Pozen Pulls Plug on Migraine Drug
Aug. 6–After investing years of research and $39 million to develop an experimental migraine treatment, Pozen pulled the plug following an all-day meeting with federal regulators Thursday.
The Food and Drug Administration advisory committee determined that the risks associated with the drug, known as MT 100, outweighed the benefits. The panel cited patients’ risk of developing tardive dyskinesia, which can cause side effects that include involuntary grimacing and eye blinking.
In May 2004, the FDA rejected the migraine drug because of concerns about its safety and effectiveness. The agency held Thursday’s meeting to review the risk and benefit of MT 100 before Pozen conducted more research on the drug.
“It’s time to close the book on MT100 in the United States,” John Plachetka, chief executive of Pozen, said Friday.
British regulators continue to consider whether to approve the sale of the drug.
Hoping to make MT 100 its first drug on the market, the Chapel Hill drug development company spent $39 million on the drug’s development, according to filings with the Securities and Exchange Commission. That included 11 studies involving more than 8,000 patients.
Pozen has been researching migraine drugs since its inception in 1996. The most promising experimental drug in Pozen’s pipeline is Trexima, a different migraine treatment with the potential to generate $1 billion in annual sales.
The company expects to apply for regulatory approval with the FDA to sell Trexima by the end of September.
“I am pleased that they will not be spending more time and money on MT 100,” Tanina Linden, senior investment officer with Princeton Capital Management in Princeton, N.J., told Bloomberg News. “Most people feel that the maximum value for the company is in Trexima.”
Pozen has licensed Trexima’s marketing rights to GlaxoSmithKline, a British pharmaceutical giant with a U.S. headquarters in Research Triangle Park.
Pozen shares closed at $8.29 Friday, up 32 cents.
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