Pozen makes deadline for FDA

Migraine pill on track for decision by May 15

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CORRECTION

A story in the Business section Wednesday incorrectly reported that the Food and Drug Administration would respond by May 15 to a request by Pozen, a Chapel Hill drug development company, to approve its new migraine drug. The deadline is April 15.

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Pozen could win regulatory approval in mid-May for its long-awaited migraine pill after the Chapel Hill company met a key deadline to answer safety concerns raised by the Food and Drug Administration.

It also has a new name for the pill. Pozen reports that the FDA has tentatively accepted Treximet after rejecting Trexima, the name by which the drug was known during late-stage testing.

Previous safety concerns have extended regulatory scrutiny of the drug by more than 18 months. Some of the FDA's worries may linger or new ones may emerge. But by submitting additional information before Tuesday, Pozen locked in May 15 as the day by which the FDA must issue a decision.

An approval would give Pozen its first product on the market. The company is developing the treatment with British drug maker GlaxoSmithKline.

"This is great news for them," said Ken Trbovich, an analyst with RBC Capital Markets who tracks Pozen.

Shares rose 8 percent Tuesday, closing at $12.85. Trbovich projects the stock's value will increase to $15 over the next 12 months.

Treximet has fallen short of regulatory approval twice -- in June 2006 and in August 2007. The first delay was triggered by FDA worries about Treximet's potential to cause heart attacks, strokes and genetic damage. The second time, the result of a laboratory safety test had caught regulators' attention.

For the company to file its answers before the deadline -- Pozen actually submitted the study results last week, said company spokeswoman Fran Barsky -- came as a pleasant surprise, Trbovich said.

Investors who thought the company might miss the deadline had projected that Treximet may come to market in the third quarter, he said. Now, a launch in the second quarter is likely.

The FDA previously acknowledged that the lab safety test result in question could be false.

In October, Pozen submitted information about the test to address the FDA's concerns. The study results further bolster Pozen's position, Trbovich said. "Without this data, there would still be a doubt."

The study results show that Treximet didn't cause genetic aberrations in volunteers who took the drug for seven days, Pozen reported.

Treximet would give GSK a chance to protect its leadership position in the migraine-drug market. Imitrex, which generated $1.3 billion in sales for GSK in 2006, will face competition from generic versions by the end of this year.

GSK plans to package Treximet at its plant in Zebulon.