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DEVELOPMENT PROGRAMS

Dysport® – Type A botulinum toxin

Medical indications

As part of the FDA application process for the approval for Dysport®, Ipsen launched three phase III studies in the US in 2011:

• muscle spasticity of upper limbs in adults,
• muscle spasticity of lower limbs in children,
• muscle spasticity of lower limbs in adults.

The Group intends to initiate a fourth phase III study: muscle spasticity of upper limbs in children suffering from cerebral palsy.

Dysport® Next Generation

Ipsen is working on a liquid, ready-to-use formulation of the toxin, Dysport® Next Generation. To its knowledge, the Group is the only company to have formulated a ready-to-use toxin. Two clinical studies are ongoing:

• a phase II study for glabellar lines,
• a phase III study for cervical dystonia.

The studies have started in Europe and the sites are ready in North America. The FDA has requested additional information on product stability before beginning clinical trials in the US.