar results from a proof-ofconcept study in hemophilia A a few days ago, highlighting the competition for best
results.Asked whether the company could still expect to make a big splash in immuno-oncology,
where there’s been a frenzy of deal making and development work, Ornskov was clear that
Shire would take a very measured, “step-by-step” approach to building a new franchise. “I think
that this is not a commitment at this stage for Shire to be spending significant resources on
research or commercially,” Ornskov noted. (article in Endpoints)
SRNE has entered into a binding term sheet to create a joint venture ("JV") with CHA Biotech
Co. LTD,(of South Korea to develop and commercialize proprietary Chimeric Antigen Receptor
("CAR") modified cellular therapies based on CBT's Activated Killer Cell ("AKC") technology and
five of Sorrento's CARs for all disease conditions, including oncology and infectious diseases.
The JV covers products on a global basis with the exception of the Greater Chinese market.
Sorrento Therapeutics, Inc. In addition, Sorrento will obtain an exclusive license to develop and
commercialize CBT's novel investigator-initiated trial stage AKC technology in major territories,
including the United States, Europe, and with a co-exclusive license in China. The AKC
technology utilizes proprietary methodologies for the generation of highly activated, patientderived Natural Killer (NK) Cells from 60 mL (60 cc or less than 3 fl. oz.) of peripheral blood.
The expansion and activation process takes less than 3 weeks and yields sufficient cells for
several treatment cycles. Notably, the resulting AKC product can be cryopreserved as efficient
freeze-thaw protocols have been established. Thus far, more than 1,000 AKC batches have
been produced and used in ongoing clinical studies in Japan. The treatment protocol does not
require lympho-depleting preconditioning of the patients prior to administration of the AKC.
Both CBT and Sorrento will make contributions of $2 million to the JV. In addition, Sorrento will
grant the JV an exclusive license to five CARs solely for combination with the AKC technology,
while CBT will contribute its AKC technology. CBT will initially own 51% of the JV while Sorrento
will initially hold the remaining 49%. Sorrento, under a royalty bearing license, will also gain
access to the AKC technology for use outside the JV alone or with any other Sorrento products.
SYN completed end-of-Phase 2 meeting with FDA for SYN-010 to treat irritable bowel syndrome
with constipation.SYN said FDA provided guidance for design of Phase 2b/3 adaptive trial
Dose exploration and sensitivity analysis of breath methane levels for trial participation among
elements to be addressed in first pivotal trial for SYN-010
Takeda ESRX 2017 formulary exclusion list says colchicine is excluded from coverage and
Takeda Colcrys and Hikma’s Mitigare are both preferred alternatives to treat gout.
Takeda TiGenix 24-week results of the Phase 3 ADMIRE-CD trial show Cx601 met primary
goal, data published in The Lancet Achieved Primary Endpoint in Crohn’s, data published in The
Lancet Says significantly greater proportion of patients in the Cx601 group vs placebo group
achieved the primary endpoint of combined remission at week 24 in the ITT population, 50% vs
34%, and the mITT population, 51% vs 36% respectively Says pivotal Phase 3 trial for Cx601
for the treatment of complex perianal fistulas is expected to start in the U.S. in 2017 In the U.S.,
TiGenix intends to apply for fast track designation from the FDA
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TiGenix Takeda 24-week results of the Phase 3 ADMIRE-CD trial show Cx601 met primary
goal, data published in The Lancet Achieved Primary Endpoint in Crohn’s, data published in The
Lancet Says significantly greater proportion of patients in the Cx601 group vs placebo group
achieved the primary endpoint of combined remission at week 24 in the ITT population, 50% vs
34%, and the mITT population, 51% vs 36% respectively Says pivotal Phase 3 trial for Cx601
for the treatment of complex perianal fistulas is expected to start in the U.S. in 2017 In the U.S.,
TiGenix intends to apply for fast track designation from the FDA
Trek Therapeutics announced the acquisition of the development and commercialization rights
to the infectious disease inhibitors lomibuvir and merimepodib. Both previously owned by
Vertex Pharmaceuticals Inc., lomibuvir (VX-222) is a non-nucleoside inhibitor of the hepatitis C
virus NS5B polymerase and merimepodib (VX-497) is an inhibitor of inosine monophosphate
dehydrogenase. Lomibuvir and merimepodib completed phase 2b clinical studies in HCV
patients. The lomibuvir trial enrolled 106 people with chronic HCV genotype 1. Results
suggested that, when used as part of a combination regimen, lomibuvir had the potential to
clear the virus in as little as 12 weeks. In the merimepodib trial, according to results of the 30
enrolled patients, the inhibitor reduced liver inflammation in patients with HCV.
VRML ASPiRA Labs expands coverage for OVA1 in California VRML announced an agreement
has been reached with Sacramento-based Sutter Valley Medical Foundation (d/b/a Gould
Medical Foundation) for coverage of OVA1, Vermillion's ovarian cancer risk assessment test
commercialized by ASPiRA LABS.
Biotuesdays on ProMIS Neurosciences
ProMIS Neurosciences (TSX:PMN) expects to reports results in the second half this year of in
vitro validation studies in cadaveric brain tissue from Alzheimer's disease patients to
demonstrate the binding profile of its monoclonal antibody (mAb) drug candidates to treat the
root cause of AD."These therapeutic mAbs selectively bind to distinct epitope targets specific for
the neurotoxic, prion-like strains of misfolded Amyloid beta peptide, which are widely believed to
play a key role in the development and progression of AD," CEO, Dr. Elliot Goldstein, says in an
interview with BioTuesdays. "Based on the work of our CSO, Dr. Neil Cashman, and recent
scientific evidence, it is becoming increasingly well supported that these prion variants are the
drivers of neurotoxicity, and are the drivers of the regional spreading of neurotoxicity to different
areas of the brain, leading to progressive cognitive decline," he suggest According to Dr.
Goldstein, TDP43 is present in every cell in the body and plays a critical role in transferring
proper genetic information. In neurodegenerative diseases, TDP43 loses its normal function and
forms clumps of misfolded TDP43.“Our goal is to specifically target misfolded TDP43 without
disrupting the role that the normally-folded TDP43 protein plays in cell biology.”
ProMIS is in active discussions to partner its SOD1 portfolio in ALS and “we think a potential
partner would also be interested in our TDP43 program,” Dr. Goldstein adds.
In addition to AD and ALS, the ProMIS mAb therapeutic candidates targeting toxic prion forms
of Amyloid beta could be developed against Down’s syndrome-related AD.
Dr. Goldstein explains that Down’s patients have three copies of chromosome 21, which
contains the genetic sequence for a protein precursor for Amyloid beta. “These patients have a
greater reservoir of Amyloid beta in their brains, which can be corrupted by prion misfolding. As
a result, they often develop early and severe AD.”
As an orphan indication, Down’s could be an opportunity for a first clinical trial, he adds.
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YCBB on AAPL AAPL could be on the cusp of a prolonged China downturn unless it can roll
out smartphones with new breakthrough technology, as it gets overwhelmed by similar Chinese
models that sell for far lower prices. Apple China sales tumble 33 pct in Q2 The latest financial
report from Apple (AAPL) shows the company continues to struggle as sales of its core iPhones
pass their prime, and nowhere is that story more apparent than in China. The company’s
Greater China sales, which also includes Hong Kong and Taiwan, fell 33 percent in its latest
reporting quarter, accelerating from an already sharp drop of 26 percent in the first 3 months of
this year. The rapid decline dropped China to Apple’s third largest market globally from its
former spot as the company’s second largest, with Europe taking over the number two position.
Apple’s story is hardly unique, as the world’s other global leader Samsung (Seoul: 005930) has
also seen a sharp reversal over the last year after its own recent rise to take the global
smartphone crown.
Endpoints on REGN Adicet news
REGN is jumping into CAR-Ts and TCR tech, determined to leap directly into a blockbuster
brawl with a plan to emerge as a leader in the fast-growing immuno-oncology field. REGN
selected the startup Adicet Bio for its collaboration. A new face in immuno-oncology, the biotech
popped up only last January with a hefty $51 million A round to get started. But it’s helmed by
Aya Jakobovits, the founding president and CEO of Kite Pharma, a leader in developing
personalized CAR-Ts. Jakobovits gets a modest $25 million upfront to get started on
engineering a pipeline of immune cells with chimeric antigen receptors and T cell receptors, a
one-two approach aimed at zeroing in on both surface antigens found specifically on targeted
cancer cells as well as intracellular targets. There’s a support package for research as well, with
additional funds to back up the collaboration, but no one is disclosing any of that this morning.
Both companies emphasize that they’re concentrating on off-the-shelf drugs that will be
primarily focused on solid tumors, the new new thing in immuno-oncology where first-gen
hematological immunotherapies have encountered hard barriers. The pact with Regeneron
covers a “broad pipeline,” emphasizing that the key to creating a safe, effective immune cell
therapy is being “specific to the tumor target.” But Jakobovits, who set up the company as a
partner at Orbimed, is very careful to stay inside some narrow boundaries on explaining exactly
what distinguishes their work. Regeneron’s not-so-secret weapon in the new front on cancer
includes its unique VelocImmune mouse models, which are described as “the largest
mammalian genetic engineering project ever accomplished.” It helped them develop
REGN1979, a bispecific antibody therapy that R&D chief George Yancopoulos has highlighted
excitedly for its ability to target the B cell marker, CD20, and the CD3 component of the T cell
receptor, which triggers redirected killing of B cells. Its anti-PD-1 antibody is REGN2810. Any
targeting molecules that come out of this new collaboration can be redirected into any other
programs Regeneron has, including its pact with Sanofi. Regeneron doesn’t do many of these
pacts, says Aberman. There was the Intellia deal back in April that brings CRISPR-Cas9 gene
editing tech, Avalanche’s gene therapy pact, and now Adicet. But they expect a lot out of the
few deals they do with the select biotechs they want to work with. For Jakobovits, the deal also
allows her to push the quick expansion of the new biotech. The staff of 14 is slated to double,
with additional input coming from her Israeli subsidiary.
Crain's Chicago Health more news about lovely Obamacare
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Health insurance premiums for Illinois residents who buy coverage through the Affordable Care
Act's marketplace could increase by as much as 45 percent according to proposals submitted
by insurers.The leading insurer on Illinois' exchange, Blue Cross Blue Shield, is proposing
increases for 2017 ranging from 23 percent to 45 percent for individual health care plans,
according to proposals posted by Heathcare.gov. Another insurer, Coventry Health Care of
Illinois, proposed rate increases as high as 21 percent.
YCBB on UBER
UBER the Didi Chuxing merger with Uber China was driven by investor pressure to end their
fierce price wars, and the newly combined company is likely to quickly reduce its subsidies and
become profitable by year-end.Just a week after reports emerged of a truce in the nonstop price
wars between private car specialists Didi Chuxing and Uber China, the pair have suddenly
announced a merger that will become the latest marriage of former bitter rivals in China. Didi
Chuxing and Uber China swap shares in a deal that would give Uber about 20 percent of the
merged company and give the rest to Didi. That ratio is roughly comparable to each of the 2
companies’ market values following their latest mega fund-raisings earlier this year. The most
recent of those saw Didi Chuxing valued at $28 billion, while Uber’s China operations were
worth $7 billion.Thus the combined company will be worth about $35 billion, making it instantly
one of China’s most valuable Internet firms. By comparison, China’s 2 largest Internet
companies, BABA and Tencent, are each worth about $200 billion, and search leader BIDU is a
distant third with a value of $55 billion.Observers will probably say the merger marks a major
surrender for Uber, whose aggressive founder Travis Kalanick repeatedly boasted that he was
prepared to spend billions of dollars and fight for years to build up his China business. But
Kalanick still has plenty of other markets where he can dominate, and this merger shows that
backers of his China business were unwilling to keep funding a brutal price war that really could
have dragged on for years.So, what’s likely to happen next? My best guess is that the highly
subsidized prices that many in China were previously enjoying to use Didi and Uber service will
disappear very quickly, probably within the next 2-3 months. That could deal a big blow to their
newly combined business, with the potential for the price for an average ride will rise 20-30
percent and in many cases could become more expensive than traditional taxis. Still, the current
situation was clearly unsustainable over the longer term, and this new company should still do
quite well due to its huge size and can probably become profitable by year end.
YCBB on VIDEO: Wanda Moves Into Online Video, China Telecom Checks Out
CHA China Telecom’s sale of its online video business looks like an exit from the space under
its new chairman, while Wanda’s purchase of an online movie site could mark the start of a
major new round of investment in online video.A few days after BIDU abandoned plans to spin
off its iQiyi video unit, 2 more online video headlines are reflecting the rapid changes taking
place in the space. The larger will see China Telecom ( CHA), the smallest of China’s 3 telcos,
sell its online video unit TV189 to a hotel operator called Besttone Holdings (Shanghai: 600640)
for 3.9 billion yuan ($580 million).
The deal will see Besttone, described as a Shanghai-based hotel management company, pay
the 3.9 billion yuan for all of TV189’s shares from its current owners, which include China
Telecom and a number of other stakeholders.
The strategic reasons aren’t extremely clear for the deal, which was revealed late last week in
an announcement that didn’t contain any detail beyond the actual share sale. But it looks like
99
China Telecom is attempting to spin off the unit into a separately run company that will have
more flexibility to do business. Right now the unit carries one of China Telecom’s own brands,
meaning it’s probably marketed mostly to the carrier’s own relatively small base of about 200
million subscribers. None of China’s 3 telcos have managed to develop strong video or other
Internet-based services for their high-speed 3G and 4G networks, and now it appears China
Telecom is jettisoning its own video service that probably had a very small audience. The move
looks like part of a broader cleanup of the company under new Chairman Yang Jie, who was
named to his position earlier this year and is making some major shifts as he attempts to revive
the carrier.
Wanda fast-growing Wanda Group buy the online movie site Mtime for $280 million.Each of
these deals reflects the rapid changes taking place in China’s online video sector, where most
major players have been sold to cash-rich backers looking for a slice of the market. The sector
has huge potential due to its ability to challenge traditional broadcasters by delivering video and
other entertainment content over the Internet. Yet at the same time, nearly all players are losing
big money as they look for profitable business models to support their growth. Wanda has been
quite active in building up its entertainment business, which includes cinemas, film studios and
theme parks. But this would be one of the company’s first moves into the crowded online video
space, where it will compete with much larger rivals like iQiyi, as well as LeEco (Shenzhen:
300104) and Alibaba’s (NYSE: BABA) Youku Tudou.Wanda has been quite aggressive in the
entertainment space over the last couple of years, and this looks like its latest move to expand
there. Accordingly, and I suspect this new purchase could mark the start of a massive new
round of investment as the company tries to compete with larger rivals
Real Clear Health
Donald Trump's Plan for Heroin Addiction: Build a Wall
Dylan Scott, Stat
FDA-Approved Knock-Offs of Biotech Drugs May Safely Save Money
Kodjak, NPR
23andMe Uncovers Depression DNA in a Huge Crowdsourced Study
Regalado, TR
Theranos CEO Speaks on Its Rise and Fall
Jen Christensen, CNN
CMS Picks Markets for Primary Care Reforms
Lauren Clason, The Hill
Long-term Care Costs Force Many Seniors into Medicaid
Gorman & Ostrov, MCN
Health Insurers Squeeze Rural Americans
Linda Newman, Billings Gazette
Nano-Toothpaste And Nano-Mouthwash? Rat Study Suggests Maybe
E. Betuel, CH
Playing Catch-Up With Zika
Stephen Morse, U.S. News & World Report
ACA Getting More Expensive, But it's Still Cheaper Than Predicted
Cohn, HuffPost
Striving for Equity in Access and Use of Specialty Care
Patricia Doykos, HAB
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Clinton is the Only One Not Pandering to Anti-Vaccine Movement
G. Lopez, Vox
Health Services Skyrocket for People with Opioid Dependence
Julie Appleby, MCN
Eminent Domain Won't Lower Drug Prices, Might Raise Costs
BioWatch News on CAPR
CAPR on Aug 1 2016 CAPR filed an 8-K to announce the first (general) indication for its
Exosome technologies. It is also discussed in Capricor’s corporate presentation that was
released on August 1, 2016 Exosomes are nano-sized, lipid vesicles that contain microRNA and
other proteins. They are made by cells and provide a means to get the benefits from cell therapy
without using the cells themselves. As you can imagine, a cell free material as a therapeutic is
much less complicated to make, store, distribute and deliver. Exosomes has many of the
properties of a traditional pharmaceutical although it is still regulated as biologics. In theory,
exosomes should provide the regenerative power associated with current stem-cell treatments
but with fewer drawbacks and at a lower cost. It is scheduled to enter the clinic in 2017. As
supported by recent preclinical findings, the Company has determined that the first clinical
indication for which it will develop its therapeutic development candidate, CAP-2003, will be
within the area of ophthalmology, and this indication will be one among alkali burn injury, ocular
graft-versus-host disease, and inflammatory dry eye disease. We aren’t surprised. On March
17 2016, Capricor provided an update on the exosomes program and presented the positive
results from using exosomes to treat a rabbit model of eye injury.
In the short term, we’re awaiting results from Capricor’s cenderitide trials. In a somewhat longer
time frame, Capricor has major results arriving in early 2017.
1) HOPE-Duchenne Muscular Dystrophy Cardiomyopathy treatment – Results, Q1-2017
2) ALLSTAR Trial on Heart Attack Patients – Results, Q1-2017
3) Janssen (J&J) Option to License CAP-1002 – Decision, Q2-2017
Bioworld headlines for subscribers only
A new monoclonal antibody (MAb) is being added to the biosimilar toolbox as a standard to
evaluate the precision and accuracy of several analytical methods used to develop the followons. The "anchor molecule" also may lead to more tools to improve the analytics that are
foundational to characterizing a biosimilar and moving it from cell line to market.
ADMA Manufacturing issues snag BLA for Adma's lead candidate
Flawed research delays patients' access to new medicines
Biomedical science is facing a "reproducibility crisis" in which time, money and effort is being
wasted pursuing flawed research, with patients' access to new drugs delayed as a result.
IONS BIIB Early surprise phase III news from Biogen Inc. and Ionis Pharmaceuticals Inc. with
nusinersen – which led to $75 million more in the latter's bank account – cranked up speculation
regarding would-be rival Avexis Inc.'s AVXS-101 for spinal muscular atrophy
GSK, Google parent to explore potential of bioelectronic medicines
Japan looks to reform high-priced drugs market, starting with Opdivo
Japan will lower the price of Ono Pharmaceutical Inc.'s Opdivo (nivolumab) and reform the
guidelines on its usage as the country looks to a future in which the price of drugs add billions in
government spending.
KERX Production woes halt newly revving Auryxia sales, dent Keryx's Q2
101
NIST MAb first step to eliminating clinical trials for biosimilars?
PFE plucks Bamboo Therapeutics, rAAV tech in potential $645M gene therapy play
Bamboo is the largest and one of the fastest growing members of the grass family, with
individual shoots reaching their full height in a single growing season. In an apt metaphor,
August 1, 2016
New events to add to the work
NVDA is expected to announced Pascal GPUs for notebooks at Gamescom
Nvidia's Pascal-based discrete graphics cards for notebooks are expected to be unveiled
during Gamescom in Europe, hosted from Aug 17-21 2016,
Notebook players including Asustek Computer, Micro-Star International (MSI), Gigabyte
Technology and Clevo will showcase their latest products using the GPUs. Gamescom in
Europe, hosted from Aug 17-21 2016
NUS Hearing on settlement scheduled f in federal court in Salt Lake City Oct 6 2016
MDCO ABP-700 PH I data at Intl Society for Anesthesiologists Oct 21 2016
MDCO ABP-700 data at American Society Anesthesiologists Oct 22-26 2016
BMY BMS-9860106 I PK/PD PH I data at SITC Nov 9-13 2016
BMY Nivo + BMS 936558/ BMS 986016 at SITC Nov 9-13 2016
ADXS AZN ADXS-HPV MEDI14736 durvalumab PH I data at SITC Nov 9-13 2016
AZN ADXS ADXS-HPV MEDI14736 durvalumab PH I data at SITC Nov 9-13 2016
BMY INNATE PHARMA nivo lirilumab PH I data for solid tumors and NSCLC, RCC
melanoma colorectal cancer ovarian carcinoma at SITC Nov 9-13 2016
MESO MPC300 IVS revascor PH II IV data at ACR Nov 11-16 2016
Takeda and SGEN announced that the Phase 3 ALCANZA data presentation at ASH Dec
3-6 2016
SGEN and Takeda announced that the Phase 3 ALCANZA data presentation at ASH Dec
3-6 2016
The Promise of Digital Healthcare: Commercialization & Beyond MassBio Cambridge MA
Aug 4 2016 8:00 AM - 10:00 AM
The Coverage Conundrum - Why Won't Payers Cover My Device - and What Can We Do
About It? Aug 11th, 2016
FDA webinar to address questions associated with the draft for companion diagnostics
Aug 18 2016
SoCalBio Workshop on Accessing Government Funding for Life Science Research West
Los Angeles 10:00 AM to 3:00 PM Sep 6 2016
RF Today
Cystic Fibrosis: EMA Considers Revisions to Guidance for Developing New Drugs
The (FDA) announced that it is beginning a new pilot project linked to its intercenter
consult request (ICCR) process for combination products of drugs, medical devices
and/or biologics.
Today the European Medicines Agency (EMA) launched a public consultation on revised
guidance for companies developing new drugs to treat tuberculosis
Endpoints on Bioniz
102
Bioniz David Pyott has a new project to add to his post-Allergan CV. Pyott and Takeda co-led a
$13 million startup round for Bioniz, an Irvine, CA-based developer which just had its first IND
approved.Bioniz is building a peptide platform based on blocking particular cytokines that can
trigger disease. It has two lead programs, BNZ-1 and BNZ-2, with two completely different
disease targets. BNZ-1 is aimed at HTLV-1 Associated Myelopathy (HAM), an orphan disease,
and for certain T-cell leukemias. The preclinical BNZ-2 targets cytokines IL15/IL21 for celiac
disease and other immuno-inflammatory disorders in the GI tract.Pyott is taking the chairman’s
post for himself while Nazli Azimi takes the CEO’s role. Azimi worked on cytokine research at
the NIH and later moved on to the faculty of the prestigious Fred Hutchinson Cancer Research
Center, where she specialized in the herpes virus. Bioniz’s Azimi had this to say in a statement
this morning: This financing is an important step needed to drive the development of new
potential treatments for patients affected by very serious cytokine-driven diseases. The
acceptance of the BNZ-1 IND is a great accomplishment by our team and we are excited to
collaborate with the NIH on the clinical advancement of this program.
MIT Review on 23andMe
23andME in scientific expedition into the DNA of more than 450,000 customers of gene-testing
company 23andMe has uncovered the first major trove of genetic clues to the cause of
depression.The study, the largest of its kind, detected 15 regions of human genome linked to a
higher risk of struggling with serious depression. The study was carried out by drug giant Pfizer
as part of an alliance with 23andMe, the California company whose gene reports have been
purchased by more than 1.2 million people. So far the vast majority of efforts to locate genetic
risks for depression have failed, probably because the efforts have been too small to find
anything. “Everyone is recognizing that this is a numbers problem,” says Ashley Winslow,
formerly a neuroscientist at Pfizer and now the director of neurogenetics at the Orphan Disease
Center at the University of Pennsylvania. Winslow led the research effort. “It’s hard if not
impossible to get to the numbers that we saw in the 23andMe study.” The authors of the report
called the finding an endorsement of 23andMe’s data. But Levinson noted that depression is
also the perfect test case for a consumer database. It’s a common disease and no longer highly
stigmatized, so people are willing to say they have it. But other psychiatric ailments are much
less common. “It they tried to do it in schizophrenia or anorexia they’d probably fail,” says
Levinson. “That’s the caveat here.”
FT FM
Biotech investors still feel the pain, global pricing is going to take a step towards reality
Retirement healthcare could bust the budgets of US cities
YCBB on Fosun
Fosun private equity giant two newest acquisitions indicate it could soon become more active in
the asset management and drug sectors outside China, with a focus on emerging markets like
the BRICS countries.
Pharmaceuticals and real estate have been 2 of Fosun’s focus areas in its shopping spree both
at home and abroad, though the move into developing markets is relatively new.
Fosun has more traditionally focused its global buying on western markets in the US and
Europe. So this latest pair of deals could signal a new focus on emerging markets, especially
ones like Brazil and Russia where recent economic malaise could be pressuring some debtladen companies to sell off assets at bargain prices to raise cash.
103
One of the deals, which will see Fosun purchase Rio Bravo, a Brazilian company that offers a
wide range of fund management services focused on the real estate sector
The reports point out that the purchase is the first for Fosun in Latin America, though no terms
were given for the deal. Rio Bravo currently manages the equivalent of about $3 billion in
assets, and Fosun chief executive Guo Guangchang said the purchase reflects his company’s
plans to move into more strategic emerging economies. Brazil certainly fits that definition, and
we can probably expect to see one or two more similar deals there and in other BRICS
countries later this year.Financial services has emerged as one of Fosun’s key investment
areas, with a heavy focus on insurance companies. Fosun is quickly earning a reputation as one
of China’s most aggressive private equity buyers under the leadership of Guo, a billionaire who
some liken to US investor Warren Buffett. In the asset management space, Fosun has
purchased several smaller European companies, though one of its largest bids for BHF
Kleinwort Benson ultimately failed last year.
Fosun also announced it will pay up to $1.3 billion for 86 percent of Gland Pharma, a drug
maker backed by US private equity giant KKR. (English article; Chinese article) Unlike the
Brazilian deal, which was probably driven partly by that country’s ailing economy, the main
driver of the Gland Pharma deal is probably the big potential for drug production in India.
Fosun is purchasing most of its stake from KKR, which invested in Gland Pharma in 2014. The
company makes a wide range of medicines that are injected through syringes, bags and pumps,
which are typically more difficult to make than other conventional medicines. India is already a
major supplier of drugs to the US, and I expect that Fosun will use this new acquisition to try
and export more of the company’s products to the fast-growing China market.
Real Clear Health headlines
Hospital Star Ratings Show Not All Care Is Equal
Rita E. Numerof, RealClearHealth
How I Was Wrong About ObamaCare
Bob Kocher, Wall Street Journal
Harnessing the Immune System to Fight Cancer
Denise Grady, New York Times
"Natural" Label May Not Mean What You Think
Natalie Pompilio, Philadelphia Inquirer
In Florida Zika Probe, Federal Scientists Kept at Bay
Julie Steenhuysen, Reuters
Majority of Americans Misuse Prescription Drugs
Ed Silverman, Pharmalot
Bundled-Payment Expansion Brings Risk, Opportunity
Elizabeth Whitman, ModHC
Is Non-Celiac Gluten Sensitivity Real?
Dennis Thompson, HealthDay
Do Opioids Make Pain Worse?
Peter Grace, The Conversation
How Your Health Data Lead a Not-So-Secret Life Online
Angus Chen, NPR
It’s Time for Lawmakers to Take Zika Seriously
Neil Silverman, The Hill
104
CMS’s Latest Report Is Bad News for Medical Homes
Kip Sullivan, Health Care Blog
Why Dems Didn't Talk More About Healthcare at the DNC
Harris Meyer, Mod Hlthcare
Florida Announces 10 New Zika Cases; Travel Advisory is Expected
Lena Sun, WP
Device Makes Single Doses of Drugs on Demand
Stephen Feller, UPI
Google Spinoff, GSK Aim to Treat Disease by Zapping Nerves
Stephanie Simon, Stat
Watching TV Tied to Fatal Clot Risk
Nicholas Bakalar, New York Times
Making Philly a Hub of Medical Research?
Daniel R. Hoffman, Philly.com
BioSpectrum Asia Magazine on Cipla
Chandru Chawla, head of Cipla New Ventures to elaborate on Cipla’s plans for its new South
African facility, the biosimilar opportunity, challenges and their expansion plans for the future.
Recently, Indian pharmaceutical giant Cipla announced that its proposed biotech subsidiary in
South Africa will invest just over R1.3 billion into the country's first state-of-the-art biotech
manufacturing facility, for the production of biosimilars. As per the company's release, the facility
will have the necessary design capacity and capabilities and will seek regulatory approvals to
supply both to the local market and to export into the rest of Africa and Europe. The factory,
which will be located in the Department of Trade and Industries Special Economic Zone of Dube
Tradeport in Durban, will manufacture biosimilar drugs made from living organisms and used in
the treatment of cancer and other diseases. At full capacity, the facility will create up to 300
jobs, primarily in the engineering and biological science fields. This facility will run
independently. This is not Cipla's first foray in the African market. In 2013, Cipla had acquired
South African drug firm MedPro, one of its first large foreign acquisition and has been ramping
up presence in the African nation since then. Last September, Cipla had made an
announcement that all its biologic business will be consolidated under Cipla Biotech, which will
focus on drug development in cancer, respiratory, and diabetes treatments. The company also
said in its release that, in South Africa, people without access to private insurance cannot afford
biologic medicine due to the very high prices of the innovator molecules. Currently about 1-in-50
patients in Africa have access to biologic medication. Cipla further added that with this new
venture they are striving to reduce this number to about 1-in-5 cancer patients through the
production and supply of biosimilar medication at an affordable price.
Bionap CFA HedgePath Pharmaceuticals, Inc. (HPPI)
HPPI is a Tampa-based biopharma company developing an improved, patent-protected, oral
capsule formulation of itraconazole for the treatment of solid tumors. Itraconazole has been
marketed for over 25 years in the U.S. as an antifungal. It decreases ergosterol synthesis which
is critical to fungal replication, a mechanism that makes the drug highly effective as an
antifungal agent. It was brought to the market as an antifungal by Johnson & Johnson in the
U.S. under the brand name Sporanox® and posted peak worldwide sales of over $600 million
prior to the patent expiration. It is now widely available as a generic. Recent evidence points to
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itraconazole’s strong inhibition of the Hedgehog pathway in human cells, with broad implications
for the treatment of cancer. In particular, in the case of basal cell carcinoma (BCC), this
molecular pathway plays an apparently essential role in the development and growth of tumors.
Two recently approved Hedgehog inhibitors, Roche's Erivedge® and Novartis' Odomzo® are
indicated for the treatment of locally advanced or metastatic BCC, validating the market for
HedgePath's SUBA™-Itraconazole product. I see SUBA-Itraconazole as a potential blockbuster
drug for HedgePath given the improved efficacy and tolerability over generic formulations of
itraconazole and existing medications, including Erivedge and Odomzo, where side-effects
deter long-term use and discontinuation of therapy results in the reappearance of BCC tumors.
Below is an introduction to the story ahead of the preliminary data expected shortly.
Pharmalot interview with Moncef Slauoi on Galvani Bioelectronics news from GSK
GOOGL Verily
Slaoui we wondered if there are other modalities that we can use to engage the body and
change it. So three years ago, I put a small team together — three from outside and three from
inside the company — to explore what else we can use. We honed in on electrical signals,
because that’s what the nervous system uses to regulate most functions in our body. That’s how
information is translated from the brain to the organs — electrical impulses travel along the
neurons. So we started to research this concept and scouted the world for people who working
on this. … And we realized we needed to integrate sciences that were not working together —
not just biologists and chemists, but also nanotechnologies experts in wireless technology,
powering. … We think we have a new way to develop and discover medical interventions. We
believe it can be a whole new industry, a little bit like in the 1800s, when chemical companies
working on paint realized they could use their expertise to develop pharmaceuticals.
After we put together that small team, we started to work with a large network or 50 academic
centers, the NIH, and DARPA to test the concept, since bioelectronic medicines require different
sciences and electronics and data analytics, which are things we don’t know at GSK. And we
realized very quickly that we need to find a partner to create the hardware, the device. We
contacted most of the large companies with technologies and most were interested, but at the
same time, they were concerned about the complexity of transplanting their devices into the
human body and the complexities that regulators would create around that. … But we were
incredibly aligned on the vision — the integration between technology and biology to create new
therapeutics.
Actually, we’ve already accomplished a lot over the past three years. Besides the collaborations
with the academic centers, we also work with small companies. We started a $50 million
venture capital fund devoted to bioelectronics. … In the process, we have shown in animal
models that stimulating or blocking nerve signals at the level of the organ can have a
therapeutic benefit. So the mission of the new company within the next three years is to take
three of these disease models — metabolic, inflammatory, and endocrine disorders — from the
preclinical proof of principal concept to a clinical proof of principle concept. And in the next 18
months, we plan to start clinical trials with a prototype device to establish clinical proof of
concept. And hopefully we will have that in the next three years. Once we do, all resources will
be devoted to making the first commercial version of a bioelectronic medicine. And we hope to
have approval and be in the marketplace in the next seven to 10 years. It’s not science fiction.
And it’s progressing quite well.
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Clearly, it’s a high-risk endeavor, but it has a strong base in terms of clinical demonstrations of
the concept. The first objective is now to establish if it works in a disease state. … But among
the challenges, not necessarily in any order, a device needs to be the size of a grain of rice and
have a lot of computing capability. This is an engineering challenge, but it’s being addressed.
We also need to provide power to such a device and wirelessly transmitting power across the
body mass is a technical challenge, and we’re working on that, as well. And it has to exchange
data. And the material to be used in the device needs to be designed in such a way that it’s not
rejected by the body and doesn’t harm the nerve. Then there’s the surgical procedure to implant
the device on the nerve.
The new company is owned 55 percent by GSK and 45 percent by Verily. So the ($715 million)
investment is apportioned that way. I’m the chairman of the board of the new company. I believe
you know that I’m going to retire from GSK in June 2017, but will remain with Galvani. … We’ll
have about 30 employees — scientists and engineers. And we’ll contract some of the key work
with Verily; about 100 of their engineers will be dedicated to creating the first-generation device.
And we’ll continue partnerships with about 50 collaborators.
Bioelectronic medicines hold the potential to be almost equivalent to a cure. … It will be a
device implanted for the rest of your life, which means it will be a one-time intervention. … So
how do you price it? I think the appropriate and responsible thing to do is price interventions like
this so the cost is spread over time — a pay-for-performance approach. I could imagine patients
or payers would pay a fee on a monthly or yearly basis, as long as they receive the clinical
benefits from the device, so that the charge to the health care system isn’t a huge peak (in cost)
that happens at once, which we saw happen with other health care interventions.
WSJ Why TWTR should buy Nuzzel
TWTR while it reports 313 million monthly active users, Twitter’s “total addressable audience” is
800 million. That includes people who see tweets outside Twitter’s website or apps, as when
they are embedded in a webpage or news article. And that doesn’t even count things Twitter
can’t measure, like the segment of seemingly every cable news show that consists of simply
reading tweets aloud.
Twitter likes to tout these numbers because they illustrate its influence. But all of this
consumption of tweets outside Twitter also can be read as a massive failure of product design.
It shows that Twitter is so bad at surfacing its most valuable content that, in a form of
information arbitrage, a whole ecosystem of other players has arisen to do it for Twitter, from
apps and data-mining services to the news media itself.
It is possible the future of the company, which doesn’t turn a profit, depends on its ability to
capture more of this audience—especially after it reported last week that the number of people
using Twitter in the latest quarter rose a mere 1% from the previous one. More broadly, Twitter’s
problem is the same as the media with which it has become symbiotic: Twitter is a place that
people create content, yet it is ceding to others the control over how people consume it.
Here’s an experiment all Twitter users who thinks of themselves as conscientious consumers of
news should try: download the Twitter client app Nuzzel, and use it for a week instead of the
Twitter app. Two-year-old Nuzzel shows you which links are tweeted the most among the
people you follow.
A year ago I wrote about how I use it every day, and my reliance on it has only increased. Better
than Twitter itself, it fulfills the purpose of Twitter, as described in Twitter’s latest ad campaign:
“see what’s happening.”
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It’s not that Twitter isn’t trying. Recent changes include an algorithm to order some of the tweets
it shows users, and its Moments tab, designed to surface even more content outside the strictly
time-ordered stream that has been Twitter’s hallmark since it launched 10 years ago.
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“We’re making the right decisions on our product and it gives us a foundation for future growth,”
Chief Executive Jack Dorsey said on Tuesday after Twitter announced quarterly results.
“If you look at the pace that Twitter is making changes to the product now, it’s significantly faster
than it has ever been,” says Ian Ownbey, an early Twitter employee who subsequently built the
Twitter posting app OneShot.
“There’s a huge amount of valuable data on Twitter people can’t access easily enough,” says
Jonathan Abrams, founder and CEO of Nuzzel. “For every scientist or librarian who is on Twitter
there are probably 10 who are not,” he adds.
In Twitter’s defense, it is facing the classic dilemma of popular services: How to enact radical
change to win new customers without alienating a large and loyal existing fanbase. A person
familiar with the inner workings of the company said this debate is animating just about
everyone who is working at the company now.
“I think everybody can see that another 300 million people are not going to use what you call
core Twitter,” says Mr. Abrams. And yet hundreds of millions more are already using what we
might call “extended Twitter.”
Perhaps Twitter’s core interface, built as much around producing content as consuming it—that
is, tweeting—isn’t compatible with capturing its much larger existing and future audience. Many
hybrid tech/media companies face this dilemma. From Reddit and Pinterest to Facebook and,
increasingly, Snapchat, the majority of content on these services is created by a small minority
of users. Most of us are, after all, just consumers of content.
Twitter’s incremental changes in this direction feel like a good step, but as evidenced by stalled
user growth, they aren’t radical enough. Twitter client apps like Nuzzel point the way to the
future, but there are other experiments further afield that are just as interesting. The app Pocket,
born as a service for saving content for later, is building its own Twitter-like content
recommendation service inside the app itself, and it’s good. Last quarter Twitter also made $67
million in revenue on licensing its data to companies like Bloomberg, International Business
Machines Corp. and Salesforce. com Inc., so there’s a possibility that Twitter could capture
more business-to-business revenue by doing more of that data processing itself
ALS news
Researchers have identified three new genetic risk loci for amyotrophic lateral sclerosis (ALS).
ALS is a fatal neurodegenerative disorder. Despite the fact that it is around 65 percent heritable,
the majority of genetic risk remains unexplained, in part because of its late-onset nature and the
fact that most genetic risk variants are not highly penetrant. The authors used two separate
methods to identify new genetic risk variants for ALS. In one study, they used a method called
exome-wide rare variant burden analysis, in which the combined frequency of rare variants in
each gene is compared. Because different variants in the same gene can converge on the same
functional deficit, rare variant burden analysis can identify possible risk genes with a relatively
small number of cases. In another paper, the team analyzed genotype data from nearly 15,000
ALS patients and nearly 28,000 controls, including previously published data as well 7,763
newly genotyped ALS cases and 4,669 controls. The rare variant burden analysis identified
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NEK1 as a gene where mutations confer susceptibility to ALS, while the whole-genome
sequencing study identified C21orf2, MOBP and SCFD1 as new risk loci.
STAT
A new study suggests that a group of biosimilar drugs, which are used to treat such afflictions
as rheumatoid arthritis, psoriasis, and inflammatory bowel disease, appear as safe and effective
as their more expensive brand-name counterparts, which are known as biologics. A The
analysis arrives as the US health care system, which is increasingly overwhelmed by highpriced medicines, looks toward biosimilars to provide savings. In the United States, where
regulators have approved just two such drugs, some estimates say prices will be 20 percent to
30 percent less than the cost of biologics.
But until more biosimilars become available, there is some debate over the extent to which
physicians will become sufficiently comfortable prescribing these drugs. Biologics are made
from living cells and the brand-name biotech industry, for instance, says the complex processes
needed to develop biosimilar drugs may produce slight changes that can affect safety and
effectiveness. The threat of lower-priced competition has prompted brand-name drug makers to
petition the Food and Drug Administration to delay approvals, among other tactics.
Health news
23andME in scientific expedition into the DNA of more than 450,000 customers of gene-testing
company 23andMe has uncovered the first major trove of genetic clues to the cause of
depression.The study, the largest of its kind, detected 15 regions of human genome linked to a
higher risk of struggling with serious depression
AAPL Apple granted motion for new trial vs VHC in July 29 ruling in Texas court
ABBV news that ESRX posted a list of drugs it will not cover in its 2017 formulary, along with
preferred alternatives in each drug category. ESRX is reviewing its HCV category based on
recent product launches. ABBV has negotiated exclusive formulary status for its HCV therapies,
including Viekira Pak ombitasvir/paritaprevir/ritonavir plus dasabuvir and Technivie
ombitasvir/paritaprevir/ritonavir. GILD Sovaldi sofosbuvir remains on the list of exclusions,
although the new document did not name two Gilead HCV therapies that were on its list of 2016
exclusions: Harvoni ledipasvir/sofosbuvir and newly approved Epclusa sofosbuvir/velpatasvir
Accutron CMN Cantel Medical bought Accutron, the leading maker of nitrous oxide delivery
systems and single-use nasal masks.CMN expects deal to add to earnings per share starting in
FY17 Accutron had 2015 rev. of $20.5m Deal allows CMN to expand presence in dental offices
with bundled portfolio of equipment and consumables
AEZS and Rafa Laboratories sign exclusive license for Zoptrex in Israel AEZS and Rafa
Laboratories, Ltd. announced the signing of an exclusive license agreement for the company’s
lead anti-cancer compound, Zoptrex (zoptarelin doxorubicin), for the initial indication of
endometrial cancer, for Israel and the Palestinian Territories .
Allied Minds’ SciFluor Life Sciences has achieved the necessary scientific and regulatory
milestones to enter clinical trials.Investigational New Drug (IND) application to the FDA now in
effect for SF0166 Topical Ophthalmic Solution (SF0166), enabling co. to initiate clinical testing
of SF0166 in both wet Age-related Macular Degeneration (AMD) and Diabetic Macular Edema
(DME) patients
Altimmune HHS's Biomedical Advanced Research and Development Authority (BARDA)
awarded it a contract for up to $120.2 million to fund clinical development of anthrax vaccine
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candidate NasoShield (formerly AdVAV anthrax vaccine).The five-year contract provides $14.3
million to fund a Phase I trial of NasoShield that is scheduled to begin in 2H17, with options for
an additional $105.9 million that would fund further development.NasoShield is an intranasal
recombinant protein antigen (rPA)-based vaccine. Altimmune formerly was known as Vaxin Inc
Araclon Biotech SL majority-held by GRFS Grifols SA, said that a phase I study of its active
immunotherapy against Alzheimer’s disease, ABvac40, showed the vaccine produced an
immune response in more than 87 percent of patients who received the product during the trial,
supporting its continued development. The study did not evaluate the treatment’s efficacy.
Araclon presented the results of the trial at the Alzheimer’s Association International
Conference. GRFS, through Araclon, has also developed an early diagnostic test, ABtest, that
makes it possible to detect and quantify different amyloid beta fractions.
Autifony Therapeutics Ltd., of London, completed a phase I safety and tolerability trial of its Kv3
modulator, AUT00206, designed to treat schizophrenia, in approximately 60 healthy volunteers.
In fed and fasted states, AUT00206 was safe and well tolerated, with pharmacokinetics
confirming drug concentrations at levels required to generate a clinical effect, as predicted by
preclinical models. The company plans to advance the compound into a phase Ib ketamine
challenge study and a second phase Ib study investigating clinical biomarkers of efficacy in
patients with schizophrenia.
ARIA news that PDLI completes second tranche payment under royalty transaction with ARIA
As a result of the second tranche payment, under the terms of the ARIAD Royalty agreement,
PDL's royalty percentage will increase to 5.0% of the U.S. and European net revenues of Iclusig
and 5.0% of the payments ARIAD receives elsewhere in the world until 31-Dec-18 Beginning 1Jan-19 and thereafter, the royalty rate will increase to 6.5% in all jurisdictions and continue until
31-Dec-33, subject to a put option of PDL upon the occurrence of specified events and a call
option of ARIAD.
ARRY expected to announce Phase 3 data of its selumetinib in lung cancer in 2H 2016 and of
binimetinib-encorafenib combo in melanoma in calendar 3Q 2016
Askelpios news that PFE acquired the 78% of Bamboo Therapeutics Inc It did not already own
for $150 million up front and $495 million in milestones. In 1Q16, the pharma obtained a 22%
stake in Bamboo for about $43 million.Bamboo develops adeno-associated viral vector (AAV)based gene therapies that preferentially target tissues affected by CNS and neuromuscular
disorders. The company spun out of gene therapy company Asklepios BioPharmaceutical Inc.
(in 2015 with an initial focus on BMB-D001, a systemic gene therapy for Duchenne muscular
dystrophy (DMD) that is due to enter a Phase I trial this half.Pfizer also will gain a Phase I
treatment for giant axonal neuropathy (GAN) and preclinical gene therapies for Friedreich's
ataxia and Canavan's disease, as well as Bamboo's recombinant AAV design and production
technology and a manufacturing facility In February, Bamboo raised $49.5 million in a series A
round that included CureDuchenne Ventures LLC. Asklepios also held an equity stake in
Bamboo.Bamboo's executive chairman and CSO Jude Samulski will join Pfizer. He is the
director of the University of North Carolina Gene Therapy Center
Autifony Therapeutics completed a phase I safety and tolerability trial of its Kv3 modulator,
AUT00206, designed to treat schizophrenia, in approximately 60 healthy volunteers. The
company plans to advance the compound into a phase Ib ketamine challenge study and a
second phase Ib study investigating clinical biomarkers of efficacy in patients with schizophrenia
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AZN HCM Hutchison China MediTech announced with AZN an amendment to the 2011 global
licensing, co-development, and commercialization agreement regarding savolitinib. The
companies have expanded the global development plan to include NSCLC, Kidney, gastric and
colorectal cancer. The Amendment provides that Chi-Med will contribute up to $50M, spread
primarily over three years, to the joint development costs of the global pivotal Ph 3 study in cMet-driven PRCC.
Bamboo PFE acquired the 78% of Bamboo Therapeutics Inc It did not already own for $150
million up front and $495 million in milestones. In 1Q16, the pharma obtained a 22% stake in
Bamboo for about $43 million.Bamboo develops adeno-associated viral vector (AAV)-based
gene therapies that preferentially target tissues affected by CNS and neuromuscular disorders.
The company spun out of gene therapy company Asklepios BioPharmaceutical Inc. (in 2015
with an initial focus on BMB-D001, a systemic gene therapy for Duchenne muscular dystrophy
(DMD) that is due to enter a Phase I trial this half.Pfizer also will gain a Phase I treatment for
giant axonal neuropathy (GAN) and preclinical gene therapies for Friedreich's ataxia and
Canavan's disease, as well as Bamboo's recombinant AAV design and production technology
and a manufacturing facility In February, Bamboo raised $49.5 million in a series A round that
included CureDuchenne Ventures LLC. Asklepios also held an equity stake in Bamboo.
Bamboo's executive chairman and CSO Jude Samulski will join Pfizer. He is the director of the
University of North Carolina Gene Therapy Center.
BIIB and IONS drug for a deadly muscle disorder in infants met its main goal in a late-stage
trial.Babies with spinal muscular atrophy who got the experimental drug, nusinersen, achieved
motor-skills development milestones better than those who didn’t get the treatment, the
companies said Monday in a statement. The drug also showed an acceptable safety profile,
they said. Biogen said it paid Ionis a $75 million licensing fee and will soon file with regulators
for approval. All 122 patients in ENDEAR will be able to enroll in the open-label SHINE
extension study to receive nusinersen. Nusinersen also is in the 15-month Phase III CHERISH
trial, which enrolled 126 non-ambulatory patients with later-onset SMA. Data from CHERISH are
due in 1H17.
BIOL to raise $10M from institutional and individual investors in convertible preferred private
placement Under the terms of the private placement, BIOLASE has agreed to sell an aggregate
of 88,494 shares of its convertible preferred stock at a per share price of $113.00, and each
share of preferred stock will initially be convertible into 100 shares of BIOLASE common stock,
reflecting a conversion price equal to $1.13 per share, which is the closing price of BIOLASE
common stock quoted on NASDAQ on 29-Jul-16. In addition, the investors will receive warrants
to purchase up to an aggregate of 2,035,398 shares of BIOLASE common stock at an exercise
price of $2.00 per share. The warrants become exercisable on Feb 8 2017, six months after
the closing of the private placement, and have a term of five years from the date of issuance.
The closing of the transaction is expected to occur on 8-Aug-16, subject to customary closing
conditions.
Bioniz David Pyott has a new project to add to his post-Allergan CV. Pyott and Takeda co-led a
$13 million startup round for Bioniz, an Irvine, CA-based developer which just had its first IND
approved.Bioniz is building a peptide platform based on blocking particular cytokines that can
trigger disease. It has two lead programs, BNZ-1 and BNZ-2, with two completely different
disease targets. BNZ-1 is aimed at HTLV-1 Associated Myelopathy (HAM), an orphan disease,
and for certain T-cell leukemias. The preclinical BNZ-2 targets cytokines IL15/IL21 for celiac
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disease and other immuno-inflammatory disorders in the GI tract.Pyott is taking the chairman’s
post for himself while Nazli Azimi takes the CEO’s role. Azimi worked on cytokine research at
the NIH and later moved on to the faculty of the prestigious Fred Hutchinson Cancer Research
Center, where she specialized in the herpes virus. Bioniz’s Azimi had this to say in a statement
this morning: This financing is an important step needed to drive the development of new
potential treatments for patients affected by very serious cytokine-driven diseases. Bioniz said it
expects to begin a Phase I study "shortly" of lead candidate BNZ-1 in collaboration with NIH. It
plans to develop the selective inhibitor of interleukin-2 (IL-2), IL-9 and IL-15 to treat human T
cell lymphotropic virus type 1 (HTLV-1) associated myelopathy and some T cell leukemias.
The company also is developing BNZ-2, a selective IL-15 and IL-21 inhibitor that is in preclinical
development to treat immuno-inflammatory gastrointestinal tract disorders
Biophytis SA, , France, said it received approval from Bpifrance for a €1.1 million (US$1.2
million) innovation loan to finance the pharmacokinetic trial of Sarconeos (SARAPK). The trial,
to be conducted in two phases during the second half of this year, will assess pharmacokinetics
and safety of the drug in elderly volunteers, with results to be used for approval of a phase IIb
trial, set to start in the first half of 2017. Sarconeos (BIO101) is in development for sarcopenic
obesity
BLRX signs exclusive worldwide agreement with Hadasit for in-licensing of a drug candidate for
the treatment of liver fibrosis, and in particular, non-alcoholic steatohepatitis.The drug
candidate, to be called BL-1210, is the first project to be in-licensed under the framework of the
company's strategic collaboration with Novartis Pharma AG for the screening and development
of novel drug candidates. The newly in-licensed pre-clinical project, developed by Prof. Rifaat
Safadi, Head of the Liver Unit, Department of Medicine at Hadassah Medical Center,
Jerusalem, Israel, offers a novel mechanism for controlling liver fibrosis through modulation of
the immune system. BioLineRx will address the novel drug target that will modulate the immune
system to ultimately reduce the liver fibrogenesis and therefore reduce liver scarring. Limiting
the fibrosis process this way will potentially control the disease progression.
BMY news that ESRX posted a list of drugs it will not cover in its 2017 formulary, along with
preferred alternatives in each drug category. ESRX will exclude from its formulary new psoriasis
drug LLY Taltz ixekizumab and rheumatoid arthritis therapy BMY Orencia abatacept
CAPR provides update on its Exosome program As supported by recent preclinical findings, the
company has determined that the first clinical indication for which it will develop its therapeutic
development candidate, CAP-2003, will be within the area of ophthalmology, and this indication
will be one among alkali burn injury, ocular graft-versus-host disease, and inflammatory dry eye
disease
CELG is under fire this morning following allegations made in court that the company donated
millions of dollars to charities that help patients afford high-priced drugs for cancer as part of a
scheme to turn a profit of billions of dollars.A whistleblower lawsuit alleges the company
donated the money and then worked with the charities to ensure their own medicines were
covered, such as its multiple myeloma drug, Revlimid, a violation of U.S. federal law, Bloomberg
reported this morning. The scheme made CELG eligible to receive reimbursements from
Medicare and other government health programs. The lawsuit was filed by a former Celgene
sales rep, Beverly Brown, The lawsuit pegs two charities, Patient Access Network Foundation
and Chronic Disease Fund as two charities Celgene coordinated with. The lawsuit alleges
Celgene gave the donations to the two foundations, described as kickbacks, in order to ensure
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those foundations pushed patients to using Celgene drugs, such as Revlimid and Thalomid,
used to treat multiple myeloma and leprosy.
CHUGAI RHHBY news that ESRX posted a list of drugs it will not cover in its 2017 formulary,
along with preferred alternatives in each drug category. ESRX will exclude from its formulary
new psoriasis drug LLY Taltz ixekizumab and rheumatoid arthritis therapy BMY Orencia
abatacept. Express Scripts lists ten preferred alternatives in the inflammatory disease category,
including PFE Xeljanz tofacitinib and Xeljanz XR , RHHBY CHUGAI Actemra tocilizumab)
(Xeljanz was excluded in 2016.) ESRX may reassess Actemra this year "to reflect anticipated
product launches." Among possible competitors would be REGN SNY sarilumab (REGN88)
which is under FDA review.
CMN Cantel Medical it bought Accutron, the leading maker of nitrous oxide delivery systems
and single-use nasal masks.CMN expects deal to add to earnings per share starting in FY17
Accutron had 2015 rev. of $20.5m Deal allows CMN to expand presence in dental offices with
bundled portfolio of equipment and consumables
COLL receives European patent allowance covering Xtampza ER The European Patent Office
has issued an intention to grant letter for European Patent Application No. 05759527.4, an
application with claims covering Xtampza (oxycodone) extended-release (ER) capsules.
Xtampza ER is Collegium’s first product utilizing the DETERx technology platform. Collegium
currently has eight U.S. patents that are listed in the FDA Orange Book in addition to issued
patents in Canada, Japan and Australia.
CVM reports monthly patient enrollment in July for its phase 3 head and neck cancer trial CVM
announced that during the month of July it has enrolled 29 patients in its ongoing Phase 3 trial
of its investigational immunotherapy Multikine (Leukocyte Interleukin, Injection) in patients with
advanced primary head and neck cancer.
DBV Technologies announced a strategic investment in the global clinical program of Viaskin
Peanut for the treatment of peanut allergic children four to 11 years of age by initiating the
REAL LIfe Use and Safety of EPIT (REALISE) Study, a Phase III trial designed to assess the
use and safety of Viaskin Peanut 250g in routine clinical practice REALISE is a multicenter,
randomized, double-blind, placebo-controlled Phase III study designed to assess the use of
Viaskin Peanut 250g in routine medical practice and generate safety data after six months of
blinded treatment in patients four to 11 years of age. The study is expected to be conducted in
~30-40 centers in North America. DBV intends to enroll ~335 subjects in REALISE. With the
ongoing PEPITES trial, the company's pivotal Phase III study of Viaskin Peanut, the launch of
REALISE marks the expansion of the largest global clinical development program to date in
children suffering from peanut allergy. Topline results from both trials are expected in H2 of
2017.
DiaSorin targets higher revenue from DNA tests, cross-selling strategies after recent acquisition
of Focus Diagnostics, Il Sole 24 Ore says, citing co.’s plans.
Didi Chuxing and Uber China, announced a merger that will become the latest marriage of
former bitter rivals in China. Didi Chuxing and Uber China swap shares in a deal that would give
Uber about 20 percent of the merged company and give the rest to Didi. That ratio is roughly
comparable to each of the 2 companies’ market values following their latest mega fund-raisings
earlier this year.
DXTR news that ISRG, inked a joint development deal with DXTR Dextera Surgical to develop
a surgical stapler and cartridge for Intuitive’s da Vinci robotic surgical system.The company said
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the new development follows completion of a 6-month feasibility evaluation of Dextera’s
MicroCutter as part of an ongoing deal between the companies. Through the deal, Intuitive
Surgical will take charge of development work for the robotic-compatible stapler system, while
Dextera Surgical will focus on developing the stapler cartridge for the device.
EBS completes spin-off of Aptevo Therapeutics The company has completed its previously
announced spin-off of Aptevo Therapeutics Inc. (APVO) through the distribution of all of the
shares of Aptevo common stock to the holders of Emergent BioSolutions common stock As a
result of the spin-off, Aptevo is now an independent public company and listed on the Nasdaq
Global Select Market under the ticker symbol “APVO.”
ESRX GILD removed from ESRX Express Scripts’ “excluded medications” section of its 2017
Preferred Drug List Exclusions
ESRX posted a list of drugs it will not cover in its 2017 formulary, along with preferred
alternatives in each drug category. ESRX will exclude from its formulary new psoriasis drug LLY
Taltz ixekizumab and rheumatoid arthritis therapy BMY Orencia abatacept. Express Scripts lists
ten preferred alternatives in the inflammatory disease category, including PFE Xeljanz
tofacitinib and Xeljanz XR , RHHBY CHUGAI Actemra tocilizumab) (Xeljanz was excluded in
2016.) ESRX may reassess Actemra this year "to reflect anticipated product launches." Among
possible competitors) would be REGN SNY sarilumab (REGN88) which is under FDA review.
Pulmonary drugs GSK Arnuity Ellipta fluticasone furoate and Flovent Diskus/HFA fluticasone
propionate are now preferred drugs that had been excluded in 2016. ESRX is reviewing its HCV
category based on recent product launches. ABBV has negotiated exclusive formulary status for
its HCV therapies, including Viekira Pak ombitasvir/paritaprevir/ritonavir plus dasabuvir and
Technivie ombitasvir/paritaprevir/ritonavir. GILD Sovaldi sofosbuvir remains on the list of
exclusions, although the new document did not name two Gilead HCV therapies that were on its
list of 2016 exclusions: Harvoni ledipasvir/sofosbuvir and newly approved Epclusa
sofosbuvir/velpatasvir. Express Scripts no longer breaks out cardiovascular drugs as a class on
the new list.
EYEG announces positive top-line data from Phase 1B/2a Clinical Trial of EGP-437 EyeGate
Pharmaceuticals announces positive data from its Phase 1B/2a trial assessing its lead product
candidate, iontophoretic EGP-437, in the treatment of post-operative ocular inflammation and
pain in cataract surgery patients.
FLTX VZ aims to build on its growing business in the automotive and commercial vehicle
Internet of Things segment with the acquisition of GPS vehicle-tracking company Fleetmatics for
$2.4 billion. This follows fast on the heels of Verizon's July 25 announcement that it intends to
acquire Yahoo!'s core web business for $4.83 billion. Both deals are part of Verizon's effort to
rapidly expand into new growth segments such as content and Internet of Things, as its core
wireless and wireline businesses slow.This deal will build on Verizon's small but growing
presence in the commercial fleet management segment. Verizon previously bought Hughes
Telematics in 2012 and Telogis in June to marry its nationwide wireless coverage with fleet
management to offer services such as route optimization.
FMS Fitch raises FMS to investment grade, Outlook Stable Increasing scale and diversification
in co.’s selective healthcare operations is translating into strong profitability and cash
generation, Fitch says. Fitch views the underlying operations as mature and defensive with low
cyclicality and volatility of earnings Fitch sees Fresenius to continue its successful acquisition
strategy, albeit less strategic and more bolt-on in nature
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Fosun Group, one of China’s most acquisitive conglomerates, is preparing to sell as much as 40
billion yuan ($6 billion) in assets as it turns its focus towards raising its credit rating to above
junk. As it steps back from the more than $15 billion in overseas purchases made or "We will
sell assets to repay debts," Liang, 47, said in Shanghai. "We have ample capability to get
investment grade ratings.
Galvani Bioelectronics news that GSK and GOOGL Verily Life Sciences have agreed to form a
company to enable the research, development and commercialization of bioelectronic
medicines.JV to be called Galvani Bioelectronics: Verily Life Sciences was formerly known as
Google Life Sciences and is part of AlphabetGlaxo will hold a 55% equity interest in the new
jointly owned company and Verily will hold 45%Galvani will be based at Glaxo’s global R&D
center in England, with a second research hub at Verily’s facilities in San Francisco
Garwood Medical Devices a Buffalo medical device startup intends to create 40 jobs over five
years through a partnership with a University at Buffalo genomic research program, the
university announced Thursday.Garwood Medical Devices, which develops devices to treat
chronic wounds and control joint-replacement infections, will receive $1.48 million in support
from UB’s Buffalo Institute for Genomics and Data Analytics, known as BIG, as part of the
agreement.
GEN makes headway in capital strengthening initiatives The company also announced an
agreement in principle on terms of a settlement with the Department of Justice (the DOJ) and an
extension of the lock-up for a majority of the shares of the company's common stock
GILD removed from ESRX Express Scripts’ “excluded medications” section of its 2017
Preferred Drug List Exclusions
GILD explores whether Gilead should spin-off its HCV business Amid declining and less
predictable hepatitis C virus (HCV) revenues, and a scarcity of acquirable assets that would
move the needle, the firm takes a counterintuitive look at spinning off the HCV franchise to
sharpen its focus on HIV, pipeline and business development. Firm believes it could unlock
value, improve sentiment, and make for a leaner more nimble acquirer, but the strategy does
not come without risks
GILD news that ESRX posted a list of drugs it will not cover in its 2017 formulary, along with
preferred alternatives in each drug category. ESRX is reviewing its HCV category based on
recent product launches. ABBV has negotiated exclusive formulary status for its HCV therapies,
including Viekira Pak ombitasvir/paritaprevir/ritonavir plus dasabuvir and Technivie
ombitasvir/paritaprevir/ritonavir. GILD Sovaldi sofosbuvir remains on the list of exclusions,
although the new document did not name two Gilead HCV therapies that were on its list of 2016
exclusions: Harvoni ledipasvir/sofosbuvir and newly approved Epclusa sofosbuvir/velpatasvir
GLMD appoints Professor Ran Oren, M.D., as Chief Medical Officer Dr. Oren replaces Dr. Maya
Halpern, who previously served as Galmed's CMO. Dr. Oren currently serves as Professor of
Gastroenterology & Hepatology at the Faculty of Medicine, the Hebrew University of Jerusalem,
Israel, as well as the Head of the Institute of Gastroenterology and Liver Disease at Hadassah
Medical Center, Jerusalem, Israel . Dr. Oren will serve as CMO while maintaining his ongoing
commitments at Hebrew University and Hadassah.
GRFS news that Araclon Biotech SL majority-held by GRFS said that PH I study of its active
immunotherapy against Alzheimer’s disease, ABvac40, showed the vaccine produced an
immune response in more than 87 percent of patients who received the product during the trial,
supporting its continued development. The study did not evaluate the treatment’s efficacy.
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Araclon presented the results of the trial at the Alzheimer’s Association International
Conference. GRFS, through Araclon, has also developed an early diagnostic test, ABtest, that
makes it possible to detect and quantify different amyloid beta fractions
GSK news that ESRX posted a list of drugs it will not cover in its 2017 formulary, along with
preferred alternatives in each drug category . For Pulmonary drugs GSK Arnuity Ellipta
fluticasone furoate and Flovent Diskus/HFA fluticasone propionate are now preferred drugs that
had been excluded in 2016.
GSK and GOOGL Verily Life Sciences have agreed to form a company to enable the research,
development and commercialization of bioelectronic medicines.JV to be called Galvani
Bioelectronics: Verily Life Sciences was formerly known as Google Life Sciences and is part of
AlphabetGlaxo will hold a 55% equity interest in the new jointly owned company and Verily will
hold 45%Galvani will be based at Glaxo’s global R&D center in England, with a second
research hub at Verily’s facilities in San Francisco
GOOGL Verily Life Sciences and GSK have agreed to form a company to enable the research,
development and commercialization of bioelectronic medicines.JV to be called Galvani
Bioelectronics: Verily Life Sciences was formerly known as Google Life Sciences and is part of
AlphabetGlaxo will hold a 55% equity interest in the new jointly owned company and Verily will
hold 45%Galvani will be based at Glaxo’s global R&D center in England, with a second
research hub at Verily’s facilities in San Francisco
HistoGenetics (Private) and PACB a global leader in high-resolution HLA sequence-based
typing services, has received a multi-year contract to perform HLA typing using PacBio
sequencing. The contract is expected to drive demand for several thousand samples per week
over the next several years.
HOLX notes new guidelines from NCCN regarding breast tomosynthesis HOLX announced that
new guidelines published by the National Comprehensive Cancer Network (NCCN) recommend
that physicians consider breast tomosynthesis exams as an option for their patients' annual
breast cancer screening.
HRTX reports top-line results from phase 2 studies of HTX-011 for management of post-op pain
Heron Therapeutics announced preliminary, positive, top-line efficacy results from two Phase 2
clinical studies of HTX-011, its lead product candidate for the management of post-operative
pain in patients undergoing bunionectomy (Study 208) and inguinal hernia repair (Study 202)
and safety data from the ongoing Phase 2 program. Study 208 – Bunionectomy
HCM Hutchison China MediTech announced with AZN an amendment to the 2011 global
licensing, co-development, and commercialization agreement regarding savolitinib. The
companies have expanded the global development plan to include NSCLC, Kidney, gastric and
colorectal cancer. The Amendment provides that Chi-Med will contribute up to $50M, spread
primarily over three years, to the joint development costs of the global pivotal Ph 3 study in cMet-driven PRCC.
HZNP comments regarding Express Scripts formulary - Horizon recognizes that the Express
Scripts published formulary exclusion list, which will take effect on Jan 1 2017, includes
DUEXIS and VIMOVO. Horizon continues to have discussions with Express Scripts and sees a
potential pathway, while not guaranteed, to completion of a potential partnership with Express
Scripts beginning in 2017. In addition, Horizon continues discussions and negotiations with
other pharmacy benefit managers and payers with the goal of further increasing patient access
to its clinically relevant primary care medicines in 2017.
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IBM in the Aug. 1 issue of Nature Nanotechnology, researchers from IBM highlighted dramatic
improvements in a technology called nanoscale deterministic lateral displacement. The end
result is a biochip that can sift 20 nanometer (a billionth of a meter) samples of DNA, RNA,
exosomes and possibly viruses away from larger structures.“We’ve created a structure in silicon
that contains nanoposts — pillars that are about 100 to 200 nanometers,” said Gustavo
Stolovitzky, program director of Translational Systems Biology and Nanobiotechnology, IBM
Research and the paper’s co-author. “For IBM, this is a high profile entry into the race for a fast
and accurate liquid biopsy. These diagnostics could detect cancer early, track a therapy’s
effectiveness in real time and accelerate drug development. Liquid biopsy represents a multibillion dollar market and dozens of companies have entered the ring, including sequencing giant
Illumina.The study is a first step for IBM, proving they can sort by size. The next phase will
improve the system’s efficiency, collecting enough exosomes to determine if they come from
cancer cells. Eventually, disease information won’t be limited to cancer. Exosomes could
provide important clues about neurodegenerative, metabolic and other conditions. The chip
could also separate viruses – at least in principle – though that has yet to be tested
systematically. While some have expressed surprise that IBM has entered the liquid biopsy
space, Stolovitzky and Smith believe it’s a natural extension of their existing skills.“IBM is the
perfect place to do what we’re doing because of the deep expertise in microelectronics and
nanotechnology,” Stolovitzky said. “The goal is to do a non-invasive analysis from urine to
detect exosomes that indicate the presence of prostate cancer,” says Stolovitzky. “This study is
the first proof-of-concept.”
IONS BIIB drug for a deadly muscle disorder in infants met its main goal in a late-stage
trial.Babies with spinal muscular atrophy who got the experimental drug, nusinersen, achieved
motor-skills development milestones better than those who didn’t get the treatment The drug
also showed an acceptable safety profile, they said. Biogen said it paid Ionis a $75 million
licensing fee and will soon file with regulators for approval. All 122 patients in ENDEAR will be
able to enroll in the open-label SHINE extension study to receive nusinersen. Nusinersen also is
in the 15-month Phase III CHERISH trial, which enrolled 126 non-ambulatory patients with lateronset SMA. Data from CHERISH are due in 1H17.
InVentiv Health news that Advent International Corp. will buy a 50 percent stake in InVentiv
Health Inc. that will value the pharmaceutical services firm at $3.8 billion, making Advent a coowner of the business with Thomas H. Lee Partners. The two private equity firms said in a
statement that they’ll be equal equity owners in InVentiv. InVentiv doesn’t plan to pursue an
initial public offering at this time, the companies said. A private equity group led by Thomas H.
Lee bought
IPSEN the FDA approved Dysport (abobotulinumtoxinA) for injection for the treatment of
pediatric lower limb spasticity in children two years of age and older.
ISRG inked a joint development deal with DXTR Dextera Surgical to develop a surgical stapler
and cartridge for Intuitive’s da Vinci robotic surgical system.The company said the new
development follows completion of a 6-month feasibility evaluation of Dextera’s MicroCutter as
part of an ongoing deal between the companies. Through the deal, Intuitive Surgical will take
charge of development work for the robotic-compatible stapler system, while Dextera Surgical
will focus on developing the stapler cartridge for the device.
KERX disclosed an “unexpected supply interruption” for Auryxia (ferric citrate) attributed to a
production-related issue in converting the iron-based drugs’ active pharmaceutical ingredient to
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the finished product. The company said the plan is to be back on line during the fourth quarter.
But it means Keryx had to yank its sales guidance for the year, just as Auryxia had finally
started making headway in the market, fighting a slow launch after approval in 2014 for
hyperphosphatemia in patients with chronic kidney disease on dialysis.
KND acquires in-home health care operations from the Arkansas Department of Health KND.
KOOL has update on the status of the FDA’s review of its Investigational Device Exemption
(IDE) Supplement for a phase III pivotal trial, designed to demonstrate the safety and
effectiveness of the company’s SurgWerks system for the treatment of late stage, no option,
critical limb ischemia patients. In addition to a number of protocol changes intended to improve
patient enrollment and study flow, the IDE Supplement, submitted at the end of May, proposed
a change in the primary efficacy endpoint from Amputation Free Survival (AFS) to Change in
Transcutaneous Oxygen Pressure (TcPO2). The company believes that published literature in
peer reviewed journals over many years has shown a strong correlation between improvements
in TcPO2 over time and limb salvage, a correlation which has since been reinforced by Cesca’s
own feasibility study data. The company had previously concluded that Amputation-Free
Survival (AFS) would not be practical as a primary endpoint for the study because it couples
limb-related outcomes with all-cause mortality, a characteristic that unreasonably burdens the
statistical analysis necessary to specifically demonstrate treatment effectiveness in preventing
amputations among late stage CLI patients. The FDA has approved the changes in Cesca’s
pivotal trial design as proposed in the IDE Supplement, including the use of Change in TcPO2
as the primary measure of efficacy. There are now no regulatory impediments to the company
enrolling patients and beginning the trial. The FDA also indicated that regardless of the
outcome of the study, it would require the company to further validate TcPO2 as a surrogate for
clinical outcome for the proposed indication prior to granting marketing (PMA) approval. In light
of this, the company is now engaged in a follow-on dialog with the FDA to explore various
alternative pathways to securing a PMA.
LIVN appoints Damien McDonald as its new COO effective Oct 3 2016
LLY news that ESRX posted a list of drugs it will not cover in its 2017 formulary, along with
drug LLY Taltz ixekizumab and rheumatoid arthritis therapy BMY Orencia abatacept
MCRB on Market Exclusive: Seres Therapeutics just put out interim data from its lead trial, and
the data doesn’t look good. SER-109 takes the concept of a fecal transplant and adapts it to oral
administration. It’s essentially a sample of healthy spores taken from health, human stools,
mixed up and combined in a pill. When taken by the recurrent CDI sufferer, it enters the GI
system and the spores multiply, filling out the environment with the healthy flora. Well, that’s
what the company is going for, and looked to have shown to be true heading into the phase II.
So what happened? Well, Seres’ management held a conference call on the morning of the
announcement, and we sat in on it to see if we could garner any insight separate from that
which we drew from the press release.Basically, all that anyone knows right now is that the data
showed the drug had no effect when compared to placebo – indeed, the active arm of the trial
looked inferior to the placebo arm from an efficacy perspective.
The measurement took place eight weeks into the study, and measured recurrence based on
the criteria of diarrhea for 2 or more consecutive days, a positive CDI test, and the requirement
for antibiotic treatment.Across the full population, recurrence occurred in 44% of subjects who
received SER-109, compared to 53% of subjects who took placebo. The data was split into two
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further groups, over 65 and under 65. In the under 65 group, recurrence occurred in 43% of
subjects who received SER-109 and 27% of subjects who received placebo. In the over 65
group, CDI recurrence occurred in 45% of subjects who received SER-109, and 80% of those
who received placebo.The general tone of the call was one of these data being totally
unexpected, and management (as yet) is not able to explain the reason for the discrepancy
between this interim and the topline from a phase Ib (this is a phase II trial). The latter
demonstrated significant clinical benefit, so why this one didn’t doesn’t make that much sense.
What’s next? Management has set its full resource pool loose on the data, and the company is
picking apart the numbers as we speak to see if it offers any insight into the discrepancy
between phase I and phase II. The phase I wasn’t split into age groups, but apparently the
makeup is pretty much identical to the phase II from, so it should be pretty easy to compare.
MDT receives CE Mark for CoreValve Evolut R System The company announced CE
(Conformité Européenne) mark for the self-expanding, recapturable and repositionable
CoreValve Evolut R System to treat aortic stenosis patients who are at intermediate risk for
open-heart surgery as determined by a heart team. The Evolut R System is the first
transcatheter aortic valve implantation (TAVI) therapy to obtain an expanded indication in
Europe for this patient population.
MEIP Pracinostat receives breakthrough therapy designation from FDA The FDA has granted
Breakthrough Therapy Designation for the investigational drug Pracinostat in combination with
azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are
≥75 years of age or unfit for intensive chemotherapy. In addition, agreement has been reached with the
FDA on the company's proposed Phase III study design.
MESO has 24-month results from the 100-patient, four-arm, randomized, placebo-controlled
Phase 2 trial of its chronic low back pain (CLBP) product candidate MPC-06-ID were presented
at the 24th Annual Scientific Meeting of the Spine Intervention Society (SIS) held in New
Orleans July 27-30, and received the 2016 Best Basic Science Abstract award at the meeting.
MNKD assumes responsibility for distribution of Afrezza; launches patient reimbursement and
adherence support programs MannKind announced it is now distributing MannKind-branded
Afrezza (insulin human) Inhalation Powder directly to major wholesalers and that Afrezza is
available by prescription from retail pharmacies nationwide. With distribution channels now
stocked, the company announced several key programs to promote access, adoption and
adherence to Afrezza therapy, including: A new 30-day titration pack combining 90 4-unit
cartridges and 90 8-unit cartridges MannKind Cares, a patient reimbursement support program
MSTX announces initiation of Phase II study of AIR001 The company reported that the first
patient has been enrolled in a multicenter, randomized, double-blind, placebo-controlled Phase
2 clinical study of AIR001 in patients with heart failure with preserved ejection fraction (HFpEF).
The 100-patient study, known as the Inorganic Nitrite Delivery to Improve Exercise Capacity in
HFpEF (INDIE-HFpEF) study, is sponsored by Duke Clinical Research Institute (DCRI) as the
Coordinating Center for the Heart Failure Clinical Research Network (HFN) and is being
conducted at premier clinical centers that are part of the HFN. The INDIE-HFpEF study is a
randomized, double-blind, placebo-controlled crossover study to evaluate the effect of AIR001
on peak exercise capacity as assessed by cardiopulmonary exercise testing (CPET).
Approximately 100 patients with a diagnosis of HFpEF will be enrolled across approximately 20
clinical centers in the United States. The primary endpoint will be the peak oxygen consumption
(VO2) after four weeks of treatment.
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NTRA enters collaboration with UCSF to study DNA markers of kidney transplant rejection The
company announced a research collaboration with the University of California, San Francisco
(UCSF), a leader in renal transplantation medicine in North America, to study the level of donorderived cell-free DNA (dd-cfDNA) in over several hundred retrospectively banked plasma
samples from kidney transplant recipients with and without organ injury
NUS and insurers to pay $1.28m, with insurers paying $1m of total. NUS officers, directors
(current and former) were accused of breaching fiduciary duties by “causing or allowing” China
ops to function as a pyramid scheme, violating Chinese law as well as failure to “disclose this
fact” to the SEC: filing Individual defendants continue to deny all allegations of wrongdoing, any
liability NUS continues to deny the action’s claims Hearing on settlement scheduled for Oct. 6
2016 in federal court in Salt Lake City
OFIX discloses agreement in principle to pay $8.3M penalty as part of resolution of SEC
investigation into accounting matters -- 10-Q From the 10-Q: In connection with the initiation of
the Audit Committee’s independent review [in July 2013, see linked comment], Orthofix initiated
contact with the staff of the Division of Enforcement of the SEC to advise them of these matters.
The company is currently engaged in discussions with the SEC Enforcement Staff regarding a
possible negotiated resolution of these matters as to the company. Although such discussions
remain ongoing, and any agreement reached between the SEC Enforcement Staff and the
company will be subject to approval by the full Commission, the company has reached an
agreement in principle with the SEC Enforcement Staff that any negotiated resolution will
include a civil money penalty of ~$8.3M. Accordingly, the company has recorded a charge of
~$8.3M during Q2 in connection with such amount. However, no assurance can be given that
the company will be able to achieve a final, definitive resolution with the SEC to resolve this
matter on these or other terms, and the failure to resolve this matter on these or other terms
could adversely affect our business and operations
OREX announced that wholly owned subsidiary Orexigen Therapeutics Ireland Ltd. and Laboratorios
Farmacéuticos Rovi, S.A. (ROVI.SM) have executed a commercialization and distributorship agreement
for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in Spain. Mysimba is approved by the
European Medicines Agency for the management of weight in adult patients (≥18 years) with an initial
Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the
presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidemia, or controlled
hypertension). Orexigen will supply Mysimba tablets to ROVI for an upfront fee, a transfer price, and
various potential commercial milestone payments. ROVI expects to begin marketing Mysimba by yearend 2016
OTIC completes one-year, multiple-dose safety trial for OTO-104 in Ménière’s disease patients
This prospective, randomized, placebo-controlled clinical safety trial enrolled a total of 128
patients across multiple trial sites in the United Kingdom and demonstrated that quarterly dosing
of OTO-104 was well tolerated.
PACB announced HistoGenetics (Private), a global leader in high-resolution HLA sequencebased typing services, has received a multi-year contract to perform HLA typing using PacBio
sequencing. The contract is expected to drive demand for several thousand samples per week
over the next several years.
PDLI completes second tranche payment under royalty transaction with ARIA As a result of the
second tranche payment, under the terms of the ARIAD Royalty agreement, PDL's royalty
percentage will increase to 5.0% of the U.S. and European net revenues of Iclusig and 5.0% of
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the payments ARIAD receives elsewhere in the world until 31-Dec-18 Beginning 1-Jan-19 and
thereafter, the royalty rate will increase to 6.5% in all jurisdictions and continue until 31-Dec-33,
subject to a put option of PDL upon the occurrence of specified events and a call option of
ARIAD.
PFE acquired the 78% of Bamboo Therapeutics Inc It did not already own for $150 million up
front and $495 million in milestones. In 1Q16, the pharma obtained a 22% stake in Bamboo for
about $43 million.Bamboo develops adeno-associated viral vector (AAV)-based gene therapies
that preferentially target tissues affected by CNS and neuromuscular disorders. The company
spun out of gene therapy company Asklepios BioPharmaceutical Inc. (in 2015 with an initial
focus on BMB-D001, a systemic gene therapy for Duchenne muscular dystrophy (DMD) that is
due to enter a Phase I trial this half.Pfizer also will gain a Phase I treatment for giant axonal
neuropathy (GAN) and preclinical gene therapies for Friedreich's ataxia and Canavan's disease,
as well as Bamboo's recombinant AAV design and production technology and a manufacturing
facility In February, Bamboo raised $49.5 million in a series A round that included
CureDuchenne Ventures LLC. Asklepios also held an equity stake in Bamboo.Bamboo's
executive chairman and CSO Jude Samulski will join Pfizer. He is the director of the University
of North Carolina Gene Therapy Center.
PFE news that ESRX posted a list of drugs it will not cover in its 2017 formulary, along with
drug LLY Taltz ixekizumab and rheumatoid arthritis therapy BMY Orencia abatacept. Express
Scripts lists ten preferred alternatives in the inflammatory disease category, including PFE
Xeljanz tofacitinib and Xeljanz XR , RHHBY CHUGAI Actemra tocilizumab) (Xeljanz was
excluded in 2016.) ESRX may reassess Actemra this year "to reflect anticipated product
launches." Among possible competitors would be REGN SNY sarilumab (REGN88) which is
under FDA review.
PSDV and HSS Innovation Center announce opening of IND for sustained-release implant for
severe knee osteoarthritis The implant is surgically implanted into the non-articulating area of
the knee in an outpatient procedure. While the study is designed to evaluate the implant for six
months, the duration of release following a single treatment is expected to extend to one year or
more. The study is an open-label, single dose, safety and tolerability study of the screw implant
to deliver dexamethasone, a corticosteroid previously proven to provide pain relief in knee
osteoarthritis. Six patients will receive the implant in one knee. Although it is a safety and
tolerability study, change from baseline in weekly mean of pain intensity scored at rest, during
activity and at night will be assessed weekly through 24 weeks.
Rafa Laboratories and AEZS sign exclusive license for Zoptrex in Israel AEZS and Rafa
Laboratories, Ltd. announced the signing of an exclusive license agreement for the company’s
lead anti-cancer compound, Zoptrex (zoptarelin doxorubicin) for the initial indication of
endometrial cancer, for Israel and the Palestinian Territories .
RDHL announced that the last patient has completed the final scheduled follow-up visit in the
Phase IIa proof-of-concept clinical study evaluating RHB-104 in patients treated for relapsingremitting multiple sclerosis (RRMS). The open label Phase IIa study (the CEASE-MS study)
enrolled eighteen patients suffering from RRMS and was designed with a series of exploratory
endpoints to evaluate the safety and potential efficacy of fixed oral dose RHB-104 as an add-on
therapy to interferon beta-1a. Patients received treatment with RHB-104 for 24 weeks and were
evaluated for an additional 24-week follow-up period during which they were treated with
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interferon beta-1a without RHB-104 add-on. The analysis of the study is currently ongoing and
top-line final results are expected to be announced in Q4 of 2016, subject to completion of
review requirements and completion of the clinical study report (CSR).
REGN the EMA has accepted for review the marketing authorization application (MAA) for
sarilumab, an investigational human monoclonal antibody directed against the IL-6 receptor, for
treatment of adult patients with moderately to severely active rheumatoid arthritis RA
REGN SNY news that ESRX posted a list of drugs it will not cover in its 2017 formulary, along
with preferred alternatives in each drug category. ESRX will exclude from its formulary new
psoriasis drug LLY Taltz ixekizumab and rheumatoid arthritis therapy BMY Orencia abatacept.
Express Scripts lists ten preferred alternatives in the inflammatory disease category, including
PFE Xeljanz tofacitinib and Xeljanz XR , RHHBY CHUGAI Actemra tocilizumab) (Xeljanz was
under FDA review.
RHHBY CHUGAI news that ESRX posted a list of drugs it will not cover in its 2017 formulary,
along with preferred alternatives in each drug category. ESRX will exclude from its formulary
new psoriasis drug LLY Taltz ixekizumab and rheumatoid arthritis therapy BMY Orencia
abatacept. Express Scripts lists ten preferred alternatives in the inflammatory disease category,
including PFE Xeljanz tofacitinib and Xeljanz XR , RHHBY CHUGAI Actemra tocilizumab)
(Xeljanz was excluded in 2016.) ESRX may reassess Actemra this year "to reflect anticipated
product launches." Among possible competitors would be REGN SNY sarilumab (REGN88)
which is under FDA review.
RHHBY FDA has granted 510(k) clearance and Clinical Laboratory Improvement Amendments
waiver for cobas Influenza A/B & RSV test for use on cobas Liat System. Says the test is the
third assay on the cobas Liat System to receive CLIA waiver
Scifluor Life Sciences Inc said the IND application to the FDA is now in effect for SF0166 topical
ophthalmic solution. The firm will start clinical testing of SF0166 in wet age-related macular
degeneration and diabetic macular edema.
SCYX announced the results of an interim analysis of its Phase 2 study evaluating the
pharmacokinetics (PK), safety, and tolerability of its novel and structurally distinct glucan
synthase inhibitor, SCY-078, as an oral step-down treatment in patients initially treated with
intravenous (IV) echinocandin therapy for invasive Candida infections. A once daily oral dose of
750Mg of SCY-078 was identified as the dose that achieves the target exposure with favorable
safety and tolerability in patients with invasive candidiasis. SCY-078 was safe and well
tolerated, achieving the additional primary study objective. “We are pleased that this study met
all primary objectives. We identified a safe and well tolerated dose that achieves our target
exposure in invasive candidiasis patients. Additionally, we observed antifungal activity,
confirming the clinically meaningful efficacy previously shown in our recent proof-of-concept
Phase 2 study in vulvovaginal candidiasis".
SELB announced that Nature Nanotechnology has published an article that presents preclinical
results from Selecta’s research which demonstrate the broad potential applicability of Selecta’s
novel immune tolerance platform. Details that elucidate the mechanism of action of the
company’s immune tolerance therapy, SVP-Rapamycin (SEL-110), were also shown. Data in
the publication support the company’s lead clinical program, showing Selecta’s SVP-Rapamycin
(SEL-110) induces antigen-specific immune tolerance and mitigates the formation of anti-drug
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antibodies (ADAs) to biologic drugs, including pegsiticase (for gout) and adalimumab (for
rheumatoid arthritis).
SGEN and Takeda news that the Phase 3 ALCANZA clinical trial evaluating ADCETRIS
(brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL) met its primary
endpoint, demonstrating a highly statistically significant improvement in the rate of objective
response lasting at least four months (ORR4). The safety profile associated with ADCETRIS
from the ALCANZA trial was generally consistent with the existing prescribing information An
abstract will be submitted for data presentation at the American Society of Hematology annual
meeting, Dec 3-6 2016
SHPG FDA approves BAXJECT III reconstitution system for ADYNOVATE, this new system
reduces the number of steps in the reconstitution process for hemophilia A patients and
caregivers. ADYNOVATE and the diluent will be pre-packaged in the BAXJECT III reconstitution
system. The BAXJECT III reconstitution system reduces the number of steps in the treatment
process by two, compared to the previous process with the BAXJECT II Hi Flow Needleless
transfer device. The BAXJECT III system with ADYNOVATE will be available to most customers
in Q4 of 2016
Silvergate Pharmaceuticals Inc., of Denver, said the FDA approved Qbrelis, an oral solution of
ACE inhibitor lisinopril, for the treatment of hypertension in adult patients and pediatric patients,
6 and older, as adjunct therapy for heart failure and as treatment of acute myocardial infarction
in adults.
SNY the EMA has accepted for review the marketing authorization application (MAA) for
sarilumab, an investigational human monoclonal antibody directed against the IL-6 receptor, for
treatment of adult patients with moderately to severely active rheumatoid arthritis RA .
SNY REGN news that ESRX posted a list of drugs it will not cover in its 2017 formulary, along
with preferred alternatives in each drug category. ESRX will exclude from its formulary new
psoriasis drug LLY Taltz ixekizumab and rheumatoid arthritis therapy BMY Orencia abatacept.
Express Scripts lists ten preferred alternatives in the inflammatory disease category, including
PFE Xeljanz tofacitinib and Xeljanz XR , RHHBY CHUGAI Actemra tocilizumab) (Xeljanz was
under FDA review.
Stada Arzneimittel AG CVC could "easily" pay "mid-sixties" per Stada share and still make
money -- investor Wyser-Pratte says CVC interested in taking over Stada Arzneimittel
Headlines only
Takeda and SGEN news that the Phase 3 ALCANZA clinical trial evaluating ADCETRIS
(brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL) met its primary
endpoint, demonstrating a highly statistically significant improvement in the rate of objective
response lasting at least four months (ORR4). The safety profile associated with ADCETRIS
from the ALCANZA trial was generally consistent with the existing prescribing information An
abstract will be submitted for data presentation at the American Society of Hematology annual
meeting, Dec 3-6 2016
Theranos AACC news Holmes used the session at the American Association for Clinical
Chemistry’s annual scientific meeting to introduce the “miniLab” testing device, a 95-pound
diagnostic tool that can fit on a tabletop. The device isn’t yet for sale and hasn’t been approved
by regulators, Theranos said in a statement.Along with the new device came a scaled back
123
vision for the company that not long ago, promised to upend the world of clinical lab testing by
running hundreds of tests using a single drop of blood. The miniLab appears to pack a variety of
tests that can already be done on a small scale into a single box. At the session, Holmes
showed several slides comparing test results run on the new machine to existing accuracy
standards, including one for a cholesterol panel, that appeared to show the new machine was
within guidelines. One expert said that “I can buy a point-of-care instrument that does a lipid
panel,” he said, referring to existing products already on the market that can run cholesterol
tests in a doctor’s office. The company also said it has developed a test for Zika virus with the
miniLab machine that’s been submitted to the U.S. Food and Drug Administration. Angela Stark,
an FDA spokeswoman, declined to comment on whether or not the agency had received an
application.
Tract Therapeutics reported phase I data at the American Transplant Congress in Boston,
showing that its personalized regulatory T-cell therapy showed promise in restoring a kidney
transplant patient’s immune balance so the body will accept the foreign organ. The approach
uses a patient’s own cells, expanded in the laboratory and infused back into the patient after an
organ transplant, with the aim of reducing or eliminating lifelong use of immunosuppressive drug
therapy. A phase II study is expected to start within a few months, and phase I trials in liver
transplant and inflammatory bowel disease are in preparation for next year.
TTPH initiates phase 1 clinical trial for TP-6076, an antibiotic candidate highly active against
MDR bacteria TTPH announced the initiation of patient dosing in a phase 1 clinical trial for
intravenous (IV) TP-6076, a novel antibiotic candidate being developed for the treatment of
serious and life-threatening bacterial infections, including those caused by pathogens otherwise
resistant to current treatment options. The study is being conducted under a Clinical Trial
Authorization in a single center in up to 32 healthy volunteers. This is the first study in the phase
1 clinical program for TP-6076 which is also expected to include a multiple-ascending dose
study.
TTOO The company continues to target closing a total of 45 hospital commitments globally
during 2016 although it recognizes that there is risk to achieving this goal given the
unpredictable timing for the closing of contract commitments. In addition, and perhaps of more
importance, the company is targeting closing commitments with hospital and hospital systems in
H2 of 2016 that would provide access to an additional 100,000 or more symptomatic patients at
high risk of sepsis. The company anticipates higher product revenue in Q3 of 2016 than was
realized in the first and Q2s of 2016, primarily as a result of additional hospitals going live and
the increased use of the T2Candida Panel at institutions that are already testing patients.
Research revenue is expected to be comparable to what was realized in Q2 of 2016.
Uber China and Didi Chuxing announced a merger that will become the latest marriage of
former bitter rivals in China. Didi Chuxing and Uber China swap shares in a deal that would give
Uber about 20 percent of the merged company and give the rest to Didi. That ratio is roughly
comparable to each of the 2 companies’ market values following their latest mega fund-raisings
earlier this year.
Vaccinex gained FDA fast track status for VX15 as a potential treatment for Huntington’s
disease. The company anticipates completing an interim analysis in the third quarter of 2016
and top-line data in 2018.
VICL announced an agreement by AnGes, MG, Vical’s long-time partner and an existing
shareholder, to purchase approximately $7.8M of Vical’s common stock in a private placement.
124
The shares are being sold at a price of $4.24 per share, the 90-day volume weighted average
price of Vical’s common stock and a premium compared to the closing price on 29-Jul. With the
new investment, AnGes’ equity position in Vical will increase from 2.4% to approximately 18.6%
of Vical’s outstanding shares. Since 2006, Vical and AnGes have partnered on various product
candidates leveraging Vical’s patented DNA delivery technologies across multiple disease
areas.
VZ aims to build on its growing business in the automotive and commercial vehicle Internet of
Things segment with the acquisition of GPS vehicle-tracking company Fleetmatics for $2.4
billion. This follows fast on the heels of Verizon's July 25 announcement that it intends to
acquire Yahoo!'s core web business for $4.83 billion. Both deals are part of Verizon's effort to
rapidly expand into new growth segments such as content and Internet of Things, as its core
wireless and wireline businesses slow.This deal will build on Verizon's small but growing
presence in the commercial fleet management segment. Verizon previously bought Hughes
Telematics in 2012 and Telogis in June to marry its nationwide wireless coverage with fleet
management to offer services such as route optimization.
XENT submitted a supplemental premarket approval submission to the FDA seeking approval
for a new Nova steroid releasing implant for treating patients with chronic sinus disease.
The new Nova device is designed with a lower profile to allow for placement in smaller sinus
openings, and will expand the usable patient population for the steroid releasing implants, the
Menlo Park, Calif.-based company said.“The expanded indication from the company will allow
the company to market the placement of the Propel mini in the frontal sinuses behind the
eyebrows. Previous indication only allowed for placement in the ethmoid sinuses behind the
bridge of the nose.
ZeptoMetrix is expanding into additional space across the street from its Buffalo headquarters,
ZeptoMetrix Corp. is looking at its options as it continues to grow.The company last July took
over 11,000 square feet at 847 Main, supplementing its corporate/administrative offices and
laboratory facility, housed in adjacent buildings across the street at 878 Main and 872 Main,
respectively. Total employment at the three sites is about 60, with another 50 employees
working from Franklin, Mass., where ZeptoMetrix runs its molecular diagnostics division as well
as distribution and fulfillment.ZeptoMetrix, a private life sciences firm, is focused primarily on
diagnostic tools and testing for virus specimens, providing inactive specimens and cultures for
such deadly diseases such as SARS, HIV and tuberculosis as well as Zika.
ZYNE first patients have been dosed in the Company’s Ph 2 STAR 1 (Synthetic Transdermal
Cannabidiol for the Treatment of Epilepsy) clinical trial, a randomized, multi-center, multi-dose
study to evaluate ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with refractory focal
seizures. We are pleased by the pace of the clinical program for ZYN002 and remain on track to
initiate additional Phase 2 studies in OA and FXS in the second half of this year. We expect to
report top line results from all three studies in the first half of 2017.”
Bioworld
Rebiotix news will come out during scientific sessions this fall from Rebiotix Inc., with RBX2660,.
RBX2660 has fast track, orphan and breakthrough status from the FDA. Behind it is an oral
therapy for CDI, as well as candidates for inflammatory bowel disease/ ulcerative colitis,
hepatic encephalopathy and multidrug resistant
125
Proteins acting as RNA-binders may point to new heart disease cure A new study led by
scientists at the Australian National University (ANU) has provided valuable insights into how
the function of the human genome depends on RNA-binding proteins, an important discovery
that could ultimately lead to the development of new treatments for heart disease.
Unanswered questions linger on co-development of companion diagnostics The FDA has
published the long-awaited draft guidance for co-development of a therapeutic drug and a
companion diagnostic, but the agency has scheduled an Aug. 18 webinar to address questions
Talkin Pointz Scoping Out Microsoft’s Next Possible Acquisition.
MSFT Taking a gander at possible acquisitions that could benefit Microsoft’s UC&C offering.
Microsoft’s decision to acquire LinkedIn was a big surprise. The strategic fit has become clear,
but at the time it didn’t seem like either company was in need of the other. It got me wondering
about the next logical acquisition for Microsoft, specifically from a UC and collaboration
perspective Microsoft continues its transition from provider of desktop and server software to a
cloud- and mobile-first company, and its recent acquisitions complement that journey. For
example, LinkedIn provides Microsoft a cloud directory, Solair expands Microsoft Azure-based
Internet of Things (IoT) services, and with Swiftkey Microsoft improves its mobile development
capabilities.
Microsoft already has a strong UC&C offer that includes Skype for Business, which integrates
tightly with Office 365 — Exchange/Outlook, Office productivity apps, Yammer, and new apps
such as Delve and Graph — and supports federation with consumer Skype for interorganizational rich communications. Skype for Business continues to lead the industry in
growth.
I started with considering the partners that commonly complete a Microsoft UC&C solution.
Polycom, for example, often provides the endpoints in Skype for Business deployments as
Microsoft is one of the few UC premises-based vendors that does not make its own phones.
However, an acquisition seems unlikely as there is no apparent market gap, and Microsoft
doesn’t likely see long-term strategic value to phones.
On the other hand, a Microsoft-branded contact center could strengthen the portfolio.
Genesys is a reasonable contender since its CX Platform has a strong integration with
Skype for Business and is in use by Microsoft internally. However, Microsoft may be
concerned that Genesys serves a broader market than just Skype for Business users.
I could also see Microsoft strengthening its hosted collaboration offering by acquiring
Velocloud or other a software-defined WAN partner, though it’s still early in that game.
Many UC vendors have integrated new workstream messaging capabilities, and at one
point Microsoft was rumored to have considered acquiring Slack, walking away possibly
in favor of investing in Skype for Business. Providing Skype for Business (or Yammer)
with a conversational UI may have been the motivation behind Microsoft’s recent
acquisition of Wand Labs, which brings “expertise around semantic ontologies, services
mapping, third-party developer integration and conversational interfaces,” as noted in a
Microsoft blog.
I can see lots of acquisition options, but Vidyo is one potential that stands out. Vidyo
provides video communications applications and toolkits. The combination of Skype for
126
Business and Vidyo could strengthen the offerings of both companies. Here are some
reasons why:
Software Development Kit (SDK) – Many enterprises use the Vidyo SDK to integrate video
conferencing capabilities into applications and physical products such as ATMs and healthcare
equipment. On the other end, the video can run on desktops, rooms, or even Skype for
Business clients. This positions Microsoft with video reach into devices such as Amazon has
with Mayday video support for Kindle users. Video conferencing is breaking out of conference
rooms to all types of devices. Vidyo has announced several high-profile wins for this exact
feature, including Barclays and Bloomberg (see related post, “Bloomberg Trades on Ease of
Video Calling“). Cisco recently also announced a new video SDK.
Scalable Video Coding (SVC) – Vidyo has extensive capabilities (and patents) in SVC.
Microsoft and Cisco only support temporal SVC, but not spatial SVC as Vidyo does. If Microsoft
were to expand its support of SVC, it could reduce network and CPU overhead and improve
error resilience. Vidyo’s solution also offers improved performance over mobile networks.
Timing – The timing is right for Microsoft to take a fresh look at video. It needs to review its
strategic relationship with Polycom given that company’s recent purchase by private equity firm
Siris Capital Group. Microsoft recently introduced its Surface Hub as its first and only room
solution, and sales of its Lync Room System (LRS) solution from Smart and Crestron are drying
up. Conversely, Cisco leads with video, which is central to its Cisco Spark strategy (which
includes WebEx, telepresence rooms, Acano, mobile apps, and the SDK).
Hosted Conferencing Gateway – Microsoft announced a video interoperability service at
Enterprise Connect 2016, with availability expected later this year. Vidyo already offers such a
service.
Fit – Vidyo is a software-based solution available as a cloud service. It supports H.264, H.265,
VP8, VP9, and WebRTC. The Vidyo platform interoperates with Google Hangouts (Vidyo H2O),
and Vidyo is working with Google to develop VP9 SVC. Vidyo excels with backend
infrastructure, and Microsoft has strong clients. In addition, Vidyo has repackaged its solutions
for the cloud (APIs and communications platform as a service) and offers mobile-ready SDKs.
Vertical Reach – Vidyo has momentum with banking, finance, and healthcare. Large Vidyo
customers include the U.S. Department of Defense, Bloomberg, NCR, Philips, and CERN.
Broad Applicability Across Portfolio – The Vidyo technology has applicability beyond UC and
Skype for Business. Microsoft could integrate the technology into Yammer, Xbox (Nintendo
uses Vidyo), LinkedIn, Azure, Dynamics, and HoloLens. Partners can utilize the SDK and
integration tools to extend video into other devices and applications.
Standards –Vidyo is standards-based, and uses patents to protect its implementation
practices. Microsoft could control its video integrations by licensing interfaces that use Vidyo’s
patents.
Emerging Markets – The future is bright for augmented reality and IoT. Vidyo is already
supporting augmented reality with smart glasses and could provide a bridge between Skype for
Business and HoloLens. A variety of connected device manufacturers use Vidyo’s SDK for their
respective healthcare equipment, game consoles, drones, and so on.
Microsoft could accomplish all of the above without acquiring Vidyo. It could develop these
video capabilities internally. Microsoft already has video conferencing capabilities such as autopan, LRS, and the Surface Hub. What’s more, acquiring Vidyo would create short-term
confusion regarding existing partnerships. However, that might take a while.
127
Confusion about Microsoft’s approach to video exists now. Interoperability has been limited, and
partners and products have come and gone. The approach to room systems has transitioned
from LRS (abandoned?) to the Polycom RoundTable 100 (killed prior to launch) and Surface
Hub (more than a year late). Acano was building momentum as a Skype for Business gateway,
but is now a Cisco company. Adoption of WebRTC is slow and in process. In acquiring Vidyo,
Microsoft could quickly address all of these issues, create competitive disruption, and offer
benefits across the portfolio.
Health IT Strategist
Bundled-payment expansion brings providers more risk—and opportunity
Heart attacks strike about 735,000 people in the U.S. every year. For about 210,000 of them, it's
not the first time. The Obama administration, with less than six months on the clock, is betting
that changing the way Medicare pays hospitals and physicians to treat them can trim those
numbers and save money.
The CMS announced a proposal last week to put three new episodes of care under mandatory
experiments with bundled payments, potentially compelling hundreds of additional hospitals into
becoming financially accountable for what happens to Medicare patients long after they leave
the hospital. It was just one in a series of steps in an effort to move Medicare and the entire
industry toward models that pay for the quality of healthcare rather than the quantity of services.
But the nature of the care in the new proposal—treatment for acute myocardial infarction (heart
attack), coronary artery bypass grafts, and treatment for hip or femoral fractures—constitutes a
bigger ask for the participants, which haven't been chosen yet. And for hospitals with limited
experience with bundles, the brisk pace of the transition could pose additional challenges.
Nonetheless, many are cheering the aggressive adoption of mandatory bundles because, they
say, it gives them a framework to provide better care for patients.
“They are increasing the risk profile for the hospital and for the treating physicians who are
falling within the bundled-payment program,” said Dr. James Caillouette, chief strategy officer
for the Hoag Orthopedic Institute in Irvine, Calif. “All those involved in healthcare have always
wanted the best for their patients. Providers now have a greater amount of skin in the game and
risk in the outcome.”In bundled-payment programs, the payer—in this case, it's Medicare—sets
a target price for a medical or surgical episode, like a heart attack or a broken hip. Although it
still pays providers on a fee-for-service basis, the total costs are then reconciled with the target
amount. Hospitals either pocket or pay back the difference.
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