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DEVELOPMENT PROGRAMS

Dysport® – Type A botulinum toxin

In April 2009, the U.S. regulatory authorities (FDA) approved the Biologics License Application (BLA) for Dysport (abobotulinumtoxinA) in the treatment of cervical dystonia. Moreover, the unique name “abobotulinumtoxin A” differentiates Dysport® from other botulinum toxin-based products on the market. The Group launched Dysport®. At the same time, the FDA also approved the application for authorisation to market Dysport® (abobotulinumtoxinA) for aesthetic indications. It is designed to temporarily correct moderate to severe frown lines in adults aged under 65. Moreover, as part of the applications for FDA approval of

Dysport®, the Group is planning to start, in 2011, four phase III studies in the United States:

• Spasticity of upper limb muscles in children.
• Spasticity of upper limb muscles in adults.
• Spasticity of lower limb muscles in children.
• Spasticity of lower limb muscles in adults.

Azzalure® – Type A botulinum toxin

In Europe, on 2 February 2009 – Azzalure® was given the collective green light by health authorities in 15 European countries to issue national marketing authorisations for the treatment of frown lines. This evaluation was based on the results of clinical trials involving over 2,600 patients which confirmed the product’s tolerance profile and efficacy. Its launch in all the countries concerned has been ongoing since 2009.

Fipamezole

In September 2010, the Group announced the signing of a licensing agreement for the development and marketing of fipamezole (alpha-2 adrenergic receptor antagonist) outside North America and Japan. This molecule, the first of its class, is currently being evaluated in the treatment of levodopainduced dyskinaesia in Parkinson’s disease. The product has completed its Phase 2 trial.