CHAPEL HILL, N.C. – Shares in pharmaceutical firm Pozen soared 16 percent in pre-market trading on Friday after the company said the Food and Drug Administration has “accepted for review” new information about a proposed migraine drug.
However, as trading closed Friday, Pozen posted a modest 2.46 percent gain.
Pozen (NASDAQ: POZN) is working with GlaxoSmithKline to win FDA approval for a proposed migraine drug called Trexima. Shares finished at $14.97.
After the markets closed Thursday, Pozen said that the FDA had accepted the amended response that it had filed in February following a rejection in December.
While Pozen officials issued no comment with the short announcement on Thursday, the news triggered an immediate run-up in Pozen stock. Just before the markets opened Friday, Pozen shares were selling at $16, up 9.5 percent or $1.39 from Thursday’s close on $14.61.
The FDA is expected to make a decision about the drug within six months, Pozen said.
In a conference call in December, Pozen Chairman and Chief Executive Officer John Plachetka said the company had gotten “the message” from the FDA December rejection and would submit the new information accordingly.
"There is nothing in the letter that leads us to believe we are in any different situation than we were in November when we sent in our response," Plachetka said in the call. "This is more an issue of how the data was presented." He added that "I wouldn’t read any more into [the letter] than that."
The FDA sent Pozen a so-called approvable letter in June that raised concerns about the safety of Trexima. Pozen and GSK teamed up to provide additional information in November.
Plachetka said Pozen and GSK executives "felt we had submitted adequate information" and added that the two companies have already agreed of "new data presentations."
"We feel we now have a much better understanding of how the FDA wants the information submitted," he explained. "We got the message. We will deliver the information in a different format."
Trexima is a combination of Imitrex, a GSK drug, and an anti-inflammatory drug called naproxen. More than 28 million people in the U.S. are affected by migraines.
Pozen received a $20 million milestone payment last fall from GSK following the submission of the new drug application for Trexima to the FDA.
GSK made as $15 million milestone payment to Pozen in May of 2004 based on reaching Phase III clinical trial milestones. At that time, the companies said they hoped to file the new drug application in the second half of 2005.
The FDA first asked for additional information from Pozen and GSK in June. The news sparked a sell-off in Pozen stock, dropping the price to $5.26 – a 52-week low – from $13.90 in one day. More than 25 million shares were traded.
Pozen shares closed 2006 at $19.99.