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Merz Pharmaceuticals Announces Results of Three Clinical Trials With NT-201 (Botulinum Neurotoxin Type A Free From Complexing Proteins) in Movement Disorder Patients
Date:4/28/2009

SEATTLE, April 28 /PRNewswire/ -- Results from two prospective, double-blind placebo controlled multi-center studies in patients with cervical dystonia and blepharospasm, and pooled European efficacy and safety data in patients with focal dystonia and upper limb spasticity will be presented at the American Academy of Neurology's (AAN) 61st annual meeting in Seattle. The studies were sponsored by Merz Pharmaceuticals, which plans to file a Biologic License Application (BLA) for NT-201 in the USA in the near future.

"The data to be presented at AAN complement the European data. We now have robust U.S. data for Xeomin (the brand name for NT-201 in Europe) for the symptomatic management of movement disorders," said Eric Pappert, M.D., Vice President of Medical Affairs, Merz Pharmaceuticals, USA.

NT-201 is a botulinum neurotoxin type A free from complexing proteins approved for marketing in Europe since 2007 to treat various movement disorders, and recently approved in Canada for the indications of symptomatic management of blepharospasm, cervical dystonia and post-stroke spasticity of the upper limb. Through advanced manufacturing processes, NT-201 combines high biologic activity with low bacterial protein load, making it a neurotoxin therapy free from complexing proteins. In pre-clinical work, the exposure to complexing proteins has been found to heighten the immune system response to botulinum toxin.

"Xeomin - the proposed brand name for NT-201 -- potentially offers a new option to treat movement disorders. Because Xeomin combines high biologic activity with low protein load, it is a neurotoxin that is free from complexing proteins," said David M. Simpson, M.D., Professor of Neurology and Neuromuscular Diseases at Mount Sinai Medical Center in New Yo
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