Orange County Register

Would-be Botox challenger Reloxin is back in the race and could reach the U.S. marketplace next year.

Its corporate sponsors, Medicis Pharmaceutical of Scottsdale, Ariz., and Ipsen of Paris, announced today that they have refiled their application for Food and Drug Administration approval to market the wrinkle-fighting injectible drug in the United States.

Medicis said it is hoping for FDA action on the application by early 2009.

Ipsen makes the drug, a dilute form of botulinum toxin similar to Botox, and sells it in about 20 countries under the name Dysport. If the two companies win FDA clearance, Medicis would market it in the United States under the name Reloxin.

Newport Beach dermatologist Dr. Dore Gilbert predicts that Reloxin will face difficulties when it goes up against  Botox.

“Will people trust a new toxin?  I believe my patients will want the original,” he said.

Medicis had filed a Reloxin application in late 2007, but the FDA rejected it, saying that the application didn’t spell out Medicis’ role in relation to manufacturing the product. Medicis and Ipsen said the new application by the two companies is basically the same as the first one, except for changes related to “sponsorship and ownership of the filing.”

In March 2006, Ipsen granted Medicis rights to cosmetic uses of the drug in the United States, Canada and Japan. Under the terms of its deal with Ipsen, Medicis said it will pay Ipsen about $25 million once the FDA accepts the Reloxin application.

Botox, made by Irvine-based Allergan, is the No. 1 cosmetic medical treatment in the United States, with more than 3 million injections in 2006, according to the American Society for Aesthetic Plastic Surgery. Medicis estimated that the U.S. market for cosmetic botulinum toxin injections totals $300 million to $400 million.

(This post was updated at 1:15 p.m. March 17 to include Dr. Dore Gilbert’s comment.)

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