Merz research Shows Long-term Benefits for Patients With Dystonia

FRANKFURT AM MAIN, Germany, October 21, 2011 -

At the 5^th International Dystonia Symposium (IDS) in Barcelona, Spain (20-22 October 2011), Merz Pharmaceuticals presented important clinical data concerning the long-term, sustained efficacy and safety of XEOMIN^® for the treatment of patients with dystonia.

Dystonia is a particularly debilitating condition where involuntary muscle contractions can cause abnormal twisting, postures or movements, and is the third most common movement disorder after essential tremor and Parkinson’s disease.^[1] New data presented at recent neurological congresses and summarized at the IDS indicate that patients treated with XEOMIN^® for cervical dystonia or blepharospasm (involuntary closing of the eyelids) experienced long-term sustained efficacy with a favorable safety profile in studies of up to 121 and 88 weeks duration, respectively.^[2-4] Furthermore, the incidence of adverse events decreased with each injection session, indicating no cumulative effect of the drug with repeated treatments.^[2,4] Professor Alberto Albanese from the Istituto Neurologico Carlo Besta, Milan, Italy, who is the lead author of the recently published new European Federation of Neurological Societies guidelines on the diagnosis and treatment of dystonia,^[5] stated that “Botulinum neurotoxin type A should be regarded as the first-line treatment for patients with dystonia. It is also important to know that repeated treatments are safe and efficacious over many years. These data give physicians more confidence in using this medication over the long term”.

Professor Alberto Albanese indicated that “most patients with dystonia require long-term treatment. Moreover flexibility is needed with respect to time interval between treatment sessions to facilitate individualized care. Long-term clinical studies involving XEOMIN^® are unique in being able to show that patients can be dosed safely also with injection intervals ranging from 6 to 20 weeks”.^[6] Individualized patient treatment also requires the use of different doses depending on the severity of dystonia and the muscle affected. XEOMIN^® is now available in both 100 and 50 unit vials,^[7,8] which limits product wastage and may result in significant cost savings for healthcare providers.

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.^[7,9,10] In addition, XEOMIN^® is the only product in its class to be refined by an FDA-approved state-of-the-art biotechnology process to remove the unnecessary accessory or complexing proteins that would otherwise be injected into the patient along with the active 150 kD neurotoxin.^[7,8,11,12]

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 draws out the pure neurotoxin with a low foreign protein content. Foreign proteins are considered as one of the factors for secondary therapy failure.^[7]

Since its launch in 2005, more than 261,000 patients have been treated with XEOMIN^® worldwide.^[13] It is approved in 21 countries for the treatment of blepharospasm, 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 US). 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.^[7]

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

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

About 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.

References

1. Defazio G. Eur J Neurol. 2010 Jul;17 Suppl 1:9-14.
2. Grafe S, Hanschmann A. Poster presented at AAN 2010. Neurol J 2010; 74 (Suppl 2): A88.
3. Dressler D et al. Poster presented at EFNS 2011; www.multiwebcast.com/eposter.efns/2011/15th/11897/.
4. Grafe S et al. Poster presented at MDS 2010. Mov Disord 2010; 25 (Suppl 2): S235.
5. Albanese A et al. Eur J Neurol 2011; 18: 5-18.
6. Truong et al. Poster presented at MDS 2011. Mov Disord 2011; 26 (Suppl 2): S211.
7. XEOMIN^® 50 U Summary of Product Characteristics. May 2011, UK. medicines.org.uk/EMC/medicine/24582/SPC/Xeomin+50+Units.
8. XEOMIN^® US Prescribing Information. July 2011, US. www.accessdata.fda.gov/drugsatfda_docs/label/2011/125360s007lbl.pdf.
9. Benecke R et al. Neurology 2005; 64: 1949-1951.
10. Roggenkämper P et al. J Neural Transm 2006; 113: 303-312.
11. Bigalke H. In: Jankovic J et al. Botulinum toxin - therapeutic clinical practice and science. Philadelphia, PA: Saunders Elsevier; 2009.
12. Frevert J. Drugs R D 2010; 10: 67-73.
13. Merz, data on file, 2010, XEO-DOF-2010-11-001.

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

For information:
Ute Weinhold
Merz GmbH & Co. KGaA
Eckenheimer Landstraße 100
60318 Frankfurt
Germany
Tel: +49-69-15-03-889
Ute.Weinhold@merz.de 

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