Reuters: Global Markets: MAP Pharma shares dive after FDA rejects migraine drug

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MAP Pharma shares dive after FDA rejects migraine drug Mar 27th 2012, 11:39 Tue Mar 27, 2012 7:39am EDT (Reuters) - Shares of MAP Pharmaceuticals Inc (MAPP.O) fell by a third in premarket trade on Tuesday, after health regulators rejected its orally inhaled treatment for migraine. The U.S. Food and Drug Administration raised issues related to the chemistry, manufacturing and controls (CMC) of the drug, Levadex, MAP Pharma said in a statement late on Monday. However, the U.S. health agency did not ask for additional trials for the drug and did not cite any safety or efficacy issues, the company said. "We believe the core issue was the inability of the FDA to complete the review of a last minute request for information on inhaler usability," Wedbush Securities analysts Liana Moussatos and Richard Lau wrote in a note to clients. Analysts at J.P. Morgan said that while they expect the shares to trade lower as the key positive catalyst for the stock has now been delayed, they continue to view Levadex as a $500 million peak sales product. Both the brokerages said that issues related to manufacturing appear manageable and can be easily corrected. "We anticipate Map should be able to complete requirements associated with CMC and correcting observations ... within three months and resubmit the (New Drug Application) in the third quarter," Wedbush analysts said. "With a rapid review, approval could occur by year-end." Other migraine therapies currently available in market include Pozen Inc's (POZN.O) Trexmet, AstraZeneca's (AZN.L) Zomig and Zogenix Inc's (ZGNX.O) SUMAVEL DosePro. European and American studies have shown that 6 percent to 8 percent of men and 15 percent to 18 percent of women experience migraine each year, according to the World Health Organization. Shares of the Mountain View, California-based company, which have gained 20 percent of their value in the last one year, were down 24 percent at $13.00 in premarket trading. They had closed at $17.14 on Monday on the Nasdaq. (Reporting by Kavyanjali Kaushik in Bangalore; Editing by Supriya Kurane) Link this Share this Digg this Email Reprints

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