FDA Approves the latest Botulinum Toxin Type A: DYSPORT

Medicis (NYSE:MRX) and Ipsen (Euronext:IPN) 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®, 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. We are excited to be entering the market for the most popular nonsurgical aesthetic procedure in the U.S., 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.”

Dysport vs. Botox?

Interestingly, in an article published in the Journal Watch Dermatology in December 15, 2006, George J. Hruza, MD commented that:

“in a manufacturer-supported, double-blind, randomized, parallel-group study, where fifty-nine patients completed the study; none dropped out because of side effects or lack of efficacy, efficacy peaked at 8 weeks in both groups, but by 12 weeks the Botox group showed greater residual effects.

By 16 weeks, this difference was statistically significant: On a four-point wrinkle-severity scale, a one-point or better improvement occurred in 53% of Botox recipients and 28% of Dysport recipients. At week 16, 23% of Botox patients and 40% of Dysport patients had recurrence of rhytids. Patient satisfaction was consistently higher with Botox. Other than infrequent bruising and one small lump, there were no significant side effects.

Comment: At a 2.5:1.0 Dysport:Botox ratio, Botox was more effective for wrinkle treatment. In a previous study cited by the authors, a 4:1 ratio produced equivalent efficacy, but the patients receiving Dysport had a significantly higher risk for adverse effects. The evidence suggests that the optimal conversion ratio will be somewhere in between. Clearly, proper use of Dysport will involve a learning curve even for experienced Botox injectors, which will slow its wide adoption unless the cost difference significantly favors Dysport. In the U.K., where both products are approved, the cost of a 100-U vial of Botox is about $250, and the cost of a 500-U vial of Dysport is about $300. When Dysport receives FDA approval, the U.S. price may reflect the U.K. price.”

View the complete Dysport announcement at http://www.globenewswire.com/newsroom/news.html?d=164270