SAN DIEGO, Jan. 5, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food
and Drug Administration (FDA), after further review of the
INGREZZA™ (valbenazine) New Drug Application (NDA),
has decided to cancel the Psychopharmacologic Drugs Advisory
Committee meeting which was originally scheduled for February 16, 2017. The FDA informed the Company
that the Priority Review of the NDA of INGREZZA for the treatment
of tardive dyskinesia is continuing as planned with the previously
announced Prescription Drug User Fee Act (PDUFA) target action date
of April 11, 2017.
The NDA for INGREZZA includes the results from the Kinect 2 and
Kinect 3 clinical trials along with the results from another 18
clinical trials; extensive preclinical testing and drug
manufacturing data were included in the NDA submission. The FDA
granted Breakthrough Therapy Designation to INGREZZA for tardive
dyskinesia in 2014.
Conference Call and Webcast at 4:30 PM
Eastern Time
Neurocrine will host a live conference call and webcast to
discuss this press release on January 5,
2017 at 4:30 PM Eastern Standard
Time (EST)/ 1:30 PM Pacific Standard
Time (PST). Participants may access the live Conference Call
by dialing 877-876-9175 (US) or 785-424-1668 (International) and
using the conference ID: NBIX. The call can also be accessed via
the Webcast through Neurocrine's website at
http://www.neurocrine.com.
If you are unable to attend the webcast a replay of the
conference call will be available approximately one hour after the
conclusion of the call by dialing 800-839-1229 (US) or 402-220-0459
(International) using the conference ID: NBIX. The call will be
archived for one month.
About Tardive Dyskinesia
Tardive dyskinesia is characterized by involuntary, repetitive
movements of the face, trunk, or extremities, including lip
smacking, grimacing, tongue protrusion, facial movements or
blinking, puckering and pursing of the lips. These symptoms are
rarely reversible and there are currently no FDA approved
treatments.
About INGREZZA
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. INGREZZA (valbenazine or NBI-98854),
developed in the Neurocrine laboratories, is a novel,
highly-selective VMAT2 inhibitor that modulates dopamine release
during nerve communication, showing little or no affinity for
VMAT1, other receptors, transporters and ion channels. INGREZZA is
designed to provide low, sustained, plasma and brain concentrations
of active drug to allow for once daily dosing. The proprietary name
INGREZZA has been conditionally accepted by the FDA.
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, may provide symptomatic
benefits for patients with these diseases.
The Company is also investigating the safety and efficacy of
INGREZZA in the treatment of Tourette syndrome. The Company has two
ongoing placebo-controlled Phase II Tourette syndrome studies
evaluating INGREZZA in adults and pediatrics, the T-Forward study
and T-Force GREEN study, respectively. Each of these studies is
expected to enroll up to 90 subjects with Tourette syndrome.
Additionally, the Company has recently launched an open-label,
fixed-dose rollover study of INGREZZA in up to 180 subjects with
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 INGREZZA, a vesicular monoamine
transporter 2 inhibitor for the treatment of movement disorders.
Neurocrine plans to commercialize INGREZZA in the United States upon approval by the
FDA.
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 contains
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 INGREZZA development. Specifically,
the risks and uncertainties the Company faces include risks that
the INGREZZA NDA may not obtain regulatory approval from the FDA
for tardive dyskinesia or such approval may be delayed or
conditioned; risks that additional regulatory submissions may not
occur or be submitted in a timely manner; risks that the FDA or
regulatory authorities outside the U.S. may make adverse decisions
regarding INGREZZA; risks that INGREZZA development activities for
Tourette syndrome may not be completed on time or at all; risks
that ongoing INGREZZA development activities may be delayed for
regulatory or other reasons; risks that ongoing or future INGREZZA
clinical trials may not be successful or replicate previous
clinical trial results, may fail to demonstrate that INGREZZA is
safe, tolerable or effective, or may not be predictive of
real-world results or of results in subsequent clinical trials;
risks that INGREZZA 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 INGREZZA; risks that the
Company will be unable to raise additional funding, if required, to
complete development of or commercialize INGREZZA; risks and
uncertainties relating to competitive products and technological
changes that may limit demand for INGREZZA; and other risks
described in the Company's annual report on Form 10-Q for the
quarter ended September 30, 2016.
Neurocrine disclaims any obligation to update the statements
contained in this press release after the date hereof.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-provides-update-on-fda-advisory-committee-for-ingrezza-valbenazine-for-the-treatment-of-tardive-dyskinesia-300386655.html
SOURCE Neurocrine Biosciences, Inc.