Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting

PARIS, June 08, 2009 /PRNewswire/ -- Results from two randomized, active-controlled clinical trials in patients with blepharospasm and cervical dystonia -- one placebo-controlled spasticity trial and one upper limb spasticity trial -- were presented at the Movement Disorder Society (MDS) 13th annual International Congress in Paris, France. 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 results of these studies reaffirm our beliefs that NT-201 (Xeomin(R); botulinum neurotoxin free from complexing proteins), can be used to potentially aid focal dystonia and post-stroke spasticity sufferers," said Eric Pappert, M.D., Vice President of Medical Affairs, Merz Pharmaceuticals, USA. "In addition, NT-201 showed results in treating upper limb spasticity sufferers of various etiologies including stroke, brain injury, spinal cord injury, multiple sclerosis or cerebral palsy, warranting additional studies as a potential treatment option for a wide scope of patients."

NT-201 is a neurotoxin therapy free from complexing proteins due to a combination of high biologic activity with low bacterial protein load. It has been approved for marketing in Europe since 2007 to treat various movement disorders, and more recently approved in Canada for the indications of symptomatic management of blepharospasm, cervical dystonia and post-stroke spasticity of the upper limb. "Studies in Europe have shown non-inferiority of NT-201 to one other botulinum toxin in the treatment of cervical dystonia," said Pappert.

Overall clinical efficacy and overall tolerability of NT-201 (Xeomin(R); botulinum neurotoxin free from complexing proteins) authored by R. Benecke, S. Grafe, I. Sassin, and G. Comes.

Efficacy in focal dystonia was analyzed on the pooled data from 2 pivotal clinical trials in blepharospasm and cervical dystonia (343 NT 201 patients; 340 BTXCo* patients) and 1 post-stroke spasticity trial (73 NT 201 patients and 75 placebo patients). For the safety analyses, 6 clinical trials (blepharospasm, cervical dystonia, and upper limb spasticity) have been included (n=539 NT 201, n=442 BTXCo and n=75 placebo subjects). For the post-launch evaluation spontaneously reported adverse events were analyzed.

In the randomized, active-controlled, double-blind studies in focal dystonia NT 201 and one other Botulinum toxin (BTXCo) have been used with a dose ratio of 1:1. The results demonstrate equivalent efficacy between the NT 201 and BTXCo. Onset, waning, and duration of effect were comparable. These findings have been confirmed by the Physician´s Global Impression of Efficacy: 70.6% of BTXCo patients and 71.8% of the NT 201 patients were rated as "good" or "very good." Additionally, in the placebo-controlled spasticity trial 62% of the caregivers rated the efficacy as good or very good compared to placebo (33%). 26.7% of patients in the NT 201 group, 26.0% in the BTXCo group, and 22.7% in the placebo group reported an adverse event. There were no clinically relevant differences between the two active treatment groups in the focal dystonia trials and between NT 201 and placebo in the post-stroke spasticity trial concerning safety aspects. All adverse reactions were either already known and/or were considered by the physician unlikely to be related to NT 201. More than 67,000 patients have been treated so far and no new safety concerns have been reported.

NT201 (Xeomin(R); botulinum neurotoxin free from complexing proteins) is efficacious and well-tolerated in upper limb spasticity of various etiologies authored by Barnes, M., Schnitzler, A., Amaral e Silva, A., Aquilar, M., Lehnert-Batar, A., and Minnasch, P.

Responder analysis of at least 1-point improvement from baseline to week 4 on the Disability Assessment Scale [DAS] for the primary therapeutic target after injection of a 20 U/mL dilution or 50 U/mL dilution was evaluated. After injection, observation over a 12-week period was followed by 8 weeks safety follow-up. Botulinum neurotoxin doses were derived from the recommendations from the organization WE MOVE. The individual injection pattern was adapted to patient's needs. A two-sided 95% Newcombe-Wilson confidence interval [CI] for the difference between groups was calculated.

192 patients with upper limb spasticity caused by either stroke (88%), brain injury (5.7%), multiple sclerosis (0.5%) or cerebral palsy (1.6%) were randomized to the 50 U/mL dilution group (95 patients) or to the 20 U/mL dilution group (97 patients). Limb position (60.4%), Dressing (24.0%), Hygiene (9.4%) and Pain (6.3%) were chosen as primary therapeutic target on the DAS. The maximum injected total dose was 495 units NT 201. Four weeks after injection 57.1% of patients had an at least 1-point DAS reduction from the baseline score for their primary therapeutic target. No dilution group was inferior to each other regarding efficacy. 79.9% of patients and 89.0% of investigators reported an improvement in global assessment of efficacy at week 4. There were no relevant differences regarding safety between groups.

Merz (KGAa) is known worldwide for its development of original compounds and formulations for medical professionals and consumers in 90 countries. Globally, Merz is a leader in research and development of pharmaceuticals for the treatment of neurological and psychological disorders as well as for aesthetic dermatology, including products for the treatment of wrinkles and aging skin, hair loss and acne. Research is concentrated in fields that have a strong need for therapeutic innovation such as Alzheimer's disease, Parkinson's disease, tinnitus, chronic pain conditions, addictions, and neuromuscular disturbances.

Merz Pharmaceuticals, LLC is the wholly owned, US subsidiary of the Merz Group of Companies. A specialty pharmaceutical company, Merz Pharmaceuticals, LLC was established in 1995 and is responsible for the commercialization of Merz (KGAa) products in the US.

CONTACT: Alissa Maupin, Merz, +1-919-923-6785

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Posted: June 2009

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