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Pozen Again Tries for Migraine Drug Approval

Posted on: Tuesday, 9 August 2005, 00:00 CDT

Aug. 9--Pozen officially began its third attempt to win regulatory approval for an experimental migraine drug, hoping to overcome obstacles that caused two previous efforts to fail.

The Chapel Hill drug-development company said Monday that it had submitted MT400 for review with the Food and Drug Administration after rejections of migraine treatments known as MT100 and MT300 in the past two years.

Also known by its proposed brand name Trexima, the new drug contains different ingredients and is expected to be a big seller if it passes regulatory scrutiny.

"Trexima is the most promising drug in [Pozen's] pipeline," said Jordan Smyth, managing director of Edgemoor Capital, a Washington, D.C.-based investor in Pozen.

In mid-April, Pozen shares doubled in value within three days after the company announced test results that indicated Trexima was safe and effective.

Pozen is collaborating with GlaxoSmithKline to bring the drug to market. The collaboration is worth $160 million in upfront and milestone payments alone. GSK also has agreed to pay Pozen royalties if Trexima is approved for sale. Analysts have said the drug has the potential to generate $1 billion in annual sales.

"This is clearly good news," Smyth said about the regulatory filing.

Analysts and investors had expected Pozen to submit the regulatory filing by the end of September. Pozen Chief Executive John Plachetka credited smooth cooperation with GSK for getting the paperwork together eight weeks ahead of schedule.

"We hardly had any glitches at all," Plachetka said.

The FDA now has 75 days to accept the filing for review. The FDA's acceptance of the paperwork signals that the filing is complete. For Pozen, which has about a year's worth of cash on hand, that would trigger a $20 million milestone payment from GSK.

The British drug maker has one of its U.S. headquarters in Research Triangle Park.

Once the filing is accepted, it will go to the FDA's neuropharm division for review. That's where Trexima could run into hurdles, Deborah Knobelman, a Piper Jaffray analyst, wrote in a research report.

"We are still cautious on Trexima's ultimate approvability," Knobelman wrote in a report to investors April 21, the day after Pozen released positive study results for the drug.

Trexima contains naproxen, a chemical that is part of the same class as painkillers under scrutiny for side effects since Vioxx was pulled off the market a year ago for increasing the risk of heart attacks.

The FDA has mandated that all drugs in the class must have a "black box" warning, Knobelman wrote. Consequently, she wrote, "we still believe it will be difficult to get new drugs approved in this class near-term."

Also, she added, "the neuropharm division is a notoriously slow and difficult division."

Still, Plachetka said he is upbeat about Trexima's chances of winning approval. The FDA, which is expected to respond by the middle of next year, could approve the drug, reject it or request additional information and testing.

Pozen, which was responsible for testing the drug on patients and submitting the regulatory filings, conducted two clinical trials on human patients and a 12-month safety test. GSK provided data from two additional studies.

Compared to MT100 and MT300, Plachetka said, "we believe Trexima is a superior product."

Pozen shares closed at $7.98 Monday, down 31 cents. The shares are up nearly 10 percent this year.

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Source: The News & Observer

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