August 13, 2010: Santhera Obtains European Patent for Use of CatenaŽ/SovrimaŽ in the Treatment of Muscular Dystrophies
Liestal, Switzerland, August 13, 2010 - Santhera Pharmaceuticals (SIX: SANN) announced today that the European Patent Office granted patent protection for the use of idebenone (brand name CatenaŽ/SovrimaŽ) in the treatment of Duchenne Muscular Dystrophy and other muscular dystrophies. A pivotal Phase III study with CatenaŽ/SovrimaŽ is currently ongoing to investigate the safety and efficacy of the drug in Duchenne Muscular Dystrophy. Santhera has partnered the commercial rights for the product in the EU and Switzerland to Takeda Pharmaceutical.
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 muscular degeneration. The patent protection in Europe lasts until 2026. In the United States, a similar patent is pending. In early 2007, both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) granted orphan drug designation providing market exclusivity for 10 and 7 years, respectively, following marketing approval.
"The European patent for CatenaŽ/SovrimaŽ in Duchenne Muscular Dystrophy is an important achievement and extends the protection considerably beyond the market exclusivity that goes together with the orphan drug status", commented Thomas Meier, Chief Scientific Officer of Santhera.
Santhera is currently conducting a pivotal Phase III study named DELOS (DuchEnne Muscular Dystrophy Long-term IdebenOne Study) in seven European centers and one in 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. Both the EMA and the FDA agreed that a single pivotal study could suffice for approval.
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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, CatenaŽ to treat Friedreich's Ataxia, is marketed in Canada. Following positive clinical results in Leber's Hereditary Optic Neuropathy, the drug is currently prepared for regulatory filings for marketing approval. CatenaŽ is also being investigated in a Phase III study in Duchenne Muscular Dystrophy. Commercial rights in Europe for Friedreich's Ataxia and Duchenne Muscular Dystrophy are licensed to Takeda Pharmaceutical. Santhera's second compound fipamezole has demonstrated efficacy in reducing levodopa-induced Dyskinesia in Parkinson's Disease. Phase III development and commercialization rights in the United States and Canada are partnered with Biovail. For further information, please visit the Company's web site at www.santhera.com.
CatenaŽ is a trademark of Santhera Pharmaceuticals. SovrimaŽ is a trademark of Takeda Pharmaceutical.
For further information, contact
Thomas Meier, Chief Scientific Officer
Phone: +41 (0)61 906 89 64
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
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.