MAP Pharmaceuticals Inc. (MAPP) announced late Monday that its orally inhaled investigational migraine drug, LEVADEX, has been rejected by the Food and Drug Administration.
In its Complete Response Letter issued for LEVADEX, the FDA has not raised any clinical safety or efficacy issues, nor has the company been asked to conduct any additional clinical studies.
The FDA has requested MAP Pharma to address issues relating to chemistry, manufacturing and controls and observations from a recent facility inspection of a third party manufacturer. The regulatory agency also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA.
The company plans to request a meeting with the FDA to discuss the issues raised in the Complete Response letter.
Timothy Nelson, President and CEO of MAP Pharma said, "MAP is committed to making this important new therapy available to people who experience migraine. We will continue to work closely with the FDA to finalize our product labeling and to address the issues raised in the Complete Response letter as quickly as possible."
In January of this year, MAP Pharma entered into a collaboration with Allergan Inc. (AGN) within the U.S. for Levadex in a deal valued at $157 million - $60 million up-front payment and up to $97 million in additional payments upon meeting certain regulatory milestones. Pursuant to the terms of the agreement, MAP Pharma granted Allergan a co-exclusive license to market and promote Levadex to neurologists and pain specialists in the United States.
MAPP has thus far hit a 52-week low of $10.54 and a 52-week high of $17.92. The stock closed Monday's trading at $17.14, up 6.92%.
by RTT Staff Writer
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