Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced
today that it has entered into a global licensing agreement with Chiva
Pharmaceuticals, Inc. for Fablyn (lasofoxifene), a selective estrogen
receptor modulator (SERM) that was approved in the EU in 2009 for the
treatment of osteoporosis in post-menopausal women at increased risk of
fracture. In return for the license, Ligand will receive $4 million in
licensing payments over the next eight months and is also eligible to
receive milestones and royalties on worldwide sales of Fablyn.
Fablyn was discovered through a research collaboration between Ligand
and Pfizer that began in 1991. The drug was fully developed by Pfizer
through regulatory approval in the EU. After Pfizer acquired a similar
SERM program, Conbriza (bazedoxifene), from its acquisition of Wyeth,
Fablyn reverted to Ligand earlier this year.
"The licensing of Fablyn is another transaction demonstrating the
strength of the Ligand business model,” said John Higgins, President and
Chief Executive Officer of Ligand Pharmaceuticals. "Ligand’s network of
worldwide partnerships enables us to quickly move into discussions when
a business development opportunity such as Fablyn arises."
"We are delighted to expand our relationship with Chiva," Higgins
continued. "Chiva has built an impressive team of management, investors
and advisors to drive a company that is largely built around several
high-quality Ligand portfolio assets. This agreement enables both Ligand
and Chiva to further tap into the burgeoning pharmaceutical investments
and enterprise in China. Beyond the obvious benefit of expanding our
access to the lucrative Chinese markets and beyond, this transaction
further expands our partnered portfolio with another potentially
near-term commercial revenue opportunity.”
"The Chiva team is extremely pleased to acquire Fablyn and broaden our
partner relationship with Ligand,” said Zhijian (David) Xi, President
and Chief Executive Officer of Chiva Pharmaceuticals. "I believe we are
raising the bar for new Chinese pharmaceutical companies by acquiring
the global rights to a major asset with efficacy and safety data from
over 10,000 patients and developed by one of the most reputable
companies in the industry. Our ability to acquire an approved asset and
potentially launch in the EU in the near future greatly enhances our
business model and again differentiates Chiva from many of the emerging
pharmaceutical companies in China. I firmly believe that both Ligand and
Chiva will continue to benefit from the unique partnership our companies
have forged by allowing us to utilize the investment energy and
government support in the Chinese pharmaceutical industry to advance
assets out of the large Ligand portfolio of proprietary programs.”
About Fablyn
The Ligand and Pfizer collaboration was formed in 1991 to develop
therapies for osteoporosis and subsequently produced lasofoxifene
(Fablyn), an estrogen partial agonist for osteoporosis treatment and
other diseases. The Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency issued a positive opinion on
December 18, 2008, recommending marketing authorization for Fablyn. The
European Commission, which has the authority to approve medicines for
the European Union, issued a Marketing Authorization on February 24,
2009.
The International Osteoporosis Foundation (IOF) reports that more than
75 million people suffer from osteoporosis in Europe, Japan and the U.S.
About 30% of all post-menopausal women have osteoporosis in Europe and
in the U.S., and at least 40% of them will suffer osteoporotic fractures
in their lifetime. In Europe alone, 3.78 million osteoporosis-related
fractures were reported in 2000, with an estimated cost of 32 billion
euros.
About Ligand Pharmaceuticals
Ligand is a specialty biotech company based on a business model of
developing or acquiring technology and royalty revenue generating assets
that are coupled to a lean corporate cost structure. Ligand’s goal is to
produce a bottom line that supports a sustainably profitable business.
By diversifying the portfolio of technologies and assets across numerous
therapeutic areas, drug targets, and industry partners, we offer
investors an opportunity to invest in the increasingly complicated and
unpredictable pharmaceutical industry. Ligand recognized the important
role of the drug reformulation segment in the pharmaceutical industry
and added Captisol® to its technology portfolio. Captisol is a powerful
formulation technology that has enabled five FDA approved products,
including Pfizer’s VFEND® IV and Baxter International’s Nexterone®. In
comparison to its peers, we believe Ligand has assembled one of the
largest and most diversified asset portfolios in the industry with the
potential to generate revenue in the future. These therapies address the
unmet medical needs of patients for a broad spectrum of diseases
including hepatitis, muscle wasting, Alzheimer's disease, dyslipidemia,
diabetes, anemia, COPD, asthma, rheumatoid arthritis and osteoporosis.
Ligand has established multiple alliances with the world's leading
pharmaceutical companies including GlaxoSmithKline, Merck, Pfizer,
Bristol-Myers Squibb and Onyx. For more information, please visit www.ligand.com.
Follow Ligand on Twitter @Ligand_LGND.
About Chiva Pharmaceuticals
Chiva Pharmaceuticals, Inc. is a biopharmaceutical company based in
China that discovers, develops and commercializes innovative medicines
in areas of unmet medical need. Founded in 2010, Chiva’s business model
was designed to thrive in the unique circumstances of China’s current
pharmaceutical sector; a very large population in need of new medicines,
an under-developed pharmaceutical industry, a world class scientific
workforce, superb public infrastructure, and cost-efficient
manufacturing capabilities. Chiva has assembled a dynamic leadership
team of Chinese pharmaceutical executives trained in US pharmaceutical
companies and professors from some of the top universities in China.
With the management team’s unique Chinese and western scientific
knowledge and pharmaceutical industry experience, Chiva’s mission is to
build a leading Chinese pharmaceutical company that competes on the
world stage. Combining a broad drug discovery program with an aggressive
in-licensing strategy, Chiva strives to develop world-class therapies
and bring the highest standard of care to the Chinese pharmaceutical
market. In July 2011, Chiva was awarded the only 2011 Category A level
drug company by the WuXi Government 530 Project, one of the most
successful local government incubators in China with strong public and
private financial backing. Chiva was also recently recognized as the
"Most Promising Company” in the annual (2011) BioBay Investor Forum.
Chiva is currently developing multiple assets in China, including the
clinical programs of Pradefovir (HepB), MB07133 (HCC), and several
pre-clinical programs in anti HBV, HCV and HCC licensed from Ligand
Pharmaceuticals in early 2011.
Caution Regarding Forward-Looking Statements
This news release contains forward looking statements by Ligand that
involve risks and uncertainties and reflect Ligand’s judgment as of the
date of this release. Actual events or results may differ from Ligand’s
expectations. For example, there can be no assurance that Fablyn or any
product in the Ligand or Chiva pipelines will be successfully developed,
that regulatory approvals will be granted, that patient and physician
acceptance of these products will be achieved, that final results of
human clinical trials will be consistent with any interim results, that
final results will be supportive of regulatory approvals required to
market products or that any revenue will be achieved from these
partnered programs. Additional information concerning these and other
risk factors affecting Ligand’s business can be found in prior press
releases available via www.ligand.com
as well as in Ligand’s public periodic filings with the Securities and
Exchange Commission at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this release. This caution
is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
