West Coast Editor

After giving up on its migraine drug MT 100 last week, Pozen Inc. has submitted a new drug application for another therapy targeting the same condition - Trexima, which is a pill that combines sumatriptan succinate and one of MT 100's ingredients, naproxen sodium.

"We have a lot of confidence in our partner, [London-based GlaxoSmithKline plc]," said John Plachetka, chairman, president and CEO of Chapel Hill, N.C.-based Pozen.

"They've worked with us, and I think this is going to be an approvable NDA," so that the drug could be launched next year, Plachetka said.

The company's stock (NASDAQ:POZN) closed Monday at $7.98, down 31 cents.

Last Friday, Pozen said it was removing MT 100 from its portfolio because the drug's other component, metoclopramide, was linked to a neurological movement disorder called tardive dyskinesia. The FDA's Peripheral and Central Nervous Systems Drugs decided that the risk of the condition outweighed MT 100's benefits. (See BioWorld Today, Aug. 8, 2005.)

"We did not have a partner in the U.S. for MT 100, so terminating development wasn't that difficult a call," Plachetka said. "It's hard to close the book on any program, but it would have taken so much more work to get [MT 100 research] turned around."

The decision to focus instead on Trexima was "not a no-brainer, but it was pretty easy."

Another Pozen migraine product candidate also has run into trouble. Two years ago, the firm got a not-approvable letter for MT 300, a new formulation of dihydroergotamine mesylate. The drug, given by injection, failed to achieve statistical significance in relief of secondary symptoms, including nausea, sensitivity to light and sensitivity to sound at two hours. (See BioWorld Today, Oct. 21, 2003.)

"The drug performed as expected, but changes at the FDA in endpoints for migraine drugs made it not approvable," Plachetka said, noting that nausea is a recognized side effect of dihydroergotamine.

"Every headache doctor knows that," he said, but the FDA would no longer accept nausea in a migraine drug's profile.

Trexima looks like a brighter story. Upon FDA acceptance of the NDA filing for the compound, formerly called MT 400, Pozen is due a $20 million milestone payment from GSK. In the summer of 2003, the companies entered a potential $160 million licensing deal. (See BioWorld Today, June 13, 2003.)

The market could be lucrative, too. More than 28 million people in the U.S. are believed to suffer migraines, with only half diagnosed and only two-thirds of those getting prescription medications.

Although companies often are characterized by what's in their pipelines at start-up, Plachetka said Pozen is "not a migraine company. We're a company that deals in pain." Migraines undoubtedly are painful, but "so is arthritis and other types of inflammatory conditions," he noted.

Pozen has its PN program, which combines proton pump inhibitors with non-steroidal anti-inflammatory drugs to provide control of pain and inflammation with fewer gastrointestinal complications compared to an NSAID taken alone.

The PN push will be "the next big project here," Plachetka said. "We're very bullish on that."

The firm also has begun exploratory work on candidates containing lornoxicam, alone or in combination with other drugs, as potential treatments for pain. That research has been done under an option agreement with Nycomed Danmark ApS, of Roskilde, Denmark. Plachetka said Pozen has $37.2 million in cash. The $20 million upon acceptance of the Trexima NDA would add to that and "we should end the year with a good deal of cash in the bank," he said. Another $10 million is due from GSK upon approval of Trexima, and $10 million more when GSK starts marketing the drug.

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