Just days after abandoning the experimental migraine treatment MT100 in the face of two rejections from the FDA, Pozen has filed an NDA for Trexima -- a new migraine therapy it's been developing with GlaxoSmithKline. If the FDA accepts the NDA, says Pozen, it will reap a $20 million milestone payment from GSK. Pozen, based in Chapel Hill, North Carolina, earned $15 million when Trexima entered a Phase III trial last year. An FDA expert committee rejected MT100 a week ago.
"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."
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