Shares of Pozen Inc. sank almost 15 percent Wednesday after the company said federal regulators have raised additional questions about its lead migraine treatment.
Less than two months after Pozen submitted what it called a "full response" to safety questions posed by the U.S. Food and Drug Administration about the migraine treatment Trexima, the federal agency has requested more data and analyses of the drug. Chapel Hill-based Pozen said Wednesday that the FDA has completed its review of the company's response to a June 8, 2006, approvable letter for Trexima and that the agency has "determined the response is not yet complete."
Pozen is developing Trexima in collaboration with GlaxoSmithKline (NYSE: GSK).
Pozen said the additional information will help the FDA assess the "relative safety" of Trexima. The company expects to submit the revised report by the end of the year.
Pozen Executive Vice President Marshall Reese said the company is still confident that the data on Trexima will demonstrate the drug's safety and efficacy.
Inverstors weren't as confident. Shares of Pozen (Nasdaq: POZN) were down $2.55, or 14.08 percent, to $15.70 in trading Wednesday afternoon.
Pozen received an approvable letter from the FDA in June indicating that Trexima was "effective as an acute treatment for migraine headaches," but that the agency wanted more safety information on the treatment - a request that could have required more drug trials.
An FDA approval of the drug based on the additional safety information would spare Pozen and GSK the time and expense of further clinical trials.
Pozen (Nasdaq: POZN) halted development of MT 100, another migraine drug, in August following an FDA committee's recommendation against approval because of safety concerns.
London-based GSK has dual U.S. headquarters in Research Triangle Park and Philadelphia. The company employs about 5,600 Triangle workers.
source - Bizournals