Sabine Vollmer, Staff Writer
CHAPEL HILL -
For Pozen, it was the kind of quarterly report that would sweeten even the most sour of days on Wall Street.
The drug developer -- which last year had a third-quarter loss of $4.1 million -- posted a profit of $14.8 million, 48 cents per share, in the third quarter of this year. Revenue, the company said, rose eight-fold to $27.6 million. And it said it has more cash -- $79 million -- than it has had in five years.
Looking ahead, chief executive John Plachetka said federal regulators had accepted Pozen's data on the safety of its Trexima migraine treatment. That starts the clock on the Food and Drug Administration's six-month deadline for a response.
"I feel good about Trexima's chances for approval," he told analysts Thursday.
On a day when most stocks were in full retreat, Pozen shares rose 75 cents to $10.11.
A $30 million payment from British drug maker AstraZeneca helped Pozen turn its most recent quarterly profit, which beat analysts' estimates by 8 cents per share.
Pozen and AstraZeneca have been working on a painkiller -- PN 400 -- for about a year. In September, AstraZeneca decided to advance the drug to tests involving about 800 patients, which triggered a $30 million payment under a partnership that could be worth another $315 million for developmental, regulatory and sales milestones.
Pozen partners with another British pharmaceutical company, GlaxoSmithKline, on Trexima. The companies have been trying to bring the drug to market for about two years and have twice had to contend with setbacks at the FDA.
In August, regulators said they needed more information on the drug's potential side effects. Plachetka said the company did not submit any new data in satisfying the agency's request.
The FDA has until mid-April to respond to Pozen's Trexima application -- a thumbs up, thumbs down or request for more data.
GSK, which has U.S. headquarters in Research Triangle Park, is eager to bring Trexima to market as a replacement for Imitrex, a migraine pill that generated $1.3 billion in annual sales last year. Imitrex, the leader in the $3.4 billion migraine market, is expected to lose patent protection next year.
Pozen, which has no products on the market and doesn't plan to establish a sales staff, depends on partnerships for revenue. Regulatory approval of Trexima would trigger a $20 million payment from GSK.
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