Vanda Pharmaceuticals Inc., announced
today 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.”
