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FDA Extends Review of Reloxin


January 7, 2009, Ipsen (Paris:IPN) announced that the U.S. Food and Drug Administration (FDA) provided notification that Reloxin® (botulinum toxin of type A) has been extended to April 13, 2009. The FDA did not issue any specific request on the occasion of this extension. The application is for approval to market Reloxin as a wrinkle-fighting injectible drug for aesthetic indications (glabellar lines).

In March 2006, Ipsen granted Pharmaceutical of Scottsdale, Ariz. rights to cosmetic uses of the drug in the United States, Canada and Japan.

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. In March 2008, Medicis and Ipsen of Paris, refiled their application for Food and Drug Administration approval to market the wrinkle-fighting injectible drug in the United States.

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Ipsen's botulinum toxin (Dysport® / Reloxin® / Azzalure®) is a neuromuscular blocking toxin which acts to block acetylcholine release. It is 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.

By blocking the acetylcholine release, the drug reduces muscular spasm. The neuromuscular blocking toxin was initially developed for the treatment of motor disorders and various forms of muscular spasticity, including cervical dystonia (spasmodic torticollis), spasticity of the lower limbs in children with cerebral palsy, blepharospasm (involuntary eye closure) and hemifacial spasm.

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.

IPSEN News Release