June 30 Allergan Inc on Monday said the U.S. Food and Drug Administration had raised issues about its application for a new acute migraine treatment and that it was working with the agency to address them.
Allergan, the Botox maker that is fighting off a hostile bid from Valeant Pharmaceuticals International Inc, said it had received a second "complete response letter" from the agency. It now expects the next action from the FDA on Semprana, formerly known as Levadex, to occur in the second quarter of 2015.
Sterne Agee analyst Shibani Malhotra wrote in a research note last week that the treatment could have sales of $150 million in 2017 and add 24 cents per share to earnings that year.
An FDA approval could underpin Allergan's efforts to resist the takeover, Malhotra wrote. If the company received a so-called complete response letter from the agency instead, the letter "may have the opposite effect," the analyst wrote.
The new treatment will be administered by inhaler rather than the currently available nasal sprays and injectables. The items in the letter have to do with "content uniformity on the improved canister filling process and on standards for device actuation" for the migraine treatment, Allergan said. (Reporting by Caroline Humer; Editing by Lisa Von Ahn)