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Pozen, GlaxoSmithKline To Try Again To Win Migraine Drug Approval

Posted July 31, 2006

— Drug partners

Pozen Pharmaceuticals



are going to make another attempt to win government approval of their proposed treatment for migraine headaches.

Pozen said Monday morning that the two firms would submit a "full response" to the Food and Drug Administration about the drug Trexima in the fourth quarter. Pozen and GSK recently met with the FDA to "reach an agreement" about how the companies would respond. Specific details of the agreement were not disclosed.

"The full response will contain additional safety information," Pozen said.

The news reignited interest in Pozen (Nasdaq: POZN), with shares climbing 27 percent, or $1.63, to reach $7.70 a share. GSK (NYSE: GSK) shares traded down 29 cents at $55.33.

The FDA set Pozen an approvable letter about Trexima in June that raised questions about its safety. The delay in approval of the drug alarmed Pozen stockholders, who sent the share price down $8.59 to $5.52.

Once Pozen and GSK supply the new information, the FDA has six months to review it, Pozen said in a statement.

"We are very pleased to reach agreement with the FDA allowing us to make a full response in a timely manner." said John Plachetka, Pozen's chief executive officer, in a statement. Some analyst firms continue to believe that Trexima will be approved by the FDA. In the approvable letter, Pozen noted in June that the "FDA has determined that Trexima is effective as an acute treatment for migraine headaches," but noted that it had "requested additional safety information on Trexima, which may require new studies."

Pozen and GSK had expected Trexima to be approved in 2006.

Trexima is a combination of the GSK drug Imitrex, which is a pain reliever for acute migraines, and a combination of other products formulated with Pozen-developed technology. Trexima also contains naproxen sodium, a non-steroidal anti-inflammatory drug used in over-the-counter drugs such as Aleve.

Pozen received a $20 million milestone payment last fall from GSK following the submission of the new drug application for Trexima to the FDA.

GSK made as $15 million milestone payment to Pozen in May of 2004 based on reaching Phase III clinical trial milestones. At that time, the companies said they hoped to file the new drug application in the second half of 2005.

More than 20 million Americans and more than 300 million people worldwide suffer from migraine headaches.

Pozen stock has traded as high as $18.62 over the last year, the price rising after Pozen and GSK filed the new drug application. Its previous low had been $7.25.


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