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Pozen Pounded on FDA's Trexima Delay

Can Pozen (POZN - Get Report) do anything right?

The Chapel Hill, N.C.-based drug company has tried three times to get three different migraine drugs approved in the U.S. Three times, the Food and Drug Administration has sent Pozen's products packing.

The first two Pozen drugs are dead; the third, Trexima, is still hanging on, but its fate remains uncertain. Thursday, the FDA said it would require Pozen and partner GlaxoSmithKline (GSK - Get Report) to collect more safety data before the drug could be approved.

The bad news sent Pozen shares tumbling 45.6% to $9.49 in recent trading. Glaxo's were up 31 cents to $51.92.

Thursday, Pozen management said it would take all steps necessary -- and fast -- to satisfy the FDA's concerns so that Trexima can be resubmitted and eventually be approved. The problem is that the clock is ticking.

Trexima faces potential competition from cheaper generics entering the market toward the end of 2008. That's why an approval Thursday was so important to Trexima (and Pozen's stock price). Now, Trexima may not make it to market (if at all) before mid-2008, leaving little time for marketing partner Glaxo to get patients on the drug.

Trexima combines Imitrex, the leading migraine headache drug marketed by Glaxo, with naproxen, an over-the-counter pain reliever and anti-inflammatory drug. Naproxen, a so-called NSAID (nonsteroidal, anti-inflammatory drug), is probably best known by the brand name Aleve.

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