FDA issues Complete Response Letter to Allergan's NDA for LEVADEX

Apr 17 2013

Allergan, Inc. (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for LEVADEX® (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults.

Allergan is pleased that, in addition to the response, the company has already received draft labeling from the FDA. Allergan anticipates minimal revisions to this labeling. The company is committed to bringing LEVADEX® to market as a potential new acute treatment to address a significant unmet need among the millions of people living with debilitating migraines.

The main issues cited in the CRL were already identified by the FDA in prior discussions with Allergan. The company has already taken the following actions to address these concerns:

1. Per the FDA's comments in the CRL, during a previous inspection, the agency noted concerns with Exemplar Pharma, LLC, the canister filling unit manufacturer. In accordance with Allergan's overall manufacturing strategy to secure our supply chain, Allergan completed the acquisition of Exemplar on April 12^th, 2013, for less than $20 million. Allergan has appointed senior members of Allergan's Global Technical Operations to oversee the facility. Allergan anticipates that the FDA will require a re-inspection of the Exemplar facility prior to approval.
2. The FDA also noted concerns regarding the manufacturing process for the final filled canisters. Allergan has already responded to this concern. As the FDA indicated in the CRL, the Agency has not yet reviewed Allergan's response under the current PDUFA timeline.

Allergan is committed to vigorously address the concerns raised by the FDA in the CRL. Based on Allergan's current understanding of the FDA's CRL, the company estimates that the next FDA action will occur by the end of Q4 2013.

In addition, based on our assessment of the above, Allergan reiterates guidance regarding earnings per share (EPS) which was previously issued on February 5^th. Even with an FDA approval under the original timeline, 2013 sales of LEVADEX® would have been minimal. Today's FDA response will not materially impact overall Allergan 2013 sales guidance. In the regular course of business, Allergan will provide a full update on the company's Quarterly Earnings call, which will take place on May 1^st, 2013.