Congratulations to Pozen, GSK for Persevering in Migraine Drug Battle

RESEARCH TRIANGLE PARK, N.C. – Here’s a tip of the hat to the folks at Pozen Pharmaceuticals who finally, FINALLY, won approval for its migraine drug Treximet on Tuesday.

Investors went on a buying spree after the news broke late last night, driving up Pozen (Nasdaq: POZN) shares more than 37 percent, or nearly $4 a share, to nearly $14.

Not only did Pozen win Food and Drug Administration approval, it also now will pull in additional money from development partner GlaxoSmithKline. GSK already has paid Pozen more than $35 million to develop Treximet and bring it to market.

Now, Pozen can cash in on an FDA approval milestone.

GSK should benefit, too, with its Imitrex drug as part of the Treximet drug combo. Imitrex is a billion-dollar cash cow for GSK but it faces generic competition. Now with a new drug GSK backers can afford a smile. Perhaps this victory will help GSK recover from the hammering it has taken in both publicity and sales about its diabetes drug Avandia.

Pozen had failed to win approval for other pain relievers MT100 and MT300. After those setbacks and repeated delays in the Treximet approval process, Pozen’s shares tool repeated poundings.

Last August, for example, Pozen shares plunged 46 percent, or $7.59 a share, to $9.36 after an FDA rejection.

“It appears the FDA is concerned about this one test,” Pozen Chairman and Chief Executive Officer John Plachetka said in a conference call at the time. But he said Pozen believed the genotoxicity issue had been addressed and that the three other “genetox” tests were negative.

The FDA had earlier expressed concerns about cardiovascular side effects of the drug, but Pozen said the FDA did not express that concern in that August letter. And he vowed to fight on, insisting that GSK was also committed to getting the drug approved.

“We have a good product here,” he said, vowing that Pozen would “move forward in this difficult regulatory environment.”

Now, with a potential billion-dollar seller in hand, Pozen’s future does indeed look bright.

Perseverance is paying dividends. Big ones.