UPDATE 2-MAP says FDA waives second trial for migraine drug

Mon Jan 11, 2010 12:07pm EST

* Says second efficacy study not needed for Levadex NDA

* Shares jump 31 pct (Adds details, analyst comments; updates share movement)

By Krishnakali Sengupta

BANGALORE, Jan 11 (Reuters) - MAP Pharmaceuticals Inc MAPP.O said U.S. health regulators informed the company that a second efficacy study was not required to apply for marketing approval of its experimental migraine drug, Levadex, sending its shares up 31 percent.

In May, MAP had said the experimental orally inhaled migraine drug reached all four goals of a late-stage study, and that it would conduct a second trial to confirm the results as requested by the U.S. Food and Drug Administration.

"This is a hugely positive news, something that is typically unheard of and goes on to show that MAP's first late-stage trial was a homerun," Leerink Swann analyst Joseph Schwartz said.

The latest news could also mean that there is significant unmet medical need for migraine drugs, he added.

MAP said the FDA's decision will allow the company to focus on the drug's remaining clinical studies and expects patients in these studies to complete treatment in 2010.

The remaining clinical trials studied under a special protocol assessment will measure the drugs safety in smokers and separately evaluate artery pressure in healthy volunteers.

"It appears that these studies are mere formalities and I don't think there is much risk in these studies as they have already given positive updates on the open label extension study in October", Schwartz added.

Earlier in September, MAP Chief Executive Timothy Nelson said in an interview to Reuters that the company was looking for potential partners, and was interested in co-marketing Levadex in the lucrative U.S. markets. [ID:nN1571487].

Analyst Schwartz said the announcement will improve the company's chances in finding better partnership deals as terms will now be drawn on pre-approval basis.

"The market value of the company is under $250 million, which is considerably low for something which has a potential of $500 million. And with these announcement we may now see multiples of that $500 million level once the drug hits the market," Schwartz added.

The company shares, which went up as much as $13.24 earlier in the session, were now trading at $13.20 Monday on Nasdaq. (Editing by Vinu Pilakkott and Anil D'Silva)

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