Biotech Values

[DewDiligence]

FDA Aproves Dysport for Therapeutic and Cosmetic Indications

[Dysport is a type-A botulinum toxin similar to—but not identical to—Botox. For therapeutic indications, it will be marketed by Ipsen; for cosmetic uses, it will be marketed by MRX. (MRX had planned to use the brand name, Reloxin, for cosmetic uses, but this idea has been scrapped.)

Botox sales are about evenly split between therapeutic and cosmetic uses. (There are fewer therapeutic procedures, but therapeutic procedures consume more toxin than cosmetic procedures, on average.) In 2008, there were 2.4M cosmetic Botox injections in the US.

Dysport has been sold outside the US for two decades, but Botox outsells it in nearly every market where the products compete. Although Ipsen attributes this to Allergan’s marketing muscle, the real reason (IMO) for Dysport’s low market share is that Botox is a technically superior product that causes less dispersion.]

http://finance.yahoo.com/news/Ipsen-and-Medicis-FDA-bw-15079732.html

›Ipsen and Medicis: FDA Approves DYSPORT for Therapeutic and Aesthetic Uses

* Ipsen’s abobotulinumtoxinA approved simultaneously for the treatment of cervical dystonia and glabellar lines under a single trade name, DYSPORT

* Major strategic milestone achieved for both Medicis and Ipsen

* Medicis to launch DYSPORT (abobotulinumtoxinA) for glabellar lines within the next 30 to 60 days

* Ipsen to launch DYSPORT (abobotulinumtoxinA) for cervical dystonia during the second half of 2009

Thursday April 30, 2009, 1:00 am EDT

SCOTTSDALE, Az. & PARIS--(BUSINESS WIRE)--Regulatory News:

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 (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. Ipsen will market DYSPORT in the United States for the therapeutic indication (cervical dystonia), while Medicis will market DYSPORT in the U.S. for the aesthetic indication (glabellar lines). Additionally, DYSPORT 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,” 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 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.”

Jean-Luc Bélingard, Chairman and Chief Executive Officer of Ipsen, said: “The approval of our DYSPORT 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. DYSPORT 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 Bélingard 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 is designed to help prevent medication errors related to the lack of interchangeability of DYSPORT with other marketed botulinum toxin products, and ensure that the potential benefits of treatment with DYSPORT outweigh any potential risk of the spread of toxin effect beyond the injection site. The labeling for DYSPORT also contains a boxed warning about the potential distant spread of all botulinum toxin products, including DYSPORT.

Ipsen anticipates launching DYSPORT 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, 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 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 for aesthetic use. Ipsen will manufacture and provide the product to Medicis for the term of the agreement, which extends until December 2036.

DYSPORT for the aesthetic indication will be available in the U.S. to patients through licensed practitioners. Physicians in the U.S. may place orders for DYSPORT for the aesthetic indication by calling McKesson directly at 1-877-520-0500.

About the Aesthetic Market

According to the American Society for Aesthetic Plastic Surgery, over 10 million cosmetic procedures were performed in the U.S. in 2008, 83% of which represented nonsurgical procedures. Injections of botulinum toxin type A have been the number one nonsurgical cosmetic procedure for the past five years, with over 2.4 million total procedures in 2008 alone. The U.S. aesthetic market for botulinum toxin type A is estimated to be approximately $300 million to $400 million. [The potential market is considerably bigger than that, IMO.]

About Cervical Dystonia

Cervical dystonia is an orphan condition in the U.S. affecting approximately 125,000 people.4 It is a chronic and painful condition characterized by neck muscles contracting involuntarily, which causes abnormal movements and awkward posture of the head and neck. Symptoms usually begin in people age 40 years or older, and women are more commonly affected by the condition than men.

About DYSPORT

The active substance in DYSPORT is a botulinum neurotoxin type A complex, which acts at the level of the neuromuscular junction in the targeted muscle. DYSPORT is a neuromuscular blocking toxin which acts to block acetylcholine release at motor nerve ends and reduces muscular spasm.

Used in patient care in the United Kingdom since 1991, DYSPORT has marketing authorizations in 76 countries for therapeutic use and in 27 countries for aesthetic use. Patient exposure is estimated to be above two million single treatment cycles, representing more than 600,000 patients year of treatment.

DYSPORT was initially developed and subsequently approved in many markets around the world, outside the U.S., for the treatment of movement disorders such as cervical dystonia (spasmodic torticollis), blepharospasm (involuntary eye closure), hemifacial spasm and various forms of muscle spasticity, including post-stroke arm spasticity, spasticity of the lower limbs (calf) in adults and children with cerebral palsy. It was later developed for the treatment of a wide variety of neuromuscular disorders and aesthetic medicine.

About Medicis

Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. Medicis 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. Medicis’ products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.

Medicis’ products include the brands RESTYLANE® (hyaluronic acid), PERLANE® (hyaluronic acid), DYNACIN® (minocycline HCl), LOPROX® (ciclopirox), PLEXION® (sodium sulfacetamide 10% and sulfur 5%), SOLODYN® (minocycline HCl, USP) Extended Release Tablets, TRIAZ® (benzoyl peroxide), LIDEX® (fluocinonide) Cream 0.05%, VANOS® (fluocinonide) Cream 0.1%, ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, BUPHENYL® (sodium phenylbutyrate) Tablets and Powder, AMMONUL® (sodium phenylacetate and sodium benzoate) Injection 10%/10%, the LIPOSONIX®6 system and the over-the-counter brand ESOTERICA®.‹