Vanda Pharmaceuticals Inc., announced that the European Commission (EC) has granted orphan drug designation for tasimelteon, an oral dual melatonin receptor agonist in phase III clinical trails for Non-24-Hour Sleep/Wake Disorder (N24HSWD) in blind individuals with no light perception. This follows the positive opinion on the designation that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency adopted previously in the November 2010 COMP Committee Meeting.
Orphan designation for a medicinal product by the EC provides benefits that can take a variety of forms including tax incentives, protocol assistance, eligibility for grants and initiatives supporting research and development related to this orphan indication, reduction of marketing application fees and annual fees for qualifying companies, and potential marketing exclusivity for up to 10 years in the European Union.
"We are very pleased to receive orphan designation from the European Commission," said Mihael H. Polymeropoulos, M.D., president and chief executive officer of Vanda. "This status represents an acknowledgement of the significant unmet medical need to develop and commercialize a treatment that may alleviate sleep/wake problems in people who are totally blind with no light perception."
N24HSWD is a chronic circadian rhythm sleep disorder that occurs when individuals are unable to synchronize their internal clock to the 24-hour light/dark cycle. As a result, the sleep/wake cycle of these individuals moves gradually later and later each day if their circadian period is more than 24 hours or earlier and earlier each day if their circadian period is less than 24 hours. This condition occurs almost entirely in individuals who are totally blind and lack the light sensitivity necessary to reset the circadian clock.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders.