SAN
DIEGO, Jan. 25, 2012
/PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
announced today that its VMAT2 inhibitor product candidate,
NBI-98854, has been granted Fast Track designation by the U.S. Food
and Drug Administration (FDA) for the treatment of
neuroleptic-induced tardive dyskinesia.
The FDA's Fast Track program is
designed to facilitate the development and expedite the review of
drugs intended to treat serious diseases and address unmet medical
needs. The Fast Track designation allows more frequent interactions
with the FDA during the drug development process, which assures
that questions and issues are resolved quickly, often leading to
earlier drug approval and access by patients.
"The FDA's Fast Track designation recognizes the significant
need for an effective treatment for tardive dyskinesia," said
Christopher F. O'Brien, M.D., Chief Medical Officer of Neurocrine
Biosciences. "We look forward to continuing to collaborate with the
FDA on the development of NBI-98854, and welcome the opportunity
for increased interactions with the Agency."
About NBI-98854
VMAT2 is a protein concentrated in
the human brain that is primarily responsible for re-packaging and
transporting monoamines (dopamine, norepinephrine, serotonin, and
histamine) among nerve cells. NBI-98854, developed in the
Neurocrine laboratories, is a novel, highly-selective VMAT2
inhibitor that modulates dopamine release during nerve
communication, while at the same time having minimal impact on the
other monoamines thereby reducing the likelihood of "off target"
side effects. NBI-98854 is designed to provide low, sustained,
plasma and brain concentrations of active drug to minimize side
effects associated with excessive dopamine depletion.
NBI-98854 may be useful in other
disorders such as Huntington's chorea, schizophrenia, Tourette's
syndrome, and tardive dystonia.
About Tardive Dyskinesia
Tardive dyskinesia is characterized
by involuntary, repetitive movements of the extremities, lip
smacking, grimacing, tongue protrusion, rapid eye movements or
blinking, puckering and pursing of the lips, or impaired movement
of the fingers. These symptoms are rarely reversible and there is
currently no known treatment.
About Neurocrine
Biosciences
Neurocrine Biosciences, Inc. is a
biopharmaceutical company focused on neurological and endocrine
diseases and disorders. Our product candidates address some of the
largest pharmaceutical markets in the world, including
endometriosis, stress-related disorders, pain, tardive dyskinesia,
uterine fibroids, diabetes, insomnia, and other neurological and
endocrine-related diseases and disorders. Neurocrine
Biosciences, Inc. news releases are available through the Company's
website via the internet at http://www.neurocrine.com.
In addition to historical facts,
this press release may contain forward-looking statements that
involve a number of risks and uncertainties. Among the factors that
could cause actual results to differ materially from those
indicated in the forward-looking statements are risks and
uncertainties associated with Neurocrine's business and finances in
general, as well as risks and uncertainties associated with the
Company's R & D pipeline and the Company overall. Specifically,
the risks and uncertainties the Company faces with respect to the
Company's R & D pipeline include risk that the Company's
clinical candidates will not be found to be safe and effective;
risk that the Company's VMAT2 clinical candidates will not proceed
to later stage clinical trials; and risk that the Company's
research programs will not identify pre-clinical candidates for
further development. With respect to its pipeline overall, the
Company faces risk that it will be unable to raise additional
funding required to complete development of all of its product
candidates; risk relating to the Company's dependence on contract
manufacturers for clinical drug supply; risks associated with the
Company's dependence on corporate collaborators for commercial
manufacturing and marketing and sales activities; uncertainties
relating to patent protection and intellectual property rights of
third parties; risks and uncertainties relating to competitive
products and technological changes that may limit demand for the
Company's products; and the other risks described in the Company's
report on Form 10-K for the year ended December 31, 2010 and Form 10-Q for the quarter
ended September 30, 2011. Neurocrine
undertakes no obligation to update the statements contained in this
press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.