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New Data On Xeomin® (IncobotulinumtoxinA) To Be Presented At The 15th International Congress Of Parkinson's Disease And Movement Disorders (MDS)
Date:6/8/2011

FRANKFURT, Germany, June 8, 2011 /PRNewswire/ -- Merz Pharmaceuticals today announced that new data on Xeomin® (incobotulinumtoxinA), a botulinum toxin type A free from accessory (complexing) proteins, will be presented at the Movement Disorder Society's (MDS) 15th International Congress of Parkinson's Disease and Movement Disorders in Toronto, Canada. The studies found that repeated injections of XEOMIN were safe and effective in the treatment of blepharospasm and cervical dystonia (CD) when administered at flexible dosing regimens, including more or less frequently than the standard dosing interval of 12 weeks.

Blepharospasm, also referred to as benign essential blepharospasm, and CD, also known as spasmodic torticollis, are rare conditions that possibly go undiagnosed or misdiagnosed. Botulinum toxin is the only FDA-approved medication for the treatment of these conditions.

The first poster presented at the meeting, titled "IncobotulinumtoxinA (NT-201) injections are safe and effective in adult subjects with blepharospasm across dosing intervals in a repeated dose-study," concludes that XEOMIN was safe and effective in the treatment of blepharospasm across dosing regimens, including injection intervals of up to 10 weeks, 10 to 12 weeks and more than 14 weeks (the approved reinjection frequency is 12 weeks or more). [Poster 609, June 8, 2011, 9 a.m. – 6 p.m.; Poster Presentation, 1:30 p.m. – 3 p.m.].

Additionally, the poster titled, "IncobotulinumtoxinA (NT-201) injections are safe and effective in adult subjects with cervical dystonia across dosing intervals in a repeated dose-study," concludes that XEOMIN was safe and effective in the treatment of CD when administered according to a flexible dosing regimen, including up to 10 weeks, 10 to 12 weeks and more than 14 weeks (the approved reinjection frequency is 12 weeks or more).[Poster 625, June 8, 2011, 9 a.m. – 6 p.m.; Poster Presentation, 1:30 p.m. – 3 p.m.]

"These findings are supportive of a flexible dosing schedule for XEOMIN, which can be determined according to individual needs," said Matthew Brodsky, M.D., Director of the Neurotoxin Injection Program and Movement Disorders Program at Oregon Health & Science University, Portland, Ore. "Cervical dystonia and blepharospasm are variable chronic conditions that affect each patient differently, so it's important that physicians work with their patients to determine appropriate treatment regimens and dosing schedules on a case by case basis."

In both studies, there were no significant differences in the overall occurrence of treatment-emergent-adverse-events among groups (using chi-square test).

About The Studies

Patients with CD or blepharospasm who completed a placebo-controlled, double-blind study (up to 20 weeks) evaluating the safety and efficacy of XEOMIN, could enter an open label extension (OLEX) phase for blepharospasm treatment or an extension phase (EP) for CD treatment.

Blepharospasm patients (n=102) who entered the OLEX phase were treated with XEOMIN (up to 50 Units) for up to 69 weeks. Repeated injection intervals were chosen at the discretion of the physician and patient, based on the Jankovic Rating Scale (JRS) Severity subscore. In the subgroup analysis the JRS Sumscore (Severity and Frequency Subscores) was the primary outcome measure and all JRS Sumscores were significantly improved after each injection (p<0.001) in each group (using paired t-test).

Cervical dystonia patients (n=214) who entered the EP were treated with XEOMIN (111 in 240 Units group; 103 in 120 Units group) for up to 68 weeks. Inter-injection intervals were chosen at the discretion of the physician and patient, based on Toronto Western Spasmodic Rating Scale (TWSTRS) Total score. In the subgroup analysis the primary efficacy outcome measure was TWSTRS Total scores, which were significantly improved after each injection (p<0.001) in each group (using paired t-test).

About XEOMIN®

In nature, Clostridium botulinum produces the toxin in association with accessory (complexing) proteins. Manufacturers isolate the therapeutically active botulinum neurotoxin together with the accessory (complexing) proteins. XEOMIN (incobotulinumtoxinA) is manufactured using a proprietary process that isolates in an additional purification step the therapeutic component and eliminates accessory proteins.

More than 127,000 patients have been treated with XEOMIN worldwide since 2005. XEOMIN is approved in 21 countries worldwide for the treatment of cervical dystonia and blepharospasm and in 17 countries for the treatment post stroke upper limb spasticity. It is currently not approved in the U.S. for the treatment of spasticity.

XEOMIN is the only botulinum toxin product that does not require refrigeration prior to reconstitution.

Merz Pharmaceuticals GmbH (www.merz.com):

Merz Pharmaceuticals, a member of the MerzPharma Group of companies, is an innovative and international specialty healthcare company specializing in the research, development and marketing of pharmaceuticals for the treatment of neurological and psychiatric diseases. In addition to developing XEOMIN®, the company has developed memantine (Axura®) -- the first drug for the treatment of moderate to severe Alzheimer's disease. The company also focuses on the development of innovative therapies within the therapeutic areas of hepatology, metabolic disease and dermatology.

XEOMIN is a registered trademark of MerzPharma GmbH & Co KGaA.


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