MAP Confident In Levadex, Plans Swift Response To FDA
March 27 2012 - 10:57AM
Dow Jones News
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;
joan.solsman@dowjones.com
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