Ligand Partner Pfizer Submits NDA for Fablyn(R)
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) (the Company or
Ligand) today announced that its partner Pfizer, Inc. (NYSE: PFE) has
submitted a New Drug Application (NDA) with the U.S. Food and Drug
Administration (FDA) for Fablyn (lasofoxifene tartrate) Tablets
(formerly, Oporia), a selective estrogen receptor modulator (SERM) for
the treatment of osteoporosis in postmenopausal women. Pfizer has
included the three-year interim data from the Postmenopausal
Evaluation And Risk-reduction with Lasofoxifene (PEARL) study in the
current NDA to support its NDA for lasofoxifene in the treatment of
osteoporosis.
"We are pleased that a Fablyn NDA has been submitted for the
treatment of osteoporosis as the potential product provides an
attractive treatment option for patients with osteoporosis," said John
L. Higgins, President and Chief Executive Officer of Ligand
Pharmaceuticals. "Fablyn's progress is a clear representation of
Ligand's expertise in the area of SERM discovery and research as well
as Pfizer's commitment to this product."
Pfizer Collaboration
The Ligand and Pfizer collaboration was formed to develop
therapies for osteoporosis and subsequently produced lasofoxifene
tartrate, an estrogen partial agonist for osteoporosis treatment and
other diseases. Pfizer is responsible for the registration and
worldwide marketing for Fablyn. Ligand is entitled to a milestone
payment upon FDA approval, and would also receive royalty payments
equal to 3% of net sales. In August 2004 Pfizer filed an NDA with the
FDA for the use of Fablyn in the prevention of osteoporosis. An
additional NDA was filed in December 2004 for the treatment of vaginal
atrophy. Pfizer received "not-approvable" letters from the FDA for
Fablyn for the prevention of post-menopausal osteoporosis in September
2005 and for the treatment of vaginal atrophy in January 2006.
About Ligand Pharmaceuticals
Ligand discovers and develops new drugs that address critical
unmet medical needs of patients in the areas of thrombocytopenia,
hepatitis C, cancer, hormone-related diseases, osteoporosis and
inflammatory diseases. Ligand's proprietary drug discovery and
development programs are based on its leadership position in gene
transcription technology, primarily related to intracellular
receptors.
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 statements include those regarding
timing and results of clinical data for Fablyn and other drug
candidates, data analysis and evaluation of Fablyn, utility or
potential benefits to patients, the potential commercial market for
Fablyn, plans for continued development and further studies of Fablyn.
Actual events or results may differ from our expectations. For
example, there can be no assurance that other trials or evaluations of
Fablyn or other SERM-related product candidates 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 Fablyn or other SERM-related product candidates will
provide utility or benefits to certain patients, that any
presentations will be favorably received, that Fablyn or other
SERM-related product candidates 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 Fablyn and other SERM-related
product candidates will not be successfully challenged. Our stock
price may suffer as a result of the failure of any trials to be
completed or meet their endpoints or if any actual events differ from
our expectations. Additional information concerning these and other
risk factors affecting Ligand can be found in prior press releases as
well as in public periodic filings with the Securities and Exchange
Commission, available via www.ligand.com. 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 January 15, 2008