Santhera Pharmaceuticals 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.
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.
For more information on orphan drugs and clinical trials, check out the World Orphan Drug Congress USA.