Pfizer to Focus On Lasofoxifene -- CP336,156 -- for Osteoporosis and Breast Cancer; Ligand to Receive Milestones and Royalties on Further Development
SAN DIEGO--(BW HealthWire)--Dec. 23, 1999--Ligand Pharmaceuticals Incorporated (Nasdaq:LGND) announced today that Pfizer Inc. has narrowed its focus to one of two compounds it was developing following conclusion of its collaboration with Ligand for treatment of patients with osteoporosis and breast cancer in post-menopausal women. Pfizer has indicated in its most recent update to Ligand as well as in recent press briefings and analyst meetings that it intends to proceed to Phase III trials for lasofoxifene, currently in Phase II trials, and discontinue work on droloxifene, a first generation selective estrogen receptor modulator (SERM) worked on by Ligand during the collaboration.
Under the terms of the agreement between Ligand and Pfizer, Ligand is entitled to receive milestones for the continued development of lasofoxifene as well as a royalty equal to 6% of net sales. The royalty rate on droloxifene worldwide sales would have been substantially lower, 1% for breast cancer and 3% for indications other than breast cancer, including osteoporosis.
"Pfizer's choice to continue development of lasofoxifene is encouraging for women who suffer from osteoporosis and breast cancer as well as for Ligand," said Andres Negro-Vilar, M.D., Ph.D., Ligand Senior Vice President of Research and Chief Scientific Officer. "Unlike the first generation SERMs, the second generation SERMs such as lasofoxifene increase bone mineral density and reduce LDL cholesterol as well as or better than currently available drugs, without the breast or uterine cancer risk associated with traditional hormone replacement therapies. Therefore, lasofoxifene represents a `best in class' choice as a true second generation SERM."
"We are pleased with Pfizer's long-awaited decision to focus on lasofoxifene for full development and registration. We believe the compound may have potential to improve the lives of a substantial number of women who suffer from osteoporosis or breast cancer," said David E. Robinson, Ligand Chairman, President and CEO. "In addition, the financial return to Ligand shareholders is significantly more attractive -- the royalty rate on lasofoxifene is twice as large as that of droloxifene and milestones are the same."
Pfizer had said that one or both of these compounds would enter full Phase III development based on the results of their respective Phase II trials. In Phase II trials, lasofoxifene, an estrogen partial agonist previously known as CP336,156, has reduced bone loss and decreased low-density lipoprotein levels (LDL, or "bad cholesterol") without the breast or uterine cancer risk associated with traditional hormone replacement therapies. Pfizer believes that lasofoxifene is the most potent of the selective estrogen receptor modulators. According to information recently released by Pfizer, lasofoxifene increases bone mineral density as well as Prempro and reduces LDL by 25% versus 16% for Evista. Pfizer said it will not go forward with droloxifene for any indications.
Droloxifene is a Pfizer compound worked on by Ligand at Pfizer's request during the research phase of their collaboration that was completed in November 1993, while lasofoxifene resulted from the Pfizer-Ligand research collaboration.
According to the National Osteoporosis Foundation, more than 28 million Americans suffer from or are at high risk of contracting osteoporosis, a debilitating disease characterized by depletion of bone mass that can lead to increased risk of fractures. Breast cancer is the second leading cancer killer among women according to the American Cancer Society. This year experts predict that more than 180,000 cases of breast cancer will be diagnosed, making it the most common non-skin malignancy in the U.S. among women. The prevalence of breast cancer in the U.S. is estimated to have reached more than 2 million.
Pfizer Inc. is a diversified, research-based health care company with global operations. Pfizer reported sales of $13.5 billion in 1998.
Ligand Pharmaceuticals Incorporated
Ligand Pharmaceuticals Incorporated discovers, develops and markets new drugs that address critical unmet medical needs of patients in the areas of cancer, skin diseases, and men's and women's hormone-related diseases, as well as osteoporosis, metabolic disorders and cardiovascular and inflammatory diseases. Ligand's first two drugs
-- Panretin(R) gel and ONTAK(R) -- were approved for marketing in the U.S. in early 1999 and are being marketed through its specialty cancer and HIV-center sales force in the U.S. Two drugs -- Targretin(R) capsules and Targretin(R) gel -- are currently under review by the U.S. Food and Drug Administration for marketing approval in the U.S., and two additional oncology-related products -- Morphelan(TM) (licensed from Elan) and Panretin(R) capsules -- are in late-stage development. Ligand's proprietary drug discovery and development programs are based on its leadership position in gene transcription technology, primarily related to Intracellular Receptors (IR) and Signal Transducers and Activators of Transcription (STATs).
This news release may contain certain forward looking statements by Ligand and actual results could differ materially from those described as a result of factors including, but not limited to the following. There can be no assurance that lasofoxifene or any other compound identified as a result of any Ligand collaboration or Ligand's internal research will be successfully developed, final clinical data will be consistent with interim clinical data, that regulatory approvals will be granted, or that patient and physician acceptance of these products will be achieved. Additional information concerning these and other factors affecting Ligand's business can be found in press releases as well as in Ligand's public periodic filings with the Securities and Exchange Commission, which are available via Ligand's web site at ligand.com. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release.
Note: Panretin(R) and Targretin(R) are registered trademarks of Ligand Pharmaceuticals Incorporated, and ONTAK(R) is a registered trademark of Seragen, Inc., a wholly owned subsidiary of Ligand.
Ligand Pharmaceuticals' releases are available on the World Wide Web at www.businesswire.com/cnn/lgnd.htm.
CONTACT:
Ligand Pharmaceuticals Incorporated
Paul V. Maier, 858/550-7573 |
