Santhera Obtains European Patent for Use of Catena/Sovrima

08-13-2010: Santhera Pharmaceuticals announced today that the European Patent Office granted patent protection for the use of idebenone (brand name Catena®/Sovrima®) in the treatment of Duchenne Muscular Dystrophy and other muscular dystrophies. A pivotal Phase III study with Catena®/Sovrima® 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 Catena®/Sovrima® 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.