Pfizer Seeks Partner After Bone Drug Increases Approval In Europe
The treatment, Fablyn, was approved by the European Commission for women who face a higher risk of fractures, said Pfizer and San Diego-based Ligand Pharmaceuticals Inc., which developed the therapy.
U.S. regulators failed to approve the drug in January, requesting more information from New York-based Pfizer. An FDA advisory panel concluded at a meeting Sept. 8 that the drugs benefits likely outweighed the risks. Advisers reviewing a clinical trial of the drug found an increase in deaths, though the panel couldnt determine if the deaths represented a “true increase” compared with patients who received a placebo.
The European approval “really does validate our research platform and drug discovery abilities,” said Ligand Chief Executive Officer John Higgins yesterday in a telephone interview. “We remain hopeful that the drug will be approved in the U.S.”
Ligand will receive a $3 million milestone payment from Pfizer and 3 percent royalty payments on net worldwide sales, Higgins said. Pfizer has worldwide marketing rights to the drug.
Pfizer will license its rights for Fablyn to another company and is “in discussions” with possible partners, Pfizer spokesman Jack Cox said in a telephone interview.
Seeking Partner
“We will seek a partner outside of Pfizer who may have an interest in commercializing this product,” Cox said yesterday. “This product is a treatment advance, and we are very interested in making sure we get the product to patients.”
Osteoporosis, a weakening of the bones, affects about 75 million people in the U.S., Europe and Japan, according to the International Osteoporosis Foundation. Pfizer has said Fablyn would provide a new treatment option for many of the 10 million Americans with the disease.
Fablyn works similarly to Indianapolis-based Eli Lilly & Co.s Evista, which generated $1.08 billion in 2008 sales. The drug also will compete with Reclast by Swiss-based Novartis AG, Swiss-based Roche Holding AGs Boniva, Cincinnati-based Procter & Gamble Co.s Actonel and Whitehouse Station, New Jersey-based Merck & Co.s Fosamax, the market leader before it went generic in February. Denosumab, Thousand Oaks, California-based Amgen Inc.s experimental treatment awaiting regulatory approvals, also has been shown to strengthen bones and reduce fractures.