Allergan says U.S. FDA delays Semprana decision, OKs Ozurdex
(Reuters) - Allergan Inc said on Monday the U.S. Food and Drug Administration had raised issues about its application for a new acute migraine aerosol but had separately approved a treatment for diabetic macular edema.
Allergan, the Botox maker that is fighting off a hostile bid from Valeant Pharmaceuticals International Inc, said the FDA had approved its Ozurdex sustained-release biodegradable steroid implant as a new treatment option for some patients with diabetic macular edema.
The FDA approved Ozurdex for use in adult patients who have an artificial lens implant or who are scheduled for cataract surgery, Allergan said.
Allergan did not receive approval for Semprana, formerly known as Levadex. It said it had received a second "complete response letter" from the agency and now expected the next action from the FDA to occur in the second quarter of 2015.
Sterne Agee analyst Shibani Malhotra wrote in a research note last week that the Semprana 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.
The company's shares were down 1 percent at $172.25 in early trading.
(Reporting by Caroline Humer; Editing by Lisa Von Ahn)