Pozen Pins Hopes on an FDA Booster Shot

An approaching Aug. 1 decision by U.S. regulators on approving Pozen's(POZN) migraine headache drug makes the stock one to watch during the next few weeks.

Pozen is seeking its first drug approval following the Food and Drug Administration's rejection of two previous migraine drugs. Each of the prior failed efforts were solo affairs, but Pozen has some big-time assistance for its Trexima drug in the form of a partnership with GlaxoSmithKline(GSK).

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 as the brand name Aleve.

Imitrex and related product sales totaled $1.4 billion in 2006, but the blockbuster migraine drug franchise has begun to lose patent protection. Glaxo is hoping to switch patients to Trexima before Imitrex goes fully generic in 2009.

For Pozen, which holds patents on the combination of Imitrex and naproxen, and conducted the Trexima clinical trials, the drug's approval represents a potential cash cow in the form of expense-free royalty payments from Glaxo tied to the drug's sales.

Pozen filed Trexima for approval with the FDA in August 2005. In June 2006, the agency issued an approvable letter, requesting additional safety data on the drug before it could be approved. Glaxo and Pozen submitted the additional safety data in November 2006. The FDA is expected to issue its approval decision by August 1.