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Ipsen and Medicis Announce Submission of Reloxin in Aesthetics to the FDA
Business Wire, Dec 6, 2007
PARIS & SCOTTSDALE, Ariz. -- Regulatory News:
Ipsen (Paris:IPN) and Medicis (NYSE:MRX) today announced the submission of the Biologics License Application ("BLA") for Reloxin([R]1) to the U.S. Food and Drug Administration ("FDA"). Upon FDA's acceptance of the Reloxin([R])filing, Medicis will pay Ipsen approximately $25 million in accordance with the agreement between the parties. In March 2006, Ipsen granted Medicis the rights to develop, distribute and commercialize Ipsen's botulinum toxin product in the United States, Canada and Japan for aesthetic use by physicians. Medicis anticipates a response from FDA in approximately 10 months following FDA's receipt of the Reloxin([R]) submission.
According to the American Society for Aesthetic Plastic Surgery, injections of botulinum toxin type A were the number one non-surgical procedure in 2006, with over 3 million total procedures. Current growth estimates in botulinum toxin type A in dollars are estimated to be in excess of 20 percent over the prior year.2 This translates into a retail U.S. aesthetic market of approximately $300 million-$400 million.
"We are extremely pleased to announce the submission of the BLA for Reloxin([R]) with FDA," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "Congratulations to the Medicis team and our talented consultants who worked tirelessly to achieve our filing. Our team has dedicated many hours compiling what we believe to be a strong filing for an important product. Our shareholders owe these persons a tremendous debt of gratitude for their extraordinary efforts. We appreciate the support given to us by our colleagues at Ipsen, and look forward to a continued excellent relationship with them as we prepare for the potential of commercializing Reloxin([R]) in the growing, multi-million dollar aesthetic botulinum toxin market in the U.S."
Jean-Luc Belingard, Chairman and Chief Executive Officer of Ipsen, stated: "The submission of the Reloxin([R]) dossier to the FDA by our partner Medicis is an important milestone for Ipsen's future growth, and we are very pleased that such an important project was carried out in a rigorous and timely manner. Both Ipsen and Medicis are dedicated to bring this product to market, so that Reloxin([R]) may be a success in the U.S.."
About Ipsen's botulinum toxin type A
As of October 2007, Ipsen's botulinum toxin type A, developed in the field of aesthetic medicine in the U.S., Canada and Japan under the trademark Reloxin([R]), is approved for aesthetic indications in 21 countries: Argentina, Australia, Belarus, Brazil, Columbia, Ecuador, Egypt, Germany, Honduras, Israel, Kazakhstan, Mexico, Moldova, New Zealand, Philippines, Slovak Republic, Ukraine, Uruguay, Venezuela, Vietnam, and Russia (in Russia, it is the first botulinum toxin type A approved in this field). Ipsen is also pursuing regulatory approval for medical indications for the product in certain additional key international markets.
Dysport([R]) is a neuromuscular blocking agent which acts as a neuromuscular blocking toxin, which was initially developed for the treatment of motor disorders and various forms of muscular spasticity, including cervical dystonia (a chronic condition in which the neck is twisted or deviated), spasticity of the lower limbs in children with cerebral palsy, blepharospasm (involuntary eye closure) and hemifacial spasm. It was later developed for the treatment of a wide variety of neuromuscular disorders Dysport([R])was originally launched in the United Kingdom in 1991 and has marketing authorisations in over 70 countries (at 31 December 2006). Ipsen has just recently submitted a BLA for Dysport([R]) in cervical dystonia to the FDA.
About Medicis
Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company's products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.
The Company's products include the prescription brands RESTYLANE([R]) (hyaluronic acid), PERLANE([R]) (hyaluronic acid), DYNACIN([R]) (minocycline HCl), LOPROX([R]) (ciclopirox), PLEXION([R]) (sodium sulfacetamide/sulfur), SOLODYN([R]) (minocycline HCl, USP) Extended Release Tablets, TRIAZ([R]) (benzoyl peroxide), LIDEX([R]) (fluocinonide) Cream, 0.05%, VANOS([R]) (fluocinonide) Cream, 0.1%, SYNALAR([R]) (fluocinolone acetonide), and ZIANA([R]) (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, BUPHENYL([R]) (sodium phenylbutyrate) and AMMONUL([R]) (sodium phenylacetate/sodium benzoate), prescription products indicated in the treatment of Urea Cycle Disorder, and the over-the-counter brand ESOTERICA([R]). For more information about Medicis, please visit the Company's website at www.medicis.com.
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