Pozen: Migraine pill's success hinges on FDA

Sales of Treximet, a new migraine medication, will take off once regulators approve advertising for the drug, the CEO of Chapel Hill drug company Pozen said.

The company's marketing partner, pharmaceutical giant GlaxoSmithKline, is awaiting Food and Drug Administration approval of its consumer advertising and other promotional materials for Treximet. The pill hit pharmacy shelves in mid-May.

"I look for a major upturn in market share and penetration once they have all their tools available to them," CEO John Plachetka said during a conference call with analysts Tuesday morning.

Plachetka said he expects the FDA to approve the Treximet promotional materials during the current quarter.

Treximet is the designated successor to GSK's Imitrex, which generated $1.37 billion in sales last year. Treximet will face competition from cheaper, generic versions of Imitrex that could debut as early as December, but analysts expect annual sales to exceed $1 billion by 2011.

GSK, based in the United Kingdom, has one of its two U.S. headquarters in Research Triangle Park. It packages Treximet at its Zebulon plant.

Pozen said Treximet accounted for 3.7 percent of new migraine prescriptions in June, according to IMS, which provides market data to the pharmaceutical industry. The company received $824,000 in royalties from Treximet sales in the second quarter.

Pozen reaffirmed that it expects revenue this year to reach between $62 million and $68 million, including $5 million to $9 million in Treximet royalty payments. Bill Hodges, the company's chief financial officer, said the company will refine its Treximet revenue estimate when it announces third-quarter earnings.

"We think it is too early to know what the exact sales trend is," he said. Pozen's royalties on Treximet, which will change in coming years, this year amounts to the mid-single digits, by percentage of total sales.

GSK spokeswoman Robin Gaitens declined to discuss the company's plans to promote Treximet but confirmed that a direct-to-consumer advertising campaign is planned.

'A very good start'

Last week GSK reported that Treximet sales through June 30 totaled $16 million.

"We feel we're off to a very good start," Gaitens said.

On Tuesday, Pozen reported a $13.3 million profit in the second-quarter -- reversing its loss of a year ago -- because of a $20 million milestone payment from GSK. The milestone payment was triggered by the FDA's April 15 approval of Treximet.

The 43 cents per-share profit compares with a loss of $3.8 million, or 13 cents per share, a year ago. Revenue in the second quarter was $33.1 million, versus $11.9 million a year ago.

Operating expenses rose to $20.3 million, up from $16.5 million a year ago, an increase the company attributed to increased drug-development costs. Pozen is developing other pain medications, including one in partnership with AstraZeneca.

Pozen shares closed Tuesday at $11.74, up 36 cents. Shares have fallen 33 percent in the past year.