MAP Pharma shares dive after FDA rejects migraine treatment

MAP Pharma shares dive after FDA rejects migraine treatment

March 28th, 2012 // 12:41 pm @

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, but analysts remain optimistic of its potential to eventually win approval.

The U.S. Food and Drug Administration, which raised issues related to the chemistry, manufacturing and controls (CMC) of the treatment, Levadex, did not ask for additional trials and did not cite any safety or efficacy issues.

“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 Securities analysts Liana Moussatos and Richard Lau wrote in a note to clients.

“With a rapid review, approval could occur by year-end.”

Levadex, which is a formulation of a drug currently available in other dosage forms to treat migraine, is self-administered using the company’s inhaler — Tempo.

“We believe that there would not be any need for changes in the device,” Chief Executive Timothy Nelson said, adding that the company will send a request on Tuesday for a meeting with the FDA.

The FDA also raised issues related to a facility of a third party manufacturer, MAP Pharma said in a statement late on Monday.

However, on a conference call CEO Nelson said the third party has already provided responses related to these issues.

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 J.P. Morgan and Wedbush analysts said that issues related to manufacturing appear manageable and can be easily corrected.

“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 analysts said.

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.

MAP Pharma, which had cash and cash equivalents of $112 million as of September 30, 2011, is also testing Levadex for pediatric migraine and cluster headache.

Shares of the Mountain View, California-based company, which have gained 20 percent of their value in the last one year, were down 17 percent at $14.12 in premarket trading. They had closed at $17.14 on Monday on the Nasdaq.

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