Healthcare Industry News:  osteoporosis 

Biopharmaceuticals Regulatory

 News Release - April 27, 2009

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

Earns Milestone Payment from Wyeth

SAN DIEGO--(HSMN NewsFeed)--Ligand Pharmaceuticals Incorporated (NASDAQ:LGND ) today announced that its partner Wyeth (NYSE:WYE ) has received approval from the European Commission (EC) for CONBRIZA(TM) (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.


Source: Ligand Pharmaceuticals

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