Map Pharmaceuticals, Inc. (MM) (NASDAQ:MAPP)
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5 Years : From Jan 2013 to Jan 2018
MAP Pharmaceuticals Inc. (MAPP) said it was moving quickly to clarify and address the Food and Drug Administration's rejection of its most advanced drug candidate, migraine treatment Levadex.
Chief Executive Timothy S. Nelson was confident MAP will bring Levadex to market. He highlighted that nothing in the FDA's complete reponse letter indicated additional safety or efficacy studies for the inhalable treatment, nor did the letter question pulmonary use or route of delivery.
"The fact that there aren't questions on that side is encouraging" for approvability, he said.
The FDA declined to approve Levadex--an aerosol administered by inhaler to treat migraines in adults--because of manufacturing, process and usability questions, including questions about how the drug's cans are filled. But the development-stage biotech company said it would quickly address the problems, if they hadn't been addressed already.
Shares, up 18% over the 10 days before the FDA's decision, fell 7% Tuesday to $15.94. The stock had fallen 35% in premarket trading when a halt held over from Monday afternoon was lifted.
MAP's Levadex is a new formulation of the drug dihydroergotamine--currently available in other dosage forms to treat migraine--that is designed to be administered through MAP's Tempo inhaler. MAP's product has peak sales potential of $500 million, according to J.P. Morgan.
The company didn't foresee anything in the complete response letter requiring major cash commitments. As of Sept. 30, the most recent data available, MAP Pharmaceuticals had about $111.8 million in cash and cash equivalents, and executives noted that last year's cash burn rate was in the vicinity of $55 million.
MAP said it aims this week to file its delayed annual report with the Securities and Exchange Commission. The company said Tuesday that the delay wasn't unique to MAP and that other biotech companies are dealing with similar SEC questions.
As for the FDA, company executives said the agency raised questions about how cans of the aerosol drug are filled. According to MAP, a third-party manufacturer already had provided a response to the issues, which were about one specific facility, and that the questions were addressable.
The executives also said MAP is working to put in place a redundant supplier, though that isn't part of Levadex's new drug application.
The FDA also raised questions about MAP's process control, which executives wouldn't specify before getting more clarity from the regulator. The company would move quickly to get those details, planning later Tuesday to formally request a meeting with the FDA, executives said. The regulator has up to 14 days to respond to that request. If it agrees to meet, the FDA has another 60 to 75 days to set the meeting.
"We hope to get it done quicker than that," CEO Nelson said, adding the company would update investors when it knows more.
Wedbush Securities analyst Liana Moussatos said in a note earlier Tuesday that she expects MAP should be able to address the third-party issues within three months and resubmit the Levadex's application in the third quarter. With a rapid review, approval could occur by year's end, she said.
The FDA, also in its letter, said it hadn't had sufficient time to review additional usability data it requested--and MAP provided--late in the review process. Executives said they believed MAP has already provided the information the regulator was looking for and didn't foresee any need to change the inhaler.
Finally, the FDA provided MAP with revisions to product labeling and packaging, which executives said they would work on with the FDA parallel to the other issues.
Like many development stage drug makers, MAP has little revenue and posts frequent losses. In last year's third quarter, MAP received payments from Allergan Inc. (AGN) for its marketing partnership on Levadex. Last year, Allergan agreed to leverage its existing U.S. sales force dedicated to headache specialists using Botox to prevent headaches in chronic-migraine patients, which will be supplemented by a planned 50-person MAP sales force.
Tuesday, Nelson said the FDA's letter didn't have any contractual effect on the Levadex partnership with Allergan. He said he believes MAP has strong support from its partner and that MAP is ready to bring Levadex to to market with Allergan after addressing the FDA's concerns.
Shares in Allergan gained 52 cents to $95.26 in recent trading.
-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291; firstname.lastname@example.org