UPDATE 2-US FDA delays Allergan migraine drug approval, OKs new eye drug use

Mon Jun 30, 2014 1:51pm EDT
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(Adds company comment from conference call, analyst comment; updates share movement)

By Bill Berkrot

June 30 (Reuters) - Allergan Inc said on Monday that the U.S. Food and Drug Administration would not approve its acute migraine aerosol treatment until certain concerns are addressed, but the agency approved a new use for its implantable eye drug, Ozurdex.

The Botox maker, which is fighting a hostile takeover bid by Valeant Pharmaceuticals International Inc, said Semprana, formerly known as Levadex, had received a second "complete response letter" from the FDA delaying its approval. Allergan now expects the agency's next action in the second quarter of 2015.

Allergan shares were down 2.4 percent at $169.81.

In its letter, the FDA expressed concern about the delivery device for the aerosol migraine medication, citing "content uniformity on the improved canister filling process and on standards for device actuation," Allergan said.

"We believe we may have existing data to answer FDA's questions," Allergan research and development chief Scott Whitcup told analysts on a conference call on its pipeline of drugs in development.

"There is no scenario I can imagine under which we would not take this forward," Whitcup said.

JPMorgan analyst Chris Schott called the Semprana delay a modest negative, but added in a research note: "We expect the company to respond to the FDA by year end and now believe we could see an approval by the second quarter of 2015."   Continued...