Ligand Announces Market Launch of Bazedoxifene in Japan and Spain for the Treatment of Postmenopausal Osteoporosis
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced
that its partner Pfizer, Inc. (NYSE:PFE) launched Viviant(R)
(Bazedoxifene) in Japan for the treatment of postmenopausal
osteoporosis. Under the brand name Conbriza(R), the drug is also marketed
in Spain through a co-promotion with Almirall, an international
pharmaceutical company based in Spain. Pfizer received manufacturing and
marketing approval for the product in Japan in July 2010. Viviant was
approved in April 2009 by the European Commission (under the trade name
Conbriza(R)) for the treatment of postmenopausal osteoporosis in women at
increased risk of fracture.
Viviant, a selective estrogen receptor modulator (SERM), is a result of
the successful research collaboration between Wyeth (now Pfizer) and
Ligand that began in 1994. Pfizer is responsible for the registration
and worldwide marketing of bazedoxifene, a synthetic drug specifically
designed to reduce the risk of osteoporotic fractures while also
protecting uterine tissue. Ligand is entitled to receive tiered
royalties on net sales of bazedoxifene.
"We are excited to see the progress of Viviant as it provides a new
osteoporosis treatment option to postmenopausal women. This is now the
third product that Ligand will earn royalties from out of a large
portfolio of partnered, royalty bearing programs," said John L. Higgins,
President and Chief Executive Officer of Ligand Pharmaceuticals.
"Viviant's commercial introduction in Japan and Spain reflects the
quality of Ligand's collaborations and the expertise of its partners in
business, product development and international regulatory affairs."
Bazedoxifene
In a pivotal Phase III study involving more than 7,600 women worldwide,
Viviant achieved a significant 42 percent reduction in the incidence of
new vertebral fractures. In addition, a post-hoc analysis showed the
incidence of non-vertebral fractures in a high-risk population was
reduced by 50 percent and 44 percent compared to placebo and raloxifene,
respectively.
Due to this efficacy data on relative risk reduction for vertebral and
non-vertebral fractures, and the product's endometrial tissue profile
compared with placebo, bazedoxifene is positioned to become the leading
representative of third generation SERMs and a promising therapeutic
innovation for women with postmenopausal osteoporosis at increased risk
of fractures.
About Ligand Pharmaceuticals
Ligand discovers and develops novel drugs that address critical 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's
proprietary drug discovery and development programs are based on
advanced cell-based assays, tissue-specific receptor ligand interactions
and gene-expression tools. Among its peers, we believe Ligand has
assembled one of the largest portfolio of assets including commercial
therapies developed in partnership with pharmaceutical companies. Along
with several internal programs, Ligand has established multiple
alliances with the world's leading pharmaceutical companies including
GlaxoSmithKline (GSK), Merck, Pfizer, Roche, Bristol-Myers Squibb and
AstraZeneca, and more than 30 programs in various stages of development.
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. These forward-looking statements include comments
regarding bazedoxifene and other drug candidates, data analysis and
evaluation of bazedoxifene, utility or potential benefits to patients,
the potential commercial market for bazedoxifene and plans for continued
development and further studies of bazedoxifene. Actual events or
results may differ from Ligand's expectations. For example, there can be
no assurance that other trials or evaluations of bazedoxifene will be
favorable or that they will confirm results of previous studies, that
data evaluation will be completed or demonstrate any hypothesis or
endpoint, that bazedoxifene will provide utility or benefits to certain
patients, that any presentations will be favorably received, that
bazedoxifene will be useful as a single agent or in combination with
other drugs, that marketing applications will be filed or, if filed,
approved, or that clinical or commercial development of these product
candidates will be initiated, completed or successful or that our rights
to bazedoxifene will not be successfully challenged. The failure to meet
expectations with respect to any of the foregoing matters may reduce
Ligand's stock price. Additional information concerning these and other
risk factors affecting Ligand can be found in prior press releases
available at www.ligand.com
as well as in public periodic filings with the Securities and Exchange
Commission, available at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this press release. This
caution is made under the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995.
Source: Ligand Pharmaceuticals Incorporated
Released October 13, 2010