When is Dysport FDA approval expected?

Dysport (formerly Reloxin) is now approved by the US FDA. Here is a snippet from the Medicis press release about Dysport:

FDA Approves DYSPORT(TM) for Therapeutic and Aesthetic Uses - Ipsen's abobotulinumtoxinA approved simultaneously for treatment of cervical dystonia and glabellar lines under a single trade name, DYSPORT(TM)

Major strategic milestone achieved for both Medicis and Ipsen - Medicis to launch DYSPORT(TM) (abobotulinumtoxinA) for glabellar lines within the next 30 to 60 days - Ipsen to launch DYSPORT(TM) (abobotulinumtoxinA) for cervical dystonia during the second half of 2009

SCOTTSDALE, Ariz. and PARIS, April 30, 2009

Medicis (NYSE:MRX) and Ipsen (Euronext:IPN) today announced the U.S. Food and Drug Administration's (FDA) approval of the Biologics License Application (BLA) for DYSPORT(TM) (abobotulinumtoxinA), an acetylcholine release inhibitor and a neuromuscular blocking agent. The approval includes two separate indications, the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain, and the temporary improvement in the appearance of moderate to severe glabellar lines in adults younger than 65 years of age. Reloxin(R), which was the proposed U.S. name for Ipsen's botulinum toxin product for aesthetic use, will be marketed under the name of DYSPORT(TM). Ipsen will market DYSPORT(TM) in the United States for the therapeutic indication (cervical dystonia), while Medicis will market DYSPORT(TM) in the U.S. for the aesthetic indication (glabellar lines). Additionally, DYSPORT(TM) is differentiated from other marketed botulinum toxin products with the unique established name abobotulinumtoxinA. "We are extremely pleased to announce FDA's approval of DYSPORT(TM)," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "Medicis and Ipsen have been diligent in efforts with FDA to achieve this goal. DYSPORT(TM) was evaluated for the treatment of glabellar lines in robust clinical studies, which included approximately 2,900 patients at more than 80 clinical study sites.(1) We are excited to be entering the market for the most popular nonsurgical aesthetic procedure in the U.S.(2), and anticipate being highly competitive. We believe physicians and their patients will appreciate the benefits of this new product offering. Additionally, we are grateful to our colleagues at Ipsen, who have worked tirelessly alongside the Medicis team to make this approval possible, and to our shareholders, who have supported our efforts with eagerness and patience. We look forward to continuing our strong partnership as we endeavor to maximize the commercial success of DYSPORT(TM)." Jean-Luc Belingard, Chairman and Chief Executive Officer of Ipsen, said: "The approval of our DYSPORT(TM) BLA by the FDA for both therapeutic and aesthetic indications is the fruit of hard work and efficient organization of both the Ipsen and Medicis teams. We are proud to have closely collaborated with the FDA on the labeling and Risk Evaluation and Mitigation Strategy (REMS) for increased patient safety awareness in the use of DYSPORT(TM). DYSPORT(TM) represents an important new treatment option for patients suffering from cervical dystonia, and we hope to capitalize on our successful therapeutic focus worldwide to build as strong a position in the U.S." Jean-Luc Belingard concluded, "Today marks a major strategic milestone in our history, being now in a position to effectively market four products in the U.S., whilst benefiting from Medicis' presence in the fast-growing aesthetic market." The REMS for DYSPORT(TM) is designed to help prevent medication errors related to the lack of interchangeability of DYSPORT(TM) with other marketed botulinum toxin products, and ensure that the potential benefits of treatment with DYSPORT(TM) outweigh any potential risk of the spread of toxin effect beyond the injection site. The labeling for DYSPORT(TM) also contains a boxed warning about the potential distant spread of all botulinum toxin products, including DYSPORT(TM).

Ipsen anticipates launching DYSPORT(TM) for the treatment of cervical dystonia in the U.S. during the second half of 2009. Furthermore, in terms of post-marketing commitments for DYSPORT(TM), Ipsen is notably committed to perform clinical studies in children and adults with spasticity. In March 2006, Ipsen granted Medicis the rights to develop, distribute and commercialize Ipsen's botulinum toxin product for aesthetic use by physicians in the U.S., Canada and Japan. In accordance with the agreement, Medicis will now pay Ipsen approximately $75 million as a result of the approval by FDA. Ipsen will receive a royalty based on sales and a supply price, the total of which is equivalent to approximately 30% of net sales as defined under the agreement. Medicis anticipates shipping DYSPORT(TM) for aesthetic use in the U.S. during the next 30 to 60 days. During that time, Medicis will complete the training of its aesthetic sales force. McKesson will serve as the U.S. distributor of DYSPORT(TM) for aesthetic use. Ipsen will manufacture and provide the product to Medicis for the term of the agreement, which extends until December 2036.