Orexigen Therapeutics wound up playing catch-up with its two rivals in the race to develop the first new weight drug in more than a decade. But it has the pedal to the metal in a late-stage drive to win a speedy regulatory approval and start competing for the growing obesity market in the U.S.
Today Orexigen ($OREX) rounded a regulatory turn in that race, saying the FDA's CDER has expressed some enthusiasm for seeing if Orexigen can make an early resubmission of Contrave--partnered with Takeda--before it lands interim data from its forced march through another Phase III study. And it claimed speedy success in enrolling 7,000 patients for the trial, with a plan to hit 9,000 before the end of this year.
In a statement, Orexigen said that CDER "highly supports further discussions regarding a faster path to resubmission of the Contrave" NDA. "Under this scenario data from the planned interim analysis (which could be ready as early as the second quarter of 2012) would be provided during the anticipated review period. Although procedural details need to be addressed, the company is optimistic that these discussions could result in a faster path to resubmission of the Contrave NDA."
By itself, an indication by the FDA that it is open to accelerating the process isn't worth a lot. The agency is open to all sorts of suggestions it ultimately disregards. But with investors counting the days before the biotech has its NDA back in front of regulators, analysts are scrutinizing every twist and turn Orexigen makes as it strives to shave time off of its trial speed. Its stock was up about 4% this morning.
"We are encouraged by the ongoing dialogue with the FDA and are happy that FDA recognized the benefit of being prepared to act on Contrave soon after the interim data are available," said Michael Narachi, CEO of Orexigen. "We and our commercial partner, Takeda, are excited that the possibility of an earlier resubmission coupled with higher patient enrollment may result in a reduction in the time to potential approval for Contrave."
If Orexigen succeeds in a speedy resubmission and approval, its competitors may not be so far ahead in the race. Vivus' ($VVUS) Qsymia was recently rejected in Europe and analysts expect tepid initial sales figures later this year. Eisai, meanwhile, plans to start selling Belviq in the early part of next year, leaving Orexigen time to continue to eat up the gap.
- here's the press release