Liestal, Switzerland, August 24, 2011 - Santhera Pharmaceuticals (SIX: SANN) announced today that the United States Patent and Trademark Office granted patent protection for the use of idebenone (brand name Catena®) in the treatment of Duchenne Muscular Dystrophy and other muscular dystrophies. The patent in the United States is supplemented by a similar patent in the European Union granted in 2010.
The patent granted covers the treatment or prevention of weakness and loss of skeletal muscle tissue as well as cardiomyopathy associated with certain forms of muscular dystrophies including Duchenne Muscular Dystrophy, one of the most common and devastating types of muscle loss. The patent protection in the United States lasts until 2027. In Europe, a similar patent has been granted in 2010. In early 2007, both the European Medicines Agency and the US Food and Drug Administration granted orphan drug designation for idebenone in Duchenne Muscular Dystrophy providing for seven and ten years, respectively, of market exclusivity following approval.
"The patent for Catena® in Duchenne Muscular Dystrophy is an important achievement in our efforts to develop and eventually commercialize the drug in the United States. The US patent extends the IP protection considerably beyond the market exclusivity that will go together with the orphan drug status", commented Thomas Meier, Chief Scientific Officer of Santhera.
Catena® is currently being investigated in Duchenne Muscular Dystrophy in a pivotal Phase III trial (the DELOS trial) with study centers enrolling patients in Europe and the United States. The primary endpoint of this 12-month, double-blind, placebo-controlled study is the change in respiratory function measured by peak expiratory flow. Additional respiratory parameters, muscle strength and motor function tests as well as quality of life assessments are secondary efficacy variables.
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About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of severe neuromuscular diseases, an area of high unmet medical need which includes many orphan indications with no current therapy. Santhera's first product, Catena®, to treat Friedreich's Ataxia is marketed in Canada. Catena® is currently under review for marketing authorization by the European Medicine Agency as first therapy for patients suffering from Leber's Hereditary Optic Neuropathy. For further information, please visit www.santhera.com.
Catena® is a trademark of Santhera Pharmaceuticals
For further information, contact
Thomas Meier, Chief Scientific Officer
Phone: +41 (0)61 906 89 64
thomas.meier@santhera.com
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach@santhera.com
Disclaimer/Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.
