Pozen Pounded on FDA's Trexima Delay

It's Going to Take Some Time

Forget about the fact that a new positive genotoxicity test is not a sure thing, but even if it is OK, it will still likely take Pozen until the end of the year, realistically, to submit new data to the FDA.

After that, there doesn't seem to be any reason why the agency will take less than six months to review and issue another approval decision.

With that sort of timeline, Trexima doesn't reach the market until the middle of 2008, which puts generic competition looming on the near horizon.

Sell-side analysts Wednesday were nearly unanimous in their opinion that Trexima would be approved. They were all wrong.

I spoke this morning with a hedge fund analyst who was short Pozen going into Thursday's decision because she believed safety concerns would hold up approval. Now, she wasn't counting on potential chromosome damage as being the direct cause for an FDA rejection, but she did believe that neither Pozen nor GlaxoSmithKline was completely transparent about the reasons for Trexima's first approvable letter in June 2006.

On top of that, checks she made with migraine specialists found lackluster support for Trexima. The most aggressive prescribers told her that they'd probably use Trexima in half their patients.

Overall, the analyst's survey checks found that doctors would generally prescribe Trexima to only about 25% of their patients, in part because payors were likely to saddle Trexima with a high copayment.

"Doctors are not seeing a huge need or demand for a drug like Trexima," she said, adding that after today, it seems clear that the FDA doesn't really seem to be in a rush to approve it either.

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