SAN DIEGO, March 2, 2016 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) announced today that on
April 20, 2016, data from the Phase
III Kinect 3 study of valbenazine (NBI-98854) for tardive
dyskinesia will be presented during a plenary session at the
American Academy of Neurology Annual Meeting in Vancouver. In addition, data from the Kinect 1
and Kinect 2 clinical trials of valbenazine will also be reviewed
in two platform presentations on April 19,
2016 at this important meeting. The AAN Annual Meeting is
the largest international conference of neurologists, bringing
together over 10,000 clinicians and scientists to address current
topics in neurology.
The April 20th plenary
session, "KINECT 3: A Randomized, Double-Blind, Placebo-Controlled
Phase 3 Trial of Valbenazine (NBI-98854) for Tardive Dyskinesia,"
will be led by Dr. Robert Hauser
from the University of South Florida
Parkinson's Disease and Movement Disorders Center. Two
platform presentations, "Open-Label Extension of KINECT: A Phase 2
Study of Valbenazine (NBI-98854) for Tardive Dyskinesia" and
"A Phase 2 Study of Valbenazine (NBI-98854) for Treatment of
Tardive Dyskinesia: KINECT 2" will occur the morning of
April 19, 2016. All three
presentations will describe the methodology of each clinical trial,
safety and efficacy results, and statistical findings along with
key clinical observations.
"We are very pleased to have our Kinect 3 data accepted for
presentation and discussion during a plenary session at the 68th
Annual Meeting of the American Academy of Neurology in Vancouver in April. This, coupled with two
additional platform presentations, allows us to share the breadth
and depth of our late-stage tardive dyskinesia clinical efforts
with the worldwide experts in movement disorders," said
Chris O'Brien, M.D., Chief Medical
Officer at Neurocrine. "These presentations describe the conduct
and outcomes of three rigorous, well-controlled clinical trials in
tardive dyskinesia, representing a significant advance for this
therapeutic area. Our medical affairs team will also be present at
this key meeting next month to discuss this important data."
About Valbenazine
VMAT2 is a protein concentrated in the human brain that is
primarily responsible for re-packaging and transporting monoamines
(dopamine, norepinephrine, serotonin, and histamine) in
pre-synaptic neurons. Valbenazine (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. Valbenazine is designed to provide low, sustained,
plasma and brain concentrations of active drug to minimize side
effects associated with excessive monoamine depletion.
Modulation of neuronal dopamine levels in diseases such as
tardive dyskinesia, Tourette syndrome, Huntington's chorea,
schizophrenia, and tardive dystonia, which are characterized, in
part, by a hyperdopaminergic state, should provide symptomatic
benefits for patients with these diseases.
Neurocrine has received Breakthrough Therapy Designation from
the FDA for valbenazine in the treatment of tardive dyskinesia and
expects to file a New Drug Application for tardive dyskinesia in
2016. Valbenazine is also currently in Phase II development for
Tourette syndrome.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. discovers and develops innovative
and life-changing pharmaceuticals, in diseases with high unmet
medical needs, through its novel R&D platform, focused on
neurological and endocrine based diseases and disorders. The
Company's two lead late-stage clinical programs are elagolix, a
gonadotropin-releasing hormone antagonist for women's health that
is partnered with AbbVie Inc., and valbenazine, a vesicular
monoamine transporter 2 inhibitor for the treatment of movement
disorders. Neurocrine intends to maintain certain commercial rights
to its VMAT2 inhibitor for evolution into a fully-integrated
pharmaceutical company.
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 NBI-98854 (valbenazine)
development. Specifically, the risks and uncertainties the Company
faces include risks that valbenazine development activities may not
be completed on time or at all; risks that valbenazine development
activities may be delayed for regulatory or other reasons, may fail
to demonstrate that valbenazine is safe and effective, or may not
be predictive of real-world results or of results in subsequent
clinical trials; risks that valbenazine regulatory submissions may
not occur or be submitted in a timely manner; risks that
valbenazine may not obtain regulatory approval or that the U.S.
Food and Drug Administration or regulatory authorities outside the
U.S. may make adverse decisions regarding valbenazine; risks that
valbenazine may be precluded from commercialization by the
proprietary rights of third parties, or have unintended side
effects, adverse reactions or incidents of misuse; risks associated
with the Company's dependence on third parties for development and
manufacturing activities related to valbenazine; risks that the
Company will be unable to raise additional funding, if required, to
complete development of valbenazine; risks and uncertainties
relating to competitive products and technological changes that may
limit demand for valbenazine; and other risks described in the
Company's annual report on Form 10-K for the year ended
December 31, 2015. Neurocrine
disclaims any obligation to update the statements contained in this
press release after the date hereof.
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SOURCE Neurocrine Biosciences, Inc.