Santhera Pharmaceuticals has announced 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.