Feuerstein's Biotech-Stock Mailbag

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Moving on, Robert P. asks, "The FDA is due to release a decision on Pozen's(POZN Quote) migraine drug by April 15. Do you have any predictions on that decision? I haven't read anything bad about it and Pozen seems to have answered all of the FDA's concerns."

The Pozen migraine drug is called Treximet, formerly known as Trexima. Pozen developed the drug for GlaxoSmithKline(GSK Quote), which is facing imminent generic competition for its leading migraine drug Imitrex. (Treximet combines Imitrex with the pain reliever naproxen.)

I don't have any clue how the FDA will rule on April 15. What I do know is that Pozen has a terrible track record when it comes to FDA approval decisions.

Two previous efforts to get drugs approved ended in failure. Treximet has been under review by the FDA since 2005. Last August, regulators turned the drug back again, asking for more clinical data. Pozen says that data has been provided, setting up another FDA decision next month.

Should you trust these guys? I guess Pozen could get it right this time, but geesh, talk about a crapshoot.

The other issue is timing: Does an approval of Treximet now really benefit Pozen financially? Glaxo is running out of time to switch migraine sufferers from Imitrex to Treximet before generics hit the market late this year. Pozen gets an expense-free royalty on Treximet sales, but that won't amount to much if doctors and their migraine patients choose cheaper, generic Imitrex over Treximet.

Pozen's stock price has climbed fairly steadily from around $8 at the time of the last FDA rejection in August to about $12 Friday. That seems to price in Treximet's value plus the company's pipeline. If Treximet is approved, I imagine the stock will go higher, but not by much.

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One more, a quickie: Eldon M. asks, "What do you think the chances are that there is another pharmaceutical company willing to go over the top of Pfizer's(PFE Quote) bid for Encysive Pharmaceuticals(ENCY Quote)?"

Zero.