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April 2012 Volume 8, Number 4
www.drugdiscoverynews.com
Global News
6
Tools & Technology
12
what’s inside
Diagnostics15
Omics & Systems Biology
22
research & development
26
Contract Research Services
30
finance.........................................................3
Markets........................................................4
Editorial/commentary..............................10
products & services................................36
facts & figures..........................................38
pink-slippers find pot of gold
A new sun Pharma
Six years after founding
rises for
company for downsized R&D
Boston Biomedical
vaccines scientists,
is acquired by Japanese
GSK, Daiichi Sankyo
announce Japanese
joint venture
By Kelsey Kaustinen
LONDON—If
an ounce of prevention is
worth a pound of cure, two companies’
worth of prevention might be worth its
weight in gold, and pharmaceutical
giants GlaxoSmithKline (GSK) and
Daiichi Sankyo are banking on that.
The companies recently announced the
signing of an agreement to form a joint
venture together, one that is expected
to result in the No. 1 vaccines company
in Japan.
The joint venture, which will be
based in Tokyo, will hold development
japan continued on page 8
pharma DSP for $2.63 billion
By Amy Swinderman
NORWOOD, Mass.—Just a few years after rising
from the ashes of a pharma company “restructuring,” Boston Biomedical Inc. (BBI), a private biotechnology company with a clinicalstage product pipeline targeting cancer stem
cells (CSCs), has been acquired by top Japanese pharma Dainippon Sumitomo Pharma
Co. Ltd. (DSP) for as much as $2.63 billion.
As announced on March 1, DSP will pay
$200 million up front, $540 million in development milestone payments and up to $1.89
billion in sales milestone payments to acquire
BBI, which was founded in November 2006
by Dr. Chiang J. Li to provide employment for
approximately 30 R&D scientists facing layoffs from Woburn, Mass.-based biotech
ArQule. The transaction is expected to be
Osaka, Japan-based Dainippon Sumitomo Pharma Co. Ltd.’s acquisition of Boston Biomedical Inc. gives the
company access to a unique pipeline of drug candidates that target cancer stem cells as well as the
opportunity to establish R&D operations in the United States.
finalized sometime this month.
The acquisition gives DSP a solid foothold
in the oncology space—a new focus for the
company, which has until now concentrated
its research efforts in the area of central
bbi continued on page 27
BGI on board with ‘Novo Nordisk Way’ Bridge over the
Denmark’s Novo
Nordisk and China’s
BGI establish global
collaboration framework
to accelerate growth
Charles River
The Bridge Project,
a landmark cancer
research initiative,
pairs Koch Institute,
Dana-Farber/Harvard
Cancer Center
By Lori Lesko
COPENHAGEN, Denmark—With
diabetes striking 280 million people
across the world —a statistic that is
expanding—Novo Nordisk, a world
leader in diabetes care, and Shenzhen, China-based BGI Europe, a
genomics company, are collaborating to create a global framework to
“accelerate their growth, execute
their global partnering strategy and
bgi continued on page 33
By Ashley Abraham
CAMBRIDGE, Mass.—The David H.
Novo Nordisk is an organization “built on heritage and places huge emphasis on the
‘Novo Nordisk Way,’” a value-based framework which defines the principles for how the
company does business from vision to policies.
Koch Institute for Integrative
Cancer Research at the Massachusetts Institute of Technology
(MIT) and the Dana-Farber/Har-
Great minds think alike
Experimental Bio 2012
brings together numerous
specialty societies to advance
knowledge in drug discovery,
development and more
SEE PAGE 18
vard Cancer Center (DF/HCC)
have launched an extensive collaboration aimed at uniting
oncology and bioengineering.
Termed the Bridge Project, the
initiative aims to raise and deploy
$50 million over the next three to
five years into additional research
teams focused on potentially
transformative initiatives.
According to the partners, the
Bridge Project is the most extensive collaboration of its kind
bridge continued on page 25
First part in a two-part series
Everything old
is new again
Drug repositioning
provides cost
savings, shortcuts
SEE PAGE 34
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For more information, visit www.DrugDiscoveryNews.com
FINaNCe
APrIl 2012 • Drug Discovery News
3
Aragon Pharmaceuticals nets $42 million for cancer therapies
SAN DIEGO— An oversubscribed
Series C financing closed recently
for Aragon Pharmaceuticals, raising $42 million for the company for
use in advancing its pipeline of
therapeutics for hormone-driven
cancers, including ARN-509, its
lead compound. The Topspin Fund,
a new investor, led the financing,
with existing investors Aisling
Capital, OrbiMed Advisors and the
Column Group also participating.
In keeping with the financing, Leo
A. Guthart, CEO of Topspin Partners, will join Aragon’s board of
directors.
“This $42 million round of
financing puts Aragon on strong
footing to execute on its promising
pipeline in prostate cancer and
Series D funds
will advance
ophthalmic,
fibrotic
candidates
MALVERN, Pa.— Promedior
Inc.
recently netted itself $21.5 million
in the first closing of a Series D
financing round, bringing the company’s total capital raised to $62
million. New investor Fibrotec Ventures LLC led the financing, and all
of Promedior’s existing venture
investors participated, including
HealthCare Ventures, Forbion Capital Partners, Morgenthaler Ventures, Easton Capital Investment
Group and Polaris Venture Partners.
“This successful financing further validates Promedior’s scientific platform and clinical progress,
as well as the tremendous therapeutic potential of our new class
of Pentraxin-2 therapeutics,”
Dominick C. Colangelo, Promedior’s
president and CEO, said in a press
release. “Building on the success
of our initial Phase I study, in which
PRM-151 showed activity against
biomarkers of disease in IPF
patients, this financing allows us
to aggressively advance the
development of both PRM-151
and PRM-167 for patients who are
in critical need of effective therapies for the treatment of fibrovascular diseases.”
The funds will be used to
advance Promedior’s pipeline of
Pentraxin-2 therapeutics, including
its two lead drug candidates, PRM151 and PRM-167. PRM-151 is
currently being tested in a Phase
Ib clinical study in idiopathic pulmonary fibrosis (IPF), and recently
received an orphan drug designation for the treatment of IPF
from the U.S. Food and Drug
Administration. Promedior is
expanding clinical development of
the compound to include myelofibrosis. PRM-167 is currently being
developed for fibrovascular retinal
diseases. ddn
breast cancer,” Dr. Richard A. Heyman, president and CEO of
Aragon, said in a press release.
“The addition of an investor like
Topspin with a like-minded vision
and considerable financial resources strategically provides Aragon
with access to significant capital in
the future.”
ARN-509, Aragon’s lead compound for the treatment of castration-resistant prostate cancer
(CRPC), is an androgen receptor
antagonist that inhibits nuclear
translocation and DNA binding of
the receptor, which helps to modulate expression of the genes responsible for driving prostate cancer
growth. In a Phase I/II clinical trial,
ARN-509 proved to be safe and
well-tolerated in patients with progressive metastatic CRPC and demonstrated encouraging preliminary
antitumor activity.
“We are also tremendously excited about the progress we’ve made
with our pipeline,” said Heyman.
“In addition, over the next year we
will be aggressively advancing our
second program into the clinic,
which is targeting breast cancer via
a novel mechanism for estrogen
receptor degradation.”
Aragon notes on its site that with
most hormonally driven cancers,
“these cancers eventually become
resistant to existing first-generation antihormonal therapies, and
follow-up treatments are largely
ineffective or toxic.” Aragon’s
Selective Estrogen Receptor
Degraders (SERDs) for treating
breast cancer bind the estrogen
receptor, serving as antagonists
while also initiating a conformational change that leads to degradation of the receptor. The SERDs
may be a solution to some patients’
resistance to antihormonal therapies, and are being developed to
target late-stage, progressive metastatic breast cancer. ddn
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EMD Millipore and the M logo are trademarks of Merck KGaA, Darmstadt, Germany. © 2012 EMD Millipore Corporation, Billerica, MA USA. All rights reserved.
markets
4 Drug Discovery News • April 2012
Pharmaceutical and biotech market indices
F
inancing is gaining some momentum for the year, with
four companies completing their IPOs on U.S. exchanges.
Cempra Pharmaceuticals, ChemoCentryx, Greenway Medical
Technologies and Ceres all completed their offerings, though
par for the course in recent months, all four companies
had to price their shares below their original target ranges. The companies raised $227.4 million collectively, 33 percent less than the
$337.5 million they had hoped for. All four companies’ issues have
increased from their IPO price, however, and have posted a 19-percent
gain collectively.
IPOs are still low compared to the same period last year, which featured
six companies making their IPOs and raising a total of $380 million.
Amex Pharmaceutical Index
335.18
318.66
325.53
331
306.68 306.14
315.13
318.11
338.09
352.22 330.68 332.25
350
300
250
200
150
100
50
0
Source: Yahoo Finance
Burrill Select
1159
1231
1346
1338
1400
Burrill Mid-Cap Biotech and Small-Cap Biotech
1265
1149
1179
1079
1138
1126
974
74
1974
1200
1120
1041
1752
75
1000
800
2000
1800
1600
1510
5
1404
1406
1375
1353
1386
1391
1277
1385
600
1266
1265
1229
400
1400
1248
6
1096
1136
1140
1111
1034
1076
1000
1034
200
824.55
829.11
800
0
0
Source: Burrill & Co.
1200
Source: Burrill & Co.
Industry sees improvement in stocks, though IPOs remain lackluster
By Burrill & Co.
SAN FRANCISCO— The
industry is gaining
momentum early in the year, with biotech
stocks reporting encouraging results. Out of
340 life-sciences companies trading at or
above $1 at the end of 2011, 74.4 percent are
trading higher year-to-date, with 25 percent
of them up more than 25 percent so far in 2012,
according to the latest report from Burrill &
Co. All of the Burrill Indices came in higher
by the end of February, and the Burrill Biotech
Select Index was up 15.5 percent for the year.
The Dow Jones Industrial Average was also
up, 6 percent for the year, and managed to
close above 13,000 for the first time since 2008.
“We are still in an environment where markets can turn quickly and sharply in response
to negative news,” says G. Steven Burrill, CEO
of Burrill & Co. “Smart companies will take
advantage of opportunities to secure financing and get deals done.”
Though four companies completed their
IPOs on U.S. exchanges, all four had to price
their offerings below their targets ranges, collectively raising 33 percent less than they had
anticipated. Through secondary offerings,
life-sciences companies raised $924 million
in February in 18 deals. While there has been
a 21-percent increase in the amount of funding
raised in follow-on offers year-to-date in the
United States compared to 2010, follow-on
financings have dropped nearly 25 percent
globally year-to-date.
Financing is sluggish in other aspects of the
industry, as the U.S. Food and Drug Administration’s (FDA) budget for 2013 will remain
flat in terms of government contributions.
The Obama Administration budgeted $4.5
billion for the FDA, up 17 percent from the
$3.8 billion it received in 2012. The FDA notes
on its website that “industry user fees would
fund 98 percent of the proposed budget
increase,” and the fees are expected to comprise roughly 45 percent of the agency’s
budget.
In other regulatory news, the TREAT and
ULTRA bills have started moving through
Congress, bills that are intended to accelerate
approval for drugs for unmet medical needs
P
u
b
l
ic
to $2.6 billion.
“Privately held companies that are being
acquired today often find they will have to
wait to reap the rewards of a transaction,”
Burrill notes. “In the absence of a vibrant IPO
market, buyers have the upper hand and often
insist on sharing risk. Increasingly, the structure of these agreements may borrow from
those of partnerships and may mean investors seeking exits will have to be patient to
realize their full return.” ddn
and accelerate approval for ultra-rare diseases, respectively.
The month saw some strong M&A activity
as well, with Biogen Idec announcing the
acquisition of Stromedix for $75 million
upfront, with milestones that couldbring this
total to $562.5 million. Dainippon Sumitomo
announced that it would acquire Boston Biomedical, which develops oral therapies targeting cancer stem cells, for $200 million upfront,
though milestones could bring the total value
C
o
mpa
n
y
N
e
w
s
GSK posts
$43.4B in sales for 2011
Q4 revenue up
148 percent for GenMark
Income up,
revenue down in Accelrys’ Q4
LONDON—For its fourth quarter of 2011, GlaxoSmithKline (GSK) reported profits of $2.2 billion,
up from a loss of $1.1 billion in the same period
last year, in which the company recorded legal
costs of $3.5 billion related to Avandia and other
products. Sales for the quarter dropped 3 percent,
coming in at just under $11.1 billion and falling
short of analysts’ estimates of $11.6 billion. Pharmaceutical sales stayed flat at $7.8 billion, and
revenue from vaccines decreased to $1.3 billion,
an 18-percent drop. Sales for the full year were
reported at $43.4 billion, down 4 percent from the
previous year, though profit was up, reaching $9
billion, up from $2.5 billion in 2010. Revenue in
the United States stayed flat at $13.8 billion, but
sales dropped in Europe, declining 4 percent to
$13.1 billion. Sales in emerging markets fared
better for the company, rising 15 percent to $8.4
billion. GSK pegged the “impact on sales of European austerity price cuts and U.S. healthcare
reform” at approximately $498.3 million for 2011.
CARLSBAD, Calif.—The end of its fourth quarter
and fiscal year 2011 saw GenMark Diagnostics Inc.
reporting quarterly revenues of $2 million, an
increase of 148 percent over the $805,000 the
company reported in the same quarter of 2010.
Revenue growth was seen largely in the company’s
reagents, with that figure rocketing 159 percent from
$695,000 to $1.8 million, while instrument and
other revenues rose 104 percent from $110,000
to $224,000. Gross profit for the quarter was 20
percent of sales, with operating expenses increasing
to $5.8 million.
For the full fiscal year, GenMark saw its revenues increase 92 percent, up from $2.6 million
to $5 million, thanks in part to two new assays
being introduced, a hepatitis C virus genotyping
RUO test and a multiplexed Respiratory Viral
Panel, the latter of which was submitted to the
U.S. Food and Drug Administration for 510(k)
clearance. By the end of the year, GenMark had
$30.3 million in cash and short-term investments.
SAN DIEGO—Accelrys Inc. recently reported its
financial results for the fourth quarter of 2011 as
well as the full year 2011. Non-GAAP net income
was $4.6 million, or 8 cents per diluted share, for
the quarter, up from $4.3 million in Q4 2010. NonGAAP revenue for the quarter was $40.8 million, a
4-percent drop from the $42.5 million in revenue
that Accelrys reported in the same quarter last year.
Non-GAAP free cash flow for the quarter was recorded at $7.9 million, up from $5.7 million in the same
quarter of 2010. Non-GAAP revenue for the full year
was $155 million, a 24-percent increase over the
$124.7 million the company recorded last year. For
the full year, non-GAAP net income was $19 million,
or 34 cents per diluted share, up from $10.6 million,
or 25 cents per diluted share, in 2010. The company’s free cash flow for the year was $33.2 million,
more than twice the figure of $15.5 million recorded in 2010. Research and development spending
was up for the year, coming in at $33.98 million
compared to $22.1 million the previous year.
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b r i e f s
University of Dundee
granted $15.7 million
from Wellcome Trust
DUNDEE, U.K—The Wellcome Trust has granted
the University of Dundee more than $15.7 million to support research into highly neglected
parasitic diseases. The deal includes $13.5 million of support for a partnership with GlaxoSmithKline PLC (GSK) for new drug treatments, in
which the Drug Discovery unit at Dundee will
collaborate with GSK’s Kinetoplastids Discovery
Performance unit at the company’s Tres Cantos
Medicines Development Campus in Spain. The
partners will seek to develop treatments for leishmaniasis, Chagas disease and African sleeping
sickness, with the goal of having at least one
treatment for one of the diseases in the next five
years. Work has been underway at the university
on a treatment for African sleeping sickness for
the past five years, and the university says there
have been encouraging developments in terms
of potential treatments for leishmaniasis.
Hot target for HCV Jumping
Enanta Pharmaceuticals,
Novartis collaborate on
hepatitis C virus drug in deal
worth up to $440 million
on JAK1
Abbott and Galapagos
collaborate on novel
oral therapy for
autoimmune diseases
By Lori Lesko
WATERTOWN, Mass.—Enanta Pharmaceuticals
Inc., a research and drug development company, has entered into an exclusive collaboration and license agreement with Switzerlandbased Novartis for the development of EDP239, Enanta’s lead candidate from its NS5A
hepatitis C virus (HCV) inhibitor program. The
venture could be worth up to $440 million.
Under the terms of the agreement, Novartis
has agreed to pay Enanta $36 million up front,
and as much as $404 million more if Enanta
hits certain clinical, regulatory and commercial milestones. Enanta is also eligible to
receive tiered double-digit royalties on worldwide sales of products, and retains co-devel-
By Lloyd Dunlap
Enanta scientist Dr. Gyoyou Xu watches for a
chemical reaction in the lab at Enanta’s Watertown,
Mass., headquarters.
opment rights in the United States.
Research efforts have shown that targeting
NS5A gives rise to profound antiviral activity,
and as a result, this protein has emerged as
an important target for antiviral drug devel-
MECHELEN, Belgium—Abbott and Galapagos NV have entered into a global collaboration to develop and commercialize an oral, next-generation JAK1 inhibitor in Phase II development with the
potential to treat rheumatoid arthritis
(RA) and other autoimmune diseases
such as psoriatic arthritis, inflammatory
bowel disease and systematic lupus.
hcv continued on page 9
Medicyte, PRIMACYT
to develop hepatocytes
HEIDELBERG, Germany—Medicyte and PRIMACYT recently received a $393,000 grant from the
BMBF for the development of culturing methods
of human hepatocytes for use in cell-based
therapies. The upcyte technology from Medicyte
enables the expansion of human primary liver
cells to large amounts with consistent quality,
producing hepatocytes that are functionally
equivalent to human primary liver cells and suitable for use in cell-based bioartificial liver systems. Cell-based therapies and transplantable
bioartificial livers often fail due to a lack of cells
of appropriate quantities and quality. The two
companies will work to develop modified liver cells
in large amounts in a project support by a University of Tübingen team led by Prof. Andreas Nüssler.
GDBP gains license to
monoclonal antibody for China
GANSU, China—Privately
held Apexigen and
Gansu Duyiwei Biological Pharmaceutical (GDBP)
have announced a collaboration that will provide
GDBP with an exclusive license to develop and
commercialize APX004 in China. APX004 is a
humanized monoclonal antibody directed against
VEGFR2 for the treatment of certain cancers and
angiogenic diseases. Under the agreement, GDBP
will be solely responsible for researching, developing and commercializing APX004 in China,
while Apexigen will collaborate with GDBP to
advance the development program and will retain
all rights to the compound outside of China.
Apexigen will receive an upfront payment, regulatory milestone payments and a royalty, though no
specific financial details were disclosed. Zhiping
Duan, CEO of GDBP, said the deal will become a
developmental milestone for the company.
Shire researchers prepare for lab work. The company will pay an access fee, research funding and preclinical
success payments to arGEN-X, which will handle discovery and preclinical support. In return, Shire will gain a
license option for promising candidates for further development and commercialization worldwide.
Antibody potential
a ‘SIMPLE’ fact
Human monoclonal
antibodies focus of new Shire,
arGEN-X alliance
By Kelsey Kaustinen
ROTTERDAM, The Netherlands—You
can never
have too many friends, and the same seems
to go for business partners, as Shire recently
announced yet another partnership in the
area of rare genetic diseases.
Shire and biopharmaceutical company
arGEN-X, which specializes in discovering and
developing human monoclonal antibodies,
have entered into an alliance to create novel
JAK1 is one of a family of enzymes that play a
key role in the signaling mechanism used by a
number of cytokines that are involved in
autoimmune diseases. In previously reported
results from a four-week Phase IIa study,
GLPG0634 demonstrated efficacy measures
among the best reported in RA, according to
Onno van de Stolpe, Galapagos’ CEO.
therapeutic antibody products against multiple
targets. The alliance represents the first time
the two companies have worked together.
“We are delighted to pioneer human antibodies as novel, first-in-class therapies for rare
diseases with a partner of Shire’s caliber.
Shire’s depth of experience in protein-based
therapies is the perfect complement to our own
discovery capabilities,” Tim Van Hauwermeiren, CEO of arGEN-X, said in a press release.
“We are confident that our SIMPLE Antibody
platform, which consistently delivers antibodies of therapeutic quality against complex tar-
Under the terms of their agreement,
Abbott will make an initial upfront payment of $150 million for rights related to
the global collaboration. Upon successful
completion of the RA Phase II studies,
Abbott will license the program for a
one-time fee of $200 million if the studies
meet certain pre-agreed upon criteria.
Galapagos will perform and fund the
Phase IIa and Phase IIb trials in RA.
Abbott will assume sole responsibility
for Phase III clinical development and
global manufacturing. Pending achievement of certain developmental, regulatory, commercial and sales-based milestones, Galapagos is eligible to receive
additional milestone payments, potentially amounting to $1 billion, in addi-
simple continued on page 7
jak1 continued on page 8
global news
April 2012 • Drug Discovery News 7
Coming into the light
Lonza signs Light Path discovery
agreement with LegoChem to
provide preclinical material of
novel therapeutic compound
By Jeffrey Bouley
BASEL, Switzerland— Lonza
announced in
March an agreement with Korean biotechnology company LegoChem Biosciences Inc. for
the custom material production of a monoclonal antibody that will be used for in-vivo
proof-of-concept studies for their technology
platform development.
Under this agreement, Lonza will produce
preclinical material using Light Path Discovery Services at its applied protein services
facility in Cambridge, U.K. The deal is important in both the short-term and long-term goals
of LegoChem, Lonza’s Sze Guan Chu tells ddn.
“In the short term, LegoChem Biosciences
needed custom material in a short timeframe
to meet their clinical development timelines,”
says Chu, who is in the Asia sales and business
development arm of Lonza’s Development Services operation. As for the long term, “LegoChem Biosciences is in the process of developing a new technology platform and will need
material for future proof-of-concept studies.”
And as for Lonza’s particular strength in
this deal, Chu says, “Lonza brings a fully developed and optimized GS Expression System to
allow for high titers of material to be delivered
in a reduced timeline. LegoChem Biosciences
needed someone to produce a relatively large
amount of material in a short period of time.
simple
continued from page 6
gets often intractable with other technologies, will bring significant value to
this alliance. We believe this alliance represents an industry first and we are looking forward to an exciting and productive collaboration with Shire.”
Per the terms of the agreement,
arGEN-X will receive an upfront technology access fee, research funding and
preclinical success payments, and will be
responsible for the discovery work, as
well as preclinical support and providing
antibody development candidates for
Shire. Shire will gain an option to license
promising leads for additional preclinical and clinical development as well as
commercialization worldwide, and will
also pay arGEN-X fees, milestones and
royalties on future product sales. Specific
financial details were not disclosed, and
no details were released as to how many
targets the alliance would focus on, or in
which indications.
“As a leader in innovative therapies
for rare diseases, Shire is continuing to
apply new technologies to address the
needs of patients,” Philip J. Vickers,
senior vice president of research and
development at Shire Human Genetic
Therapies, said in a press release.
“Monoclonal antibody therapy is an
underutilized approach to the treatment
of rare diseases, and this novel platform
has the potential to bring multiple drug
candidates into our early-stage pipeline.
Partnerships such as this one with
arGEN-X are an important part of our
Their timeline was a critical factor to the
advancement of their development milestones.
Lonza’s Light Path offering is well-suited to
customers that meet this criteria.”
Lonza’s Light Path Custom Material Services
supports projects in their early phase, providing cGMP product within 11 months, according
to the company. In addition, Lonza’s Light Path
Discovery Service reportedly provides nonGMP product in six to 10 weeks to support
customers in the discovery-testing phase. Since
the launch of Light Path in early 2011, Lonza
says it has seen an increased demand for this
offering, which is focused on a reduced timeline
to IND filing. Light Path allows customers to
reach their clinical milestones more efficiently,
the company maintains.
“Lonza’s Light Path Discovery Services
were specifically designed with the demands
of preclinical assessment in mind,” said Janet
White, head of Lonza’s Development Services,
in the news release about the deal. “Lonza has
built a strong reputation for CMO excellence.
Today, we’re also focusing efforts on supporting emerging biotechnology innovation at
every stage of development to allow each customer the best chance for clinical success.”
“We have chosen to work with Lonza on
this important project because of their reliability and solid reputation in field of mammalian development,” said Dr. Woo Sung Ho,
biology director and vice president of LegoChem, in the official statement about the deal.
Chu says the two companies have not
worked together before, and were introduced
strategy to bring new therapies to those
suffering from rare diseases
worldwide.”
arGEN-X’s Superior Immunodiversity with Minimal Protein Lead Engineering (SIMPLE) Antibody platform
is based on the active immunization of
Camelids—specifically llamas—with
target antigens in order to deliver antibody variable regions that are essentially identical to those of human anti-
“We believe this deal
between arGEN-X and Shire is
an industry first, but we would
not anticipate it being the last,
since antibodies have been
widely accepted as a valuable
class of drug across the entire
biopharmaceuticals industry.”
Dr. Debbie Allen, senior
director of business
development for arGEN-X
bodies. According to arGEN-X’s site,
“active immunization of outbred llamas
with human proteins elicits strong,
unrestricted IgG responses. The variable regions of such IgGs reveals an
extraordinary degree of similarity to
their human antibody counterparts.”
The end result is SIMPLE Antibodies
that display “extremely high binding
affinities for their targets, translating
into high potencies in functional bioassays.” With the platform, arGEN-X can
generate full-size, human therapeutic
antibodies by combining the variable
regions with human constant domains.
Swiss company Lonza will produce preclinical material for Korean biotech LegoChem Biosciences using Light
Path Discovery Services at its applied protein services facility in Cambridge, U.K.
through a Korean consultant.
In other recent news from Lonza Development Services, late February saw an
announcement of another early-stage development deal, with Lonza and San Diegobased Eclipse Therapeutics Inc. announcing
an agreement for the production of Eclipse’s
novel cancer therapeutic antibody, ET-101,
“arGEN-X’s SIMPLE Antibody platform is a rapid, efficient way of identifying multiple different, high-potency
human antibodies, even against very
complex targets,” says Dr. Debbie Allen,
senior director of business development
for arGEN-X. “Multiple discovery candidates enable you to choose only the
best possible lead for development as a
therapeutic antibody product. The
majority of existing antibody platforms
do not give this high degree of lead
choice.”
Jessica Cotrone, senior director of
corporate communications for Shire
HGT, says the company has not seen
widespread use of such monoclonal
antibody technology, which was “very
attractive to us.”
“There are many possibilities that
are aligned with Shire’s focus on the
orphan disease space, meeting the
needs of the specialist physician and
pursuing innovative treatment options
in areas of high unmet need that deliver
value for physicians, patients and the
healthcare community,” says Cotrone.
Allen adds that arGEN-X expects to
see the rare disease market gain more
attention as time goes on, “both from
antibody companies and from other platform technology players.”
“We believe this deal between arGENX and Shire is an industry first, but we
would not anticipate it being the last,
since antibodies have been widely
accepted as a valuable class of drug
across the entire biopharmaceuticals
industry,” she says. ddn
EDITCONNECT: E041207
using Light Path Development Services.
ET-101 is under investigation for the inhibition of the growth of cancer stem cells. Under
the agreement, Lonza will produce Phase I
clinical materials at its development and
manufacturing facility in Slough, United
Kingdom. ddn
Lonza and Eclipse
Therapeutics
announce
development and
manufacturing
agreement
L
onza and Eclipse Therapeutics
announced at the end of February an agreement for the production of Eclipse’s novel
cancer therapeutic antibody, ET-101, using
Light Path Development Services.
ET-101 is a novel therapeutic antibody designed to
target cancer stem cells. Eliminating cancer stem cells,
in conjunction with other therapies that address the
tumor bulk, represents a new cancer treatment paradigm that could offer a distinct advantage over existing
strategies, and a solution for chemoresistance, according to Eclipse.
Under the agreement, Lonza will produce Phase I
clinical material at its development and manufacturing
facility in Slough, U.K.
“Lonza’s best-in-class antibody manufacturing capabilities will greatly support our development strategy
to deliver the highest quality and most effective therapeutics targeting cancer stem cells. Moving into cell-line
development and subsequent manufacturing represents
an important milestone for Eclipse,” says Dr. Christopher Reyes, chief scientific officer of Eclipse. ddn
global news
Abbott’s STARLIMS
business acquires
distribution partners
ABBOTT PARK, Ill.—As part of a series of strategic moves to build its labo-
Pictured here at a press conference announcing the joint venture, from left to right: Philippe Fauchet,
president of GSK K.K.; Toshihiro Ishikiriyama, future chairman and co-CEO of Japan Vaccine; Akira Nakano,
president and co-CEO of Japan Vaccine; Joji Nakayama, president and CEO of Daiichi Sankyo Co. Ltd.; and
Christophe Weber, senior vice president of GSK Biologicals.
japan
and commercial rights for existing
preventative vaccines from both
companies, including vaccines for
seasonal flu, human papillomavirus, rotavirus, mumps, diphtheria
pertussis and measles rubella.
“This collaboration marks another step in our strategy to build our
presence in key growth markets
and will create the first and largest
company dedicated solely to vaccines in Japan,” Christophe Weber,
president designate of GSK Vaccines, said in a press release. “We
are very pleased to be partnering
with Daiichi Sankyo, a highly
regarded company and an established leader in Japan. Both companies have strong track records in
commercialization and, in combination, will create further significant
economies of scale in the development and distribution of vaccines
in the Japanese market.”
The two companies will form
Japan Vaccine Co. Ltd., each selling
their respective vaccines into the joint
venture at agreed-upon prices, and
will receive sales synergies. GSK and
Daiichi will hold equal stakes in the
joint venture and will split profits
50/50, with the partners equally splitting the minimum total cash investment of 100 million Yen (approximately $1.2 million) for start-up capital requirements. No additional
financial terms were disclosed.
Masaya Tamae, director of the
public relations group in Daiichi’s
corporate communications department, says that the opportunity to
partner with GSK was “extremely
significant” for the company, adding
that Daiichi has “high expectations
that the partnership will prove
fruitful in the roles it will take on,
such as vaccine development, marketing and sales, as well as in other
areas such as vaccine research and
manufacturing.”
“Moreover, we expect the company to contribute greatly to the
group’s business results, as well as
improve our presence in the growing Japan domestic vaccine market,” Tamae adds. “As a Japanese
pharmaceutical company, we feel an
acute responsibility to contribute to
improved health and welfare in
Japanese society, as well as to do
everything we can to help protect
people living in Japan from infectious diseases.”
The location of the joint venture
in Japan is a benefit for GSK as well,
a company spokesman notes, as
GSK already has “a strong presence
in Japan in its own right.” The company reported 28-percent growth in
Japan in 2011 on an underlying
basis, and the Japanese market, in
addition to the U.S. market, “is one
of the key pro-innovation markets
where we are focusing our R&D
efforts.” The company feels that
combining Daiichi Sankyo’s history
in the country with GSK’s vaccine
expertise together in the joint venture will “have a positive impact on
public health in Japan.”
“There are many factors that GSK
takes into account when deciding on
whether to enter into a JV. The choice
of partner, the development potential
and how the venture will fit into our
growing global vaccines development network were all important
considerations,” says GSK’s spokesman. “Daiichi Sankyo meets all of
these criteria and holds similar values and commitment to excellence
and meeting public health needs to
GSK, and emerged as the natural
choice to partner with on this JV.”
They went on to note that “Japan
is emerging as a key driver of innovation in the pharmaceutical sector,
and we expect this to translate into
growth in the future as more companies focus their efforts in the
region,” adding that the pharmaceutical market has seen 5.6 percent
growth in Japan.
“Naturally, as our home market,
the Japanese domestic market is
very important to Daiichi Sankyo.
As in many countries, there are
pressures on healthcare cost and so
on, but overall we see the future of
the pharmaceutical market in Japan
as being bright,” says Tamae.
“Regarding the vaccine market in
particular, due to the Japanese government’s strong support of market
growth in terms of the introduction
of foreign, innovative vaccines, there
is great expectation for continued
market expansion in the future.”
The transaction is expected to be
complete in the third quarter of this
year, subject to local regulatory
approvals. ddn
Medicago and Mitsubishi
Tanabe Pharma in vaccines deal
QUEBEC CITY— Medicago
Inc.
announced in February a strategic
alliance with Mitsubishi Tanabe
Pharma Corp. (MTPC) through the
execution of a master research collaboration agreement.
The alliance aims to develop and
commercialize at least three new
vaccines with MTPC, which will
provide funding for all research and
development costs. In exchange for
granting licensing rights, Medicago
will be entitled to receive upfront
and milestone payments as well as
royalties for each product. MTPC
will have the option to license a
rotavirus-like particle (RLP) vaccine target and assume global development, regulatory and commercialization responsibilities, while
Medicago will be eligible to receive
up to $33 million in upfront and
milestone payments as well as royalties on future sales of the RLP
product. Medicago will receive an
upfront payment of $3 million to
begin the initial research on rotavirus. Work on an RLP vaccine target
will begin immediately. Additional
targets will be selected later.
“This collaboration is consistent
with our business strategy to develop new vaccine targets with significant market potential along with a
knowledgeable partner that is committed to supporting rapid development,” says Frederic Ors, vice president of business development of
Medicago. ddn
ratory information management system (LIMS) business in Europe and
emerging markets in Latin America and Africa, STARLIMS Technologies, an
Abbott company, has announced the acquisition of several longtime distribution partners.
These acquisitions include STARLIMS’s French distributor Varilab; operations of two privately held Spanish businesses, now operating as STARLIMS
Iberica; a privately held Dutch company, now operating as STARLIMS
Netherlands, with a branch office in Solna, Sweden; and the business of its
Israeli distribution partner, STARLIMS Israel Ltd. In addition, the company
established STARLIMS Germany GmbH, with offices in Witten, Germany, to
provide direct support for its German and Swiss customers.
“The successful completion of these transactions represents Abbott’s commitment to invest in and accelerate the growth of STARLIMS’ core business,”
says Isaac Friedman, head of Abbott’s STARLIMS business. ddn
jak1
tion to tiered double-digit royalties on net sales upon commercialization. Galapagos retains copromotion rights in Belgium, the
Netherlands and Luxembourg.
JAK1 is one of a family of
enzymes that play a key role in
the signaling mechanism used by
a number of cytokines that are
involved in autoimmune diseases.
In previously reported results
from a four-week Phase IIa study,
GLPG0634 demonstrated efficacy
measures among the best reported in RA, according to Onno van
de Stolpe, Galapagos’ CEO.
“GLPG0634 achieved the primary endpoint in the Phase II
proof-of-concept study in rheumatoid arthritis patients, with a
42 to 58 percent improvement in
ACR20 scores compared to placebo,” Stolpe observes. “Although
the study was not powered to
achieve statistical significance,
the improvement observed in
ACR20 scores (a 20-percent or
more reduction in tenderness
and swelling) was so dramatic
that the results were statistically
significant.”
All patients completed the
study, and few experienced any
side effects. No anemia, change in
blood pressure or lipids were
observed. An additional Phase
IIa dose-range finding study with
GLPG0634 is expected to begin
shortly.
“The addition of this novel,
oral compound offers patients
the potential for advanced treatment options and an improved
patient experience to address RA
and other autoimmune diseases,”
notes Dr. John Leonard, Abbott’s
senior vice president of global
research and development.
“This collaboration with
Abbott, the global leader in autoimmune diseases, is a great recognition of the value of GLPG0634.
We view Abbott to be the best
partner possible to deliver a complete clinical program and a powerful market introduction. We are
excited to continue the Phase II
trials and expect to deliver to
Abbott a complete Phase II package in 2014,” adds Stolpe. “With
GLPG0634, we have proven that
we can deliver from target to clinical proof of concept, and we aim
to do the same on many novel target programs in our pipeline.”
Stolpe notes the collaboration
is transformational for Galapagos, providing the means to progress these innovative products
into the clinic.
“This deal with Abbott really
validates our entire approach to
target and drug discovery and
development,” he states. “Also, the
financial terms provide the company sufficient cash to fund other
promising programs in our pipeline, which were discovered using
the same approach as for
GLPG0634. We will take the time
to set the priorities going forward,
but we have so many promising
programs to choose from, including novel mode-of-action programs in cystic fibrosis, antivirals,
atherosclerosis and respiratory
diseases.”
The Galapagos Group has
about 800 employees—almost
doubling its head count over the
past three years—and operates
facilities in six countries. More
than half of the growth has come
via the acquisitions of Argenta
and the Zagreb research center of
GSK, Stolpe notes.
“These acquisitions allowed us
to solidify the leadership position
that BioFocus already had in the
premium segment of drug discovery services, and provided muchneeded additional and high-quality R&D capacity,” Stolpe says.
“The rest of the growth in personnel has come organically, as we
expanded our alliance franchise
and matured into a full-grown
development company.” ddn
opment, Enanta states.
HCV is a liver disease affecting
more than 170 million people worldwide, according to the World Health
Organization (WHO). The virus is
spread through direct contact with
the blood of an infected person.
HCV increases a person’s risk of
developing chronic liver disease, cirrhosis and liver cancer. Liver disease
associated with HCV infection is
growing rapidly, and there is an
acute need for new therapies that are
safer and more effective.
Enter Enanta.
Enanta has already received
Investigational New Drug (IND)
approval for EDP-239 from the U.S.
Food & Drug Administration.
Under the new deal, Novartis will
pick up all costs associated with the
development, manufacture and
commercialization of EDP-239.
Novartis will fund some other compounds that Enanta is working on
that target NS5A.
“Novartis is a recognized leader
in the field of HCV, and access to its
global expertise combined with our
shared vision for commercializing
HCV therapies will support the successful development and commercialization of products targeting
NS5A,” Jay R. Luly, president and
CEO of Enanta Pharmaceuticals,
stated in a Feb. 21 news release. “We
believe EDP-239 has great potential
as a potent ingredient in combination drug therapy, and our preclinical studies have demonstrated high
potency against multiple genotypes
of the virus.”
Luly tells ddn, “Enanta did not
need to partner with Novartis for
EDP-239, but there are circumstances for both companies that
supported doing the deal now.
NS5A is a ‘hot target,’ and for good
reason. Research efforts have
shown that targeting NS5A gives
rise to profound antiviral activity,
and as a result, candidates aimed at
this target are being tested in the
much-anticipated all-oral, interferon-free drug regimens.”
In HCV, pharmaceutical companies are looking at the performance
of drug combinations at very early
stages in development, he says.
“People are still trying to figure
out what the best combinations are,”
Luly says. “And they are looking to
identify the minimum combination
of agents that can be put together to
effectively treat the virus and stave
off the possibility of resistance.”
Enanta has now done two earlystage deals “that allow our HCV
compounds to participate in multiple potential combination regimens—our HCV protease inhibitor
program, ABT-450 is partnered
with Abbott, and now our NS5A
inhibitor, EDP-239, is partnered
with Novartis,” he says.
Novartis has a late-stage
cyclophilin inhibitor, alisporivir,
which it licensed from Debiopharm
SA, Luly says. Many believe that the
treat genotype 1 cases of HCV.”
Luly is aware of the competition
among companies to come up with
an effective treatment for HCV.
“There are a number of companies developing drug candidates for
HCV, some bigger, some smaller,”
Luly says. “I believe Enanta is
unique in that we have applied our
novel chemistry approach and drug
discovery capabilities to develop
one of the broadest pipelines of candidates targeted against HCV.”
Novartis spokesman Jeffrey
Lockwood is also optimistic about
the possibilities of discovering an
effective treatment for HCV.
“We believe that oral combination therapy is the likely future of
HCV treatment,” Lockwood tells
ddn. “An NS5A inhibitor is an
attractive potential partner for
Novartis’ cyclophilin inhibitor,
Alisporivir (also known as DEB025
in Phase III trials). The combination
of a highly potent NS5A inhibitor
plus a cyclophilin inhibitor with
high barrier to resistance may provide an effective combination for
HCV treatment, especially consid-
ering that both also have broad
genotypic coverage.”
In October, Enanta won a fiveyear, $42.7 million contract from
the National Institute of Allergy
and Infectious Diseases (NIAID),
a National Institutes of Health division, to support the company’s
efforts in developing treatments of
infections stemming from methicillin-resistant Staphylococcus aureus
(MRSA), vancomycin resistant
enterococci (VRE) and resistant
streptococci. ddn
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“There are still several years of
clinical development ahead for
EDP-239 given that it hasn’t started
in human clinical trials yet,” Luly
says. “But there is a broader sense
of urgency in the development of
new HCV compounds due to the
constant threat of drug resistance
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editorial
The little biotech that could
D
idea: He would form a new company that would,
via an eight-month, $5 million contract with
you’d expect to be living on a min- ArQule, perform the early research work that
imum-wage salary. A graduate of ArQule no longer wanted to handle. Li would
the Harvard-MIT Division of use that $5 million to start BBI and give jobs to
the nearly three-dozen employees
Health Science and
facing layoffs—saving ArQule sigTechnology and Harvard Medical
nificant costs, negative media
School, he completed his residency
reports and shareholder disappointand fellowship at Brigham &
ment in the process.
Women’s Hospital/Dana-Farber
“It truly was a win-win situation,”
Cancer Institute and Beth Israel
Li tells me. “Still, the idea made
Deaconess Medical Center before
sense, but no one had ever done this
moving on to found or co-found
before,” he concedes. “We were not
Cyclis Pharma and Cequent Pharma,
going to be a spinoff, so there was
both of which were later acquired,
some concern about who was going
and ArQule Oncology. Li has more Amy Swinderman,
to lead the new company. I volunthan 60 inventions to his name and ddn Chief Editor
teered myself to lead this initiative.”
has translated a number of his mediBBI successfully completed its outsourcing
cal innovations to patients for the treatment of
contract with ArQule, but there were other
cancer and other life-threatening disorders.
challenges waiting in the wings. By late 2008,
Would you like fries with all of that?
Li is not some down-on-his-luck life-science the economic recession hit with full force. BBI
casualty of a poor economy, though. Quite to the temporarily downsized its employees, but then
contrary, he is the founder, chairman, CEO and hired them all back—and to ensure that no one
chief medical officer of Boston Biomedical Inc. lost a job, Li cut his own salary down to mini(BBI), a private biotechnology company with a mum wage.
“It was a tough time to be an entrepreneur,”
clinical-stage product pipeline targeting cancer
stem cells based in Norwood, Mass. So why is he admits Li, who lived on this meager salary for five
years, until last month when the unexpected hapsubsisting on a minimum-wage salary?
pened: Top Japanese pharma Dainippon SumiBy choice.
In 2006, when Li learned that he and about tomo Pharma Co. Ltd. (DSP), with whom BBI had
30 other employees of ArQule Inc. were on the an exclusive product option license agreement for
chopping block due to a company restructuring, the development of a cancer stemness inhibitor
Li decided to take a major leap of faith. He program in Japan, swooped in to acquire BBI for
approached ArQule’s executives with a novel a cool $2.6 billion (see “Pharma pink-slippers find
By Amy Swinderman
r. Chiang Li is not the kind of guy
pot of gold,” on our cover this month).
“To be honest, we were not looking to be
acquired—we were just mainly focusing on product innovation,” Li says. “But after partnering
with us on BBI608, the team liked what they saw,
not just from the program’s data, but also with
how BBI operates. Our teams collaborate so well
together, so an M&A felt very natural. We came
to the conclusion that teaming up with DSP was
a good idea because of its resources, expertise in
other areas and track record would help us accelerate this program.”
All BBI employees get to keep their jobs when
the acquisition closes, and with $2.6 billion in the
can, Li can probably give himself a muchdeserved raise—but he laughs, “truthfully, right
now I am too busy to think about getting my salary back.”
Knowing what he knows now, would Li have
done anything differently?
“If I had to do this all over again, I might be
more scared. If I knew that one year later, the
recession would hit, I probably wouldn’t do it,”
he admits. “But sometimes, the best solution is
to take a risk. Sometimes, the risk is not taking
a risk. From an executive’s standpoint, I am
excited because we have created a world-leading
portfolio that provides a new direction for cancer stem cell treatment. From a business manager’s standpoint, I’m glad things worked out
so that no one was out of a job. The moral to our
story is that this provides an example of what
can be done.”
And a biotech story with a happy ending is
something we can all enjoy. ddn
Taking inventory of life-science headcounts
K
By Peter T. Kissinger
odak once had 60,000 employees
in Rochester, N.Y. Today, they have
tenfold less and are operating
under bankruptcy protection.
Given that all visual records of my
youth are recorded on chemistry developed by
Kodak, I wish them well as they reinvent themselves. The fact that they have already been trying
for over 20 years tells us it’s not been easy. They
tried pharmaceuticals. They tried clinical diagnostics. Remember that the Ektachem was to
revolutionize the hospital clinical lab. Kodak even
invented digital imaging. They have had some of
the best chemistry and materials scientists
around and hired many top graduates from the
best universities.
We’ve seen over and over how infrastructure
has become a brake on speed and how successful
firms become, and as a result, vulnerable to failure.
This has been well reflected in the Midwest economy. It’s nearly taken out entire mid-sized cities.
Today, we hear an endless drum beat about job
creation as a metric used to judge crony capitalism with its government incentives. Think green
energy. Today, many still judge a person or company by how many report on the organization
chart. These are mistaken metrics.
What we really want is “wealth creation”
through innovation that truly advances the cause
of customers through enhanced productivity. The
number of customers determines impact. Nevertheless, this, too, is not sustainable. Survival requires
innovating again and again at a greater and greater
speed. Customers create jobs. No one else can.
Agriculture makes my point. Productivity
replaced 95 percent of the jobs over a century,
customers have more and better food than ever
and we export more soybeans in a week than we als and life-science legal practices. On the phargrew in a year in 1900. In the traditions of modern maceutical side we also have a very deep complejournalism, but with the honesty of science, I ment of contract research firms and manufacturmade up the numbers in the last sentence just ers. Many in this network earned their battle scars
at the deceased Searle, Upjohn, Marlike the best newspapers and politiion Labs, Merrill, Parke-Davis,
cians often do today. Few would
Guidant and others. Some also
think it a good idea to trade mechahatched from transportation and
nized agriculture for more jobs.
communications industries with their
Industries have been shedding as
strengths in plastics, metals, electronmuch infrastructure as possible. We
ics and software.
know the $100 million factory or
Creative destruction is alive and
laboratory today can overnight
well. Is the value derived from inbecome a $5 million auction. Success
house headcount? No. The wealth
is best not measured by headcount,
creation comes from helping patients
but by making a difference.
and learning how to use the network.
The pharmaceutical, scientific Peter T. Kissinger,
Purdue University
Jobs are now more widely dispersed
instrument and medical device
industries are embracing a networked ecosys- and more secure within the network, where they
tem. We have a number of companies today that can be applied to many projects. Success brings
are virtual. They can be strategists and project capital gains that are recycled. Many young firms
managers, networked with specialists to deliver will fail and we learn from each one. Along the
results efficiently. They can fail gracefully when way, careers are made, families supported and
needed, in a way that Kodak (named in 1888) can- wisdom gained.
Do our state governments with their executive
not today. Apple is iconic in this respect, reinventing itself over and over with very light infra- and legislative branches fully grasp this networked innovation economy? I think not. It’s
structure for its size.
Components are sourced externally, manufac- certainly not intuitive or comfortable. Life-science
turing is in Asia, distribution is through multiple risk rivals our Midwest state lotteries. It’s a risk
channels, some virtual, partnering with many. We we must keep taking. The origins of the anchor
are blessed here in the Midwest with the pieces stores of life sciences all started with single-digit
that have broken off the industrial economy ice- headcounts and no amount of planning guaranbergs as well as the new ones we’ve invented. teed their success. Some lasted a very long time,
Using medical devices and scientific instruments but not longer. The DNA of the discontinued
as examples, we have expert machine shops, injec- firms listed above continues in their acquirers,
tion molding firms, metal and plastics fabricators, divestments and their vibrant spinouts.
It is important to value failures (common) and
metallurgists, automation engineers, software
firms, regulatory affairs consultants, toxicologists, not focus only on the successes (rare) as we
reimbursement experts, purveyors of clinical triheadcounts continued on page 11
www.drugdiscoverynews.com
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Bruce Poorman
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editorial
Commentary: Completing the picture
with regulatory information management
By Gillian King & Joel Finkle,
CSC Life Sciences
ata, data and more data.
D
Pharmaceutical companies
depend on data to bring products to market, but companies
struggle to cohesively and
coherently manage all that data and all that
information. In response, regulatory information management (RIM) has come to the fore,
and companies are recognizing its value—at
least in terms of how companies
communicate with regulatory
authorities. But exactly what RIM
is and how it fits into the broader
scheme of managing products and
submissions is perhaps less well
understood.
RIM is the method of bringing
together all of the pieces of information and data that tell a product’s complete story. But it’s not
Joel Finkle
used simply to collect information
or have a nice picture of data; rather, the purpose is to help companies achieve two things:
to stay in compliance with health authorities’
requirements and to make well-considered
commercial decisions around a product and
the portfolio.
Drivers to better oversight
A few years ago, the concept of regulatory
tracking appeared on companies’ radars, but
there wasn’t necessarily a clear understanding as to why tracking was a good idea. With
changes in the regulatory and commercial
landscapes, companies realize they need a
better way to track—and, more importantly,
manage—critical regulatory information.
First, the need for better oversight of regulatory information must be seen in the context
of the regulatory authorities’ sharp focus on
safety. Health authorities have become far
more risk averse, and companies need to demonstrate compliance with the regulations.
that would therefore not be in one place. Similar information is needed for the U.S. Structured Product Labeling listings and registrations, though it’s less complex for companies
to navigate, because the United States is a
single regulatory market—meaning, companies don’t have alternative versions of products, or translations of product names, or
labels they have to produce for dealing with
the 27-member European Union.
Other drivers have been the economic climate and companies’ realization
that they need to do more with
less. Very few pharma companies
have been untouched by the economic climate as it is today; most
of them have eliminated redundancies, and they have not been
recruiting, so they have to manage
differently both their businesses
and the information that stems
from what they do. With fewer
resources to achieve their objectives, companies are looking to technologies
and improved processes instead.
So while regulations require that companies
have better control of their regulatory information, smart companies are recognizing the
opportunity for using that information to their
own advantage—for example, to make decisions
about the portfolio and their future direction.
Moving on
In its early days, RIM was simply seen as a
way for companies to track what was happening with their products. Today, however, most
business leaders are looking to RIM to give
them clearer oversight of the company’s products, as well as insight into what to do next.
They want not only to know where information is held globally, but also to be able to connect that with data and information coming
from other sources. In other words, they don’t
want simply a static line of data; they want a
three-dimensional model that gives them a
Regulatory information management (RIM) has come to the
fore, and companies are recognizing its value—at least in terms of how
companies communicate with regulatory authorities. But exactly what
RIM is and how it fits into the broader scheme of managing products
and submissions is perhaps less well understood.”
With that comes a whole raft of data and the
need to track that data. Perhaps the most
prominent example of legislation designed to
provide agencies with more-extensive pharmacovigilance information is the European
Medicines Agency’s EudraVigilance Medicinal
Product Dictionary (EVMPD) mandate. The
EVMPD is the European Medicines Agency’s
central database of what products are registered where. On July 1, 2011, the agency issued
a legal notice based on pharmacovigilance legislation requiring that every company submit
EVMPD data by July 2, 2012, for its every product authorized in the European Union.
This is a mandate with wide-reaching
implications. It requires that marketing
authorization holders send to the European
Medicines Agency all information on products and substances that would ordinarily
have been stored and gathered by the individual market companies, or affiliates, and
complete picture of everything that can be
done with a particular product.
More than that, business leaders want to
be able to see themes and recognize trends in
regions, not by looking at just one product but
across a portfolio to help them make decisions
farther down the line.
By way of example, most large or mid-tier
pharma companies have numerous products
registered around the world in different ways,
under different names and in various formulations. When a new product is about to hit the
market, commercial groups will want to know
about specific markets so as to determine how
best to promote, or even establish, the new
product in a particular market. Commercial
teams might ask regulatory affairs whether
they can market the product in a particular
country—from a legal and regulatory standpoint. But without access to information about
existing products on those markets, it would
be impossible to give the commercial teams the information they
need to make a well-considered
decision.
From a purely commercial
standpoint, RIM is probably the
most important way of knowing
what, where and when a company
can market as well as how future
markets are going to look, because
the knowledge will be based on Gillian King
information collected about the
products a company has in various markets.
Quite simply, RIM puts more information at
a company’s disposal so decision makers can
better decide how to move forward.
Challenges to implementation
Companies that have long-established products on the market face challenges to comprehensive RIM because trying to piece together
those histories could be overwhelming. Companies have to decide whether it’s worth collating information on products that might
have been on the market since, say, the 1970s.
It’s quite understandable that companies
might decide they will start implementing
regulatory information management only
from the past five years, for example. The first
decision companies will need to make is
where to start—and that decision will depend
on where that company is in its own history
and where its products are in their life cycles.
Equally, companies need thorough understanding of how they currently gather and
manage information. For example, do they
have centralized or decentralized points of
control? Where is the information held? And
who maintains it? Sometimes companies
decide to acquire a RIM system without even
considering who will be using it and who will
be updating it. Yet those are the two criteria
most important to operating a RIM system:
(1) knowing who the customers are and what
they’ll try to use it for and (2) who is going to
keep it current.
At the start of a regulatory information
management project, companies’ biggest
challenges are to move into a single, central
repository all of the information that exists in
databases and spreadsheets and in solutions
across the enterprise and to use the same terminology for the same data.
Another difficulty companies face is that
because RIM needs to be implemented as an
internal project, it lacks the standards available
for managing submissions. Moreover, too few
comprehensive RIM solutions have been implemented in the industry as yet for best practices
to evolve. The reality is that each company has
its own way of viewing RIM—and therefore its
own needs. Some might take a project management approach; others form a pharmacovigilance perspective; and still others might be most
keenly focused on registration tracking.
There’s a trend toward greater standardization of product information. For example,
Identification of Medicinal Products (IDMP)
is an International Organization for Standardization standard that will ultimately
replace the EVMPD in 2015. IDMP has at its
root the Common Product Model, which is
also part of the FDA Structured Product
Labeling (SPL) and Individual Case Safety
Reports (ICSR) for adverse event
reporting, and which will also be
integral to the forthcoming electronic Common Technical Document (eCTD) version 4.0, which is
modeled on Regulated Product
Submissions, the Health Level
Seven International (HL7) standard in development to support
the U.S. Food and Drug Administration’s broad regulator y
commitments.
Nevertheless, even though such standards
would build greater structure into the overall
management of regulatory information,
because of the differing needs of companies—
small, large, virtual and so forth—the way a
RIM solution is maintained will vary from
company to company.
Consolidation
Regulatory information management can
touch every aspect of a company’s business—
from product management, which keeps
track of what products are on the market and
where, licensing status and whether safety
update reports are due, to submission management, which is involved with where a company’s products are registered, where it is
waiting for things to happen, what agency
correspondence has been exchanged and
requires response and so forth.
Greater opportunities to have information
stored in and shared from a central repository—thanks to the development of virtual private networks and the cloud—make RIM more
tangible for dispersed organizations, and
growing regulatory submission requirements
presage the need for improvements in the management of regulatory information. As these
factors escalate and companies become more
aware of the potential for better global pipeline
management, so too will the demand for—and
levels of sophistication of—RIM solutions. ddn
Gillian King is head of global consulting and global
professional services at CSC Life Sciences, and has
more than a decade of regulatory experience in the
life-sciences industry. Joel Finkle is senior strategist
of regulatory informatics at CSC Life Sciences and
a member of the Health Level Seven International
Regulated Clinical Research Information
Management working group.
headcounts
replace the ego system with a dynamic ecosystem. Could a business plan predict the
origins of Illumina in California from a lab at
Tufts University in Boston and the fact that
Roche wants them badly for a gazillion beans?
Nope! It only took a decade from their founding in April 1998.
Try, try again. That’s our way. Plan less, do
more. I’m sorry about Kodak’s challenges, but
it is a natural process and they had a fabulous
run while creating a lot of wealth and happiness through enhanced productivity. ddn
Peter T. Kissinger is professor of chemistry at
Purdue University, chairman emeritus of BASi
and a director of Chembio Diagnostics, Phlebotics
and Prosolia.
b r i e f s
Stem cells focus of EMD
Millipore, CCRM alliance
BILLERICA, Mass.—EMD Millipore, the life-science division of Merck KGaA, and the Centre for
Commercialization of Regenerative Medicine
(CCRM) have established a collaboration focused
on developing optimized conditions for bioreactor-based cultivation of stem cells. The partners
will collaborate on the development of a proprietary monitoring and control methodology to
encourage growth of adherent human pluripotent
stem cells in EMD Millipore’s Mobius CellReady
stirred tank bioreactor, which CCRM will be using
at its product development facility at the University of Toronto’s Banting Institute. The goal is to
deliver a commercially available kit with reagents
and associated methodologies for bioreactor
culture of stem cells on microcarriers.
Lucigen receives
$2.5 million grant from NIH
MIDDLETON, Wis.—Lucigen Corp. has announced
that it has been awarded a Small Business Innovation Research Phase II grant to fund additional
research and development, receiving $2.5 million
from the U.S. National Institutes of Health. The
money will go towards the development of
metagenomic DNA libraries that could aid in identifying new antimicrobial and other anti-infective
drug candidates. Lucigen’s partners in the Phase
II work will be the University of Mississippi and
Auburn University, its partner from Phase I, with
whom Lucigen created a DNA library from soil
microbes, which resulted in 28 new compounds
that inhibit the growth of MRSA. The organizations
will create several large metagenomic libraries and
screen them for antimicrobial activity against four
multiple-drug-resistant pathogens.
Wellspring, CTSA-IP
aim to foster public-private
partnerships
CHICAGO—A
new partnership was recently
announced between Wellspring Worldwide Inc.
and CTSA-IP, an initiative funded by the U.S.
National Institutes of Health to enhance publicprivate partnerships across the consortium of
institutions with Clinical and Translational Science
Awards (CTSA). The partners will seek to promote
collaboration among CTSA members, industry
and research institutions. Per the terms of the
partnership, members of the CTSA-IP Initiative will
be able to post technologies, research projects
and collaboration opportunities to Flintbox, Wellspring’s Open Innovation Platform, which stands
as the largest research collaboration platform with
more than 500 participating organizations.
“Increasing exposure of CTSA members’ technologies to the broad mix of industry and academic innovators on Flintbox will result in a
tremendous growth of technology transfer
opportunities,” Dr. Matt Hamilton, president of
Wellspring, said in a press release.
A biopharmaceutical bonanza
GE Healthcare
acquires Xcellerex to
broaden capabilities
in biopharma market
By Jeffrey Bouley
CHALFONT ST. GILES, England—
Looking to add a high-growth
company that will help it build an
integrated, start-to-finish industry
offering that is focused on lowering costs, increasing productivity
and reducing time to market, GE
Healthcare announced in early
March that it reached an agreement to acquire Marlborough,
Mass.-based Xcellerex Inc. The
acquisition is expected to close in
the second quarter of 2012. Financial terms were not disclosed.
Calling Xcellerex “a supplier of
innovative manufacturing technologies for the fast-growing biopharmaceutical industry,” GE
Xcellerex will likely continue operating from its Marlborough, Mass., facilities after
the acquisition and become part of GE Healthcare’s BioTechnologies business.
Healthcare notes that buying Xcellerex will allow for expanding its
offering of products and services
for the manufacture of biopharmaceuticals such as recombinant proteins, antibodies and vaccines.
“The strong strategic fit
between the two companies,
combined with expanded capabilities in product development
and marketing, will offer signifi-
cant customer benefits,” GE
Healthcare says.
“GE Healthcare is committed
to growth as a provider of innovative technologies and services for
the manufacture of biopharmaceuticals and vaccines. This is an
area of significant growth globally for many reasons, including
the increased incidence of diseases such as cancer, arthritis
and diabetes—which biopharmaceuticals often play a key role in
managing,” Catarina Flyborg,
bioprocess product marketing
leader for GE Healthcare, tells
ddn. “We’ve got a strong track
record in investment to bring
new technologies to market and
this is definitely something that
we intend to continue—it’s a key
business focus for us.”
Flyborg says that Xcellerex’s
production-scale, single-use bioreactor systems are complementary to GE Healthcare’s products
and range of media for cell culture,
adding that Xcellerex’s FlexFactory custom-designed modular
production platform helps customers deploy manufacturing
capacity more quickly.
“GE and Xcellerex share the
vision that an integrated
approach, where we can help cusGE continued on page 14
Comparing
apples to Apples
IO and Sage-N team up to discover potential
biomarkers, disease causes and prevention
By Lloyd Dunlap
St. Louis-based Certara, which
was formed through the merger of
scientific software providers Tripos and Pharsight, is a provider of
drug discovery and development
software. U.K.-based Simcyp is a
research company that provides a
modeling and simulation platform
for predicting the fate of drugs in
virtual populations, including
pediatric populations.
In making the announcement,
Certara President and CEO Jim
Hopkins says the capabilities
offered by Simcyp’s preclinical
technologies, combined with Certara’s existing software products
SAN FRANCISCO—IO Informatics, a semantic data integration
and knowledge management company, will partner with SageN Research Inc., a company that specializes in computational
proteomics, in an agreement announced last month.
The combination of their technologies creates a framework
for developing a highly specialized, large-scale application to
leverage mass-spectrometry based proteomics with “unmatched
content enrichment, interoperability and flexibility only possible with semantic data integration,” the companies say.
“Semantic data integration means putting data in context,”
explains Dr. Erich Gombocz, IO’s chief scientific officer. “I use
the example of an apple. ‘How much does an apple cost?’ is
totally dependent on if you mean the fruit or the computer;
without that context, you really cannot answer this question.
The same holds true in a much more stringent way for biological
data; data out of context is isolated and of no actionable use,
but data in context of other data provides the meaningful underlying framework to understand complex interactive and interrelated intricate biological processes on a systems level. Because
our technology is based on the Resource Description Framework, its data structure does not require predefined schemas,
but is based in its entirety on triples—sets of resources commonly described in form of ‘A is related to B’ (or, more formally,
as subject, predicate, object). Data becomes aware of their surroundings—they are ‘sentient’ of how to connect and what they
mean in their context, thus the name of IO’s tools, ‘Sentient
domain continued on page 13
semantic continued on page 14
U.K.-based Simcyp is a research company that provides a modeling and simulation
platform for predicting the fate of drugs in virtual populations.
Across
all
domains
Certara acquires
Simcyp, boosting
preclinical abilities
By David Hutton
ST. LOUIS, Mo.—With
a focus on
expanding the breadth of its technology offerings to drug developers, Certara has reached an
agreement to acquire Simcyp Ltd.
for $32 million.
The acquisition enhances Certara’s portfolio and provides key,
extensible technologies that support Certara’s translational science initiatives.
Other terms of the acquisition
were not released.
domain
and scientific consulting services,
“will provide significant drug development advantages to our mutual
and prospective clients.”
“From a translational science perspective, Simcyp’s preclinical simulation technologies, which include
prediction of drug-drug interactions, fit perfectly between Certara’s
existing discovery and clinical
research offerings, thus enabling an
end-to-end solution,” he adds. “For
example, this means broader capabilities to predict drug disposition
as a function of molecular structure,
and the ability to utilize a single unified suite of tools to facilitate preclinical and clinical PB/PK and PK/
PD modeling and analysis.”
John Evans, managing director at
Simcyp, says the acquisition by Certara will allow Simcyp to focus on
its core competence while drawing
on the broader drug development
expertise available within the Certara family.
“Clients from across the spectrum
of drug discovery and development
will have access to an expanded and
integrated range of products and
services, which will be enhanced by
combining the attributes of Tripos,
Simcyp and Pharsight science and
functionality,” he says.
According to Daniel L. Weiner,
Certara’s senior vice president and
general manager of software, the
buyout builds on Certara’s Tripos
software used in drug discovery
and its Pharsight solution for users
conducting preclinical and clinical
drug research.
“Simcyp is an ideal fit between
Certara’s existing technology in
molecular modeling and QSAR
from Tripos and PK/PD modeling
from Pharsight, making Certara the
only company that has predictive
science methods in discovery, preclinical and clinical drug research,
along with an R&D informatics
solution to integrate data across all
domains,” he says.
Many drug development organizations are looking for ways to integrate the currently divided silos in
research and development and to
improve decision-making between
and among discovery, preclinical
and clinical providers.
The Simcyp Simulator is a physiologically based pharmacokinetic
simulation tool, known as PB/PK
simulation. It is primarily used by
preclinical teams to predict key clinical decisions around drug safety,
ADME and drug-drug interactions.
Weiner adds that the addition of
Simcyp’s technologies allows Certara
“to create in-silico workflows that
reduce the need for costly and timeconsuming lab and clinical work by
focusing experimental effort only on
compounds with the desired PK,
safety and efficacy, thus improving
yields throughout the process.”
Geoff Tucker, the chairman of
Simcyp, points out that the accuracy of in-vitro/in-vivo extrapolation
TOOLS & TECHNOLOGY
Geoff Tucker, chairman of Simcyp, says that
the accuracy of in-vitro/in-vivo extrapolation
depends on the inclusivity and quality of the
input data for a particular compound. “With
good data, the prediction, for example, of the
extent of drug-drug interactions, is of the order
of 80 percent within a factor of two,” he notes.
depends on the inclusivity and
quality of the input data for a particular compound.
“With good data, the prediction,
for example, of the extent of drugdrug interactions, is of the order of
80 percent within a factor of two,” he
explains. “Extensive performance
verification both within Simcyp and
externally through the experience
and publications of its consortium
members has provided significant
confidence in the approach.”
Moreover, as a testament to the
impact of PB/PK modeling in drug
development, Tucker notes that the
current draft of the U.S. Food and
Drug Administration Guidance for
Industry on Drug-Drug Interactions provides strong endorsement
of the approach, indicating that
simulation can be used as a basis for
waiving real studies when the predicted extent of an interaction is
small.
The acquisition by Certara means
that Simcyp will continue to operate
as before, developing algorithms
and databases, providing extensive
education on PB/PK-PD modeling
through its workshops and offering
high-level consultancy.
Tucker adds that there will now
be considerable effort to align and
integrate its products with those of
Tripos and Pharsight.
Weiner says the goal of this acquisition is to position Certara as the
leading provider of tools and an
informatics infrastructure to support
translational drug development. ddn
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TOOLS & TECHNOLOGY
A ROCK-SOLID PARTNERSHIP
rockland, nci
collaboration
announces release
of new antibodies
By Kelsey KAustinen
GILBERTSVILLE, Pa.— Rockland
Immunochemicals recently
announced the release of 95 antibodies as a result of a partnership
with the National Cancer Institute
(NCI). The antibodies, which are
involved in signal transduction and
cancer research, were developed in
conjunction with the NCI’s Center
for Cancer Research (CCR).
“These Rockland antibodies are of
high interest for the cancer research
community broadly and are important tools to the advance of promising
cancer research, diagnostics and
therapies,” says Richard Smith, chief
operating officer at Rockland. “Rockland is intent on continuously
enhancing our portfolio of highly
characterized antibodies and other
reagents critical to the life sciences.”
The partnership between Rockland and the CCR began in 2005 to
develop rabbit polyclonal antibodies
“against key phospho and nonphosphoproteins implicated in cancer,” according to the Office of Science and Technology Partnerships
of the CCR. An amendment was
added in 2011 to includes the development of mouse monoclonal antibodies. Dr. Shoshana Segal, assistant
director for technology development
in the Office of Science and Technology Partnerships, says the organization was introduced to Rockland by
the leader of one of its core facilities,
which had been engaged with Rock-
Since 1962, Rockland Immunochemicals has provided products for biotechnical
research, including antibody lines, blood products and cell cultures.
land in a fee-for-service agreement.
“When we first met with Rockland and presented our partnership
plan, they showed enthusiasm for
working with our scientists regardless of their investment,” says Segal.
“The company recognized the benefit of working with thought leaders
in cancer research. Our scientists
know the most important antigens
to target for antibody development.
Furthermore, our laboratories possess a wide variety of model systems, which are ideally suited for
testing and validating the quality
and usability of the antibodies.
“We are now seven years down
the road, and the relationship is still
going strong,” she adds. “It has been
a great opportunity for our investigators to work with Rockland scientists and have their desired antibodies developed.”
According to Segal, Rockland has
successfully developed and deliv-
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a majority of which have been marketed, and 40 others are at different
stages of development.
“Rockland’s antibody technology
platform continues to be widely
received by the research and biopharma community,” James Fendrick, CEO of Rockland, said in a
press release. “We anticipate continued success in our antibody efforts
with NCI to discover and develop
both novel and existing antibody
targets that have broad application
in the life-science markets.”
Rockland’s antibody work spans
a variety of indications, including
cancer, immunology, cardiovascular, neuroscience, stem cells and
developmental biology. Antibodies
have gained significant popularity
in the field of cancer in particular,
and Smith notes, “the commercial
potential is tremendous.”
“Today, many drugs approved for
SEMANTIC
continuEd from paGE 12
Suite.’ Because of this dynamic
extensible and data-container
agnostic framework, data can be
mapped to ontological concepts and
are easily reconfigured to changing
scientific needs.”
Most importantly, Gombocz
believes, it enables discovery of pattern-based relationship clusters and
interactions not previously apparent.
Graphic icons represent proteins,
diseases and organisms, for example,
with colors and thicknesses of connecting lines indicating relative
strength of the relationships. Users
can also infer and reason across the
graph to create pattern-based queries
containing, for instance, signatures
for a specific biological function.
“With the ever-growing Linked
Open Data (LOD) in semantic format,
IO’s technology provides tools to
build and enrich knowledge bases for
specific user needs—such as liver
toxicity categorization, comparative
effectiveness of cancer treatments,
risk assessment of organ transplant
failures or differentiation of stable
versus ruptured plaques in cardiac
release are large-molecule therapeutics composed of antibodies.
These biologics, along with smallmolecule drugs, create a need and
demand for companion diagnostics
whose foundation is also antibodybased. Antibodies are critical to
diagnostics and therapies that will
make affordable, personalized cancer care possible,” he adds. “More
precise delivery of cancer therapies
both increases the quality of care
and enhances cost management.”
Smith notes that Rockland is currently involved in more than 25 collaborations in addition to the NCI
agreement. Its other partners include
Scripps Research Institute, NYU
Langone Medical Center, Emory
University and Lankenau Institute
for Medical Research. He says the
company is a strong believer in collaborations, and is “in active discussion” with other organizations in
both academia and industry.
“The pace of scientific discovery
will be set by organizations that form
partnerships to build a better understanding of the disease process.
Financial necessity is the mother of
collaboration today,” Smith states.
“But, more importantly, the combination of academic and industrial
know-how forges sheer brilliance
and entrepreneurial spirit into a
single potent force. Those leaders
who capture and combine effectively
the mindshare of top scientists and
entrepreneurs will deliver results at
a higher rate. Simply, these partnerships encourage worthy innovation
and exacting financial discipline that
together produce commercially sustainable scientific achievement.” ddn
GE
continuEd from paGE 12
diseases, which are all cases where
IO has applied its technologies in the
past. This way, knowledge is never
stale; it can keep pace with scientific
advances, and is actually actionable—
you can use it as decision support in
screening and diagnostic or therapeutic applications,” Gombocz says.
Currently, there are about 45
public databases in use by IO that
contain information on organisms,
pathogens, genes and proteins.
“One application of this novel
approach is to identify peptides
from different microorganisms with
a common mechanism of actions,
and to categorize them as potential
biomarkers, and it also has the capability to detect microbial threats
prior to onset of disease symptoms,”
says Ali Pervez, vice president of
marketing at Sage-N Research.
“Future applications of this technology will enable automated
screening for biological threats, to
characterize origin and type of disease and to develop preventive
measures (drugs or vaccines) effective for several classes of microorganism,” adds Robert Stanley,
president of IO. ddn
tomers optimize every stage of
their manufacturing process,
has the potential to increase
production flexibility and to
deliver higher yields of finished
product while reducing time to
market,” said Dr. Nigel Darby,
vice president of GE Healthcare’s BioTechnologies business and chief technology officer for GE Healthcare Life Sciences, in a news release about
the deal. “With the global focus
on spiraling health costs and
the need for sustainable healthcare, these are critical issues for
the industry.”
Xcellerex has developed
some very interesting technologies that are a great fit within
GE Healthcare, Flyborg says.
“We’re increasingly finding
that our customers are looking
for what we call a start-to-finish
approach,” she says. “Customers want more than just buying
individual components—they
want to work with a partner
who can offer an integrated
range of products and services,
and a company that can help
optimize every stage of their
manufacturing process, both
upstream and downstream.”
That customer demand for
an integrated approach is
behind many of the company’s
other recent acquisitions and
other activities, Flyborg adds.
“And now we’ve announced
our plans to acquire Xcellerex,” Flyborg says. “It’s about
linking up and integrating all
the elements of the manufacturing process.”
The plan is for Xcellerex to
become part of GE Healthcare’s BioTechnologies business. Although the integration
plan won’t begin in earnest
until after the closing of the
acquisition, Flyborg says the
intention right now is for the
Xcellerex business to continue
operating out of its existing
facilities in Marlborough.
“It’s really important to
stress that this is about growth
and development, not consolidation,” Flyborg explains.
“Xcellerex has a well-respected team of highly-talented
staff, and we plan to invest and
grow the business further.”
Zacks Investment Research
notes that Xcellerex’s modular
technology looks like it can be
integrated well with GE
Healthcare’s cell culture products, adding in an investor
note, “Also, being of a modular
nature, they will go down well
with customers because of
easier installation. This in turn
will speed up deployment,
thus showing quickly on GE
Healthcare’s top line.” ddn
eDitconnect: e041212
b r i e f s
OGI invests in Rna Diagnostics
TORONTO— The
Ontario Genomics Institute
(OGI) has announced an investment, through its
Pre-Commercialization Business Development
Fund, in Rna Diagnostics Inc., an early-stage
molecular diagnostics company developing
assays to assist in chemotherapy management.
The funding will help Rna Diagnostics develop
and validate its lead product, the RNA Disruption
Assay. The assay will aid in determining whether
a patient is responding to therapy earlier in the
course of treatment than current methods.
“One of the key aims of personalized medicine is to provide the right medicine to the right
patient at the right time. This assay monitors
molecular data from a particular patient to help
inform clinical decisions for that patient,” Dr.
Mark Poznansky, president and CEO of OGI, said
in a statement. “Rna Diagnostics has the potential to create innovative products for the
Canadian healthcare system and beyond.”
NextGen finalizes
diagnostics subsidiary
LONDON— NextGen Group PLC recently
announced that the establishment of its new
diagnostics subsidiary company, NextGen Sciences Dx Inc., has been completed. The new
company, which is located in Boston, will focus
on the discovery of biomarkers that can aid in
the development of tests for central nervous
system disorders such as Parkinson’s disease,
dementia and traumatic brain injury. The diagnostic projects the company is currently working
on will make it possible for patients to be tested both for the diseases themselves, for changes in their condition and to determine whether
drugs that are currently in use or being studied
will be effective in treating the disorders. NextGen expects that progress will be made within
the next six months on the filing of intellectual
property.
Personalized medicine
market exceeds $28 billion
NEW YORK—Kalorama
Information noted in a
recent report that the personalized medicine testing market surpassed $28 billion in 2011. Tests
for personalized medicine continue to gain popularity, especially in oncology, where many new
medicines come paired with diagnostic assays.
The tests are most popular in this area given the
need to determine ideal methods of treatment
individually and improve survival rates for patients.
Tissue tests that determine which therapy to pursue for cancer treatment, such as immunohistochemical stains and in-situ hybridization, are what
have been turning personalized medicine into a
reality, the report notes. These tests are expected
to experience better-than-average IVD industry
revenue growth rates in the next five years. Kalorama listed Abbott Diagnostics, Dako and
Roche/Ventana Medical as the market leaders in
pharmacodiagnostic histology.
Translating pilot into full collaboration
Molecular Response, OncoMed
sign deal to expand existing
relationship in oncology
By Jeffrey Bouley
SAN DIEGO—Molecular Response and Redwood City, Calif.-based OncoMed Pharmaceuticals Inc. already had what they considered a successful pilot program to develop
unique patient-derived tumor xenografts
(PDX) through the use of Molecular
Response’s proprietary cell bank of primary
tumor cells—but late February saw the two
companies announce a new agreement to
expand this relationship.
Under the terms of the agreement, the collaboration will deliver molecularly characterized PDX models for multiple cancer indications, with full utilization of Molecular
Response’s highly optimized pre-screening
and characterization methodologies.
According to OncoMed, the relationship
began in late-2010, when Molecular Response
“The alliance provides an opportunity for
OncoMed to expand their already extensive bank of
proprietary xenograft models derived from freshly
resected human cancers based on the molecular
profile of the tumors as well as complement OncoMed’s
existing biomarker and patient selection efforts.”
Dr. Ann Kapoun, vice president of translational
medicine at OncoMed Pharmaceuticals
approached OncoMed to discuss their capabilities for identifying predictive markers of
therapeutic response. In mid-2011, they began
a pilot study in which OncoMed successfully
developed patient-derived tumor xenografts
from a subset of Molecular Response’s bank
of cryopreserved tumor cells.
Communicating via email, Dr. Ann
Kapoun, OncoMed’s vice president of translational medicine, tells ddn that “OncoMed’s
expertise in developing and characterizing
PDX models coupled with Molecular
Response’s vast collection of viable patientderived cryopreserved human tumor cells
will allow the collaboration to be highly productive for both companies.”
“The alliance provides an opportunity for
OncoMed to expand their already extensive
bank of proprietary xenograft models derived
from freshly resected human cancers based on
the molecular profile of the tumors as well as
complement OncoMed’s existing biomarker
and patient selection efforts,” Kapoun adds.
pdx continued on page 17
Reinforcing
their lines
Illumina stands fast
as Roche continues
takeover attempt
By Kelsey Kaustinen
ZURICH—Facing
whether too many, or too few, copies of a particular gene are present or whether certain
genes have rearrangements that play an active
role in disease progression.
“The use of FISH to determine genomic
status and the link to therapeutic outcome in
oncology is one of the fastest-growing applications. In this instance, a FISH assay will be
developed to examine copy number of the
TP53 gene,” she adds.
The Abbott FISH assay will be evaluated
in clinical trials to help identify patients more
likely to respond favorably to Merck’s as-yet
unidentified investigational cancer therapy.
Merck evaluated number of potential partners, finally choosing Abbott for this test.
“We have proven capabilities to take a
a continuing uphill
battle in its effort to acquire Illumina
Inc., Roche announced earlier this
month that it has other alternatives in
mind if its proposed takeover fails.
“Roche and Illumina both stand to
benefit from a rapid merger. However,
this is a sector where we have other
options should the transaction fail over
price,” Franz Humer, chairman of
Roche, said at the company’s annual
shareholder meeting.
Roche’s acquisition efforts, which
began in January, have not progressed
very far as of yet. Illumina’s board of
directors rejected Roche’s $5.7 billion
offer and cautioned its shareholders not
to tender their shares to the offer, even
going as far as enacting a “poison-pill”
stock defense. The offer was due to
expire on Feb. 23, and on Feb. 27, Roche
announced that approximately 102,165
shares had been tendered, and extended its offer to March 24 at midnight.
Illumina announced on March 19
that it had filed definitive proxy materials with the U.S. Securities and
fish continued on page 16
roche continued on page 17
Merck will collaborate with Abbott to evaluate the use of a fluorescence in-situ hybridization (FISH) companion
diagnostic test to aid in the development of a Merck investigational cancer therapy.
Abbott and Merck go FISH
Companies to develop
FISH-based companion
diagnostic for oncology
By Lloyd Dunlap
ABBOTT PARK, Ill.—Abbott will collaborate with
Merck to evaluate the use of a fluorescence insitu hybridization (FISH)-based companion
diagnostic test to aid in the development of a
Merck investigational cancer therapy.
FISH-based companion diagnostic tests
are designed to identify specific DNA
sequences to help guide physicians in determining which patients are more or less likely
to benefit from a particular therapy. FISH
technology has a variety of uses, an Abbott
spokesperson points out. It can identify
diagnostics
Getting an Angle on cancer
fish
ContInued FRom page 15
parsortix signs
research agreement
with paterson Institute
GUILDFORD, U.K.—Parsortix Inc. has taken the
wraps off a two-year research agreement with
the Cancer Research UK-funded Paterson
Institute for Cancer Research.
According to Andrew Newland, CEO of
Angle, which owns 90 percent of Parsortix,
Parsortix will work with the Paterson Institute’s Clinical and Experimental Pharmacology Group (CEP), which specializes in circulating tumor cells (CTCs). While terms of the
agreement have not been released, Newland
says all of the intellectual property and commercial value resulting from the work rests
with Parsortix.
The Paterson Institute, which is part of the
University of Manchester’s cancer research
unit, is renowned for its work on validating
biomarkers based on CTCs, a key area of relevance for the treatment of cancer patients.
According to Newland, the focus of the collaboration will include cancer patient blood
studies to provide further independent confirmation of the performance of the Parsortix
device and to optimize its design; development
of research and clinical applications of the
Parsortix device utilizing cancer biomarkers;
evaluation of the Parsortix cassette CTC capture characteristics in relation to other CTC
technology platforms; and in-depth comparative studies to support regulatory approval
submissions by Parsortix for CE marking in
Europe and U.S. Food and Drug Administration approval in the United States.
“They will then be running multiple separations on cancer patients’ blood and give us
advice on how to improve the efficacy of what
we are doing,” Newland says. “They will then
be doing comparative analysis comparing our
mIKe peeL/WWW.mIKepeeL.net
By dAVid huTTon
The Paterson Institute, which is part of the University of Manchester’s cancer research unit, is renowned for its
work on validating biomarkers based on circulating tumor cells.
technology against other existing technologies, including one product on the market and
others that are being developed.”
Newland says the application of CEP’s
expertise in biomarkers will be highly beneficial to facilitating the development of Parsortix’s CTC capture device and taking it to
market.
The Parsortix CTC research at the Paterson
Institute will be led by CEP director Prof.
Caroline Dive and her deputy, Dr. Ged Brady.
“The Parsortix cell-separation technology
offers the potential for improved capture of
CTCs from cancer patient blood, and since it
does not rely on antibody affinity capture, has
the potential to be both more effective and
more widely applicable than existing techniques,” says Dive. “We hope to be able to
recover viable CTCs from the Parsortix device
and be able to detect useful predictive and/or
pharmacodynamic biomarkers, which will
enable both an improvement in patient treatment and better targeted, more effective clinical trials of new cancer drugs in the future.”
Newland adds that “a key to the Parsortix
technology is it uses a counter diagnostic by
capturing circulating tumor cells in cancer
patients. The issue here is that the patient has
a primary tumor—let’s say a woman with
breast cancer. That tumor will disseminate
cancer cells into the patient’s bloodstream.”
“We believe that a simple blood test taken
on a regular basis can look for these circulating tumor cells,” Newland says. “Ahead of any
symptoms arising, they can potentially identify that a patient is at risk of a relapse or has
just relapsed. Treatment can be deployed early
and survival can be greatly enhanced.”
Newland adds that Parsortix “has a good
prototype and we hope to optimize the separation technology so that it works well for
research purposes.”
Development of the technology could yield
a revenue stream that could bring Parsortix
an estimated $50 million a year. The goal is to
have the research technology on the market
by the end of the year. ddn
ediTconnecT: e041215
Cambridge Healthtech Institute’s Eighth Annual
BIOMARKER
world congress 2012
MAY 21 - 23, 2012 | LOEWS PHILADELPHIA HOTEL | PHILADELPHIA, PA
conference programs
Featured Speakers
Felix W. Frueh
President
Medco Research Institute
Track 1:
Geert Kolvenbag
Global Product Vice President
AstraZeneca
Track 2:
Nicholas C. Dracopoli
Head, Oncology Biomarkers
Janssen R&D
Track 3:
Walter H. Koch
Head, Global Research
Roche Molecular Diagnostics
Track 4: Executive Summit:
Michael C. Little
Global Head, Diagnostics Development
Novartis Molecular Diagnostics
Biomarkers in Drug Development
Molecular Diagnostics
Biomarker Assay Development
Drug-Diagnostic Co-Development
Stafford O’Kelly
President
Abbott Molecular
BiomarkerWorldCongress.com
Please use keycode BMCDDN when registering
Duncan McHale
VP, Global Exploratory Development
UCB Pharma
product through the regulatory process,
manufacturing, distribution and implementation in a clinical lab setting,” the
Abbott spokesperson says.
Merck will be responsible for establishing the clinical trial sites with regard
to all aspects of patient recruitment and
therapy administration. Abbott Molecular will work with Merck to select the
FISH testing labs, and then Abbott will
provide assay training and monitor the
laboratory sites.
“Our goal through this collaboration,
and others like it, is to ensure that the
right medicine gets to the right patient,”
says Stafford O’Kelly, head of Abbott’s
molecular diagnostics business. “As one
of the early pioneers in companion diagnostics, we believe that linking genetic
testing with drug development at the earliest stages can increase the effectiveness
and predictability of medicines and help
physicians make more informed treatment decisions.”
Abbott’s portfolio of companion diagnostic tests includes the PathVysion
HER-2 DNA Probe Kit, which represents
one of the first examples of innovations in
the field of personalized medicine. The test
is approved for use in selecting breast cancer patients for whom Herceptin (trastuzumab) therapy is being considered. In
addition, Abbott’s Vysis ALK Break Apart
FISH Probe kit was approved in 2011 for
use in identifying non-small cell lung cancer patients for Pfizer’s XALKORI (crizotinib) treatment in the United States,
Canada, South Korea, Japan and a number
of other markets. Global commercialization continues to progress as Xalkori and
Vysis ALK receive additional individual
country approvals, Abbott notes.
“Our collaboration with GSK was
expanded in November 2011. The existing
agreements focused on the development
of PCR tests to screen non-small cell lung
cancer and melanoma tumors for expression of the MAGE-A3 antigen. Under the
expanded agreement, Abbott will develop
a PCR test for use on the Abbott m2000rt
instrument, to screen non-small cell lung
cancer tumors for the expression of the
PRAME antigen. PRAME is a preferentially expressed antigen of melanoma that
is expressed in 69 percent of non-small cell
lung cancer cases, as well as in a wide variety of cancer types, including melanoma,
breast, ovarian and bladder cancer, with
limited expression in normal cells,” the
spokesperson tells ddn.
In an unrelated development, Abbott
will collaborate with Genetics Laboratory Inc. (GenLab) on the development of
a molecular diagnostic test that will be
designed to rapidly detect microorganisms that cause orthopedic infections.
Under terms of the agreement, Abbott,
in conjunction with GenLab, will develop
and commercialize the new assay for use
on the PLEX-ID automated microbial
identification system. In the United
States, PLEX-ID is currently intended
only for non-diagnostic use, but assays
are now being developed for future clinical diagnostic uses. PLEX-ID is capable
of generating results within hours rather
than days. ddn
ediTconnecT: e041213
roche
Exchange Commission in connection with its 2012 annual meeting,
which is set to take place on April 18.
Illumina also urged its shareholders
once again to reject Roche’s offer.
Illumina’s annual meeting has the
potential to be a turning point for
the acquisition saga if Roche’s nominees are elected to Illumina’s board
of directors and Roche’s proposals
are approved, allowing it to gain
majority control of Illumina’s board.
On March 20, Roche responded
with an announcement that it too
had filed its definitive proxy statement and had sent a letter to Illumina’s shareholders from Severin
Schwan, CEO of the Roche Group,
encouraging them to accept its
acquisition offer.
Reiterating what he sees as the
benefits of Roche’s offer, Schwan
also added that Illumina’s outlook
pdx
“This is important for us because a
strategic focus for the company is
to develop therapeutic antibodies
and to target their clinical use in the
subsets of patients most likely to
benefit. The priority is to develop
focused clinical plans, which
include patient selection strategies
at early stages of clinical testing.”
“Development of characterized
diagnostics
PDX models is a natural addition
to our core competencies in working with patient-derived primary
tumor cells. OncoMed is a leader in
cancer stem cell therapeutics and
a most discerning partner in evaluation of new PDX models,” said
Cyrus K. Mirsaidi, CEO of Molecular Response. “The expanded collaboration with OncoMed is proof
of our success and continued commitment to enable further evaluation of cancer therapeutics in better
characterized models with use of
our high-content, cell-based platforms and exclusive patientderived primary tumor cell bank.”
OncoMed is a privately held
clinical development-stage biopharmaceutical company developing
therapeutics that target the biologic
pathways critical to tumor-initiating cells, also known as cancer stem
cells. OncoMed has advanced three
anti-cancer stem cell monoclonal
antibodies into the clinic: OMP-
21M18, OMP-59R5 and OMP-18R5.
All three of them target key cancer
stem cell signaling pathways,
including Notch and Wnt. In addition, OncoMed’s pipeline includes
several novel preclinical product
candidates targeting multiple validated cancer stem cell pathways.
OncoMed has formed strategic alliances with Bayer HealthCare Pharmaceuticals and GlaxoSmithKline.
ddn
Researching protein stability,
structure or formulations?
At press time, Illumina was still urging its
shareholders to reject Roche’s now $6.5
billion acquisition offer.
is uncertain, as it “will continue to
face revenue headwinds due to
uncertainty over government funding levels, corresponding hesitation
to spend by institutional/academic
customers, competition from innovative next-generation sequencing
devices and rapidly evolving novel
sequencing technologies.”
The March deadline came and
went, and subsequently was extended to April, with only a little more
than 144,000 shares tendered at that
point. Shortly thereafter, Roche
increased its offer to $51 per share
from the original $44.50 per share.
Illumina’s board also rejected that
offer as “grossly inadequate” and
once again urged shareholders not
to tender shares to Roche.
Analysts acknowledge that there
are definitely other players in the
gene sequencing section of the market, including Ion Torrent of Life
Technologies and Oxford Nanopore
Technologies, but Illumina remains
the market leader.
“There are alternatives, but not of
Illumina’s quality,” Karl-Heinz Koch
of Helvea said in a press release.
Martin Voegtli of Kepler Capital
Markets said he does not expect
Roche “will walk away from Illumina,” adding that if Illumina’s
shareholders “notice that they can’t
get much more, the pressure will
increase to examine a combination
of the Roche and Illumina businesses.” ddn
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Experimental Biology: 2012
April 21 – 25, 2012 San Diego Convention Center
n
b r i e f s
What to expect at Experimental Bio 2012
SAN DIEGO—Experimental Biology 2012, which will be held this year from April
21 to April 25 at the San Diego Convention Center, is a multidisciplinary scientific meeting featuring plenary and award lectures, pre-meeting workshops, oral
and poster sessions, on-site career services and exhibits featuring an array of
equipment, supplies and publications required for research labs and experimental study.
Generally speaking, the offerings at the meeting cover the fields of anatomy,
physiology, biochemistry, pathology, nutrition and pharmacology. For more information about the specific programs and the societies putting them on, visit www.
experimentalbiology.org.
The meeting is open to all members of the sponsoring and guest societies
and nonmembers with interest in research and life sciences, with the major
difference between the two groups of attendees being that members enjoy discounts on the registration fees. The majority of scientists represent university and
academic institutions as well as government agencies, nonprofit organizations
and private corporations.
The meeting is typically attended by some 14,000 scientists and exhibitors,
most of who represent the six sponsoring societies and some 30 guest societies.
Continuing medical education (CME) credits can only be earned this year for
sessions of the American Society for Investigative Pathology.
The poster sessions will be held in the San Diego Convention Center, but additional poster competitions will also be held at the San Diego Marriott Marquis and
Marina and Hilton Bayfront Hotel.
Great minds
think alike
The San Diego Convention Center is located
right in the midst of the downtown area, in the
harbor area on the edge of San Diego Bay.
Obscurins in breast tissue may predict
and detect breast cancer
BETHESDA, Md.—The Federation of American Societies for Experimental Biology (FASEB) notes that new research in The FASEB Journal suggests that
obscurins suppress breast cancer formation, and this finding may lead to a new
tool to help physicians assess breast cancer risk as well as diagnose the disease.
In the report, researchers from Johns Hopkins University and the University of
Maryland explain how proteins called obscurins, once believed to only be in
muscle cells, act as tumor suppressor genes in the breast. When their expression
is lost, or their genes mutated in epithelial cells of the breast, cancer develops.
“Our studies on the role of obscurins in the development of breast cancer lay
the framework for a series of in-depth investigations aiming to understand how
these proteins act to prevent tumor formation,” said Dr. Aikaterini KontrogianniKonstantopoulos, a researcher involved in the work from the Department of
Biochemistry and Molecular Biology at the University of Maryland School of
Medicine in Baltimore. “It is our hope that our research will provide important
new insights into breast tumor biology and ultimately yield new targets for the
development of innovative therapeutic strategies.”
FASEB releases new NIH state fact sheets
BETHESDA, Md.—The Federation of American Societies for Experimental Biology (FASEB) has released a new series of fact sheets describing the importance
of National Institutes of Health (NIH) funding to each state. Available on FASEB’s
web site, each fact sheet includes NIH funding by congressional district, a summary of the institutional and commercial biomedical research profile for the state
and an overview of the role of NIH support in advancing research accomplishments. In addition, the fact sheets feature talking points summarizing how investment in NIH research benefits local economies through job creation, improved
health of citizens and the promotion of innovation.
“With increased scrutiny of all government spending and research and development activities facing unprecedented funding cuts, it is imperative that scientists and concerned citizens educate their elected officials about the impact of
NIH funding on their communities,” said FASEB’s president, Dr. Joseph C.
LaManna. “More than 80 percent of the NIH budget is distributed to researchers
in nearly every congressional district in the United States. Cutting back on this
investment will delay discoveries that can lead to new treatments and improved
health. It will also discourage younger people who are interested in pursuing
careers in science.”
Experimental Bio show
brings together numerous
specialty societies
to advance knowledge
in drug discovery,
development and more
By Jeffrey Bouley
SAN DIEGO—The six separate programs from six differ-
ent professional societies that make up the Experimental Biology 2012 (EB 2012) meeting all have some connection to the world of drug discovery, drug development and diagnostics, though admittedly some have
slimmer connections than others. As with many annual
meetings in the life-sciences realm or associated with
life sciences, there is a broad audience to satisfy and
very little time in which to do that.
In the end, that probably works for the best for us
here at ddn, since there’s not enough room to talk about
six different programs in detail in one issue. However,
a few of the societies were kind enough to connect us
with program planners and organizers who have an
eye on discovery, development and diagnostics and
could share what value the meeting might hold for
researchers and others in those areas of expertise.
A ‘PET’ project
The American Society of Pharmacology and Experimental Therapeutics (ASPET) not only had its own
program to plan in detail, but also drew the straw for
overall show direction responsibilities for EB 2012 this
year. According to Dr. Scott Waldman, ASPET’s program chair, there is definitely a trend for more discovery
and development content in his society’s own
programming.
“We’ve had a growing focus on trying to emphasize
more and more the full spectrum of experimental therapeutics from initial discovery in the lab all the way
through translation and development of novel paradigms for patient and population management,” Waldman says. “What it really comes down to is an expansion of the focus on simple signal transduction, receptors, molecules and all that into a question of: ‘How are
we really going to translate discoveries into new patient
paradigms for treatment?’ We’re working hard to make
sure each of the major points along the developmental
continuum are represented.”
He points out that he works in experimental therapeutics and therefore spends a lot of his time dealing
with issues in the translational medicine realms. He
says that compared to recent years, the annual Experimental Bio meeting used to be less relevant to the things
he does.
“But the meeting has really evolved to have a much
wider character, including metabolic, neurological, psychological, cardiovascular, cancer—it really runs across
a very broad swath of disciplines—communities of practice, as it were,” Waldman says. “We’re really trying to
balance the whole molecules-to-man paradigm. Not only
is that healthy for the discipline because of the growing
emphasis on translational medicine and patient-based
EB 2012 continued on page 19
eb 2012
La Jolla Cove is a tiny
beach tucked between two
sandstone cliffs that is
said to be one of the most
photographed beaches in
Southern California and is
a popular location for
scuba divers and
snorkelers.
care, but at the end of the day, with all that great
discovery work, we hope that it ultimately does
translate into better patient management tools
and algorithms for care.”
Getting physiological
Another organization of special note at EB
2012 is the American Physiological Society
(APS), which celebrates a very big birthday
at the meeting as well as having much to offer
for those interested in drug discovery and
development.
“This represents the 125th anniversary of
the American Physiological Society, and
physiology is the basis of medicine. As such,
the science that is presented at the meeting is
aligned with drug discovery and development, because it’s about our understanding
of physiological function, its implications in
pathology and its ability to serve as a guide to
inform us in the development of treatments
and cures for disease,” notes Dr. Martin
Frank, the executive director of the APS. “As
drugs are developed, invariably one has to see
how they function in the living organism, and
that’s where physiology comes in.”
He says this year’s APS conference will
offer a tour of a multitude of physiological
concepts and systems and ways to think
about them, understand them and work
with them. Because of the anniversary, he
says, APS has encouraged organizers of the
various symposia to provide a bit of historical precedent and perspective in their presentations. In addition, the history group
within APS will be putting on a presentation at the meeting.
“We want to provide a little flavor of the
history and the science and the sources of all
the information they’ll be receiving at the
meeting and have learned over the years,”
Frank says.
“The purpose of this meeting for APS—as
well as our sister societies that partner with
us in the Experimental Bio meeting—is that
it’s an opportunity for our members and the
communities they represent to present the
latest sciences related to our disciplines for
our members, but also realize that it’s all tied
together into a much larger tapestry,” he
says. “Each of us is what I would call a basic
science society, and each of these basic sciences informs efforts toward drug development, so it’s an important for us to continue
Who’s who
among the
societies
Sponsoring societies at
American Association of
Anatomists (AAA)
■■ The American Physiological
Society (APS)
■■ American Society for Biochemistry
and Molecular Biology (ASBMB)
■■ American Society for
Investigative Pathology (ASIP)
■■ American Society for Nutrition (ASN)
■■ American Society for
Pharmacology and Experimental
Therapeutics (ASPET)
■■
to generate and advance and push the basic
science knowledge to generate the fuel for
drug development.”
Frank notes that the meeting is also important because it reflects a responsibility
toward helping future scientists grow and
develop in their careers. For example, many
graduate students and post-docs use this
meeting, he says, as one of their first opportunities to discuss their work with other
scientists but also attend workshops and sessions to prepare them to be independent
scientists in their own right.
“For the established and active scientists,
the extensive exhibit program is an important
it, another is on really trying to understand
heterogeneity in cancer and targeting individual tumors—that’s popular right now in
terms of personalized medicine, for example—and the last one is more forward-looking and tech-focused, looking at how the
tools and technologies can be made more
relevant to drug discovery.”
Jackson says that one reason to focus on
cancer as the avenue for addressing discovery
and development with ASBMB members and
other interested parties this year is because
of the wealth of good cancer models.
“I’d say in cancer, we’re well ahead of most
areas in the life sciences in terms of models
“The meeting has really evolved to have
a much wider character, including metabolic,
neurological, psychological, cardiovascular,
cancer—it really runs across a very broad swath
of disciplines—communities of practice.”
Dr. Scott Waldman, chair of the American Society of
Pharmacology and Experimental Therapeutics (ASPET)
element because of the opportunity to talk to
vendors about their research and their needs
and—for those who consider themselves sufficiently creative—perhaps write the next
great textbook or guide. For us, that is what
for most people would be the dream of writing the great American novel,” Frank says.
Bridging basic and clinical science
PHOTO BY JOANNE DIBONA
Westfield Horton Plaza is a five-level outdoor
shopping mall occupying more than six city blocks in
downtown San Diego, adjacent to the city’s Gaslamp
Quarter, and is known for its bright colors and unique
architectural styles.
The third society to speak with ddn about EB
2012 was the American Society for Biochemistry and Molecular Biology (ASBMB), which
Dr. Peter K. Jackson and Dr. Randall W.
King—both of them the drug discovery theme
organizers for ASBMB’s annual meeting at EB
2012—say is, for the first year, taking a strong
drug discovery focus.
“Obviously, the people we have in ASBMB
have a wide variety of tools and expertise, but
many people haven’t hooked that up with figuring out how to do drug discovery, so our
forums and other offerings help with that,”
says Jackson, who is director of cell regulation
at Genentech Inc.
“In terms of focus, we decided to concentrate on drug discovery in cancer just to give
our part of the Experimental Bio conference
a little more continuity than may have been
the case in previous years,” adds King, an
associate professor at Harvard University
Medical School. “We’ve organized around
four themes. One is sort of an outlier—on
parasitology—but everything else is dealing
heavily with drug discovery in cancer. One
theme is on cell death and how best to induce
compared to other diseases, such as cardiovascular,” he notes. “There’s a lot of heterogeneity in tumors but we also see a lot of
promise in terms of current and upcoming
breakthroughs, and there’s a lot of enthusiasm. Some of the best work in biochemistry
and molecular biology and some of the best
applications right now have happened in the
cancer arena and that’s setting the life-sciences industry up for all kinds of models that
might inspire and advance other therapeutic
areas as well.”
Also, according to King, a reason to focus
on cancer is because in the last decade,
researchers have really worked out how a lot
of signaling pathways operate, and that’s been
thanks to the basic scientists.
“Now we want to look toward applying that
knowledge therapeutically. We need to build
more communication between basic and
clinical scientists to move things even farther
forward,” he says.
Jackson notes that the three cancer-related
programs in the ASBMB lineup at EB 2012
essentially represent different key parts of the
overall process of cancer drug discovery.
“I think I’d emphasize the idea that we have
an overall program that targets the full range
of the drug discovery process, from finding
compounds and targets to the latest in integrating biochem and clinical biology,” King
adds. “I think there is something for everyone
in that sense, depending on what they want
to hear about and learn about.” ddn
Guest societies
participating in
American Association
of Anatomists
■■
■■
Brazilian Society of Anatomy
Chinese Society of Anatomical
Sciences
American Society for
Pharmacology and
Experimental Therapeutics
■■
Behavioral Pharmacology Society
American Physiological Society
American Federation for
Medical Research
■■ Association of Latin American
Physiological Societies
■■ Association of Physiologists and
Pharmacologists of India
■■ Austrian Physiological Society
■■ Biomedical Engineering Society
■■ Brazilian Society of Physiology
■■ Hungarian Physiological Society
■■ Kazakh Physiological Society
■■ The Microcirculatory Society
■■ Physiological Society of India
■■ The Physiological Society – UK
■■ Sociedad Mexicana de
Ciencias Fisiologicas
■■ Société de Physiologie – France
■■ Society of Experimental
Biology and Medicine
■■ Turkish Society of
Physiological Science
■■
American Society
for Biochemistry and
Molecular Biology
■■
Division of Biological Chemistry —
American Chemical Society
American Society for
Investigative Pathology
American College of Veterinary
Pathologists
■■ American Society for Matrix Biology
■■ International Society for Analytical
and Molecular Morphology
■■ International Society for Biological
and Environmental Repositories
■■ Società Italiana di Patologia/
Italian Pathology Society
■■ Society for Cardiovascular Pathology
■■
American Society for Nutrition
American Dietetic Association
American Society of Animal Science
■■ ILSI North America
■■ Korean Nutrition Society
■■ Plant Phenolic and Human Health
Research Interest Group
■■
■■
Famous places to go when you’re not at the show
San Diego Zoo
One of the premier zoos in the United States, this facility is a sanctuary for
thousands of animals and rare plants. Exhibits include a 7.5-acre multispecies habitat featuring elephants, California condors, jaguars and more that
helps teach visitors about the zoo’s conservation efforts. Animal enclosures
are designed to be as realistic as possible to promote the natural behavior
of the animals, so that guests can get a better sense of how the animals live
in the wild, whether they are polar bears in the Arctic tundra, okapis in
the Ituri Forest or bonobos in the jungles of the Congo.
The zoo offers a guided bus tour of the grounds, as well as the Skyfari
aerial tram that provides visitors a bird’s-eye view of the 100-acre facility.
At the Wegeforth Bowl and Hunte Amphitheatre, guests can watch animals
such as sea lions and wolves that can’t be seen anywhere else in the zoo
show off some of their natural behaviors. The zoo also features restaurants
ranging from the gourmet to the casual.
Wild Animal Park
If you didn’t get enough animals at the San Diego Zoo itself, or weren’t
satisfied that the enclosures were realistic enough, try a visit to the zoo’s
213-acre Wild Animal Park, a separate location featuring huge open
enclosures that allow herds of African and Asian animals to roam and
interact with each other. Visitors can get up close to these wild and
endangered animals thanks to the Journey into Africa tour, which emulates safari tours in Africa but with vehicles that run on biodiesel for a
more eco-friendly vibe. The experience brings visitors to eye level with
animals such as white rhinoceroses, giraffes, Cape buffalo, Roosevelt’s
gazelles, African crowned cranes and more.
Other animal exhibits can be found at the park as well, in a more zoolike fashion, allowing guests to see a cheetah, alligator, owl or boa constrictor, and the park features two different animal shows daily.
Mission Beach is a San Diego community built on a sandbar between the Pacific Ocean
and Mission Bay, spanning nearly two miles of oceanfront. A boardwalk runs along the
beaches on both the ocean and bay sides of the community.
Certainly, Shamu the killer whale is the most famous denizen of this aquatic
animal park, but there is also the Shark Encounter, which allows visitors
to walk through a submerged tube while sharks swim around them; the
Wild Arctic and Penguin Encounter exhibits; a California tide pool exhibit;
a freshwater aquarium and the World of the Sea aquarium; Wonders of
the River; and the Sesame Street Bay of Play. ddn
Sea World
This park reflects just how varied and thematic the LEGO toys themselves have become
over the decades, with rides, shows and attractions in areas with such themes as heroes
and adventurers, a lost kingdom, pirates, knights and more.
The historic Gaslamp Quarter consists of
more than 16 blocks around Fourth and
Fifth Avenues, and features more than 100
of San Diego’s best restaurants, more than
30 pubs and nightclubs and 100 retail
shops, as well as theaters and art galleries.
Named after Spanish maritime explorer
Vasco Núñez de Balboa, Balboa Park is a
1,200-acre urban cultural park in San
Diego. Among the offerings is a botanical
building, as well as sports-related venues
for golf, tennis and cycling.
Career advancement Public policy programs
at EB 2012
T
A pair of public policy programs is scheduled
to take place at Experimental Biology 2012, as follows:
he Federation of American Societies for Experi-
mental Biology (FASEB) Career Resources and Maximizing Access to Research Careers (MARC) program
office will offer seminars in the Career Resources
Center at the Experimental Biology 2012 annual meeting. EB
2012 registration is required to participate in the seminars.
Among the many offerings are sessions on
the following: using LinkedIn in the Ph.D. job
search, the nuances of the industrial hiring
process, preparing for a career transition in
the life sciences, Ph.D. negotiation skills, professional development for Ph.D.s, managing
the postdoctoral experience, leadership principles, job hunting in the biotechnology
industry and compensation negotiation for
scientists transitioning to industry.
FASEB Career Resources Center opportunities will also include a virtual career fair
before, during and after the meeting; computer-assisted registration, “search-andreferral” services, interview scheduling and
message services; on-site interview facilities;
a “position available” posting area (unlimited
postings included with employer registration); cover letter and resume critique workshops; and a message center for applicants
and employers.
The FASEB MARC Program is sponsoring
EB 2012 travel awards to help support the
participation of faculty, mentors, postdoctoral
fellows and students from minority institutions and historically black colleges and universities. The travel awards are funded for
travel-related expenses and meeting registration. Travel awards are provided as reimbursements after the meeting. ddn
Tutorial: National Institutes of Health —
Programs and Policies Update from Institutes
Chairs: John Chatham and Susan Barman
Tuesday, April 24, 2 p.m.
San Diego Convention Center, Room 1A
Inside the Beltway and Up on the Hill
Joseph LaManna, president of the Federation of
American Societies for Experimental Biology
Saturday, April 21, 9:30 a.m. to 10 a.m.
San Diego Convention Center, Room 7B
Future meeting dates
April 20 – 24, 2013: Boston
April 26 – 30, 2014: San Diego
March 28 – April 1, 2015: Boston
April 2 – 6, 2016: San Diego
oVERSEEing
Career
development O
sessions
ANATomy
Climbing the Academic Ladder:
Skills Needed for Each Rung
n■ Connecting with Different
Audiences: The Anatomy of
Communication
n■ Career Networking Break
n■ Ask a Career Advisor
n■
F THE SIX SPONSORING societies for the Experimental Biology
annual meetings, each one
rotates in terms of the program chair
and overall coordination duties for the
show. This year, that duty fell to the
American Society of Pharmacology and
Experimental Therapeutics (ASPET).
But acting as a kind of umbrella, or
perhaps more accurately a policy and
advocacy touchpoint, for ASPET and
the other five sponsoring societies—as
well as 20 other societies involved with
experimental biology—is the Federation
of American Societies for Experimental
Biology (FASEB).
Located in Bethesda, Md., FASEB was
originally created by three independent
scientific organizations to provide a
forum in which to hold educational
April 2012 • Drug Discovery News
it aLL
meetings, develop publications and disseminate biological research results.
As FASEB notes on its web site,
“What started as a small group of
dedicated scientists has grown to be
the nation’s largest coalition of biomedical researchers, representing 26
scientific societies and over 100,000
researchers from around the world.
FASEB is now recognized as the policy
21
voice of biological and biomedical
researchers.”
The mission of FASEB is to advance
health and welfare by promoting progress and education in biological and
biomedical sciences. The group marked
its 100th anniversary this year and
counts among its duties society management services; management of
scientific meetings, conferences and
exhibit halls each year; publication of
The FASEB Journal; and providing career
resources through job and resume postings and educational seminars. ddn
phySioloGy
Conflict Resolution: How to Keep
Everyone Happy!
n■ Do I Need Another Degree?
n■ E-Media Tools for the Professional
Scientist
n■ Publishing 101: How to Get Your
Work Published in APS Journals and
Avoid Minefields Along the Way
Imagine if Otto Warburg
had a Seahorse XF
Extracellular Flux
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n■
BioChemiSTry
pATholoGy
Career Development Workshop and
Breakfast: Getting Your Dream
n■ Job: Preparing Your CV and
Managing Your Interview
n■ 12th Annual Career Development
Program and Lunch: Fundamental
Basics for Success: How to Write
Award-Winning Grants
n■ Nutrition
n■ Scientific Career Advancement for
Early-Stage Investigators
n■ A Nurturing Environment Produces
Future Legends: Development of
Career through Successful MentorMentee Relationships
n■ Medical Nutrition Council Clinical
Emerging Leader Award Competition
n■ Nutritional Sciences Council
Graduate Student Research Award
Competition
n■ International Nutrition Council
Kellogg International Student Prize
Competition
n■ Postdoctoral Research Award
Competition endowed by Solae LLC
Finally, a real-time, kinetic measurement of the
Warburg Effect, glucose & glutamine addictions, and
fatty acid oxidation of cancer cells in a microplate.
Seahorse’s award winning XF Extracellular Flux
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Graduate Student-Postdoctoral
Colloquium: Communication
n■ Women in Pharmacology:
Networking Session
n■ Diversity Mentoring Breakfast
n■ WIP into Shape Networking Walk
n■ Student/Post-doc Best Abstract
Competition
n■
See our Cancer
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seahorsebio.com/
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phArmAColoGy
Webinars
On-Demand
% of baseline rate
ASBMB 16th Annual Undergraduate
Student Research Poster
Competition
n■ ASBMB Graduate and Postdoctoral
Professional Development Program
n■ ASBMB Welcome and Networking
Reception sponsored by the ASBMB
Minority Affairs Committee
n■ ASBMB Women Scientists Panel
and Networking Reception
n■ Inside the JBC: A How-To
Workshop for Authors
n■ Maximizing Institutional
Effectiveness
n■ Maximizing Teaching Effectiveness
n■ Maximizing Your Marketability
n■ Maximizing Your Global Outreach
n■ Professional Development
Workshop for Students, Post-docs
and Junior Faculty
n■ Speed Dating: Finding Your
Perfect Career “Match”
(for Undergraduates)
n■
b r i e f s
NWO to fund proteomics
research facility
DEN HAAG, The Netherlands—The Netherlands
Organization for Scientific Research (NWO) will be
funding $17.6 million for a large-scale proteomics
research facility known as Proteins@Work. The
project will be coordinated by Albert Heck of the
Netherlands Proteomics Centre and PRIME-XS,
and it will receive the funds over a period of five
years as part of the Dutch National Road Map for
Large-scale Research Facilities. The new facility will
produce technology and equipment for the study
of proteins in cells and tissues that are available
for researchers in the Netherlands. The Proteins@
Work program is a collaborative effort between
Utrecht University, the UMC Utrecht, the Hubrecht
Institute, the Erasmus MC Rotterdam and the
Netherlands Cancer Institute, and it builds on the
Netherlands Proteomics Centre and PRIME-XS.
Clinical Genomics Center
established by Lab21, ITOR
CAMBRIDGE, U.K.—Lab21
recently launched
a new Clinical Genomics Center at the Greenville
Hospital System (GHS) Memorial Medical Campus in Greenville, S.C. Located in the GHS Institute for Translational Oncology Research (ITOR),
the new center continues an ongoing collaboration to introduce complex biomarker analysis
into routine cancer patient management. A strategic relationship with Life Technologies, whose
Ion Torrent Personal Genome Machine will serve
as the key launch platform technology, led to
the establishment of the facility.
“Bringing this leading-edge technology to the
cancer clinic represents a significant breakthrough and the culmination of a seven-year
journey,” Dr. Joe Stephenson, medical director
for ITOR, noted in a statement. “This genomics
center is another major step towards fulfilling
our vision to provide personalized cancer care—
better enabling us to offer the right drug, at the
right time, to the right patient.”
Pfenex, DNA2.0 establish
research collaboration
SAN DIEGO—Pfenex
Inc. and DNA2.0 recently
announced a research collaboration under which
the two companies will work together to develop
an optimized algorithm and process for the design
and synthesis of genes that will be expressed in
Pseudomonas fluorescens, the microorganism
utilized in Pfenex’s Expression Technology platform.
The platform, which Pfenex’s web site refers to as
combinatorial biology, allows for “parallel processing to expression strain development.”
“Through this collaboration, two industry leaders will leverage their respective capabilities to
advance the Pfenex Expression Technology platform,” said Dr. Bertrand Liang, CEO of Pfenex. “We
are very excited about this project ... because it
allows us to enhance the capabilities of our technology which will enable us to increase the overall value proposition to our partners.”
Sanofi cultivates ‘research ecosystem’
Pharma partners with
Spain’s Centre for
Genomic Regulation to
explore potential of
translational medicine
By Amy Swinderman
BARCELONA, Spain—With the
goal of bringing together all of
the necessary components to
create what it calls a “research
ecosystem” capable of realizing
the promise of translational
medicine, Sanofi recently signed
a master research collaborative
agreement with the Centre for
Genomic Regulation (CRG),
an international biomedical
research institute supported by
the Catalan government and the
Spanish Ministry of Science and
Innovation.
The partners will collaborate
on a set of shared research programs using state-of-the-art
experimental platforms, computational and bioinformatics
approaches, medical genetics and
epigenetics, with special emphasis in genetic and rare diseases.
Financial details of the agreement were not released.
Within the framework of the
agreement, Sanofi and the CRG
have already initiated a first set of
projects to discover innovative
therapeutic approaches for infectious diseases, develop novel
delivery systems using synthetic
biology, decipher disease-relevant
cellular trans-differentiation
Located on the coast of Barceloneta Beach in the Barcelona Biomedical Research
Park, the Centre for Genomic Regulation is an international biomedical research
institute supported by the Catalan government and the Spanish Ministry of
Science and Innovation.
pathways and identify original
targets from unexploited genomic
transcription mechanisms. The
partners will select and launch
other unspecified collaborative
projects within the three-year
period of the agreement.
According to the partners,
these projects will bring added
value to basic research by offering a better understanding of
disease for pathologies such as
tuberculosis and cancer, and by
helping to develop new therapeutic solutions for their treatment.
“We recognize that in order to
deliver on our promise to address
patients’ needs, we need to tap
into and enable innovation inside
and outside our walls,” says Dr.
Maya Said, vice president for
strategy, science policy and external innovation in Sanofi’s R&D
division. “Our new relationship
with the CRG demonstrates our
commitment to work with partners on conditions with unmet
and growing medical needs.
“What we are doing with the
CRG is an indication of where
Sanofi is headed,” Said continues.
“As how we think about our entire
approach to drug discovery and
development evolves, we are trying to put all of the pieces we need
together to better develop drugs
that address patient needs. To do
that effectively, the question we ask
is, ‘how can we accelerate science
to get from the bench to the
patients?’ If you begin from that
starting point, the only way science
can be accelerated is if you put
together around the table people
who have the complementary
expertise to do that.”
In sum, “we’re really trying to
create a research ecosystem
here,” says Said. “This speaks to
our ability to bring different partners to the table and how we look
at open innovation. It’s not about
how you put the pieces together,
but how to drive the ecosystem to
achieve the things you would not
be able to achieve independently
of this ecosystem.”
Known as the Centre de Regulació Genòmica in Spain, the CRG
is a nonprofit foundation whose
mission is to “discover and
advance knowledge for the benefit of society, public health and
economic prosperity.”
The CRG receives most of its
funding for research and infrastructures from the government
of Catalonia through the Ministry of Economy and Knowledge
and the Ministry of Health.
Additional core funding is provided by the Spanish Ministry of
Economy and Competitiveness
and through an international
partnership with the European
Molecular Biology Laboratory
(EMBL). Other funding sources
include competitive grants from
public and private institutions at
regional, national, European and
international levels.
Located on the coast of Barceloneta Beach in the Barcelona
sanofi continued on page 23
Delivering genomics to routine care
Foundation Medicine announces collaboration
with Array BioPharma to help better target
patients for certain cancer treatments
By Jeffrey Bouley
CAMBRIDGE, Mass.—Foundation Medicine Inc., a molecular information
company that touts its ability to bring “comprehensive cancer genomic
analysis to routine clinical care,” announced in March a collaboration
with Array BioPharma, headquartered in Boulder, Colo. In this collaborative effort, Foundation Medicine will use its genomic sequencing and
analytic capabilities to assess potentially relevant molecular alterations
and thus assist Array in identifying patients who are most likely to
respond to treatment.
Array has a portfolio of targeted cancer agents that are in the early
stages of clinical development, and through this collaboration with
Foundation Medicine, Array seeks to determine the genetic profile of
array continued on page 24
Foundation Medicine’s “fully informative genomic profile capability is helping
partners to better understand the molecular basis of their clinical trials’
participants’ cancer in order to conduct clinical trials more quickly and
efficiently,” says Dr. Michael J. Pellini, the company’s president and CEO.
SAnofi
Biomedical Research Park (PRBB),
the CRG’s five primary areas of
research are bioinformatics and
genomics; cell and developmental
biology; genes and disease; gene
regulation, stem cells and cancer;
and systems biology. Among the
center’s other strategic partners are
the Federación Española de Enfermedades Raras, the La Caixa Foundation, Fundacion Botin, Novartis
and Belgium’s VIB.
“Developing drugs with the
understanding of what kinds of
compounds would be viable potential solutions for therapeutic needs
is something we do extremely well
as a pharma company,” says Said.
“What a research center like CRG
does very well is the basic science
for that. What
they bring
to the table
is expertise
around biology, gene regulation and
methodologies Sanofi’s Dr. Maya
and approach- Said says what the
pharma is doing in
es that comcollaborations like
plement what the one it recently
we have. We signed with the CRG
believe this is an indication of
partnership where the company
will be able to is headed. “We’re
make the most really trying to
create a research
out of the pub- ecosystem here,” she
lic funding says. “This speaks to
investment. It our ability to bring
also ensures different partners to
that public the table and how
f u n d i n g i s we look at open
innovation.”
being used to
develop therapies that impact
patients and address unmet needs.”
Dr. Luis Serrano, director of the
CGR, tells ddn, “Going from basic
science to biotechnology is a long
jump, and it’s not easy for research
institutes. Partnering with a big
pharma company is a good way to
ensure excellence and that what we
are doing has a higher probability
of being translated into a higher
level of biotechnology. In this
respect, both sides profit from the
pursuit of basic science.”
Research “cannot remain distanced from the needs of society,”
Serrano opines. “Biology is getting
ever closer to medicine, and an
institute like the Centre for Genomic Regulation must ensure that its
research has a positive impact on
human health and national economies. We cannot do this alone, and
we need to collaborate with strategic partners for this purpose.”
The partnership’s objective is “to
accelerate science by bringing
together these complementary sets
of expertise with a translational
research mindset,” says Said, but
she is critical of translational
research efforts to date.
“I personally think that a lot of
what has happened in the last 10 to
12 years is a breakdown in R&D
productivity, which is really an
omics & systems biology
issue that we in the pharma industry are dealing with,” she says.
“The issue is that as science seems
to have progressed, we as an industry have not been able to translate
that into better therapeutics. We
moved from a world where we
didn’t know much about molecular
biology to a world where the
Human Genome Project gave us
access to data, but we have not
changed our drug discovery
approach to exploit that data. We
are still searching the space in the
same way, but the difference is that
the wealth of data available has
expanded the search space.
“The reason this whole thing
breaks down is the assumption that
data is translatable to information
in humans, which we have proven
wrong,” she adds. “This is the gap
we are trying to bridge now. We
believe we can do it via a translational medicine mindset, but there
needs to be a fundamental change
in how we think about it.” ddn
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Dr. Luis Serrano, director
of the CGR, says the
center partnered with
Sanofi because “biology
is getting ever closer to
medicine, and an
institute like the Centre
for Genomic Regulation
must ensure that its
research has a positive
impact on human health
and national economies.
We cannot do this alone,
and we need to
collaborate with
strategic partners for
this purpose.”
Acquiring a peer across the Atlantic
Abcam to buy San
Francisco-based
antibody business
Epitomics with even mix
of cash and shares
tion outlet and customer support
antibody technology and gain a
base.
significant presence in the ChiNearly a year ago, in May 2011,
nese market. Epitomics develops
Abcam agreed to acquire
and distributes rabbit monocloEugene, Ore.-based MitoScinal antibodies—RabMabs—to
ences Inc., a provider of mitopharma and biotech developers
chondrial research tools—also
seeking new monoclonal antistated as being part of the misbody therapies, and the compaBy Jeffrey Bouley
sion to become the leading supny employs some 250 people,
CAMBRIDGE, U.K.—Early March saw British
plier of protein research and
biotech Abcam PLC, which supplies pro- with roughly 80 of them based Dr. Guo-Liang Yu,
detection tools.
tein research tools, release its interim in San Francisco and another 170 president, CEO and
Commenting on the half-year
results for the six months ended Dec. 31, in China. In addition to its anti- chairman of Epitomics
2011, and announce that it had entered into body work, Epitomics also does work in result announced in March—which saw
sales increase 13.5 percent and profit before
a definitive agreement to buy San Francis- reagents and in-vitro diagnostics.
Epitomics is currently led by Dr. Guo- tax, after adding back acquisition costs of
co-based Epitomics International Inc., an
antibody company with extensive opera- Liang Yu, who serves as president, CEO Ascent, increase 15.9 percent—Milner said,
tions in China, for a gross amount of $170 and chairman of the board. Yu received his “We are particularly pleased that, despite a
undergraduate education at Fudan Univer- tough macro-economic climate, Abcam has
million in cash and shares.
sity in Shanghai before immi- delivered revenue growth ahead of our peers
At the completion of the acquigrating to the United States and whilst also delivering strong profits growth
sition, which is expected to occur
did his graduate work at the and cash generation. Once again, these
no later than May 2012, EpitoUniversity of California, Berke- results demonstrate the strength of our busimics should have net cash of $15
ley and Harvard Medical School. ness model and the scalability of our eCommillion, resulting in net considAbcam’s products are used in merce platform.”
eration for the acquisition in the
Clearly, with Abcam’s lofty proteomic
cancer, cardiovascular, immunolamount of $155 million. Of that,
ogy, neuroscience and stem cell goals, the Epitomics acquisition and the
half is payable in cash and the
research, and it says it looks for- two that preceded it should not be viewed
remainder in new Abcam
ward to the addition of the U.S. as anything near the end of the line for its
shares—with the acquiring com- According to Abcam
pany issuing 14.5 million new CEO Jonathan Milner, company as this will allow it to M&A activities.
the anticipated
“These are exciting times for Abcam as
provide custom-made antibodies
shares, or about 7.3 percent of
acquisition of
and gain access to the fast-grow- we continue to source new products to add
Abcam’s enlarged issued share Epitomics “marks a
to our catalogue whilst also searching for
ing in-vitro diagnostic market.
capital, to make that happen.
gigantic step” in his
This acquisition would make M&A opportunities to create the world’s
The new Abcam shares will be company’s goal to
the second in a six-month peri- leading life-science reagents company,” Milsubject to a lock-up on resale that become the leading
od for Abcam and would be its ner says, adding that he is “delighted” to add
expires six months after the ten- supplier of protein
research and
largest purchase to date. In Sep- Epitomic, “which marks a gigantic step
der offer closes and on other
detection tools.
tember 2011, Abcam agreed to towards our ambition of creating the world’s
restrictions on resale imposed by
U.S. securities laws. Abcam and Epitomics acquire Ascent Scientific Ltd., a specialist leading life-science reagents company.”
Reporting by Reuters has revealed opinhave agreed to a $10 million mutual break provider of biochemical reagents—a purfee payable in certain circumstances if chase that extended Abcam’s product port- ions among analysts that the fit between
folio into small molecules and is consistent, Abcam and Epitomics is good, but that the
acquisition doesn’t complete.
According to Abcam CEO Jonathan Mil- Abcam says, with its vision of becoming size of the acquisition might pose difficulties.
ner, the acquisition should be earnings the world’s leading supplier of protein Investec analyst Sebastien Jantet called the
acquisition “sensible” while adding that it is
neutral in the first full year of ownership as research tools.
Ascent Scientific brought with it a a big step financially and logistically, “with
Abcam invests funds into the new business
to expand production and accelerate “diverse and rapidly growing range” of more the earnings enhancement back-end loadgrowth. Epitomics’ acquisition is expected than 400 bioactive small molecules, manu- ed.” Keith Redpath, an analyst with finnCap
to be accretive to earnings in the second full factured both in-house and through out- Ltd. thinks earning enhancement within the
sourcing. Ascent has a specialist production next few years will have to be “significant”
year of ownership.
The main reasons for the acquisition, and analytical facility based in Bristol, U.K., to justify the purchase price. ddn
Milner has noted, are to boost Abcam’s own which also serves as the primary distribu- EDITCONNECT: E041217
Epitomics, Leica Microsystems in pact Rabbit monoclonal
to supply rabbit monoclonal antibodies technology
NEWCASTLE-UPON-TYNE, England—Epitomics Inc. and Leica Microsystems announced at
the end of February that they have signed an agreement for the supply of proprietary
rabbit monoclonal antibodies to Leica Microsystems based on Epitomics’ RabMAb
technology.
The agreement also provides long-term support for Leica’s incorporation of Epitomics’
products into higher regulatory classifications of in-vitro diagnostic products.
In December, Leica released its one-step, double-staining detection system, Leica
ChromoPlex 1 Dual Detection for BOND, and the agreement with Epitomics will allow
the company to build a supporting range of antibody cocktails based on Novocastra
mouse monoclonal antibodies and RabMAb rabbit monoclonal antibodies, says Dr.
Konstantin Fiedler, vice president of advanced staining for Leica’s Biosystems
division.
“Additionally, with a selection of Epitomics’ rabbit monoclonal antibodies, we will also
be able to further strengthen our portfolio of Novocastra concentrated and Bond Readyto-Use antibody selection for our BOND instruments,” says Fiedler.
The agreement is an “important endorsement of the quality of Epitomics products in
the rapidly growing field of IHC for anatomic pathology,” says Dr. Guo-Liang Yu, president
and CEO of Epitomics.
“Epitomics has accumulated a collection of candidate antibodies for potential future
incorporation into companion diagnostics products in recent years. This strategic relationship will take us to the next level,” says Yu. ddn
E
pitomics has developed a proprietary
method for making monoclonal antibodies from rabbits rather than the conventional method of beginning with mice, which it
says offers many advantages: “The rabbit
immune system generates antibody diversity
and optimizes affinity by mechanisms that are
more efficient than those of mice and other
rodents. This increases the possibility of obtaining a functional antibody that will work in a
variety of applications. Additionally, many small
compounds and peptides do not elicit a good
immune response in mice, but do so in rabbits,”
says Epitomics.
Epitomics’ RabMAb technology is reportedly
the only currently available hybridoma-based
technology for making rabbit monoclonals, with
broad patents that cover not only the rabbit
fusion partner cell line, but also the method for
generating rabbit fusion partner cell line and
the antibodies produced from the cell line. ddn
array
tumors of patients who are treated with certain anticancer agents in its pipeline. The
ultimate goal is to increase knowledge about
how to identify patients who may respond to
a given targeted therapy and ensure that each
patient gets the optimal drug to treat his or
her individual disease.
“Foundation Medicine has established a
remarkable portfolio of collaborations around
the discovery and clinical development of targeted cancer therapeutics,” said Dr. Michael J.
Pellini, president and CEO of Foundation Medicine, in the news release about the deal. “The
molecular information generated by our platform is designed to help biopharma companies
like Array expedite the development of targeted
drug candidates that impact the genomic pathways driving a specific cancer.”
It’s a good pairing of partners because Foundation Medicine’s industry and academic part-
Foundation Medicine is dedicated to improving
cancer care through the development of
comprehensive cancer diagnostics that will help
physicians inform treatment decisions based on an
individual patient’s molecular cancer subtype.
nerships will complement Array’s core cancer
diagnostics capability, which is a comprehensive cancer genomic test that provides physicians with genomic information to help match
patients with treatments or clinical trials specific for the genomic profile of their tumor,
Pellini says. But looking at the bigger picture
and Foundation Medicine’s capabilities both
in this deal and with respect to past and
future collaborations, Pellini tells ddn his
company’s “fully informative genomic profile
capability is helping partners to better understand the molecular basis of their clinical trials’ participants’ cancer in order to conduct
clinical trials more quickly and efficiently. It
enables the partner to better stratify patients
for the trials, to seek out better ways to identify responders and non-responders, to identify why certain patients might have adverse
reactions, etc. Potentially, we can develop
companion diagnostics and help partners
match the right patients with the right drug.”
Foundation Medicine’s comprehensive
cancer genomic test uses next-generation
sequencing to analyze routine clinical specimens—typically, small amounts of formalin
fixed, paraffin embedded tumor tissue—for
molecular alterations in approximately 200
cancer-related genes.
The test is optimized for clinical-grade
analysis of tumor tissues, reportedly overcoming multiple complexities—including purity,
ploidy and clonality—inherent to tumor
genomes. Test results are reported through a
secure, interactive web site linking genomic
data to a structured knowledge base of relevant, publicly available scientific and medical
information. Foundation Medicine also aims
to provide information on relevant clinical trials to enable a more rapid recruitment of
patients into trials for targeted therapies. ddn
bridge
between Boston’s two National Cancer
Institute (NCI)-designated cancer
centers.
“New kinds of interdisciplinary collaboration are absolutely essential in
order to rapidly translate research
discoveries into clinical strategies that
will benefit patients in the near-term,”
says Tyler Jacks, director of the Koch
Institute.
DF/HCC, composed of many of Boston’s prominent research institutes and
hospitals, has previously brought
together thousands of researchers working in varied areas of cancer research.
Their newest partner, Koch, offers expertise in technical solutions for unmet
needs in cancer treatment. Their focus
includes innovations that will allow for
more precise treatment of some of the
most clinically challenging cancers.
Funding for the Bridge Project’s
research grants comes in large part
from philanthropists Arthur Gelb and
Thomas Peterson and two nonprofit
cancer research organizations, the
Lustgarten Foundation and the
National Brain Tumor Society. Together with the bioengineering expertise of
Koch and the clinical knowledge of the
DF/HCC’s oncologists, the partners
hope to extend their research efforts by
jointly funding innovative research
programs from both organizations.
Four research teams, selected by an
external advisory board and composed
of both DF/HCC and Koch Institute
researchers, have been chosen for the
initial phase of the Bridge Project.
These research endeavors include glioblastoma analysis, improved drug
delivery systems for pancreatic cancer,
pancreatic chemotherapy and novel
immunotherapy for pancreatic cancer.
Both of these forms of cancer present as
obstinate malignancies for which there
are few or no treatments available.
“We have made tremendous advances in many cancers in recent decades,
but pancreatic cancer and glioblastoma
remain exceedingly difficult to treat,”
says David Livingston, deputy director
of DF/HCC. “From a clinical perspective, we are eager to gain a more sophisticated understanding of the underlying
biology that’s driving these diseases,
and to work with leading scientists and
engineers to design fresh approaches
for how we might intervene.”
According to the Koch Institute’s
web site, future projects may include
“new tools to deliver drugs to recalcitrant cancer tissues, newly engineered
methods to rapidly define patient-specific molecular vulnerabilities and new
embedded sensors that can rapidly
assess if drugs being used are working.” The Bridge Project may extend its
target areas to melanoma and ovarian
cancer over the next five years.
Ultimately, the Bridge Project hopes
to cure cancer with ingenuity.
“We believe that success against
cancer will come if we apply the same
creativity and innovation to the
research enterprise that we do to the
research itself,” says Jacks. ddn
Ready and aiming
RNAi therapeutics
get new boost from
Arrowhead Research and
Axolabs strategic alliance
By Lloyd Dunlap
PASADENA, Calif.—Arrowhead Research Corp.,
a nanomedicine company with development
programs in RNAi therapeutics and obesity,
and Axolabs GmbH, a custom research organization offering preclinical solutions and
consultancy in the field of oligonucleotide
therapeutics, have entered into a strategic alliance and master services agreement.
“This agreement continues the execution
of Axolabs’ strategy to become the preeminent custom research organization in the
oligonucleotide therapeutics field,” says Dr.
Roland Kreutzer, managing director of Axolabs. “We know the colleagues at Arrowhead
very well. We are happy to support them in
establishing a leading role in the area of RNAi
therapeutics and excited to be chosen as their
preclinical service provider.”
Under the terms of the agreement, Axolabs,
founded by the principals of the former Roche
Center of Excellence for RNAi Therapeutics
in Kulmbach, Germany, will provide Arrowhead and its partners with oligonucleotide
optimization, synthesis and analytics. These
services include bioinformatics for siRNA
design; lead identification, optimization and
characterization; as well as siRNA synthesis
and CMC-related activities.
“With multiple candidates in the clinic
addressing a wide range of indications, data
demonstrating the power of RNAi as a therapeutic modality are rapidly accumulating,”
says Dr. Christopher Anzalone, Arrowhead’s CEO. “Having access to Axolab’s
expertise in preclinical development complements Arrowhead’s capabilities well and
provides us with yet another tool for pre-
clinical and clinical collaborations in the
field. Now, with the company’s already
established intellectual property position
and array of proprietary delivery technologies, including Dynamic PolyConjugates
(DPC) and RONDEL, Arrowhead is uniquely positioned to build its own pipeline of
RNAi therapeutics and provide partners
entry to this promising area in a rapid and
cost-effective manner.”
Delivery (RONDEL) system, the foundation
of which is a cyclodextrin-containing
polymer.
“Naked” siRNA is degraded and destroyed
by nucleases in the bloodstream and is not
taken up by cells, and also causes harmful
immune reactions. The RONDEL system’s
cyclodextrin-containing polymers protect the
siRNA and allow it to reach its destination
and perform its intended job; for example, to
Now, with the company’s already established intellectual
property position and array of proprietary delivery technologies,
including Dynamic PolyConjugates (DPC) and RONDEL, Arrowhead
is uniquely positioned to build its own pipeline of RNAi
therapeutics and provide partners entry to this promising area in a
rapid and cost-effective manner.”
Dr. Christopher Anzalone, CEO of Arrowhead Research Corp.
Arrowhead has used a nontransgenic
mouse model of chronic HBV infection of the
liver to test the efficacy of its DPC technology
for delivery of anti-HBV siRNAs. These mice
produce HBsAg and HBV viral particles that
are secreted into the blood. As a prelude to
successful clinical development and commercialization, Arrowhead has secured a license
granting it the exclusive right to develop,
manufacture and commercialize siRNA
therapeutics against the HBV genome to treat
HBV from Alnylam Pharmaceuticals Inc.
Alnylam President and Chief Operating
Officer Barry Greene notes that there are
three known modes for overcoming the delivery hurdles that have confronted RNAi therapeutics, liposome nanoparticles and chemistry conjugates (both Alnylam’s), and Arrowhead’s Dynamic PolyConjugates approach. In
addition, there is Arrowhead’s RONDEL
technology—new targeted, siRNA-containing
therapeutics that employ a proprietary threepart RNAi/Oligonucleotide Nanoparticle
stop the runaway growth of tumor cells.
Greene points out that RNAi represents a
whole new class of therapies that have the
near-term potential to transform a number of
diseases. One he points to is TTR-mediated
amyloidosis (ATTR), in which Alnylam is
developing ALN-TTR, a systemically delivered RNAi therapeutic that targets the transthyretin (TTR) gene, to treat ATTR. ATTR is
caused by mutations in the TTR gene, which
is expressed predominantly in the liver, and
results in the accumulation of pathogenic
deposits of mutant and wild-type TTR protein
in multiple extra-hepatic tissues, including
the peripheral nervous system, heart and the
gastrointestinal tract.
“As there are currently few options for
patients suffering from this devastating disease, we aim to rapidly advance our ALNTTR program and are committed to bringing
this important medicine to ATTR patients in
need,” he states. ddn
MJFF showcases Parkinson’s
disease advances by Kinemed
EMERYVILLE, Calif.—KineMed Inc., a specialist
in the identification and measurement of the
dynamic biochemical processes that cause disease, recently announced that it has been
awarded funding by the Michael J. Fox Foundation (MJFF) Industry Partnering Program.
The MJFF sponsored KineMed’s recently
completed pathway-based biomarker study
of neuronal function, which measures differences in brain neuronal transport function in Parkinson’s patients compared to
healthy controls. Using KineMed’s proprietary proteome dynamics technology, this
research showed, for the first time, abnormalities in biochemical pathways in neurons
in the living brain that appear to be associated with the pathogenesis and disease progression of Parkinson’s disease.
“Our foundation is devoted to developing
direct, proactive relationships with industry,
in order to drive advances toward better treatments for Parkinson’s disease,” says Dr. Todd
Sherer, CEO of MJFF. “The Partnering Pro-
gram encourages select awardees like
KineMed to publicly highlight their organization, team and projects, providing a formalized process for encouraging the kind of collaboration needed to make progress.”
KineMed President and CEO David Fineman says the company welcomes new alliances with “pharmaceutical collaborators
interested in using the cutting-edge techniques that we have brought to bear on the
challenge of Parkinson’s disease.”
“Research over the last decade has revealed
this disease to be much more complex than
was thought at first, and we now understand
why earlier generations of drugs that focused
on a single metric, such as dopamine level,
could not provide a cure,” Fineman adds.
“Just as a physician is able to directly ask a
patient whether he’s feeling better, a single
cerebrospinal fluid sample allows us to
directly query the overall health of living
neurons within the brain. Our unique ability
to sample several pathways simultaneously
not only detects whether patients have Parkinson’s or other neurodegenerative conditions, but also enables us to monitor progression and therapeutic reversal of underlying,
disease-driving processes that are responsible for a patient’s clinical course. This measurement approach enables drug developers
to know early on if their investigational therapies have genuine disease-modifying effects
that allow neurons to recover.”
Dr. Marc Hellerstein, chief of the scientific
advisory board of KineMed, says this work
represents “a tremendously promising clinical application of the proteome dynamics
technolog y that KineMed has been
developing.”
“The capacity to measure the metabolic
biology of protein cargo molecules in the living human brain had not previously been
possible. This technology has the potential to
transform the clinical monitoring of Parkinson’s patients, as well as other diseases,” Hellerstein adds. ddn
b r i e f s
License agreement centered
on ulcerative colitis compound
HEIDELBERG, Germany—Lipid
Therapeutics
recently announced a licensing agreement with
its development partner Dr. Falk Pharma GmbH
for the European rights to LT-02, Lipid Therapeutics’ lead product for the treatment of ulcerative
colitis. The compound is a delayed-release formulation of phosphatidylcholine intended to enhance
the barrier function of the mucosal layer of the
colon. After a co-development and option agreement, formed in 2009, Dr. Falk GmbH will be
responsible for further development and commercialization of LT-02 in Europe. A Phase III induction
trial in ulcerative colitis is planned for the compound in the second half of 2012. While specific
financial details were not disclosed, the license
stipulates an upfront fee, milestones and royalties.
Islet Sciences acquires DiaKine,
gains diabetes therapeutic
NEW YORK— Islet
Sciences Inc. recently
announced the establishment of a Share
Exchange Agreement to acquire DiaKine Therapeutics Inc. (DTI), a biopharmaceutical company focusing on developing therapeutics for
diabetes sufferers. Islet Sciences agreed to issue
an aggregate of 200,000 shares of its Series C
preferred stock in exchange for all issued and
outstanding shares of DTI, in addition to issuing
100,000 shares of common stock to certain of
DTI’s creditors in satisfaction of DTI’s liabilities
outstanding as of the agreement’s closing. Each
share of Series C preferred stock is convertible
into 10 shares of common stock.
“DiaKine’s drugs have the potential to reshape
the diabetes market by stopping the progression
of diabetes and reversing damage already
caused by the disease … We believe this acquisition will position us to capitalize on the exciting
opportunities emerging in our industry,” said John
Steel, chairman and CEO of Islet Sciences.
ACADIA, Allergan extend
ophthalmic collaboration
SAN DIEGO— ACADIA
Pharmaceuticals Inc.
announced the extension of its drug discovery and
development collaboration with Allergan Inc., which
began in March 2003. The collaboration, which is
centered on the discovery of therapeutics for glaucoma and other ophthalmic indications, has been
extended one year to go through March 2013.
During the extension period, Allergan and ACADIA
will jointly pursue ophthalmic research. Allergan is
entitled to exclusively license specific chemistry
and related assets for development and commercialization, and ACADIA will receive research funding as well as potential license fees and milestone
payments if certain agreed-upon clinical and
regulatory milestones are met. ACADIA also stands
to receive royalties on worldwide future product
sales. The companies have two other collaboration
agreements in effect, which have progressed to
clinical programs in chronic pain and glaucoma.
Crossing the ‘Valley of Death’
The Wistar Institute and the
Moulder Center join forces to
accelerate drug development
By Ashley Abraham
PHILADELPHIA—While harsh economic con-
ditions continue to force large pharmaceutical companies and biotech firms to focus on
the bottom line and scale back research and
development budgets, researchers at the
Wistar Institute and the Moulder Center for
Drug Discovery Research are aggressively
pursuing high-risk, high-reward drug development programs.
Wistar, an independent research institution,
and the Moulder Center, an academic research
center of Temple University, recently formed
an alliance aimed at interrogating discoveries
that have the potential for drug development.
“People talk about the valley of death, especially in hard economic times. Large drugs
companies and biotechs are risk-adverse;
they need to look at the bottom line, so interesting discoveries never get pursued. This is
the vacuum we are trying to fill,” says Dr.
Dario Altieri, chief scientific officer and director of Wistar’s Cancer Center.
The Wistar Institute, an independent research institution, and the Moulder Center, an academic
research center of Temple University, have formed an alliance aimed at interrogating discoveries that
have the potential for drug development.
The research conducted at Wistar is focused
on new target identification and drug discovery for the institute’s main research areas of
cancer and immunology. Its research is aided
by the advanced molecular screening facilities
housed by the University of Sciences in Philadelphia, which partnered with Wistar in 2010.
Joined together by JNK
Scripps, OPKO Health
announce deal for
Parkinson’s therapy
By Ashley Abraham
JUPITER, Fla.— The
Scripps
Research Institute has announced
a global license agreement with
OPKO Health granting OPKO
exclusive rights to develop, manufacture and commercialize a novel
compound that could potentially
Parkinson’s is a neurodegenerative disease caused by the loss
of dopaminergic neurons in the
substantia nigra, a part of the
brain involved in motor control.
The dopamine-transmitting neurons of the substantia nigra are
responsible for inhibiting motor
behaviors. As a result, the loss of
these neurons renders those with
Parkinson’s disease unable to
control their motor movements.
“A drug like SR-3306 that prevents
neurodegeneration would be a quantum
leap in the clinical treatment of
Parkinson’s disease because all current
therapies treat only the symptoms of the
disease, not the underlying pathologies.”
Dr. Philip LoGrasso, senior director
of drug discovery at Scripps Research
JNKs have been implicated in
abate the devastating effects of
Parkinson’s disease. The com- cell death through inhibition of
pound, SR 3306, inhibits a class of the JNK pathways. SR 3306 can
enzymes called c-jun-N-terminal potentially protect the brain
kinases (JNK) that are essential to against cell death that is characneuron survival. If successful, SR teristic of Parkinson’s and other
3306 could be the first treatment neurodegenerative disorders.
Lead researcher Dr. Philip
to prevent, slow or halt the progression of Parkinson’s disease.
jnk continued on page 28
Aided by USP facilities and a large library of
assays, researchers at Wistar have been highly
successful in novel drug target identification.
The Moulder Center’s medicinal chemists
and pharmacologists will focus on “taking those
targets discovered by Wistar scientists and
wistar continued on page 29
Being flexible
with Fleximer
Mersana, Endo collaborate on
antibody-drug conjugate development
By Kelsey Kaustinen
CAMBRIDGE, Mass.—A new collaboration was announced in early
March between Mersana Therapeutics Inc. and Chadds Ford,
Pa.-based Endo Pharmaceuticals for the development of nextgeneration antibody-drug conjugates (ADCs). Per the agreement, Endo will pay Mersana an upfront fee for the right to use
Mersana’s Fleximer technology to develop novel ADC candidates against a single cancer target.
“The collaboration with Mersana further enhances Endo’s
Discovery and Early Development portfolio and is validation
of our collaborative R&D approach for drug discovery and
development,” Ivan Gergel, executive vice president of research
and development and chief scientific officer at Endo, said in a
press release regarding the deal. “Using Mersana’s FleximerADC technology, we aim to develop more efficacious and safer
treatment options to improve patient outcomes.”
Under the terms of the deal, Mersana is responsible for generating the ADCs using Endo’s antibody and its own conjugation technology. Endo is responsible for providing novel antibodies, as well as product development, manufacturing and
commercialization of any Fleximer-ADC products that result
from the collaboration. The two companies can mutually agree
to pursue two more targets over the next two years, and if all
three targets are pursued, Mersana stands to receive more than
adc continued on page 29
bbi
nervous system (CNS) diseases—
with a unique pipeline of drug candidates that target CSCs.
“DSP made a decision to focus on
the cancer area,” says Roger Matthews, a spokesman for DSP. “However, there are many companies with
oncology businesses, and we considered that to enter this area we would
need a novel approach. BBI’s pipeline targets cancer stem cells, so this
acquisition fits into our strategy.”
That pipeline includes BBI608, a
first-in-class cancer stemness
inhibitor currently in the preparatory stage for Phase III trials for
colorectal cancer in North America,
as well as Phase Ib trials and Phase
II trials for multiple solid tumors.
RESEARCH & DEVELOPMENT
ratory diseases. Acquiring BBI, we
obtain R&D personnel with high
expertise and an excellent drug discovery platform. Using this as a
base, we plan to establish a global
R&D organization in oncology for
the DSP Group, starting in the
U.S.,” he says.
For BBI, the acquisition is a
happy ending to a tremulous start
and a tumultuous few years. In
2006, when ArQule prepared to lay
off 28 employees, Li decided to form
a new company to house the affected workers. He did so in the form of
a unique $5 million contract with
ArQule that outsourced early
research work to BBI for a period of
eight months—providing nearly
three dozen employees with jobs
and saving ArQule significant costs
in the process.
“As a biotech executive, I understand the harsh realities of running
a business, but I wanted to think
more creatively about how to create
a situation that would be good for
both the company and the employee.
I had a deep conviction that we could
do this, and in the process, save jobs
for the employee and avoid any negative impact on the company. It truly
was a win-win situation.”
Because ArQule did not take an
equity stake in BBI or transfer any
intellectual property, BBI is not considered a spinoff of ArQule, but is
instead a completely separate entity.
After completing its contract with
ArQule, BBI was further challenged
first by the economy’s subsequent
nosedive, then by government
restrictions on stem cell research.
“By the time we finished the
ArQule contract, the great recession
of 2008 hit. It was a hard time for an
entrepreneurs,” Li reflects. “But we
managed to create an innovative
company, and in the process, not a
single person lost a job.”
Once the acquisition is complete,
Boston Biomedical will become a
fully owned subsidiary of DSP.
Operations will continue in the Boston area. BBI’s employees will
remain with the company, and
DSP’s significant investment will
enable the company to increase its
R&D manpower. ddn
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Boston Biomedical Inc. was founded in
2006 by Dr. Chiang J. Li to provide
employment for approximately 30 R&D
scientists facing layoffs from Woburn,
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BBI608 is actually what brought
DSP and BBI together, as in March
2011, DSP signed an exclusive product option license agreement with
BBI on the rights of development
and commercialization of BBI608 in
Japan for all indications of cancer.
“After execution of the option
agreement with BBI, DSP recognized BBI’s innovative development
pipeline and its excellent ability of
drug discovery and development,
which led to DSP’s decision to
acquire BBI,” says Matthews.
Also in the hopper is BBI503, a
first-in-class cancer stemness
kinase inhibitor currently in multicenter Phase I clinical trials in
North America for advanced solid
tumors. BBI’s work on “cancer
stemness” was particularly attractive to DSP, as it has received a number of recognitions and awards in
the United States, including the
Frost & Sullivan 2010 North American Drug Discovery Technology
Innovation of the Year Award and
a 2011 Biotech Pioneer Award at the
Alexandria Oncology Summit.
“We see these as an expected
growth driver from 2015 onward,”
Matthews says of BBI’s programs.
The acquisition also gives DSP an
opportunity to establish R&D operations in the United States, Matthews adds.
“Our current footprint in the U.S.
is centered around our wholly
owned subsidiary, Sunovion
Pharmaceuticals Inc., with expertise in treatment for CNS and respi-
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Seeking ‘heavy’ ADME
Concert Pharma to
partner with Avanir
to develop and
commercialize
deuterium-modified
dextromethorphan
for nervous system
disorders
By Lloyd Dunlap
L E X I N GT O N, Ma s s . — C o n c e r t
Pharmaceuticals Inc.—a six-yearold company which is betting that
replacing hydrogen molecules with
deuterium will significantly and
ty (DCE) platform and is a deuterium-containing analog of dextromethorphan. The d-DM compounds
are covered under U.S. patent
7,973,049, which was issued to Concert in July 2011, as well as patent
applications in other countries.
Per Avanir’s regulatory filings, the
company is obligated to make milestone and royalty payments to Concert based on successful advancement of d-DM products for one or
more indications in the United States,
Europe and Japan. Individual milestone payments range from $2 million
to $6 million, $1.5 million to $15 million and $25 million to $60 million for
clinical, regulatory and commercial
targets, respectively. In aggregate, the
dextromethorphan, potentially
without the need for an enzyme
inhibitor such as quinidine,” says
Greg Flesher, senior vice president
of corporate development and chief
business officer at Avanir Pharmaceuticals. “As part of our portfolio
strategy, we intend to explore the
utility of d-DM in neurological and
psychiatric disorders where dual
NMDA antagonists and sigma-1
agonists may be beneficial.”
Dextromethorphan, in a class of
medications called antitussives, is
commonly known for its use to
relieve cough. However, Nuedexta,
(a combination of dextromethorphan and quinidine) is approved
for pseudobulbar affect (PBA), or
“d-DM is a great example of how deuterium
modification can, in favorable cases, create drug
candidates with the unique opportunity for both
substantially improved therapeutic properties over
existing medicines, and lower development expense
and risk compared to typical new chemical entities.”
Dr. Roger Tung, president and CEO of Concert Pharmaceuticals
favorably alter ADME characteristics of many small-molecule
drugs—and Avanir Pharmaceuticals have entered into an exclusive
license agreement that provides
Avanir worldwide rights to develop
and commercialize Concert’s deuterium-modified dextromethorphan (d-DM) for the potential
treatment of neurological and psychiatric disorders.
The agreement, announced last
month, includes the rights to multiple deuterium-modified dextromethorphan compounds. d-DM
was developed using Concert’s proprietary Deuterated Chemical Enti-
payments could total more than $200
million. Royalty payments are tiered,
beginning in the single-digits and
increasing to the low double-digits for
worldwide net sales of d-DM products exceeding $1 billion annually.
Avanir will have overall responsibility for research, development
and commercialization of d-DM.
Concert will provide manufacturing support for investigational new
drug-enabling studies.
“Concert’s DCE Platform has
produced several deuterium-modified dextromethorphan compounds that we believe may provide
therapeutically effective levels of
uncontrollable emotional outbursts
of laughing or crying. Avanir estimates there are 1.8 million people
with moderate to severe PBA.
The incorporation of deuterium
into specific molecular positions of
dextromethorphan, resulting in
d-DM, was done with two purposes,
says Dr. Roger Tung, president and
CEO of Concert Pharmaceuticals.
The first was to slow metabolism to
maintain the pharmacology of dextromethorphan; the second to provide significantly enhanced resistance to CYP2D6 metabolism and
improved plasma exposure in preclinical testing. As a result, d-DM
has the potential to be effective as a
treatment for neurological and psychiatric disorders for which dextromethorphan has shown pharmacological activity.
“We are very pleased to enter into
this collaboration with Avanir, who
we believe has the unique expertise
to best maximize the broad clinical
potential of d-DM. Avanir’s knowledge of dextromethorphan-based
therapeutics and their proven track
record to bring drugs to the market
make them the ideal partner for this
program,” says Tung. “d-DM is a
great example of how deuterium
modification can, in favorable cases,
create drug candidates with the
unique opportunity for both substantially improved therapeutic
properties over existing medicines,
and lower development expense
and risk compared to typical new
chemical entities.”
Concert focuses its efforts in
areas where there is a significant
opportunity to improve the absorption, distribution, metabolism and
excretion (ADME) profile of pharmacologically well-characterized
compounds, and where such an
improvement has the potential to
provide a clinical benefit.
Concert has investigated the
effects of selective deuterium modification on dozens of such compounds, including many validated
drugs, and currently has 18 issued
U.S. patents. The company has executed on this approach to become a
clinical-stage biotechnology company with its lead program in Phase
II clinical testing: CTP-499 for
chronic kidney disease. In addition,
Concert is developing a pipeline of
preclinical candidates in several
therapeutic areas. ddn
Concert Pharmaceuticals and Fast
Forward sign deal for MS program
C
oncert Pharmaceuticals Inc. also announced
last month that it has been awarded funding by Fast
Forward LLC, the National Multiple Sclerosis Society’s
subsidiary devoted to bridging the gap between research
and drug development, to fund the preclinical advancement of a
potential treatment for multiple sclerosis (MS).
Fast Forward will commit funding for the
clinical-stage development of C-21191, a deuterium-modified subtype-selective GABAA
modulator developed by Concert with the
therapeutic potential of treating spasticity and
pain in multiple sclerosis (MS).
C-21191 is a deuterium-modified analog of
L-838417, which was discovered by Merck &
Co. Inc. and extensively profiled in preclinical
testing by Merck and in numerous academic
laboratories. L-838417 possesses an attractive
pharmacological profile including minimal
sedation and ataxia, but has a poor pharmacokinetic profile, which prevented its progression to clinical evaluation.
C-21191 has demonstrated significantly
improved pharmacokinetic characteristics in
preclinical studies compared to L-838417, while
maintaining its desired biochemical profile. In
side-by-side studies, C-21191 demonstrated a
threefold to fourfold increase in exposure compared to L-838417 in several preclinical species.
This superior pharmacokinetic profile resulted
in a prolongation of exposure and a corresponding extension of pharmacodynamic
effects.
C-21191 also demonstrated equivalent efficacy to gabapentin in a neuropathic pain
model, with a superior duration of effect, at
doses that did not cause sedation or ataxia as
assessed by a rotarod model.
“We are pleased to partner with Concert on
this new approach with the potential to treat
spasticity and pain, which are so challenging
to large numbers of people living with MS,”
says Dr. Timothy Coetzee, chief research officer
at the National MS Society and Fast Forward.
“This collaboration demonstrates Fast Forward’s commitment to pursue and fund innovative medicines that can address unmet needs
and improve the quality of life for people living
with this disease.” ddn
jnk
LoGrasso, a professor in the Department of Molecular Therapeutics and
senior director of drug discovery at
Scripps’ Jupiter, Fla., campus, has
been studying the effects of SR 3306
for several years and recently published his findings in the American
Chemical Society journal Chemical
Neuroscience. His results show that
small doses of the drug produced a
marked increase in neuron survival
in cell cultures and animal models.
“It was a surprise that that level
of neuroprotection reduced the
behavioral impact so strongly,”
LoGrasso says, “but it’s indicative
of how it might perform in human
patients. While SR-3306 doesn’t
represent a cure, it does appear to
have the potential of stopping the
progression of the disease.”
Increasing the drug’s market
potential is its ability to be administered orally, as well as the success
it has had in preventing neuron
death in a rat model that mimics the
physical symptoms of Parkinson’s
disease.
“These studies present compelling data on the first oral, brainpenetrating inhibitor to show significant efficacy in preventing neurodegeneration in both mouse and
rat models of Parkinson’s disease,”
says LoGrasso.
Executives at OPKO are equally
enthusiastic about the potential SR
3306 has as a therapeutic for Parkinson’s, with Chairman and CEO Dr.
Phillip Frost noting, “We are excited
to be working with Dr. LoGrasso
and the Scripps Research Institute
to develop this important compound
which could prevent the progression
of Parkinson’s disease, and not just
treat the symptoms of the disease.”
There are currently no other
drugs on the market that target the
cause of Parkinson’s disease, Frost
notes. Current treatments such as
levodopa and MAO-B inhibitors are
aimed at controlling symptoms.
These drugs work by creating more
dopamine in the brain to compensate for the loss of dopaminergic
neurons, thus reducing symptoms,
but their effects only extend so far.
“A drug like SR-3306 that prevents
neurodegeneration would be a quantum leap in the clinical treatment of
Parkinson’s disease because all current therapies treat only the symptoms of the disease, not the underlying pathologies,” adds LoGrasso.
Though development of SR 3306
at OPKO is just beginning, the discovery presents a promising avenue
for treating Parkinson’s disease.
According to LoGrasso, “This
licensing agreement will help ensure
that the development of this promising compound keeps moving forward. This is one of the best opportunities we have for the development of an effective neuroprotective
treatment for Parkinson’s patients.”
Financial details of the agreement were not disclosed. ddn
wistar
developing innovative lead compounds which can impact those
targets,” says Magid AbouGharbia, director of the Moulder Center. “We are going to put
in our manpower and expertise
and align it with the expertise of
the structural biologists at
Wistar to move the collaboration forward. It is a fully integrated collaboration that has all
skills and abilities to discover
new molecules.” The Moulder
Center’s primary responsibility
is to address a novel compound’s pharmaceutical properties. Researchers will focus on
how a compound will be ingested, metabolized and excreted by
the body in order to make it
available for preclinical trials in
animal models.
“This is really an
inter-institutional
collaboration that
is based on mutual
commitment. ...
It’s really an academic
collaboration in
its purest form.”
Dr. Dario Altieri, chief
scientific officer and
director of the Wistar
Institute’s Cancer Center
Several research projects
have already been selected for
further investigation, including
inhibitors that target telomerase, a protein essential in cancer growth and the natural
aging process, and EpsteinBarr, a virus responsible for
numerous diseases including
forms of head and neck cancer.
Already underway is a line of
research that focuses on inhibiting a class of molecular targets implicated in cancer.
The terms of the collaborators’ agreement are exceedingly simple. Funding is provided solely from the research
centers, with all costs split
equally between them.
Emphasizing the trust and
commitment between Wistar
and the Moulder Center, Altieri says, “We will worry about
the lawyers and intellectual
property and royalties later.”
The objectives of the alliance
are unimpeded by lengthy
legal discussions. According to
Altieri, “This is really an interinstitutional collaboration that
is based on mutual commitment. There is no money transferred, no complex legal agreements. Our agreement simply
formalizes and outlines our
commitment to work together,
but it’s not a money issue. It’s
really an academic collaboration in its purest form.” ddn
adc
$270 million in milestones, as well
as royalties on worldwide net sales
of any ADC products that result.
Mersana’s ADC technology is
based on Fleximer, its proprietary
biodegradable polymer system, as
well as a range of linkers that allow
for attachment of various antitumor
payloads. Once Fleximer is loaded
with the drug of choice, it is attached
via a different linker to an antibody
or antibody fragment to create an
ADC. The novel linker systems are
stable in the blood stream and trigger payload release once they are
inside the targeted cancer cells.
“There’s a number of features
that really make our technology
next-generation, but I think the two
most prominent ones are that we
can load much more drug and a
variety of different drugs with different mechanisms of action. We’re
not limited just to the antitubulins
that one sees currently being used
for antibody-drug conjugates,” says
Timothy Lowinger, chief scientific
officer at Mersana. “We can use
many different types of anticancer
drugs effectively. The other key differentiator is because the Fleximer
technology can simultaneously
improve the pharmacokinetics of
small proteins, we don’t need to use
a full-size antibody; we can use an
antibody fragment as the targeting
group to deliver the drug payload,
and the real advantage there is that
you can control the size and have
the potential for much better solid
tumor penetration than you do with
a full-size antibody.”
The collaboration was the result
of mutual interest and interlocking
goals on the part of the two companies, says Michael Metzger, executive vice president and chief operating officer at Mersana. Mersana can
further develop its technology and
the milestone payments will allow
for additional investments into its
platform and programs, he notes,
adding that the company hopes to
build a pipeline with its technology.
The collaboration represents “an
important deal for us,” he says. ddn
b r i e f s
Xencor, Boehringer
Ingelheim partner on
biosuperior antibodies
MONROVIA, Calif.—Xencor Inc. and Boehringer
Ingelheim recently announced a collaboration
focused on certain of Xencor’s biosuperior monoclonal antibodies. Per the agreement, Boehringer Ingelheim will provide all manufacturing
and product supply for development from preclinical through Phase I. For its part, Xencor will
be responsible for preclinical and clinical studies,
and will retain all development and commercial
rights to products under the agreement. If clinical
programs are successfully advanced past Phase
I development, Boehringer Ingelheim will have
certain manufacturing rights to supply Xencor
with clinical and commercial material.
“Xencor and Boehringer Ingelheim will share the
financial risk in early preclinical and clinical development with the incentive of sharing in future success of the programs,” Dr. Bassil Dahiyat, president
and CEO of Xencor, said in a press release.
An immunological decision
Selventa, Janssen form research
agreement targeted toward
treating immunological disease
By Lori Lesko
CAMBRIDGE, Mass.—Personalized healthcare
company Selventa Inc. has signed a multiyear research agreement with biotechnology
firm Janssen Research & Development LLC
aimed at discovering new potential drugs targeted toward treating immunological disease.
The company declined to disclose the financial details of the deal.
Selventa, specializing in patient stratification for personalized medicine, formed the
collaboration with Janssen specifically to
develop disease models using diverse biologic
data to elaborate disease-relevant mechanisms, according to a Feb. 27 company news
release. Janssen, formerly known as Centocor
Research and Development Inc., is a subsidiary of Johnson & Johnson.
David de Graaf, president and CEO of Selventa, shed light on why Janssen was chosen
for this endeavor: “A past research project
with an affiliate of Janssen R&D yielded a joint
publication that sought to identify genes associated with intestinal permeability post-antiTNF therapy in ulcerative colitis,” de Graaf
stated in a news release. “We are very excited
to have the opportunity to continue to work
with Janssen R&D. Building comprehensive
disease models and investigating different
molecular mechanisms may provide key datadriven foundations for appropriate selection
of drugable mechanisms within a disease.”
Further, Selventa includes the assessment
of single and combination therapies, segmentation of potential responder and non-responder
immuno continued on page 32
Mayo Clinic, A&G
Pharma to develop
test for dementia
Jubilant announces
collaboration with Mnemosyne
new drug discovery collaboration was established last month between
Jubilant Biosys Ltd. and Mnemosyne Pharmaceutical Inc. focused on identifying preclinical candidates in neuropsychiatric diseases. The companies
will work to develop subunit selective NMDA receptor modulators (SNRMs) identified by Mnemosyne,
and the collaboration will initially run for two years,
though it can be extended by mutual consent
across other therapeutic areas. Mnemosyne will
have exclusive ownership of all intellectual property generated and will be responsible for clinical
development and commercialization.
“We are looking forward to a successful collaboration with Jubilant that will produce firstin-class drugs that address the unmet medical
need in neuropsychiatric diseases,” Dr. Kollol Pal,
CEO of Mnemosyne, said in a press release.
BANGALORE, India—A
Quintiles, RVC Biofund team up
for Russian clinical expansion
MOSCOW—Russian
Venture Co. Biofund and
Quintiles have announced a definite agreement
to support expansion of clinical development
services in the Russian Federation. The partners
will seek to address the healthcare initiatives at
the forefront of Russia’s Healthcare 2020 Development Program, including implementing best
practices to support medical science and developing healthcare in line with international standards. The companies intend to announce plans
for joint ventures in the near future.
“RVC Biofund was established last year with the
purpose of investing into biopharmaceutical service companies and biotech start-ups, as well as
streamlining the creation of projects in the sphere
of biotechnology and increasing their number,”
said Igor Agamirzian, CEO of Russian Venture Co.
David de Graaf, president and CEO of Selventa, says
his company signed a research agreement with
Janssen Research & Development LLC after a
previous research project with an affiliate of Janssen
R&D yielded a joint publication that sought to identify
genes associated with intestinal permeability postanti-TNF therapy in ulcerative colitis.
ROCHESTER, Minn.—The Mayo Clinic also announced last month that
A lab technician deploys an update to the fully automated Complete Genomics
sequencing system.
Making genomic
research whole
Mayo Clinic taps
Complete Genomics
to provide outsourced
whole-genome
sequencing
By Amy Swinderman
MOUNTAIN VIEW, Calif.—Recogniz-
ing the value that outsourced
whole-human genome sequencing may have for its medical
researchers, the Mayo Clinic’s
Center for Individualized Medicine announced in mid-February
that it has selected Complete
Genomics Inc. to provide
sequencing services.
The clinic’s new Center for
Individualized Medicine operates
a comprehensive sequencing
laboratory in its own Medical
Genome Facility, but it determined that collaboration with
Complete Genomics could supplement the services available to
its community of medical
researchers.
Complete Genomics Chairman, President and CEO Dr. Clifford Reid explains that the company recently completed a series
of small pilot projects with the
whole continued on page 31
Mayo Medical Laboratories has signed an agreement with A&G Pharmaceutical Inc. and will receive a non-exclusive license to certain patent rights and proprietary antibody reagents for the detection and
measurement of progranulin in blood. The agreement will let Mayo
Clinic offer the first commercial blood test to predict progranulin mutation status in patients suspected to have frontotemporal dementia (FTD).
The blood test will be available in late 2012 for all Mayo Clinic
patients and will be offered through Mayo Medical Laboratories to hospitals and clinics worldwide.
FTD accounts for at least 5 to 10 percent of dementia cases and is
common among patients with early-onset dementia. FTD affects the
brain’s frontal lobe, which regulates behavior, movement, mood and
language. Most FTD patients are diagnosed when they exhibit changes
in personality, memory and ability to use language.
In 2006, researchers at Mayo Clinic published research in Nature
that found the mutation of the progranulin gene (PGRN) causes a
reduction of the protein progranulin in the brain. Along with other
changes, this leads to neuronal death and atrophy of the frontal lobes
of the brain, ultimately leading to dementia. Genetic testing is available
to find the mutation, but it is costly.
In 2009, Mayo Clinic researcher Dr. Rosa Rademakers and colleagues
discovered that FTD patients with PGRN mutations showed a reduction
in blood progranulin levels compared to controls and FTD patients without PGRN mutations. Based on these findings and using A&G’s proprietary antibody reagents, Mayo researchers developed an easy-to-use,
cost-effective blood test for measuring the level of progranulin.
“A&G has pioneered and patented research investigating expression of
progranulin in breast cancer and lung cancer,” says Dr. Ginette Serrero, CEO
of A&G. “Research has shown that breast cancer patients have an elevated
level of progranulin when compared to healthy individuals. We are delighted that our clinical studies with breast cancer patients and development
of progranulin antibodies and assays also will help FTD patients.” ddn
conract research services
Sister companies tread biosimilar path
Celerion and Ricerca Biosciences
form the Biosimilars Alliance to
provide clients a more effective
development path for biosimilars
By Lloyd Dunlap
LINCOLN, Neb.—Celerion, a provider of earlystage drug development solutions, and Ricerca Biosciences, a drug-safety assessment
specialist, have formed the Biosimilars Alliance, which will focus on preclinical and early
clinical assessment of biologics manufactured
by a new supplier.
The two new partners have long operated
as “sister companies,” says Celerion’s vice
president of global bioanalytical services, Dr.
Raymond Farmen, with Ricerca’s CEO Ian
Lennox also serving as chairman of the board
at Celerion. The formation of the new alliance
was driven by “client demand for an integrated service solution for the development of
biosimilar products,” the companies claim,
but also quite probably by the existing level
of uncertainty about regulatory issues. The
goal will be to bridge the gap between newly
sourced products and patient studies.
The market for biosimilars is forecast to
grow from $2.4 billion in 2012 to $44 billion
by 2020. While there has been an established
pathway for the approval of biosimilar products in Europe for several years, the U.S. Food
and Drug Administration has only recently
issued its guidances. And the process is not
whole
clinic in which the company
sequenced whole-human genomes
for research purposes.
“This gave them an opportunity to try out the approach of
outsourcing whole-human
genomes and evaluate the quality
of data we sent them,” Reid says.
“At the same time, the Mayo Clinic
announced the founding of its
new Center for Individualized
Medicine. They realized for the
first time that they had the opportunity to include whole-human
genomes in their research programs and evaluated the pros and
cons of outsourcing this function.
If you are doing this in-house, you
are spending millions of dollars
likely to be as simple as some may envision.
For example, Farmen cites a study where
no GMP analytical differences could be
found between batches but PK studies in
mice revealed completely different efficacy
profiles, with two batches failing completely
while two others presented good concentration curves. Also, Farmen notes the importance of determining if the assay is for free
drug or total drug when you are developing
the bioanalytical assay.
“You need to develop a strategy upfront for
developing assays,” he says, because large
molecule biosimilars are likely to result in
more variability.
The Biosimilars Alliance will offer access
to all of the specialized services required to
perform early assessment of the viability of a
potential biosimilar product before beginning
costly multicenter comparator studies in the
target patient populations. These services
include in-vitro and in-vivo pharmacological
assessments of activity and toxicological and
immunotoxicological studies to support
CTAs and INDs. The alliance also provides
access to bioanalytical assay development to
enable pharmacokinetic (PK) and pharmacodynamic (PD) assessments in animal and
human studies, PK/PD modeling, immunogenicity screening during clinical studies and
the regulatory and integrated project management support to ensure timely results for
strategic decision-making.
on hardware, sequencing equipment and computational software, not to mention training
large numbers of people to be
sequencing experts. They realized they could get the data from
us and achieve higher quality and
lower costs.”
Under the terms of the agreement, the Mayo Clinic will send
genetic material to Complete
Genomics for sequencing and
analysis. It will continue to operate
and invest in its Medical Genome
Facility. Financial details of the
agreement were not disclosed.
“We will take their samples,
sequence them and deliver them
back to the Mayo Clinic ready for
clinical use,” says Reid. “We expect
this relationship to grow in the
years to come, and hope to be a
In Complete Genomics’ sequencing center, the blue light ensures no light interference
in the biochemistry of the sequencing process.
“The formation of the Biosimilars Alliance is
consistent with Celerion’s goal of providing fully
integrated services to get to go/no-go decisions quickly.”
Dr. Susan Thornton, president and CEO of Celerion
“The announcement of the Biosimilars
Alliance demonstrates Celerion’s ability to
respond to client needs and offer effective
solutions that leverage the knowledge base
built up over the past 20 years of supporting
biologic drug development,” says Dr. Susan
Thornton, president and CEO of Celerion.
“The formation of the Biosimilars Alliance is
consistent with Celerion’s goal of providing
fully integrated services to get to go/no-go
decisions quickly.”
“Ricerca Biosciences is well-positioned in
Europe, Asia and North America to enhance
the success of the Biosimilars Alliance. Biosimilars are a rapidly growing segment of the market, and we see increasing demand from our
clients for safety and efficacy testing to assess
viability,” says Lennox. “The Biosimilars Alliance is an important step for Ricerca in supporting the future needs of our clients.”
Farmen emphasizes that the alliance
is based on the long-term working relationship between the two companies, and
there are no contracts between the two, nor
permanent outsourced partner for
whole-human genomes.”
Complete Genomics was founded in 2005 with the vision of providing academic and biopharmaceutical researchers with wholehuman genomic data and analysis
at an unprecedented quality, cost
and scale without requiring
researchers to invest in in-house
sequencing instruments, highperformance computing resources
and specialized personnel. The
company’s genome sequencing
center, which began commercial
operations in May 2010, combines
a high-throughput sample preparation facility, a collection of highthroughput sequencing instruments and a large-scale data center. Complete Genomics’ customers ship samples via common
carrier services such as Federal
Express and United Parcel Service.
The company then sequences and
analyzes these samples, providing
customers with assembled and
annotated genomic data.
“Whole-human genomes are the
ultimate in genetic diagnostics,”
notes Reid. “Right now, the industry operates by doing partialgenome measurements or looking
at specific markers or genes. For
some applications, that is perfectly
fine; for many applications, as the
price of whole-human genome
sequencing comes down, it makes
more sense to sequence the genome
all at once and look up the data as
it is needed in the years to come.”
In particular, “hospital net-
any exclusivity.
“We trust each other,” he says.
Celerion provides early-stage clinical
research solutions from facilities strategically
located around the world, with more than 730
beds in Phases I and IIa, NDA-enabling clinical pharmacology, ADME, clinical pharmacology sciences, global bioanalytical services
(discovery through late-stage) and drug development services. Sister company Ricerca Biosciences offers a suite of discovery, preclinical
and development services to support drug
candidates from discovery through IND and
NDA on a global scale. Capabilities include
molecular through in-vivo screening and profiling, medicinal chemistry, IND-enabling
toxicology, API process chemistry and cGMP
manufacturing of clinical and commercial
API. It operates out of U.S.-based facilities in
Concord, Ohio, and Bothell, Wash., and ISO
9001-certified facilities in Taipei, Taiwan, and
Lyon, France. The Lyon and Concord facilities
hold AAALAC certification. ddn
Complete Genomics’ genome sequencing center began commercial operations
in May 2010.
works realize that whole-human
genome sequencing is one of the
cornerstones of personalized medicine,” Reid adds. “We’re seeing a
real trend of healthcare systems
getting engaged in whole-human
genome sequencing. So we’re right
at the beginning of this. I think
whole-human genomes will be
seminal in changing healthcare by
enabling the whole healthcare
industry to understand for the first
time that genetic data is the basis
for all diseases. I think we are
going to especially see a real
renaissance in the understanding
of cancer and all genetic diseases.
This is an exciting time, and the
Mayo Clinic has a leadership position in the industry, and we are
very proud to be a part of that.”
The Mayo Clinic declined to be
interviewed for this story. In a
statement announcing the outsourcing deal, Dr. Gianrico Farrugia, director of the Mayo Clinic’s
Center for Individualized Medicine, said, “Access to quality
whole-genome sequencing services can only expedite our efforts
to improve care for all of our
patients with new individualized
medicine tools and techniques.”
Added Dr. Leroy Hood, president of the Institute for Systems
Biology and a member of Complete
Genomics’ Scientific Advisory
Board, “This is a big step toward
the realization of personalized
medicine. It is exciting to see a
world-renowned healthcare organization like Mayo Clinic take the
next step towards bringing highquality whole-genome sequencing
data into the clinic.” ddn
conract research services
Charles River rolls toward
improved viral clearance studies
CRO licenses EMD Millipore
technology to improve
drug product safety
By David Hutton
BILLERICA, Mass.—In an effort to improve the
viral clearance studies it provides its clients,
Charles River has reached a licensing contract with EMD Millipore, the life science
division of Merck, for the company’s
TrueSpike technology.
EMD Millipore and Charles River will
integrate the TrueSpike technology into viral
clearance services provided by Charles
River, which is designed to result in a more
predictable and consistent study outcome for
clients, ultimately helping to improve drug
product safety. The combined expertise of
these two industry leaders will result in
higher-purity virus preparations to help
ensure validation success and regulatory
compliance for biopharmaceutical
manufacturers.
“This exclusive partnership with Charles
River brings together their regulatory and
viral clearance experience and our extensive
knowledge of virus filtration and process
engineering,” says Christophe Couturier,
vice president of services and solutions at
EMD Millipore. “The increased quality of
virus preparations as delivered by TrueSpike
technology will help ensure the success of
our customers’ validation studies conducted
by Charles River.”
According to Birgit Girshick, Charles River’s biopharmaceutical services corporate
vice president, while the companies have
worked together on several projects over the
years, this marks the first formal project
between the two. Moreover, Girshick says the
goal at Charles River is to provide clients with
a complete range of required services that
Charles River recently licensed EMD Millipore’s TrueSpike Technology for viral clearance studies. TrueSpike
enables the removal of cell debris, DNA and non-viral proteins from virus preparations used to validate
biomanufacturing process virus clearance.
meet their regulatory and scientific needs.
“This partnership enhances our ability to
exceed client expectations by offering an
innovative solution that accelerates the production and safety assessment of their biopharmaceutical product,” she says.
Christophe Eyer, head of global services
at EMD Millipore, explains that TrueSpike
enables the removal of cell debris, DNA and
non-viral proteins from virus preparations
used to validate biomanufacturing process
virus clearance.
“This partnership is about combining the
expertise of both companies in order to provide a better viral clearance experience to
biopharma customers,” he says. “It will
allow them to make better decisions about
their future manufacturing process, resulting in reduced timelines and costs.”
Eyer adds that the use of TrueSpike technology reduces the impurity content of virus
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preparations. He explains that a significantly
cleaner prep can lead to increased predictability of validation studies, enabling
assured achievement of validation targets.
“TrueSpike is a process that allows us to
highly purify viruses from cell lines,” he
notes. “It allows more consistent and representative virus representation that is used in
bioclearance studies and spiking studies.”
The collaboration will lead to an enhanced
service by Charles River.
“In addition to Merck Millipore’s
TrueSpike technology that we are implementing at Charles River, customers will
have access to Millipore’s engineers as well
as our viral clearance experts during the
study at the site,” says Girshick. “That
assures the customers that there is not only
regulatory compliance, but also an integrated process engineering component during
the study that wasn’t there before.”
The long-term implications for the viral
clearance services could have a far-reaching
impact, she notes.
“We see it as a possible use for all virus
filtration steps worldwide,” Girshick says. “I
think that once the customers see the benefits of it, they will want to use a highly purified virus stock.”
While it certainly is a growing market
with a high ceiling, Girshick says putting a
figure on the potential revenue is nearly
impossible.
“Basically, every company that, from a
regulatory perspective, has to do viral clearance studies will have an interest in using a
virus stock with minimal impurities and lotto-lot variability,” she explains.
After implementation, Girshick says, “it
will become our gold standard for the virus
filtration portion of the viral clearance
study.”
It also will eliminate many challenges
inherent in the process, according to Eyer.
“Virus spiking can present some challenges because of the virus stock that often
contain impurities, which can dramatically
affect performance of virus removal filters
by reducing their throughputs and
results,” he says. “As a consequence, insufficiently purified and characterized virus
preps can cause validation failure for the
end result.” ddn
immuno
populations, evaluation of alternative
indications and optimization of proofof-concept clinical trial design through
stratification of biomarker panels. Selventa also works with pharmaceutical
and life-science companies to develop
new therapeutics for oncology, metabolic disorders, cardiovascular diseases,
inflammation and drug safety.
Selventa declined to provide more
detailed information or any specific
examples on what exactly the collaboration plans to do first, nor would the
company elaborate on the venture’s
short- and long-term plans. Selventa
spokesperson Diane Song said the
company would only answer questions
pertaining to “a general description of
Selventa’s strategies for biomarker discovery to aid drug discovery and development—and not specifically related
to the recent press release on the Janssen collaboration.”
In an email to ddn, de Graaf provided
a general description of the company,
adding, “By understanding multiple
“Building comprehensive
disease models and
investigating different
molecular mechanisms may
provide key data-driven
foundations for appropriate
selection of drugable
mechanisms within a disease.”
David de Graaf, president
and CEO of Selventa
disease-driving mechanisms of a clinically defined single disease, we can start
to address the complex heterogeneity of
the disease and better define potential
responder and non-responder populations through Selventa Therapeutic
Diagnostic (TDx). Beyond finding biomarkers for a specific drug to identify
potential responders (conventional way
of developing a companion diagnostic),
we can also identify alternative diseasedriving mechanisms in non-responding
populations for portfolio optimization
(innovative development of a TDx).”
In December 2010, Selventa promoted de Graaf to president and CEO
from his previous role as chief scientific officer.
Selventa raised nearly $4.96 million
in November in a new funding round
that has an indefinite top end, according to a document filed with the U.S.
Securities and Exchange Commission
(SEC). A total of nine unnamed investors participated in the new equity
funding round, according to the SEC
documents. Previous backers of the
company, when it was known as Genstruct Inc., include Flagship Ventures
and Pappas Ventures.
Listed as related persons in the filing
are co-founder Noubar Afeyan and
chairman Jim Matheson, both of Flagship; Sean McCarthy of Pappas; and
Michael Pavia, a former entrepreneurin-residence at Oxford Biosciences
Partners, now working as an independent consultant. ddn
BGI
Continued froM paGe 1
support disease research and development efforts.”
Under the terms of an agreement
announced March 2, BGI will contribute its next-generation sequencing platforms and bioinformatics
capabilities, and Novo Nordisk will
contribute its drug development
expertise.
Novo Nordisk plans to leverage
its portfolio of modern insulin and
delivery devices while developing
new antidiabetic agents and a new
generation of insulin to better
address future needs for effective
diabetes care, according to company
statements.
Allan Ertmann Karlsen, Novo
Nordisk’s corporate vice president,
tells ddn, “Our service framework
agreement with BGI establishes the
legal and operational boundaries
when we are using BGI’s services to
generate data in our research projects. The main goal of our collaboration is to investigate the transcriptional changes that occur when
normal tissue is being subjected to
diabetic blood glucose challenges.
Long-term, we hope that those findings will enable us to discover new
biologics that can be used in our
ongoing commitment to develop
better treatments for both type 1 and
type 2 diabetes patients.”
BGI “is the world’s largest provider of advanced sequencing technology and bioinformatics,”
Karlsen says. “We firmly believe
that BGI is the best partner for us to
pursue our goal to understand the
complexities of global transcriptional regulation in diabetes.”
In February, BGI officially opened
its European Genome Center in
Denmark, where Novo Nordisk is
headquartered. The global framework extends to Novo Nordisk’s
international production facilities in
seven countries and affiliates in 75
countries, as well as to BGI’s affiliates, BGI-Hong Kong, BGI-Europe
and BGI-Americas, among others.
BGI’s “newly established stateof-the-art facilities in the heart of
Copenhagen provides our scientists
in diabetes biology with unparalleled access to direct discussion
with BGI’s scientists on both technical and scientific issues with
regards to our collaborations,”
Karlsen says.
Ning Li, director of BGI Europe,
stated in a news release that the
agreement “will provide an excellent platform for us and our collaborators, and we are looking forward
to establishing more collaborations
with more partners across Europe
and worldwide.”
Both companies declined to discuss the specifics of its collaborative
enterprise or whether a new diabetes delivery system would be
pursued.
BGI spokesperson Jia Liu tells
ddn, “Details are not suitable for
publication now.”
Novo Nordisk is owned by the
contract research services
Novo Nordisk Foundation, a nonprofit institution “whose formal
purpose is to provide a stable basis
for its company’s operations and to
make contributions to scientific,
humanitarian and social progress,” the company has stated.
Novo Nordisk is an organization
“built on heritage and places huge
emphasis on the ‘Novo Nordisk
Way,’ a value-based framework
which defines the principles for
how the company does business
from vision to policies.
With China being the third big-
gest market in Novo Nordisk’s business and the second largest insulin
market, the company is committing
up to $100 million to expand its Beijing Research & Development center (NNST). The expansion will
enable the newly established diabetes research branch, named Diabetes Research China, to perform
drug discovery from idea generation to in-vivo pharmacology.
Novo Nordisk is pinning some of
its growth hopes on a new insulin
drug called degludec, which it submitted to regulators including the
April 2012 • Drug Discovery News
U.S. Food and Drug Administration
last year. The product is designed to
control blood-sugar levels over a
longer period of time than other
insulins do, and if degludec is
approved for sale, it will face tough
competition from products made by
Sanofi and Eli Lilly & Co.
BGI was founded in 1999 with the
mission of being a premier scientific
partner to the global research community. BGI has generated more
than 170 publications in top-tier
journals such as Nature and Science.
These accomplishments include
33
sequencing 1 percent of the human
genome for the International
Human Genome Project, contributing 10 percent to the International
Human HapMap Project, carrying
out research to combat SARS and
E. coli, playing a key role in the
Sino-British Chicken Genome Project and completing the sequence of
the rice genome, the silkworm
genome, the first Asian diploid
genome, the potato genome, and
most recently, 1,000 genomes and
the human gut metagenome. ddn
ediTConneCT: e041204
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ddn special report
DRUG REPURPOSING
Fourth
part
a multi-issue
series
First
ofof
a two-part
series
Everything old is new again
Drug repositioning provides cost savings, shortcuts
V
By Kimberley Sirk
iagra. Everyone’s heard of it. Everyone
knows what it does. But most people probably
don’t realize that sildenafil citrate began its life
intended for another purpose before it was
repurposed into the blockbuster that it is today. When the
compound was found to be unsuccessful as an anti-hypertensive agent in Phase I trials, Pfizer Inc. found success in switching the drug to the treatment of erectile dysfunction.
Long before that success,
Dr. Andreas Persidis, coother compounds have gone
founder and CEO of Biovista
on to other lives; a commonly
Inc., a private drug developcited example is thalidomide,
ment services company that is
originally used as a sedative to
headquartered in Charlottestreat morning sickness in
ville, Va. “However, they lack
pregnant women, and then
the risks of original drugs,
went on to be used as a treatwhich is a major advantage of
ment for multiple myeloma
repositioning.”
and erthema nodosum leproAnd, adds Frost & Sullivan
sum. Another success: finasTechnical Insight Research
teride, originally approved for
Analyst Ruplekha Choudhubenign prostate hyperplasia,
rie, “Toxicity studies; absorpnow also approved to treat
tion, distribution, metabolism
male pattern baldness as the
and excretion (ADME) studactive ingredient in Propecia.
ies; and other important cri“Broadly speaking, drug GlaxoSmithKline’s Paxil was the
teria, are already assessed
repurposing or drug reposi- first antidepressant formally
during clinical trials for the
tioning alludes to the develop- approved in the United States
drug. Hence, time—usually a
for the treatment of panic
ment of existing drugs or procouple of years to understand
attacks. It is also being
drugs for new indications, not investigated for the treatment
the drug metabolism, safety
necessarily related to the of premature ejaculation,
and tolerance—can be saved.
original disease focus. In gen- premenstrual syndrome, hot
Similarly, clinical trials to
eral, these drugs have proba- flashes, compulsive gambling,
understand the drug efficacy
bly failed in late-stage clinical diabetic neuropathy and
have to be carried out while
tension headache.
trials by lacking in efficacy or
repurposing, while the other
safety, or have problems associated with parameters need not be reassessed. This is a
commercial strategies, patent expiration or good option, as thousands of dollars spent on
geographic expansion,” explains business clinical trials can be saved.”
research and consulting firm Frost & Sullivan
How are they chosen?
analyst Cecilia E. Cauwenberghe.
Companies have likely invested millions of According to Cauwenberghe, two main selecdollars and countless hours in the develop- tion criteria for drug repurposing candidates
ment process. Bringing completely new can be cited: known compounds with new
drugs to market, through all the stages of targets in the first place, and known mechahuman trials and regulatory approvals, can nisms with new indications in the second
take years. Inherent in this process is risk.
place.
“A repositioned drug has the same chances
“Eli Lilly’s raloxifene hydrochloride, Evisof success as an original drug in meeting effi- ta, is an example,” she says, “as this drug was
cacy end points. There is nothing inherently conceived as an osteoporosis therapeutic
different about repositioned drugs to make agent, with its initial steps in clinical trials
them less able to succeed due to efficacy,” says related to breast cancer therapies. Similarly,
Pfizer’s Viagra was found to be unsuccessful as an
anti-hypertensive agent in Phase I trials, but later
found success after Pfizer switched the drug’s
indication to the treatment of erectile dysfunction.
Genzyme’s plerixafor (Mozobil) was recognized primarily as an inhibitor of HIV infection, and finally was launched as a hematopoietic stem cells mobilizer, particularly
related to novel advances in the treatment of
multiple myeloma. Cypress Bioscience’s milnacipran (Savella) was initially thought of as
an antidepressant, and later repurposed by
Laboratoires Pierre Fabre as Joncia for the
treatment of fibromyalgia. Another example
is GlaxoSmithKline’s paroxetine hydrochloride (Paxil), which was originally launched
as an immediate-release formulation, then
later licensed for the treatment of major
depression and anxiety disorders. GlaxoSmithKline’s ropinirole and Boehringer Ingelheim’s pramipexole were both originally
developed for the treatment of Parkinson’s
disease; however, posterior findings derived
in their development as a repurposed compound for the treatment of restless leg
syndrome.”
Persidis also cites productivity and
innovation.
“Repositioning allows an increase in Phase
II starts leading to more drugs entering the
clinic at any given time,” he says. “In addition,
repositioning may reveal new biology in a
disease, leading to innovation in therapeutic
approaches. A good example is Gleevec,
whose previously unexpected off-target pharmacology has led to it being tried in a number
of non-cancer indications, including spongyloarthritis and others.”
Last, Persidis says, but certainly on par
with the other factors, are competitor adjacency threats.
“Competitor adjacency threats drive companies to not only add new compounds to
their pipelines, but indicate when a savvy
company reacts to what its competition is
doing with a new twist on an old compound.
Several companies are doing both,” he
explains. “These strategies are complimentary. However, there are still major companies
that do not include systematic repositioning
as part of their strategy, and I believe this
makes them vulnerable to competitors repositioning their drugs instead.”
“A good example is Enbrel, which was
repositioned by BDC in sciatica, and then
acquired by Cephalon for about $40 million
upfront and about $200 million in milestones
in 2009-2010,” he adds. “Amgen, the owner of
Enbrel, does not have rights now in the use of
their drug in this new major market, and this
vulnerability is prevalent in a number of wellnew continued on page 35
Trends that drive
the repositioning phenomenon
According to Persidis, four key trends are
paving the path in drug repositioning.
First, the patent cliff: This means that companies have to find new applications and
products more quickly than the 10 to 12 years
a new drug takes to come to market, and repositioning allows that to happen.
Second, generics pressures: Generics companies are becoming more aggressive, and
they are also entering the new drug arena
themselves (e.g., Teva acquiring Cephalon).
This means that both pharmas and generics
companies are looking to repositioning as a
way to distance themselves from each other.
Eli Lilly & Co.’s Evista is an oral selective estrogen
receptor modulator that has estrogenic actions on
bone and anti-estrogenic actions on the uterus and
breast. It is used in the prevention of osteoporosis in
postmenopausal women. It has also been found to
reduce the risk of hormone-positive breast cancer
and vertebral fractures, and is being probed in trials
for the treatment of coronary heart disease.
new
known companies, because they seem to
choose to ignore the possibility that another
group may be able to find something about
their drug that they didn’t know.”
What are the good disease targets?
Frost and Sullivan’s Choudhurie singles out
two targets for further growth in repurposing;
both diseases are complex and treatments for
both are highly sought-after around the globe.
“Obesity is a complex metabolic disorder,
and drugs usually used for obesity fall into
different categories which target the disease
in different ways,” she says. “Similarly, other
complex diseases that don’t have just one target can provide a good opportunity for drug
repositioning. Oncology is another disease
area where drug repositioning activity has
been very high.”
Not without impact is the rising tide of
medical needs in the aging baby boomer population. Choudhurie’s Frost & Sullivan colleague Cauwenberghe says it’s hard to choose
targets specifically, but we can generalize
about impacts in the future.
“Regarding more appropriate disease targets, actually an in-depth prediction of the
most benefited disease areas is uncertain, as
well as the impact of new technologies over
drug repositioning approaches.” she says.
“Nonetheless, a notable expansion of the
aging population, as well as cancer, pain, diabetes, metabolic, cardiovascular and neuro-
ddn special report
Drug
Initial Indication/Marketed By
Repostioned Indication/Marketed by
Allopurinol
Neoplasms
Treatment of gout (Prometheus)
Amantadine
Antiviral (Du Pont)
Antiparkinsonism (Du Pont)
Amphetamine
Stimulant
Hyperkinesis in children
Atomoxetine
Antidepressant (Lilly)
ADHD (Lilly)
Beta-blocker
Antiarrhythmic/antianginal
Antihypertensive
Buproprion
Depression (GSK)
Smoking cessation (GSK)
Celecoxib
Osteoarthritis and rheumatoid arthritis (Pfizer)
Familial adenomatous polyposis, colon and breast cancer (Pfizer)
Chlordiazepoxide
Muscle relaxant
Tranquilizer
Chloroquine
Antimalarial
Antirheumatic
Chlorpromazine
Antihelmintic
Antischizophrenic (GSK)
Duloxetine
Depression (Lilly)
Stress urinary incontinence (Lilly)
Estrogens
Hormone replacement therapy
Contraception
Fluoxetine
Depression (Lilly)
Premenstrual dysphoria (Lilly)
Imipramine
Sedative
Antidepressant
Lignocaine
Local anesthetic (AstraZeneca)
Antiarrhythmic (AstraZeneca)
Lumigan
Glaucoma (Allergan)
Eyelash growth (Allergan)
Metronidazole
Antirichomonal
Antibacterial (Pfizer)
Minoxidil
Hypertension (Pharmacia & Upjohn)
Hair loss (Pfizer)
Pemetrexed
Mesothelioma (Lilly)
Lung cancer (Lilly)
Penicillamine
Copper chelating agent
Antirheumatic (Merck)
Raloxifene
Contraceptive (Lilly)
Osteoporosis (Lilly)
Thalidomide
Morning sickness (Celgene)
Cancer (Celgene)
Topiramate
Epilepsy (Johnson & Johnson)
Obesity (Johnson & Johnson)
Viagra
Angina (Pfizer)
Male erectile dysfunction (Pfizer)
Some are not as exuberant about the potential of this method of discovery for attacking
rare diseases. Again, limited resources juxtaposed against a small population who can
benefit makes the math sometimes tricky,
even if expensive early steps have been taken.
“There is nothing inherently different
about repositioned drugs to make them
less able to succeed due to efficacy,”
says Dr. Andreas Persidis, co-founder
and CEO of Biovista Inc. “However, they
lack the risks of original drugs, which is
a major advantage of repositioning.”
logical diseases, including Alzheimer’s and
Parkinson’s, can be remarked.
“On the other hand,” she points out, “rare
diseases have been also targeted through
numerous projects.”
Choudhurie agrees: “Another advantage of
repositioning is that diseases with a high
unmet need can be targeted with these drugs
that are already in the market,” she says.
“In orphan diseases, the driver is to find a
therapy as quickly as possible, no matter what
the approach,” adds Persidis. “Repositioning
is now recognized as a major potential contributor to this, which is why there is a dedicated NIH effort.”
Over at the Sanford Burnham Medical
Research Institute, officials promote the work
of their organization, which takes on these
orphan causes in a unique way.
“Regrettably, pharmaceutical companies
are not likely to engage in drug repositioning
efforts for rare childhood diseases,” the institute’s representatives say. “This is in part due
to the smaller patient populations and challenges in running clinical trials in these indications. In addition, competition with generic
drugs makes this effort commercially unviable, in spite of its great potential to benefit
human health. Even if companies were motivated to engage in these efforts, it is very difficult for the pharmaceutical industry to perform the type of screens Sanford-Burnham is
doing because of their limited access to
patient samples.”
Failures … or opportunities?
Schering-Plough’s Nasonex nasal spray is used to
treat upper respiratory conditions such as nasal
sinus inflammation, but is also prescribed for
inflammatory skin disorders such as eczema and
psoriasis, allergic rhinitis such as hay fever, asthma
for patients unresponsive to less potent
corticosteroids and penile phimosis.
Not every repositioning effort is a clear
winner.
“A recent example of a not successful one
is Dimebon, a cough suppressant that was
repositioned in Alzheimer’s disease by Medivation and Pfizer, but failed to meet its Phase
III end-points,” says Persidis. “However,
there is believed to be more extensive pharmacology on this drug, creating important
possibilities for it to be rescued and re-repositioned in other diseases.”
To be sure, rapid technological advances
and new business strategies in the recent past
have changed the game rapidly since the time
of thalidomide.
Says Cauwenberghe: “On that note, it is
important to highlight the fact that during the
past five years, innovation in the biopharmaceutical industry has helped counter rising
development costs, and stagnant product
output has become a leading cause for drug
repurposing.”
With little new on drug companies’ plates
for one reason or another, new therapies have
to come from somewhere.
“Two other relevant reasons rely on the
need to expand product pipelines with new
projects, as well as the increasing of the pool
of potential compounds abandoned due to
strategic reasons,” she adds.
New technologies and methods for sharing
information play a large role.
“Companies have been encouraged to
emerge from another perspective, by expanding their technology platforms for identifying
new indications,” Cauwenberghe explains.
“This has led to the success of several projects committed to the development of proprietary pipelines of candidates, while reducing
the related risks and timelines in further
clinical development. Moreover, current
business models and technology platforms
promote the public generation of proof-ofconcept clinical data to share efforts for repositioning purposes.”
An example of those new business models
is the one being developed by Transparency
Life Sciences (TLS), which is developing
repurposed drugs based on an open-innovation and crowdsourcing model.
Now beginning work with Stanford University, the company will examine developing
the blood pressure medicine lisinopril for
multiple sclerosis (MS). Preclinical data
showing how lisinopril works through autoimmune and inflammatory mechanisms to
reduce paralysis and blindness in animal
models of MS has shown promise.
The company introduced its crowdsourcing model in beta on Jan. 31, and is inviting
interested individuals to participate in the
design of the protocol for a Phase II trial of
lisinopril in MS. It hopes that opening up the
Novartis’ Methergine is a
blood vessel constrictor
and smooth muscle
agonist most commonly
used to prevent or
control excessive
bleeding following
childbirth and
spontaneous or elective
abortion. It is also used
for the prevention and
acute treatment of
migraines.
study design will allow for collaboration in
ways not before thought possible.
“The paradigm shift around drug repositioning necessarily derives a change in the
current business models utilized by pharmaceutical and biotechnology industry,” concludes Cauwenberghe. “In particular, pharmaceutical companies have to face the challenge to transform their blockbuster model
toward a more accurate, flexible and costeffective model that involves the development
of therapeutics for new prospect indications.
Indeed, a myriad of small companies have
started to play new roles in the biopharmaceutical market. Their innovative capacity, as
well as their constant nutrition with academic
fields, becomes these companies as strategic
players, leading to a novel trend of M&A
activities and licensing agreements.” ddn
UP NEXT: Cushioning the
fall off the patent cliff
Our two-part series on the trend of drug repurposing continues
next month in our May issue as we examine how drug repositioning
is helping to keep pharmas afloat amidst the dreaded patent cliff.
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ViroStat Inc. is now offering three new monoclonal
antibodies to Clostridia glutamate dehydrogenase
(GDH) validated by ELISA. Clostridium difficileassociated diarrhea, the leading cause of nosocomial diarrhea, has resistant spores that survive
on a variety of surfaces, allowing it to spread
quickly and making rapid detection a necessity.
Adding GDH detection along with toxin detection
by EIA or PCR improves assay specificity, and
ViroStat’s antibodies provide another avenue for
rapid detection development.
ViroStat Inc.
(207) 856-6620
www.virtostat-inc.com
Service expansion provides
European availability
SomaLogic Inc.
SomaLogic Inc. is now offering increased availability to its proteomic technology with the launch
of SomaSciences in the United Kingdom. The
company’s proprietary SOMAscan proteomic
assay offers a “one-stop shop” for validating
protein biomarkers, from discovery to the validation of a companion diagnostic. SOMAscan provides protein biomarker support for drug discovery and development, from target discovery and
validation and mechanism of action to efficacy
predictions, patient stratification and drug
response monitoring.
SomaLogic Inc.
(303) 625-9000
www.somalogic.com
Endogenous histone modulation
kits offer simplicity
PerkinElmer Inc.
system’s integrated timer provides the option of
running continuous or timed electrophoresis
runs, and it is compatible with all mini and
standard-sized horizontal and vertical Biometra
electrophoresis systems.
Biometra GmbH
+49 36 41 77-92 8
www.biometra.com
Workflow and documentation solution
for linking information systems
Waters Corp.
The new AlphaLISA Epigenetic Cellular Detection
Kits for H3K4, H3K9 and H3K27 from PerkinElmer
enable rapid detection of endogenous histone
modulation in one-well, no-wash assay formats.
The kits are optimized for simplicity and throughput, with an assay protocol open to automation
and appropriate for endogenous and recombinant
cell lines. PerkinElmer’s reagents provide reproducible detection and work with peptide or full-length
protein substrates, as well as endogenous histones
in cell-based formats, with detailed, ready-to-use
protocols for more than 20 epigenetic enzyme
assays.
Waters Corp. announces the launch of Water
NuGenesis 8, featuring LE (Laboratory Execution)
Technologies. LE Technology is a comprehensive
workflow and documentation solution which links
organizations’ analytical laboratory data systems
to their business IT systems. An electronic worksheet guides laboratory analysts through workflows,
ensuring the completion of each step and verifying
that the input meets all criteria. Completed tasks
are submitted for approval, and results are automatically shared with systems such as LIMS and
ERP. NuGenesis 8 captures and catalogs information from different sources, with access to
information management tools such as sharing,
reuse and sample management.
PerkinElmer Inc.
(800) 762-4000
www.perkinelmer.com
Waters Corp.
(508) 478-2000
www.waters.com
96-channel pipetting for
multiple modes
INTEGRA Biosciences
Fully configurable web-based
randomization system
Almac
INTEGRA Biosciences introduces the latest addition to its product offering, the VIAFLO 96, a
96-channel handheld electronic pipette for the
fast, precise and easy simultaneous transfer of
96 samples. The VIAFLO 96 functions like a
standard handheld pipette, with Touch Wheel user
interface for simple programming of a variety of
pipetting modes, such as repeat dispense, serial
dilute and sample dilute.
Almac introduces aXcess, an enhanced, re-launched
version of its web-based randomization system
WebEZ. The new system is fully configurable and
features enhanced functionality, with similar features to WebEZ. The state-of-the-art IVR/IWR
system includes language capabilities and data
integration. aXcess provides users a cost-effective
alternative to paper-based or manual systems,
with state-of-the-art reporting functionalities and
shorter timelines for system build, perfect for
small to mid-sized studies.
INTEGRA Biosciences
(603) 578 5800
www.integra-biosciences.com
Polymeric SPE cartridges, well plates
for solid-extraction treatment
SiliCycle
The SiliaPrepX family of polymeric SPE cartridges
and well plates from SiliCycle offers its users an
inclusive solution to their solid-phase extraction
treatment needs. The cartridges and well plates
are designed with the highest quality and lot-to-lot
reproducibility, allowing for clean extraction, reduced
ionic suppression and increased selectivity for
LC-MS/MS analysis. The SiliaPrepX family includes
hydrophilic-lipophilic balance, divinylbenzene, strong
cation and anion exchangers and weak cation and
anion exchangers.
SiliCycle
(877) 745-4292
www.silicycle.com
Power supply for multiple gel
electrophoresis runs
Biometra GmbH
Biometra GmbH, an Analytik Jena company,
introduces the Mini Power Pack PS300T, a compact power supply that needs only the space of
a DIN-A5 paper sheet and is ideal for researchers running horizontal or vertical gel electrophoresis. The Mini Power Pack provides constant
voltage and current in 1 V or 1 mA steps, with
two pairs of outlets to enable users to run two
mini or standard-sized gels simultaneously. The
Almac
(215) 660-8500
www.almacgroup.com
Low-volume flow calorimeter offers
label-free sample monitoring
TTP Labtech
The new chipCAL from TTP Labtech, a low-volume
flow calorimeter, offers fast throughput, with characterization of enzyme activity achievable within
two to 10 minutes per sample. Enzyme and substrate are passed through a thermodynamic cell
simultaneously, enabling chipCAL to detect thermodynamic changes in volumes as low as 15 µL.
With microliter flow calorimetry, users enjoy noncontact, label-free sample monitoring, and chipCAL
features a working temperature range of between
15° to 60°C. Since samples are passed to a waste
unit after analysis, bypassing a wash stage, the
unit can analyze up to 60 samples in an eight-hour
workday.
TTP Labtech
(617) 494-9794
www.ttplabtech.com
For
For more
more information,
information, visit
visit www.DrugDiscoveryNews.com
www.DrugDiscoveryNews.com
Space conservation, easy transport
with rolling centrifuge cabinet
Eppendorf
Eppendorf introduces its new space-saving rolling
centrifuge cabinet, designed for use with any
Centrifuge 5804/5804 R or 5810/5810 R. Either
model can be set up on the cabinet for storage
under most lab benches, and the rolling cabinet
allows for easy transport between laboratories as
well. The cabinet’s powder-coated steel construction provides strength and high chemical resistance,
with two lockable castors and a large drawer with
slip-resistant lining for accessory storage.
Eppendorf
(800) 645-3050
www.eppendorf.com
Hands-free bar code reading
Hamilton Robotics
Hamilton Robotics announces the launch of the
Shift-N-Scan Tube Bar Code Scanner, a patented
module for the Microlab NIMBUS Automated Liquid
Handling Platform. The unit enables hands-free
bar code reading of up to 96 sample tubes, and
is compatible with the NIMBUS4 benchtop system.
Rows of tubes are moved to positions on either
side of the scanner, recording bars codes so
samples can be tracked accurately. The Shift-NScan can detect and record errors if tubes cannot
be scanned, with empty rack spaces reported.
Hamilton Robotics
(800) 648-5950
www.hamiltonrobotics.com
Significant time savings
for digital titration
Tecan
Tecan introduces the HP D300 Digital Dispenser,
a standalone instrument that utilizes HP Direct
Digital Dispensing technology to rapidly deliver
picoliter to microliter volumes of drug compounds.
The HP D300 allows for fast, digital titration,
reducing titration times from hours or days to
minutes. The system is available exclusively
through Tecan.
Tecan
+41 (0)44 922 81 11
www.tecan.com
European services expanded to
include sample preparation
BioStorage Technologies
BioStorage Technologies announces the addition
of sample preparation services to its repertoire
Products & Services
of European operations. With the expansion,
BioStorage will now offer sample aliquoting, peripheral blood mononuclear cells processing and
nucleic acid extraction and verification, providing
customers with a sample renewal and preparation
process that maximizes samples. After sample
processing, BioStorage’s tracking and inventory
management system, ISISS, can identify aliquots
of blood and/or DNA products for future testing.
BioStorage can now offer customers improved
control over the quality of nucleic acid samples,
with all sample preparation services supported
by automated liquid handling technology.
April 2012
December
2005 • Drug Discovery News 37
adv e r t i s e r ’ s i nd e x
Applied Photophysics Ltd................................................17. www. photophysics.com
Biosearch Technologies, Inc..............................................5. www.biosearchtech.com
BioTek Instruments, Inc...................................................13. www.biotek.com
Cambridge Healthtech Institute......................................16. www.healthtech.com
Cosmo Bio USA, Inc........................................................14. www.cosmobiousa.com
EMD Millipore Corporation............................................2, 3. www.millipore.com
Epitomics Inc............................................................. Cover. www.epitomics.com
Gilson, Inc.......................................................................23. www.gilson.com
BioStorage Technologies
(866) 697-2675
www.biostorage.com
DNA monitoring in therapeutic
proteins and monoclonal antibodies
Roche
The MagNA Pure LC 2.0 System from Roche
produces high DNA recovery rates in automated
DNA isolation, with the system’s DNA purification
eliminating manual dilution of high-protein and
high-DNA loads, manual acidic sample neutralization and manual carrier RNA addition. The system
requires less hands-on time compared to similar
instruments, without the need for manual sample
preprocessing, additional proteinase K pretreatment, sample neutralization and dilution or carrier
RNA. Through use of the system, scientists developed an automated process to monitor the clearance of Chinese hamster ovary cell DNA during
capture and polishing while processing therapeutic proteins and monoclonal antibody drugs.
Roche
+49 8856 604830
www.roche.com
Label-free LC-MS data analysis
Nonlinear Dynamics
Nonlinear Dynamics announces the launch of
Progenesis LC-MS, a data analysis program to aid
in the detection and quantification of proteins of
interest in label-free samples. The program can
be harnessed for both differential protein expression and protein characterization applications.
Progenesis LC-MS helps to minimize data loss,
with quantification of all peaks, rather than just
those with MS/MS data, and support for all major
hardware vendors as well as workflows that increase
protein and proteome coverage. Progenesis LC-MS’
quantify-then-identify approach, when used with
inclusion lists or gas-phase fractionation, aids in
the retention of peptide information.
Nonlinear Dynamics
(919) 806-4401
www.nonlinear.com
Hamilton Robotics..........................................................33. www.hamiltonrobotics.com
INDIGO Biosciences........................................................29. www.indigobiosciences.com
Invitrogen, Part of Life Technologies................................40. www.invitrogen.com
KNF Neuberger................................................................32. www.knflab.com
Mirus Bio LLC...................................................................9. www.mirusbio.com
R&D Systems, Inc...........................................................27. www.RnDSystems.com
Seahorse Bioscience......................................................21. www.seahorsebio.com
3D cell culture via magnetic levitation
Nano3D Biosciences
Nano3D Biosciences introduces the 24-well BioAssembler for the promotion of development and
growth of 3D cellular structures through magnetic levitation. Using the company’s proprietary
nanoparticle-based assembly, Nanoshuttle-PL, it
delivers magnetic nanoparticles to the cells.
Preparation time and cell manipulation are similar
to that of 2D cell culture or conventional culturing
methods, allowing for a more accurate representation of in-vivo tissue, and it is compatible with
any media, diagnostic technique or cell type.
Nano3D Biosciences
(713) 790-1833
www.n3dbio.com
Benchtop DNA sample concentrator
Genevac
Genevac announces the release of the miVac DNA
for the safe and quick evaporation of solvents from
sensitive DNA, RNA and other biological samples.
The easy-to-use benchtop unit can remove low
volumes of water and organic solvents from a range
of sample formats, including tubes, vials, microplates
and round-bottom flasks. Special operational modes
allow users to speed up the concentration of mixtures, and the lack of motor guarantees a minimum
of noise. With digital control of concentrator temperature and short concentration times, the unit
can minimize the risk of heat damage to samples.
Genevac
+44-1473-240000
www.genevac.com
Multiplex immunoassays for Th17
cytokine and cancer biomarkers
Bio-Rad Laboratories
Bio-Rad Laboratories introduces a set of new
magnetic bead-based multiplex immunoassays,
the Bio-Plex Pro Human Th17 cytokine panel and
the Bio-Plex Pro human cancer biomarker panel 1,
for human T-helper type 17 (Th17) cytokines and
cancer biomarkers respectively. The Bio-Plex Pro
Human Th17 panel incorporates nine new targets,
as well as one unique to the Bio-Plex system, while
the Bio-Plex Pro human cancer panel incorporates
eight new targets, including three unique to the
Bio-Plex system. The assays offer faster assay run
times, with results in three hours, as well as better
performance and flexible ordering options.
Bio-Rad Laboratories
(800) 224-6723
www.bio-rad.com
Combined supercritical fluid
chromatography and ultra highperformance liquid chromatography
Agilent Technologies
Microplate multimode reader features
sensitivity, robustness
Berthold Technologies GmbH
Biomolecular quantitation system
EMD Millipore
TriStar 2 LB942 is Berthold Technologies’ secondgeneration basic microplate multimode reader,
featuring a new proprietary optical design for
sensitivity and robustness. The system supports
all basic reading technologies, including luminescence, absorbance, FRET, fluorescence and BRET
and BRET2. The TriStar2 supports a fully modular
approach, with temperature control, plate height
adjustment, robot integration and three built-in
reagent injectors. Also included are adapters for
non-microplate sample containers and ICE,
Instrument Control & Evaluation software.
The Direct Detect! system from EMD Millipore,
the Life Science division of Merck KGaA, is its
latest system for rapid, simplified protein quantitation. The system enables infrared-based measurement of amide bonds in protein chains without requiring amino acid composition, dye-binding
properties or redox potential. Thanks to its IR-based
detection of biomolecules, the system delivers
accurate and reproducible protein quantitation in
the presence of reducing agents and detergents,
and is capable of measuring protein concentrations from 0.2mg/mL to 5 mg/mL within seconds.
The 1260 Infinity Hybrid SFC/UHPLC system from
Agilent Technologies Inc. represents the first
commercial instrument to perform both supercritical fluid chromatography and ultra high-performance liquid chromatography. The only SFC
system with 600-bar capability, it delivers LC-like
sensitivity over the UHPLC power range. In SFC
mode, the system uses standard-grade gaseous
CO2. The SFC module can be purchased alone
as an upgrade to existing 1100, 1200 and 1260
LC systems, and the 1260 Infinity Hybrid SFC/
UHPLC system is compatible with Agilent 6100
Series single quadrupole LC/MS systems.
Berthold Technologies GmbH
+49 7081 177 200
www.berthold.com
EMD Millipore
(800) 645-5476
www.millipore.com
Agilent Technologies Inc.
(877) 424-4536
www.agilent.com
facts & Figures
Report: CRO outsourcing
market to reach $20B by 2017
C
ontract research organizations (CROs) offer
versatility and increased options for pharmaceutical
businesses, allowing companies to bypass weighty
investments in infrastructure and technology by
outsourcing projects. In a new report, “U.S. Contract Research
Outsourcing Market: Trends, Challenges and Competition in the
New Decade,” Frost & Sullivan forecasts that those benefits will
continue to attract companies, leading to significant growth in
the CRO market at a CAGR of 8.4 percent from 2010 to 2017.
While revenues for the U.S. CRO market reached approximately $11.44 billion in 2010, up
8 percent from 2009, that number is expected to reach roughly $20.1 billion in 2017.
Global expansion for the CRO market is also on the rise, with CROs now accounting for
more than two-thirds of all Phase I to Phase III trials globally. Rising drug development costs
and increasingly strict regulatory requirements have been some of the major drivers for outsourcing, with cost in particular serving as a stumbling block.
The report highlights several drivers for the market, including organizations aiming for
higher operating efficiency through outsourcing, low market penetration, strategic alliances
and a shift from transactional outsourcing driving long-term growth and long-term fundamentals remaining strong for outsourcing. Market restraints include weak demand and market
volatility; shortage of manpower, leading to higher employee retention; excess capacity and
commoditization (which is expected to threaten smaller CROs); and a growing disconnect
“between data availability and connectivity.” The CRO market’s growth rates are expected to
“remain in the high-single digits until 2015 before rebounding.”
“While oncology is the largest revenue contributor, metabolic disorders is projected to have
the highest growth rate,” according to the report, with the top five therapeutic areas accounting
for “over 63 percent of the total development pipeline.” Metabolic diseases, oncology and cardiovascular diseases are all expected to see an increase in outsourcing over the next five years. ddn
Market Segments Life Cycle Stage
CRO Market: Revenue Forecasts, 2007-2017
CRO Market: Growth Forecasts by Segment, 2007-2017
CRO Market: Company Market Share by Revenues, 2010
CRO Market: Growth Forecasts by Therapeutic Area, 2007-2017
Drug Discovery News (USPS 024-504) is published monthly by Old River Publications LLC, 19035 Old Detroit Road, Suite 203, Rocky River, OH 44116; 440-331-6600. Periodical postage paid at Cleveland, Ohio and additional mailing
offices. Publisher assumes no responsibility for unsolicited material or prices quoted in the magazine. Contributors are responsible for proprietary classified information. ©2012 by Old River Publications. All rights reserved. Reproduction,
in whole or in part, without written permission of the publisher is expressly prohibited. Back issues, when available, cost $7 each within the past 12 months; $12 each prior to the past 12 months. Back orders must be paid in advance
by check. Drug Discovery News is distributed without charge in North America to qualified drug discovery research professionals. Paid subscriptions to those not qualified cost $65 annually to the U.S. and Canada and $150 to all other
countries. All payments must be made in U.S. funds drawn on a U.S. bank. Publications mail agreement no. 41401058 return undeliverable Canadian addresses to PO Box 503, RPO West Beaver Creek, Richmond Hill, ON L4B 4R6.
For subscription services, including subscription information, please call 215-785-5196. POSTMASTER: Send address changes to Drug Discovery News, PO Box 3100, Langhorne, PA 19047-8800.
INTRODUCING
Your gateway
to the latest
oncology
news, trends
and resources
■
■
■
■
■
Top cancer-related news
and opinion stories
Archive of all of ddn’s
cancer-related news stories
Interviews with key
oncology leaders
Links to various companies,
research centers and
organizations involved
in the field of oncology
and much more!
Visit: www.ddncancer.com
explore custom assays and services for your
unique research
Drug discovery demands custom solutions, personalized support
At Life Technologies, our scientists help you do more with your discovery research by providing physiologically relevant tools and
services that enable predictive answers. With dedicated specialists who listen to your needs and a Custom Biology R&D group ready
and able to design assays and tools to meet your unique requirements, we can extend your research team, providing you support
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For research use only. Not intended for any animal or human therapeutic or diagnostic use. ©2012 Life Technologies Corporation. All rights reserved.
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