Merz Pharmaceuticals, LLC Release: XEOMIN(R) (IncobotulinumtoxinA) Data to be Presented at the 72nd Annual Assembly of the American Academy of Physical Medicine and Rehabilitation

FRANKFURT, Germany, Nov. 17, 2011 /PRNewswire/ -- Merz Pharmaceuticals today announced that results from five studies examining XEOMIN® (incobotulinumtoxinA), a botulinum neurotoxin type A preparation free from accessory proteins, will be presented at the 72nd Annual Assembly of the American Academy of Physical Medicine and Rehabilitation (AAPM&R) in Orlando, Fla.

The first poster being presented at the meeting, titled "Sustained efficacy of incobotulinumtoxinA (XEOMIN®; botulinum neurotoxin type A free from accessory proteins) in cervical dystonia demonstrated by investigator and patient-rated outcomes," assessed the long-term efficacy and tolerability of XEOMIN® in cervical dystonia in a setting similar to clinical practice. The prospective, multicenter, open-label single-arm Phase IV study found that XEOMIN® showed sustained efficacy and was well tolerated in the treatment of cervical dystonia for up to 121 weeks. [Poster 130; Dressler, et al.]

The second poster, titled "Significant and sustained efficacy of incobotulinumtoxinA (XEOMIN®; botulinum neurotoxin type A, free from accessory proteins) in upper limb spasticity," included two studies. The first consisted of a randomized, double-blind, placebo-controlled main period and an open-label extension period and evaluated patients with upper limb (UL) post-stroke spasticity. The second was a randomized study of two dilutions of incobotulinumtoxinA that assessed patients with UL spasticity of various etiologies. Study results showed that incobotulinumtoxinA was well tolerated and demonstrated significant, sustained efficacy in UL spasticity. [Poster 138; Kanovsky, et al.]

"The positive findings presented at AAPM&R reinforce that XEOMIN® is a safe and effective option for patients in need of treatment for certain movement disorders," said Petr Kanovsky, MD, PhD, Department of Neurology, Palacky University Medical School, Olomouc, Czech Republic, and an investigator for XEOMIN®. "Merz has established a positive presence in the movement disorder community and XEOMIN® continues to provide value for patients and doctors."

XEOMIN® is approved in 20 countries for the treatment of blepharospasm, in 21 countries for the treatment of cervical dystonia (also known as spasmodic torticollis), and in 17 countries for post-stroke spasticity of the upper limb. XEOMIN® is not approved for the treatment of spasticity in the U.S.

The results of an additional study evaluating the safety and efficacy of XEOMIN® in the treatment of cervical dystonia when administered at flexible dosing regimens, as well as data showing the safety and efficacy of XEOMIN® in the treatment of UL post-stroke spasticity, will also be presented:

• Poster 129: Sustained efficacy with incobotulinumtoxinA (XEOMIN®; botulinum neurotoxin type A, free from accessory proteins) for up to 89 weeks in upper limb post-stroke spasticity (Kanovsky, et al.)
• Poster 131: IncobotulinumtoxinA (XEOMIN®; botulinum neurotoxin type A, free from accessory proteins): Flexibility of dosing and injection intervals in cervical dystonia (Evidente, et al.)

About XEOMIN®

Botulinum toxin type A is naturally produced by Clostridium botulinum as a larger protein complex containing therapeutically unnecessary accessory or complexing proteins.

XEOMIN® (incobotulinumtoxinA) is manufactured using an FDA-approved state-of-the-art biotechnological process, which yields the pure neurotoxin with a low foreign protein content. Foreign proteins are considered as one of the factors for secondary therapy failure.

Since its launch in 2005, more than 261,000 patients have been treated with XEOMIN® worldwide. It is approved in 20 countries for the treatment of blepharospasm, in 21 countries for the treatment of cervical dystonia (spasmodic torticollis), and in 17 countries for post-stroke spasticity of the upper limb (XEOMIN® is not approved for the treatment of spasticity in the U.S.). Due to unit differences in the LD50 assay, XEOMIN® units are specific to XEOMIN®. Therefore unit doses recommended for XEOMIN® are not interchangeable with those for other preparations of Botulinum toxin. Comparative clinical study results suggest that XEOMIN® and the comparator product containing conventional Botulinum toxin type A complex (900 kD) are of equal potency when used with a dosing conversion ratio of 1:1.

XEOMIN® is the only botulinum toxin product that does not require refrigeration during transport or storage.

XEOMIN® is available in 50 and 100 unit vials. The 50 unit vial helps facilitate flexible dosing and offers reduced product wastage as well as cost savings.

Merz Pharmaceuticals GmbH (www.merz.com):

Merz Pharmaceuticals, a member of the Merz Pharma 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 (Namenda®, Memary®, Axura®, Ebixa®) - the first drug for the treatment of moderate to severe Alzheimer's disease, which is marketed by Forest in the US, Daiichi-Sankyo in Japan, and Merz/Lundbeck in Europe and rest of the world. The company also focuses on the development of innovative therapies within the therapeutic areas of hepatology, metabolic diseases and dermatology.

XEOMIN® is a registered trademark of Merz Pharma GmbH & Co KGaA.

SOURCE Merz Pharmaceuticals GmbH