Uphill battle for migraine drug

Jun 23, 2009 (The News & Observer - McClatchy-Tribune Information Services via COMTEX) -- POZN | Quote | Chart | News | PowerRating -- The CEO of Pozen, which developed the migraine drug Treximet, says he remains optimistic about the drug's prospects, despite roadblocks being erected by insurers that criticize its price.

UnitedHealth Group, the nation's largest health insurer, won't pay for Treximet on most of its plans. Treximet, which was introduced in April 2008, costs UnitedHealth about $18 per pill.

Other insurers -- Aetna, WellPoint and Cigna -- in effect discourage use of Treximet by requiring the maximum patient contribution for the drug.

Still, John Plachetka, the founder and top executive at Chapel Hill-based Pozen, said "well over 100 million" patients are covered by insurers that have granted Treximet preferred status -- the top rating for a brand-name drug, which minimizes the cost for patients. More are coming, he said.

"The key element here is that people need to try Treximet," Plachetka said. "If they try it, they will like it better than anything else."

GlaxoSmithKline, which is based in London and has its U.S. headquarters in Research Triangle Park, licensed Treximet from Pozen and pays the company a royalty based on sales.

"It's selling at a pretty good clip today," Plachetka said. "It is very likely going to be more than a $100 million product this year."

But Tim Heady, chief of UnitedHealth's pharmaceutical solutions unit, isn't a fan.

"There is nothing in Treximet that one can't get for significantly less dollars," Heady told Bloomberg News. "There are instances where drugs are being brought to market that really aren't different or offering any real benefit from a clinical or cost perspective. In those instances, it makes sense not to cover the drug at all."

Navid Malik, an analyst at Matrix Corporate Capital, once projected that Treximet sales could reach $650 million a year by 2015. But resistance to the drug's price has prompted him to reduce that projection by about half.

Treximet combines two generic drugs: GSK's migraine drug Imitrex, whose patent protection expired in February, and the anti-inflammatory naproxen. The combination is more potent than Imitrex alone, GSK says.

About 93 percent of Treximet patients are able to resolve their migraines with a single dose, whereas other treatments may require multiple doses, GSK spokeswoman Mary Anne Rhyne said. "That needs to be factored into the cost-effectiveness of it all," she said.

GSK hopes new drugs such as Imitrex will make up for revenue it loses when cheaper generics spring up as its drugs lose patent protection.

Although Treximet has been criticized as GSK's attempt to preserve its Imitrex franchise, despite the expiration of its patent, Plachetka said Pozen started developing the drug years before GSK got involved.

"We didn't do it to extend the patent on Imitrex," Plachetka said. "We didn't own Imitrex."

The deciding factor, he said, was that using Imitrex would produce the best drug. Plachetka is a former GSK executive and directed the development of Imitrex.

Treximet is Pozen's only product. The company is on the verge of seeking Food and Drug Administration approval for an arthritis treatment, PN 400, that it has licensed to AstraZeneca.

Annual sales of PN 400 could reach $250 million in the U.S. and $425 million worldwide by 2013, Cowen and Co. analyst Ian Sanderson said.

Still, Sanderson expects PN 400 sales to suffer the same price resistance as Treximet because it also is a combination of two generic drugs. "Managed care is looking for any way they can to reduce costs," he said.

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