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August 2012 Volume 8, Number 8
www.drugdiscoverynews.com
Global News
6
Tools & Technology
12
what’s inside
Diagnostics16
Omics & Systems Biology
20
research & development
24
Contract Research Services
28
finance.........................................................3
Markets........................................................4
Editorial/commentary..............................10
products & services................................37
facts & figures..........................................38
Valeant all Surprising and sizable injection
smiles over BMS-AstraZeneca
diabetes partnership gets
boost with
OraPharma $7-billion
BMS’ acquisition of
Valeant acquires oral health
company for $312 million
Amylin Pharmaceuticals
By Kelsey Kaustinen
By Amy Swinderman
MONTREAL—Valeant
Pharmaceuticals
International Inc. recently announced
that it will acquire OraPharma, a specialty pharmaceutical company specializing in oral health, for approximately
$312 million. Valeant will acquire the
company from Water Street Healthcare
Partners, a private equity firm solely
valeant continued on page 8
SAN DIEGO—A diabetes partnership initiated
in 2007 by Bristol-Myers Squibb Co. (BMS)
and AstraZeneca PLC received a huge boost
last month in the unlikely form of a multibillion-dollar acquisition—of Amylin Pharmaceuticals Inc. by BMS for $31 per share in
cash, or approximately $5.3 billion.
The acquisition is pursuant to a cash tender
bms continued on page 26
BMS’ acquisition of Amylin is part of an ongoing diabetes alliance between BMS and AstraZeneca that will now
develop and commercialize Amylin’s portfolio of GLP-1 agonists for the treatment of type 2 diabetes.
Hiding in plain sight The life science DREAM team
By Lloyd Dunlap
EDINBURGH, Scotland—A group of research-
YORKTOWN HEIGHTS, N.Y.—In the case of amy-
ers in the United Kingdom and the United
States, notable among them University of
Edinburgh Prof. Paul Digard, have located
and described a previously unknown
influenza gene that, while it may not be a
total game changer, sheds an important
light on the dynamics of flu infections.
The results, published in the July 13
issue of Science magazine, prompted Discover magazine to gush that the finding is
“like someone took the text of Macbeth, put
the spaces in different places, and got
Hamlet.” Digard tells ddn that’s a bit of
hyperbole, and it’s probably more accurate
to say that it’s like finding an excellent sonnet hidden in the text of a short play.
As Digard summarizes the process, he
otrophic lateral sclerosis (ALS), why do some
patients—such as renowned baseball player
Lou Gehrig—die quickly, while others—Stephen Hawking comes to mind—survive for
In addition to playing a key role in finding out what
the hidden PA-X flu gene does and where it hides
in the influenza virus, the team at University of
Edinburgh led by Prof. Paul Digard will soon be
publishing the findings of another previously
unknown flu gene.
and other researchers discovered a new
gene in the influenza virus that helps the
virus control the body’s response to
infection and, while this control is exerted by the virus itself, the surprising part
flu continued on page 22
many years? This is one of the questions that
Dialogue for Reverse Engineering Assessment and Methods (DREAM) Project leader
and founder Gustavo Stolovitzky hopes can
be answered in the coming weeks by “the
wisdom of crowds.”
Established in 2006 by the IBM Computational Biology Center and the MAGNet
National Center for Biomedical Computing at
Columbia University, DREAM’s main objective is “to catalyze the interaction between
experiment and theory in the area of cellular
dream continued on page 14
THE STEM CELLS ISSUE, PART 2
Regenerating interest in stem cell medicine
In the second part of our two-part series on
trends in stem-cell research, we examine the
potential of stem cell technologies to assist
in the replacement of organs and tissues, or
possibly even ‘cure’ some diseases.
special report
By Jeffrey Bouley
PHOTO BY Philip Allfrey
Researchers working on both
sides of the Atlantic describe
new influenza gene hidden
among the known ones
Seventh-annual Dialogue for
Reverse Engineering Assessment
and Methods (DREAM) challenge
seeks informatics solutions to
support translational medicine
SEE PAGE 32
PLUS:
GUEST COMMENTARY
FACTS & FIGURES
Dr. Andrew Pecora, chief medical officer
and director of NeoStem Inc., remarks on
the potential for adult stem cell therapies
to manage and treat chronic illnesses
Frost & Sullivan report examines
promise, adoption challenges for stem
cell research tools in Europe
The promise of cell
therapies in treating
chronic diseases
SEE PAGE 11
Report calls Europe’s stem
cell research tools market
‘a hype and a hope’
SEE PAGE 38
28 Drug Discovery News • August 2012
For more information, visit www.DrugDiscoveryNews.com
b r i e f s
Solving the
insoluble
AMAG moves to
outsource manufacturing
LEXINGTON, Mass.—AMAG Pharmaceuticals Inc.
has announced a number of changes to its operating expenses in keeping with its focus on advancing Feraheme, its IV injection for treating iron
deficiency anemia in adult patients with chronic
kidney disease, and expanding its portfolio with
commercial-stage assets. The company expects to
eliminate 45 positions by the end of 2012, primarily in the manufacturing and development infrastructure, as it moves to an outsourced manufacturing model. In conjunction with the elimination
of its manufacturing facility, AMAG will cease production of GastroMark, having established various
agreements for the sale of the product in the
United States and European Union. External development costs will decrease as AMAG’s Phase III
broad iron deficiency anemia clinical program for
Feraheme comes to an end, and AMAG will be
reducing internal development expenses as well.
Cyprotex, Sirius Analytical
announce alliance
CHESHIRE, U.K.—Cyprotex PLC and Sirius Analytical Instruments Ltd. have announced a strategic
alliance under which Cyprotex will be able to offer
Sirius Analytical’s physiochemical property services
to its customers. Sirius Analytical’s instrumentation
is widely used for physicochemical property determination, and its latest addition, the SiriusT3, is a
fully automated system for measuring physicochemical properties using small quantities of material. Financial details were not disclosed.
“Physicochemical property determination is key
to our understanding of how a drug behaves in the
body … Sirius have an impressive record of over
20 years’ expertise in this specialist field. By partnering with Sirius, Cyprotex customers will have
access to a broader range of expert services which
complement our existing portfolio of ADME-Tox
services,” said Dr. Anthony Baxter, CEO of Cyprotex.
New forecast for CRO markets
in Indonesia, Philippines
LONDON—A
new report from GBI Research on
emerging pharmaceutical markets has recently
been published by Market Publishers Ltd. The
report, “Emerging Pharmaceutical Market in Indonesia and Philippines—100 Percent Foreign Direct
Investment in Indonesia and Extensive Insurance
Coverage in the Philippines Attract Foreign Pharma
Companies,” notes that although Indonesia and
the Philippines only account for a very small share
of the global CMO market, the two countries are
positioned to take advantage of increasing outsourcing opportunities from Western countries.
Indonesia and the Philippines recently made the
list as two of the world’s top-20 most populated
countries, and between that large patient base
and a constructive regulatory environment, the
Philippines’ CRO market is drawing global attention. Indonesia’s market, however, faces a hurdle
in the form of its drug registration procedures.
Quotient and Capsugel seek
to hasten early development
and clinical evaluation for
poorly soluble drugs
By Lloyd Dunlap
development industry.
The new company will be renamed Renaissance Pharma. As a result of the transaction,
DPT’s former parent company, DFB Pharmaceuticals, will maintain what has been
described as a “meaningful interest” in the
combined business and will provide oversight
and counsel through representation on
Renaissance’s board of directors.
“We are extremely proud of DPT’s growth
and contribution to the San Antonio community over the past 22 years,” DFB Group President and Co-Founder John W. Feik says. “This
investment by Renaissance indicates a confidence level in the local healthcare workforce
and in San Antonio, which has proven to be a
great location for the operations we have developed in the areas of pharmaceutical research,
development and manufacturing. This partnership provides the resources we need to
accelerate our long-term strategic plans, which
include maximizing our semi-solid and liquid
business in San Antonio, and achieving aggressive growth in our sterile and specialty products business in Lakewood, N.J.”
Pierre Frechette, president and CEO of
MORRISTOWN, N.J.—Capsugel, whose
2,800 hundred staffers produce more
than 180 billion capsules per year, and
Quotient Clinical, a contract research
organization (CRO) that specializes in
early-stage drug development services,
have joined forces in an effort to provide
rapid development and clinical assessment of lipid-based formulations.
Together, the companies will use
their technology and expertise to
address the drug delivery challenges of
poorly soluble molecules with limited
oral bioavailability. With up to 70 percent of the industry’s development pipeline consisting of molecules with poor
solubility, the collaboration will fasttrack the effective clinical evaluation of
lipid-based drug delivery systems in
man, while optimizing the drug product
for downstream development.
The collaboration came about, notes
Capsugel’s senior vice president of
R&D, Keith Hutchison, when Quotient
contacted his company about using
Capsugel’s CFS liquid filling and sealing
technology—a benchtop piece of equipment that delivers about 1,000 capsules
an hour—for clinical trials. In the process, Quotient and Capsugel found out
they had both worked on the same project for a third party. From there, it was
simple to proceed to the next step and
integrate Quotient’s RapidFACT realtime clinical manufacture and testing
service with Capsugel’s lipid-based formulation expertise and manufacturing
capability. As part of the collaboration,
Quotient will utilize Capsugel’s CFS
liquid capsule filling and sealing technology at its facility in Nottingham,
U.K., and will be able to access the formulation expertise in Capsugel’s Development Centre in Strasbourg, France.
Mark Egerton, managing director of
Quotient Clinical, points out that while
the collaboration will help customers
address prevalent drug delivery challenges for poorly soluble compounds
in a more effective way, it will also “further empower our RapidFACT service
by ensuring that selected drug products can be rapidly scaled-up and transitioned into downstream develop-
cdmo continued on page 29
solving continued on page 30
With the new alliance, Catalent will provide Bend Research clients with analytical/CMC, optimization and
clinical and commercial manufacturing services in a cGMP environment.
Control issues
Bend Research and Catalent
partner to provide integrated
solutions for oral controlledrelease technologies
By Jeffrey Bouley
BEND, Ore.—Late June saw Bend Research Inc.
and Somerset, N.J.-based Catalent Pharma
Solutions Inc. enter into an agreement to pro-
vide integrated solutions for pharmaceutical
companies that are seeking to develop and
manufacture specialized multiparticulate oral
controlled-release products. The team-up is
particularly focused on bringing complex
controlled-release products to market faster
and more efficiently with optimal therapeutic
and release profiles.
Catalent and Bend Research have entered
oral continued on page 29
Renaissance Pharma
acquires DPT, a CDMO
Pharma drawn to DPT’s
contract development and
manufacturing capabilities
By Lori Lesko
LAKE FOREST, Ill.—Taking industry healthcare
leaders and stockholders by surprise, Renaissance Acquisition Holdings, a portfolio company of RoundTable Healthcare Partners, has
acquired DPT Laboratories, known for its
world-class semi-solid, liquid and sterile
pharmaceutical contract development and
manufacturing capabilities (CDMO). The
business venture that some are calling a takeover underscores Renaissance’s goals to
expand and diversify.
DPT, headquartered in San Antonio, Texas,
will retain its management personnel and will
not lose jobs. The financial details of the deal,
announced July 5, were not disclosed.
Paul Dorman, former CEO of DPT, said in a
statement that the company was not planning
a sale of DPT when it first started discussions
with RoundTable about future opportunities.
The move came out of the blue because Renaissance and DPT are competitors in the drug
For more information, visit www.DrugDiscoveryNews.com
oral
continued from page 28
into “a number of successful collaborations in the past,” Ian Muir, president of Catalent Pharma Solutions’
Modified Release Technologies business, tells ddn. Dr. Rod Ray, president and CEO of Bend Research,
says joint discussions between the
companies go back at least to 2009,
noting, “We had colleagues in common and attended many of the same
professional conferences, which
gave us the opportunity to learn
more about each other.”
Based on past successes together,
Muir says, discussions became more
serious in the past few months. This
more formal alliance now provides
several synergies, Muir and Ray
note, with Ray pointing out that
Bend Research provides world-class
expertise in formulation and modeling of controlled-release multiparticulate dosage forms to Catalent’s
clients, while Catalent provides
Bend Research clients with analytical/CMC, optimization and clinical
and commercial manufacturing services in a cGMP environment.
“This is the right time for this collaboration because the number of
cdmo
continued from page 28
Renaissance Acquisition Holdings,
agrees.
“As we review investment opportunities, we look for outstanding
companies that deliver a valueadded proposition, with strong
management teams and excellent
reputations in the markets in which
they compete,” Frechette says. “As
a market leader in the contract
development and manufacturing
space, DPT’s experienced management team has established a worldclass reputation in semisolids and
liquids, as well as a sterile business
with an outstanding regulatory
track record that is poised for significant growth. Partnering with
DPT to invest in its continued
growth and success is a perfect fit
with our strategy of building companies for the long term.”
DPT’s capabilities in sterile and
non-sterile products, as well as
soon-to-be-added parenteral drug
manufacturing capabilities, were
the key motivations for the deal
from Renaissance’s perspective,
Frechette says.
Paul Johnson, group president
and COO of DPT, emphasizes that
the deal is expected to boost DPT’s
growth potential.
“Renaissance and its management team bring a depth of industry
experience, including a specific
understanding of the contract manufacturing and development space,
along with a successful history of
partnering with companies like ours
to help them grow,” Johnson says.
“This partnership provides the
resources we need to accelerate our
long-term strategic plans.” ddn
EDITCONNECT: E081225
CONTRACT RESEARCH SERVICES
difficult-to-formulate compounds
in most companies’ pipelines has
never been higher, requiring the
combined skill sets of both companies,” Ray says. “In addition,
because of the intensely competitive
nature of the pharmaceutical industry, the need for improved efficiency
in bringing products to market has
never been greater. This alliance
addresses both of those issues.”
“This is the right pairing,” he
adds, “because our two firms both
specialize in controlled-release multiparticulate formulations and offer
different, but complementary, services—all of which are needed in
advancing formulations from discovery to market.”
Philosophically, both companies
fit well, Muir says, as they each
work toward the same end goal of
providing optimal solutions to customers for challenging controlledrelease products, with Catalent in
particular focused on helping the
pharmaceutical industry with compounds that are difficult to formulate and manufacture using modified release technologies.
August 2012 • Drug Discovery News 29
“This alliance will provide our
customers with industry-leading
formulation scientists and innovative manufacturing technologies
across both companies to bring
more products to market in an efficient approach, from formulation to
commercialization through lifecycle
management,” Muir says.
Reportedly, Catalent and Bend
Research are developing joint operations and technology-transfer protocols to make the customer experience seamless and efficient while
leveraging the strengths of both
companies to develop better treatments for patients globally.
“Our integrated approach is
geared toward complex, multiparticulate controlled-release products,
which traditionally have presented
a high scale-up risk when they are
transferred to commercial manufacturing sites,” said Ray in the news
release about the deal. “This partnership with Catalent will provide
an efficient pathway for these medicines from early development
through commercialization.” ddn
EDITCONNECT: E081227