Medicis Says FDA Rejects Wrinkle Drug Reloxin

Medicis Pharmaceutical said on Thursday the U.S. Food and Drug Administration had decided that the company's Biologics License Application for the botulinum toxin type A, called Reloxin, in aesthetics was incomplete.

JP Morgan analyst Adam Greene downgraded his rating on the company's stock to "neutral" from "overweight" in response to the news, noting that while the delay "may only be a short-term hiccup, we are moving to the sidelines until we have more visibility."

The maker of wrinkle fillers and other cosmetic products said in a filing that the letter, received on Wednesday, indicated that the FDA had decided not to accept the application for filing.

The FDA said the application did not address how Medicis would fulfill its responsibilities as the manufacturer of the product.

Medicis in the filing said the letter "only addressed administrative deficiencies in the application and did not reference any substantive deficiencies." It said it still believes its application was strong, and it would continue to work with the FDA.

"At this point, we think this will at least delay the approval of Reloxin in the U.S. by five months," Wachovia Capital Markets analyst Larry Biegelsen wrote in a research report, noting that the original submission was made in early October 2007.

"By our estimates, this could be worth about $30 million in additional Botox sales by Allergan in 2009," Biegelsen said.