WASHINGTON, May 31, 2013 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (VANDA) (NASDAQ: VNDA) today announced the
submission of a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for tasimelteon, a circadian
regulator. Vanda is seeking FDA approval of
tasimelteon for the treatment of Non-24-Hour Disorder (Non-24) in
the totally blind. Tasimelteon was developed to
address a significant unmet medical need, the treatment of Non-24,
for which there are currently no FDA approved products.
Non-24 is a serious and rare, circadian rhythm disorder that
affects the majority of totally blind individuals who lack light
perception and who therefore cannot entrain (synchronize) their
master body clock to the 24-hour day.
"The NDA submission of tasimelteon for Non-24 represents a
significant accomplishment for Vanda in our efforts to address
unmet medical needs," said Mihael H.
Polymeropoulos M.D., Vanda's President and Chief Executive
Officer. "We are excited to have submitted an
application for the first circadian regulator, representing a new
class of therapeutics. The data demonstrates
that tasimelteon is able to reset the master body clock and
synchronize the melatonin and cortisol circadian rhythms, resulting
in significant clinical benefits to patients".
Vanda previously announced that the FDA confirmed, at a recent
pre-NDA meeting, that the efficacy, safety and supporting data
package proposed to be included in the NDA would be adequate to
support filing of the NDA for review by the
Agency. The tasimelteon Non-24 NDA includes data
from the largest clinical program conducted to date for any
investigational therapy for the treatment of Non-24.
About Non-24-Hour Disorder
Non-24 is a serious, rare,
and chronic circadian rhythm disorder characterized by the
inability to entrain (synchronize) the master body clock with the
24-hour day-night cycle. Non-24 affects the majority of totally
blind individuals, or between 65,000 and 95,000 people in the
U.S. Non-24 occurs almost entirely in
individuals who lack the light sensitivity necessary to entrain the
master body clock in the brain with the 24-hour day-night
cycle. Most people have a master body clock that
naturally runs longer than 24-hours and light is the primary
environmental cue that resets it to 24-hours each
day. Individuals with Non-24 have a master body
clock that continually delays, resulting in prolonged periods of
misalignment between their circadian rhythms and
the 24-hour day-night cycle, including the timing of melatonin and
cortisol secretion and the sleep-wake cycle. As
a result of this misalignment, Non-24 is associated with
significant impairments in social and occupational functioning and
marked subjective distress. For more information
on Non-24, please visit www.Non-24.com.
About Tasimelteon
Tasimelteon is a circadian regulator
in development for the treatment of Non-24.
Tasimelteon is a dual melatonin receptor agonist
(DMRA) with selective agonist activity at the MT1 and MT2
receptors. Tasimelteon's ability to
reset the master body clock in the suprachiasmatic nucleus (SCN)
results in the entrainment of the body's melatonin and cortisol
rhythms with the 24-hour day-night cycle. The
patent claiming tasimelteon as a new chemical entity extends
through December 2022, assuming a
5-year extension to be granted under the Hatch-Waxman
Act. Tasimelteon has been granted orphan drug
designation for the treatment of Non-24 from both the U.S. and the
European Union.
About Vanda Pharmaceuticals Inc.:
Vanda
Pharmaceuticals Inc. is a biopharmaceutical company focused on the
development and commercialization of products for the treatment of
central nervous system disorders. For more on Vanda, please
visit www.vandapharma.com.
Company Contact:
Jim
Kelly
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
Media Contact:
Laney Landsman
Assistant Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.com
SOURCE Vanda Pharmaceuticals Inc.