MAP Pharma: Preparing to ease regulatory pain of migraine drug (RTTNews) - Oct 4, 2012 - MAP is ready to play its part of making resubmission for the inhalation aerosol; Based on its meeting with the FDA, the NDA will be resubmitted in the late Q3 Q4 2012; The FDA will determine the type of resubmission (Class 1 or Class 2) and the resulting review timeline after the resubmission has been accepted for filing; $60M up-front payment and up to $97M in additional payments upon meeting certain regulatory milestones
Anticipated financing • Anticipated NDA • Migraine
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After facing disappointment when its investigational, orally inhaled migraine drug, Levadex, failed to win U.S. approval in March of this year, MAP Pharmaceuticals Inc. (MAPP:Quote) is gearing up to play its part of making resubmission for the inhalation aerosol.
This will be Levadex's second go-around with the FDA if the resubmitted NDA is taken up for review by the regulatory agency. Seeking to obtain clarity on what is needed to address the issues raised in the Complete Response letter, the company had an End-of-Review meeting with the FDA in the second quarter of 2012. A statement issued by the company in June said that based on its meeting with the FDA, the NDA will be resubmitted in the late third quarter/early fourth quarter 2012 timeframe.
The FDA will determine the type of resubmission (Class 1 or Class 2) and the resulting review timeline after the resubmission has been accepted for filing. The targeted review period of Class 1 resubmission is 2 months and that of Class 2 is 6 months.
MAP Pharma has a collaboration agreement with Allergan Inc. (AGN) that was signed in January of 2011 to market and promote Levadex to neurologists and pain specialists in the U.S. - a deal valued at $157 million, $60 million up-front payment and up to $97 million in additional payments upon meeting certain regulatory milestones...
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