Pozen, which withdrew support for its MT-100 migraine drug for approval in the US last week, has filed a new drug application for another migraine treatment.
Pozen (Nasdaq: POZN) submitted the paperwork to the FDA on Monday for Trexima. That is the proposed trade name for the drug it is developing along with GlaxoSmithKline.
If the FDA accepts the application, Pozen will earn a $20 million milestone payment from GSK, Pozen said in a statement.
The NDA announcement was made before the markets opened Monday.
“We are pleased to submit the Trexima NDA ahead of schedule and within four months from the database lock on the last pivotal clinical study for the NDA,” said Marshall Reese, executive vice president of product development at Pozen. “This has been a well-executed development program with good collaborative efforts put forth by team members from both GlaxoSmithKline and POZEN.”
A week ago, a special FDA panel rejected an appeal from Pozen for MT-100, which the FDA had already rejected.
GSK made as $15 million milestone payment to Pozen in May of 2004 based on reaching Phase III trial milestones. At that time, the companies said they hoped to file the NDA in the second half of 2005.