Manufacturing questions lead to another CRL for Allergan migraine drug

Allergan ($AGN) is mired in a fight to remain independent from serial acquirer Valeant ($VRX), so having to tell investors it received a complete response letter (CRL) is not what it wants to do. But the FDA has again delayed approval of an inhaled migraine treatment because of uncertainties about the production process with the canisters used to administer it.

The California-based company announced Monday that it had received the CRL for Semprana, formerly called Levadex. It said that the agency had no problems with the clinical safety and efficacy of the product, for which it received draft labeling a year ago. But it does have concerns "related to specifications around content uniformity on the improved canister filling process and on standards for device actuation." The FDA told the company that it had made improvements, but more work is needed. Allergan said it now expects it will be the second quarter of 2015 when the "next action" by the FDA will occur.

Allergan already had co-promotion rights to the inhaled treatment, but gained full control of it in January 2013 with its $958 million acquisition of Map Pharmaceuticals ($MAPP). Allergan told investors a few months later that it expected a delay in the drug's approval because the FDA would want to re-inspect the Exemplar Pharma plant that fills the inhalers before it approves the product.

The FDA expressed concerns about the manufacturing process in 2012 when Map was seeking approval of the drug, which is a reformulated version of the IV drug dihydroergotamine that can be administered alone with an inhaler. At that point, Map said, the agency found issues with chemistry, manufacturing and controls (CMC), and had questions about its third-party manufacturer noted in a recent inspection. At that point, analysts were thinking the matter would be resolved within months, not years.

The drugmaker, which has been battling Valeant's attempts to call a shareholders' meeting to consider its $53 billion offer, was able to take investors some good news Monday. It said the FDA had approved its sustained-release biodegradable steroid implant, Ozurdex, as a new therapy for diabetic macular edema.

- here's the announcement