Pozen hopes for OK of migraine pill

Champagne corks could begin popping today at Pozen.

The Chapel Hill drug company expects to find out today whether the Food and Drug Administration has approved its first drug for sale.

"We'll treat Wednesday as a big day for the company," said John Plachetka, Pozen's chief executive.

Trexima is Pozen's third attempt to get a drug to market since it was formed in 1996. The company, which employs 35, has spent more than four years testing the migraine medicine, which combines two pills. A thumbs-up from the FDA would be a breakthrough for Pozen and its partner, GlaxoSmithKline.

Trexima would give GSK a chance to protect its leadership position in the migraine-drug market from competition. GSK, a British drug maker that has a U.S. headquarters in Research Triangle Park, paid for much of the drug's development. GSK expanded its plant in Zebulon, partly to package Trexima, and its salespeople are ready to promote the drug. In return, GSK would get more than 80 percent of Trexima's sales.

"It's a huge step that we're hoping is positive," said Robert Hazlett, a pharmaceutical analyst with BMO Capital Markets. "It's important to GSK. It's extremely important to Pozen."

But, Hazlett added, "there is some risk here."

Concerns about cardiovascular side effects prompted the FDA last year to request more safety data about Trexima, causing a 14-month delay.

If it passes the regulatory hurdle on the second try, the pill has to prove itself again. The delay in getting to market may cut Trexima's promotional introduction short and stunt sales, analysts said.

Aggressive marketing would be of the essence. Some doctors aren't sold on the two-in-one combination pill, especially because the two older medicines that are wrapped up in Trexima will be available as generic drugs by the end of 2008.

"I won't prescribe ... [Trexima] unless a patient insists on switching to it," said Dr. Cheryl Bushnell, a neurologist at Duke University.

For at least a year, Bushnell has prescribed a migraine drug and an anti-inflammatory pill to better treat her patients' migraines. One pill corrals the pain, the second prevents a rebound headache when the painkiller wears off.

Trexima: two in one

GSK funded clinical tests on migraine sufferers that have shown that Trexima works better than the painkiller and anti-inflammatory taken separately. The pill is designed to release its active ingredients -- sumatriptan and naproxen -- as a one-two punch.

Trexima "looks like a very solid drug," said Dr. Alan Finkel, a migraine specialist at the University of North Carolina at Chapel Hill who participated in Trexima studies. The pill's design and staggered drug release promise to reduce the amount of medicine that migraine patients have to take, Finkel said.

But Bushnell, who didn't participate in Trexima studies, suggested that much of what Trexima will add is convenience. She said her patients report good results on the two-pill combination of Imitrex and Aleve.

Naproxen is available over the counter as a generic anti-inflammatory under the name Aleve.

Sumatriptan is the active ingredient in Imitrex, a GSK migraine drug that will face competition from generics by the end of 2008. At $1.3 billion in sales last year, Imitrex is the market leader in the $3.4 billion migraine market, according to research firm Datamonitor.

Trexima could initially hurt Imitrex sales, but patients who switch prescriptions are seen as less likely to switch to generics later on.

Analysts project that Trexima will generate $250,000 to $300,000 in sales next year. But competition from generics and another migraine medicine -- a Merck drug that in final testing looks as effective and may be safer -- is expected to slow Trexima demand in 2009.

To convert Imitrex patients to Trexima, Pozen and GSK need to move along, Hazlett said: "Timing is important now."

GSK reported last week that the Zebulon plant is ready to start shipping Trexima to pharmacies before the end of September. But company spokeswoman Mary Anne Rhyne declined to provide details about GSK's marketing strategy.

Plachetka, a former GSK executive in RTP, said "we've done everything we could from a regulatory and research point of view." He added that Trexima's success in the marketplace is now up to GSK.