Ligand Announces Approval in Europe of CONBRIZA for Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture

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Mon Apr 27, 2009 9:05am EDT

Earns Milestone Payment from Wyeth
SAN DIEGO--(Business Wire)--
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced that its
partner Wyeth (NYSE:WYE) has received approval from the European Commission (EC)
for CONBRIZA (bazedoxifene), a selective estrogen receptor modulator (SERM) for
the treatment of postmenopausal osteoporosis in women at increased risk of
fracture. 

CONBRIZA was submitted for approval in Europe in September 2007. This is the
first regulatory approval for bazedoxifene, a product stemming from a 1994
research collaboration between Wyeth and Ligand. Wyeth 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 breast and uterine tissue. 

As a result of the European approval of bazedoxifene, Ligand has earned a
$550,000 milestone payment, and is entitled to receive royalty payments on net
sales of the product. Wyeth intends to introduce CONBRIZA in Europe following
receipt of necessary reimbursement authorizations. 

"Today`s announcement is an exciting development for Ligand as the European
approval of CONBRIZA marks the fifth drug associated with Ligand`s research
platform that has been approved and the third to be approved in just the past
six months," said John L. Higgins, President and Chief Executive Officer of
Ligand Pharmaceuticals. "We are very pleased with Wyeth's development progress
and commitment to bringing a new osteoporosis treatment option to postmenopausal
women in Europe." 

Wyeth is pursuing U.S. regulatory approval of bazedoxifene for the prevention
and treatment of osteoporosis in postmenopausal women. In June 2006 Wyeth
submitted a New Drug Application (NDA) for bazedoxifene to the U.S. Food and
Drug Administration (FDA) for the prevention of postmenopausal osteoporosis, and
in July 2007 submitted an NDA for bazedoxifene for the treatment of
postmenopausal osteoporosis. Wyeth has indicated that it will file a complete
response in 2009 and anticipates the FDA to convene an advisory committee to
review the pending NDAs for both indications. Ligand is entitled to an $850,000
milestone payment upon approval of bazedoxifene in the U.S. 

Wyeth is also studying bazedoxifene/conjugated estrogens, an investigational
compound for the treatment of moderate to severe menopausal vasomotor symptoms
such as hot flashes and night sweats and for the prevention of postmenopausal
osteoporosis. Wyeth expects to file an NDA for this compound no earlier than the
first half of 2010. Ligand is entitled to receive tiered royalties on
bazedoxifene and bazedoxifene/CE. 

Osteoporosis Prevalence

The International Osteoporosis Foundation reports that more than 75 million
people suffer from osteoporosis in Europe, Japan and the U.S. In Europe, about
30% of all post-menopausal women have osteoporosis, and 3.78 million
osteoporosis-related fractures were reported in 2000, at an estimated cost of 32
billion euros. In the U.S., the National Osteoporosis Foundation projects that
10 million American women will have osteoporosis in 2010 and that at least 40%
of them will suffer osteoporotic fractures in their lifetime. Another 26 million
are expected to have osteopenia (low bone mass), placing them at increased risk
of osteoporosis. 

Osteoporosis is characterized by low bone mass and structural deterioration of
bone tissue, leading to bone fragility and an increased risk of fractures. Up to
20% of a woman's expected lifetime bone loss can occur in the years immediately
following menopause. The treatment of postmenopausal osteoporosis could lead to
significant improvement in the overall health for millions of women worldwide as
well as reduce costs associated with postmenopausal osteoporosis-related
fractures. 

About Ligand Pharmaceuticals

Ligand discovers and develops new drugs that address critical unmet medical
needs of patients with muscle wasting, frailty, hormone-related diseases,
osteoporosis, inflammatory diseases, anemia, asthma, rheumatoid arthritis and
psoriasis. Ligand's proprietary drug discovery and development programs are
based on advanced cell-based assays, gene-expression tools, ultra-high
throughput screening and one of the world`s largest combinatorial chemical
libraries. Ligand has strategic alliances with major pharmaceutical and
biotechnology companies, including Bristol-Myers Squibb, Celgene, Cephalon,
GlaxoSmithKline, Schering-Plough, Pfizer and Wyeth Pharmaceuticals. With nine
pharmaceutical deals and more than twenty different molecules in various stages
of development, Ligand utilizes proprietary technologies for identifying drugs
with novel receptor and enzyme drug targets. 

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 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
bazedoxifene or other SERM-related product candidates will provide utility or
benefits to certain patients, that any presentations will be favorably received,
that bazedoxifene 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 bazedoxifene and other SERM-related product candidates 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. 





Ligand Pharmaceuticals Incorporated
John L. Higgins, President and CEO or Erika Luib, Investor Relations,
858-550-7896
or
Lippert/Heilshorn & Associates
Don Markley, 310-691-7100
dmarkley@lhai.com



Copyright Business Wire 2009

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