Merz Pharmaceuticals Announces Long-Term Efficacy and Safety Data with
Repeated Xeomin(R) Injections in Upper Limb Post-Stroke Spasticity


    



    
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<p><span class="xn-location">TORONTO</span>, <span class="xn-chron">April 13</span> /CNW/ -- MERZ Pharma <span class="xn-location">Canada</span> Ltd. today announced results from a long-term extension study examining Xeomin® (botulinum toxin type A free from complexing proteins), also referred to as NT 201, in the treatment of patients with upper limb post-stroke spasticity after repeated injections. Data from the 89-week study, which showed Xeomin® was efficacious, well-tolerated and did not result in the development of neutralizing antibodies, was presented today at the 62nd American Academy of Neurology (AAN) annual meeting in <span class="xn-location">Toronto</span>.</p>
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<p>The Phase III study assessed the impact of Xeomin® on muscle tone, functional disability and caregiver burden, utilizing a randomized, double-blind, placebo-controlled multicenter-study followed up by a long-term, open-label extension of 48-69 weeks. During the open-label phase, patients received up to five additional Xeomin® injections. Upon completion of the study (20 weeks after the final injection), the Ashworth scale score was significantly improved compared to the score upon entry in the open-label period. Results indicate that Xeomin® is significantly more efficacious than placebo in the long-term treatment of patients with post-stroke upper limb spasticity.</p>
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<p>"Post-stroke spasticity can significantly decrease the quality of life for patients and it can increase the burden of care for caregivers. It can also cause pain and discomfort in some patients," said <span class="xn-person">Dr. Chris Boulias</span>, neuro rehabilitation specialist in the Comprehensive Spasticity Management Clinic at West Park Healthcare Centre, <span class="xn-location">Toronto</span>. "These positive findings in efficacy and safety suggest that Xeomin® is a promising option for patients in need of long-term treatment for post-stroke spasticity," confirmed <span class="xn-person">Dr. Farooq Ismail</span>, neuro rehabilitation specialist, West Park Healthcare Centre.</p>
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<p>According to the National Stroke Association, 58 percent of stroke survivors experience post-stroke spasticity and only 51 percent of those are receiving treatment for that condition. Aside from pain and significant discomfort, post-stroke muscle spasticity can negatively impact mobility, ability to carry out personal hygiene and other activities of daily living.</p>
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<p>"As a competitive triathlete, living with spasticity and experiencing the symptoms associated with the condition, like involuntary muscle contractions, impacted my training and daily life," said Lorene Hatelt, a seven-time International Triathlon Union World Champion in the Athletes with a Disability division. "Since I began Xeomin® injections, I've been able to manage my symptoms and maintain a better quality of life, and I continue to run, bike or swim every day."</p>
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<p>Xeomin® has been granted approval for the symptomatic management of post-stroke spasticity of the upper limb in <span class="xn-location">Canada</span> and several European countries, as well as for spasticity in <span class="xn-location">Mexico</span> and focal spasticity in <span class="xn-location">Argentina</span>. Merz has also filed a Biologics License Application (BLA) with the U.S. Food and Drug Administration, and if approved, the U.S. will be the 20th country to approve Xeomin®.</p>
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    About the Phase III Study

    
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<p>The Phase III study, conducted at 23 sites in <span class="xn-location">Europe</span>, included patients who, at least 6 months prior to enrollment, had experienced a stroke resulting in focal spasticity of the wrist and finger flexors (scores of greater than or equal to 2 on the Ashworth Scale). Participants were required also to have Disability Assessment Scale (DAS) scores of 2 or higher (at least moderate disability) in their chosen therapeutic target domain: dressing, limb position, hygiene or pain.</p>
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<p>Medications to treat spasticity such as centrally-acting muscle relaxants and/or benzodiazepines and physical and occupational therapy regimens were permitted if they had been stable in the 2 weeks before screening, but no treatment changes were allowed during the study.</p>
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<p>While treatment of the wrist and finger muscles was mandatory, other spastic upper limb muscle groups were treated as individually needed according to the investigator's clinical judgment. The maximum intended dose of study medication was 400 U. Follow up was conducted from week 12 to week 20.</p>
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<p>Patients could then enter a 4869-week open-label phase, receiving up to five additional injections of Xeomin® (maximum intended dose/injection 400 U). Outcome measures included change in Ashworth scale score at 4 weeks after each injection, frequency of adverse events (AEs), and development of neutralizing antibodies.</p>
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<p>During the study, 147 patients received at least 1 injection of Xeomin®. Across the whole study period, the mean duration of Xeomin® exposure was 63.6 +/-17.6 weeks; median dose 374 Units; and mean cumulative dose 1.333 +/-494 Units. The Ashworth scale score was significantly improved at 4 weeks after all 5 injections in all flexor muscle groups (p<0.0001, after the 6th injection patient numbers were too low for a meaningful analysis). At the study termination visit (20 weeks after the final injection), the Ashworth scale score was significantly improved compared to the score at the entry in the open label extension (OLEX) Period. Ninety patients (61.2%) reported greater than or equal to 1 AE. The most common adverse drug reactions were injection site pain (4.1%), muscular weakness (3.4%), dysphagia (2.1%), pain in extremity (1.4%). No serious AE were considered related to Xeomin®. AEs led to drop-out in 9 patients (6.1%). No patients developed neutralizing antibodies during the 89-week study period.</p>
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    About Xeomin® (NT 201)
    
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<p>Xeomin® is a neurotoxin therapy, free from complexing proteins, that combines high specific biologic activity with low bacterial protein load. It has been approved for marketing in <span class="xn-location">Europe</span> since 2005 to treat various movement disorders, and more recently was approved in <span class="xn-location">Canada</span> for symptomatic management of blepharospasm, cervical dystonia and post-stroke spasticity of the upper limb. It was also granted an extension of indication for the treatment of post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults in various European countries, as well as for spasticity in <span class="xn-location">Mexico</span> and for focal spasticity in <span class="xn-location">Argentina</span>.</p>
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    About Merz
    
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<p>Merz Pharma <span class="xn-location">Canada</span> Ltd, a wholly owned subsidiary of the Merz Pharma Group of Companies was established in 2009 to commercialize Xeomin and expand other Merz franchises in the Canadian marketplace.</p>
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    Merz Pharmaceuticals GmbH (www.merz.com):
    
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<p>Merz Pharmaceuticals, a member of the Merz Pharma Group of companies, is an innovative and international healthcare company specializing in the research, development and marketing of pharmaceuticals for the treatment of neurological and psychiatric diseases. Merz is a leader in the field of neurology. In addition to developing Xeomin®, the company has developed memantine (Axura®)  the first drug with a unique mechanism of action that focuses on the glutamatergic system 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.</p>
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For further information: For further information: Dawn Sciortino at Medical Dynamics, +1-212-537-9495 Web Site: http://www.merz.com

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