FDA hands out its third rejection for Allergan's migraine drug Semprana

The FDA has handed out its third rejection of a new, inhalable migraine therapy Allergan ($AGN) had hoped could be used to help fend off Valeant's ($VRX) buyout bid. The big biotech did get some good news, though, announcing that the agency approved Ozurdex for diabetic macular degeneration.

In an R&D update out this morning Allergan--best known for its wrinkle-remover Botox--put out the word that regulators had once again turned their thumbs down on Semprana, formerly known as Levadex. The drug had already been rejected by the FDA before Allergan acquired the migraine therapy in the billion-dollar buyout of MAP Pharmaceuticals in early 2013. Now Allergan says that any approval will likely be delayed until the second quarter of 2015.

The FDA issued its first CRL on the therapy in the spring of 2012, with a detailed list of demands for more information on MAP's chemistry, manufacturing and controls process as well as more time to inspect a third-party manufacturer's facility and review the company's inhaler. But last spring the FDA had lingering manufacturing concerns, triggering another rejection for the inhalable version of a 60-year-old treatment. And today the company is still struggling to get this program through the approval process--citing the FDA's questions on "specifications around content uniformity on the improved canister filling process and on standards for device actuation."

An approval here would have helped Allergan argue against Valeant's $53 billion buyout with fresh evidence of its ability to develop new therapies--something Valeant has never been keen about. Instead it had to trumpet the news about Ozurdex and downplay Semprana.

Allergan CSO Scott Whitcup

The approval of Ozurdex for certain patients with DME further strengthens Allergan's leadership position in ophthalmology and the retina subspecialty," said Scott M. Whitcup, the CSO at Allergan. "In addition to receiving this important FDA approval, we are also pleased that two of our innovative pipeline programs are advancing to Phase III clinical development. These therapies involve novel molecules or innovative drug delivery systems which may help to improve patient outcomes."

Valeant and Allergan have been exchanging harsh words just about every day for the past several weeks. Late last week Allergan and Valeant's ally, Pershing Square Capital Management, struck an agreement to call a special meeting of Allergan's stockholders without triggering a poison pill defense.

- here's the release