Press Release
New XEOMIN® – The First Botulinum Neurotoxin Type A That Is Free From Complexing Proteins – Is Now Available. Indicated For The Treatment of Blepharospasm, Cervical Dystonia* and Post-Stroke Spasticity.
TORONTO, Canada – July 21, 2009
Merz Pharma Canada Ltd. announces that XEOMIN® can now be prescribed to treat patients with a numberof serious, debilitating conditions.
The treatment of patients with Botulinum neurotoxin type A can require high doses and long-term treatment. This may be associated with the formation of antibodies when using neurotoxins with a high foreign protein load.1,2,3
New XEOMIN® has eliminated complexing proteinsthroughchromatographic filtering technology. This innovative manufacturing process yields a highly pure botulinum toxin formulation that can be stored at room temperature for up to 3 years – greatly reducing the risk of a compromised storage temperature either during shipping, at the pharmacy or in a medical office.4
“Based on available data and my own clinical experience, XEOMIN® is a new therapy option that is easy to use and highly efficacious,” said Dr. Mandar Jog, Professor of Neurology, University of Western Ontario and the Director of the Movement Disorders Program, London Health Sciences Centre, London, Ontario.
In the largest randomized, placebo-controlled double-blind trial to date in post-stroke spasticity of the upper-limb, XEOMIN® has shown high response rates and significant improvement in functional disability.5 In one study, there were statistically significant Disability Assessment Scale (DAS) improvements through the entire 12-week period (in the principal selected therapeutic target p≤ 0.005)5 with an equivalent long duration of therapy.6 For upper-limb post-stroke spasticity, XEOMIN® has shown sustained efficacy and a favorable safety profileduring the one year open label extension period. Repeated treatments were well tolerated with a median dose of 400 units in patients with post-stroke spasticity of the upper limb. None of the patients in this trial had developed neutralizing antibodies.4 Additionally, in focal dystonia6 and the largest spasmodic torticollis7 and blepharospasm8 trials to date, it was demonstrated that XEOMIN® showed comparable therapeutic effect to Botox®.
"The Dystonia Medical Research Foundation Canada (DMRFC) welcomes XEOMIN® as a new therapy choice for people in Canada affected by dystonia” said Diane Gillespie, DMRFC National Director.
New XEOMIN® is now available in Canada. Botulinum neurotoxin type A is considered by many to be the treatment of choice for focal spasticity9,10,11 and dystonia7. We are confident that physicians and patients will find
new XEOMIN® an innovative neurotoxin option that combines new levels of purity and convenience.
For further information, please contact Glenn Block, President and General Manager, Merz Pharma Canada Ltd. at
(Glenn.Block@merz.com).
* Predominantly rotational form (spasmodic torticollis)
1. Dressler D. Pharmacological aspects of therapeutic botulinum toxin preparations. Nervenarzt 2006 Aug;77(8):912–21. 2. Jankovic J, Vuong KD, Ahsan J. Comparison of efficacy and
immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology 2003 April;60(7):1186–8. 3. European Medicines Agency. Guideline on immunogenicity assessment
of biotechnology-derived therapeutic proteins. 2007 January:1–17. 4. XEOMIN® product monograph. Merz Canada Ltd. March 10, 2009. 5. Kanovsky P, Platz T, Sassin I, Comes G, Grafe S,
for the XEOMIN® Study Group. Efficacy and safety of NT 201 (XEOMIN®) in upper limb spasticity after stroke: a double-blind, placebo-controlled, randomized, multi-center trial. Poster
presented at the 5th World Congress on NeuroRehabilitation 2008 Brasília, Brazil, September 24–27, 2008. 6. Jöst W, Blümel J, Grafe S. Botulinum neurotoxin type A free of complexing
proteins (XEOMIN®) in focal dystonia. Drugs 2007;67(5):669-683. 7. Benecke R, Jöst W, MD, Kanovsky P, Ruzicka E, Comes G, Grafe S. A new Botulinum toxin type A free of complexing
proteins for treatment of cervical dystonia. Neurology 2005;64:1949-1951. 8. Roggenkämper P, Jöst W, Bihari K, Comes G, Grafe S. Efficacy and safety of a new Botulinum toxin type A free ofcomplexing proteins in the treatment of blepharospasm. J Neural Transm 2006;113(3):303–312. 9. Ward A, Aguilar M, De Beyl Z, Gedin S, Kanovsky P, Molteni F, et al. Use of botulinum toxin type A in management of adult spasticity –– a European Consensus Statement. J Rehabil Med 2003 Mar;35(2):98–9. 10. Simpson DM, Blitzer A, Brashear A, Comella C, Dubinsky R, Hallett M,et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of theAmerican Academy of Neurology. Neurology 2008 May;70(19):1699–706. 11. Albanese A, Barnes M, Bhatia K, Fernandez-Alvarez E, et al. A systematic review on the diagnosis and treatment of
primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task Force. Eur J Neurol 2006,13:433–444.
XEOMIN® is a registered trademark of Merz GmbH. Full product monograph available on request. Botox® is a registered trademark of Allergan Inc.
MERZ PHARMACEUTICALS
Merz Pharma Canada Ltd.