FDA Rejects MAP Pharmaceuticals' Migrane Drug Candidate Print E-mail
By Staff and Wire Reports   
Tuesday, 27 March 2012 05:51
The FDA has asked drugmaker MAP Pharmaceuticals (NASDAQ:MAPP) to address issues tied to chemistry, manufacturing and controls before it can decide whether to approve its potential migraine treatment Levadex. The company's shares dropped dramatically in premarket trading  onTuesday.

Traders will be watching the trading action closely and MAPP becomes a good candidate for a "dead cat bounce" play as retail investors appear to be over- reacting to the news.

Regulators told the Mountain View, Calif., company in a letter that they have not finished their review of inhaler usability information, which was requested late in the FDA's review cycle. The FDA also asked MAP to address "observations from a recent facility inspection of a third party manufacturer," MAP said in a statement released Monday after markets closed.

The drugmaker said it will work with the FDA to address issues raised in the letter as quickly as possible. The company noted that regulators did not ask for additional studies and did not cite any potential safety issues or concerns about effectiveness.

"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."

The FDA did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval.  The Company is pleased with the FDA-provided revisions to product labeling and packaging, including correct use of the LEVADEX trade name.

Other migraine therapies currently available in market include Pozen Inc's (NMQ:POZN - News) Trexmet, AstraZeneca's (LSE:AZN.L - News) Zomig and Zogenix Inc's (NMQ:ZGNX - News) SUMAVEL DosePro.

MAP is working with Allergan Inc. to develop Levadex as an inhaled migraine treatment for adults, and the companies will share profits on sales of the drug if it is approved.

MAP said last August that the FDA had accepted its marketing application for Levadex, which triggered a $20 million payment from Allergan.




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