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Map Pharmaceuticals Drops on Migraine Drug Rejection


Inhaled treatment gets thumbs down from the FDA. Shares recover somewhat after falling by double digits.

Shares of Map Pharmaceuticals (MAPP) are dropping this morning after US officials refused to approve the company's inhaled migraine treatment Levadex.

The Food and Drug Administration told Map that it rejected the drug because of concerns about manufacturing, according to the company. Map noted that the FDA cited an inspection of a manufacturing contractor's plant. (The contractor makes the canister for the inhaler that administers the drug.) The agency also had questions about use of the inhaler, according to the company.

Map is trying to win approval to sell an older drug that would be inhaled through the mouth to treat people with acute migraine headaches. Botox maker Allergan (AGN) agreed to help sell the drug if it gets approved and will pay a milestone to Map if it can get market clearance.

The rejection is a setback for Map even though the company said the FDA didn't raise questions about the safety or effectiveness of the drug. The problem is the company isn't providing a lot of detail about the FDA's concerns or the discussions leading up to the drug's rejection. Predicting a possible future approval is hard without a little more color on the situation.

CEO Timothy Nelson told investors on a conference call that he didn't think the FDA would require the company to change the device. He also said the agency didn't indicate that it would inspect the contractor's plant again. In fact, he said he believes the contractor answered the concerns raised by the FDA. Otherwise, Nelson said he wanted to better understand what the FDA was requesting before he would go into more detail.

After dropping by double digits, shares of the company fell 6% to $16.11 in late-morning trading. So even with news of the Levadex rejection, the shares are up 22% on the year.

Two other companies -- Affymax (AFFY) and Chelsea Therapeutics (CHTP) -- are expecting drug-approval decisions by the FDA today and tomorrow. (See Betting on the FDA: Another Round of Approval Decisions Coming for Drug Companies.)

Affymax fell more than 5% to $13. Shares of Chelsea rose 1% to $3.71.

Update (1:53 pm): The FDA said Tuesday it approved Affymax's drug to treat anemia in patients with kidney failure.

Twitter: @brettchase

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