SAN DIEGO, Feb. 14, 2018 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused
on neurological and endocrine related disorders, today announced
that the U.S. Food and Drug Administration (FDA) has provided
guidance on the regulatory path forward to support the New Drug
Application (NDA) for opicapone, an investigational drug for
Parkinson's disease, after receiving meeting minutes from the
January 2018 meeting with the FDA.
Most importantly, the Neurology Division of the FDA has not
requested that Neurocrine conduct an additional Phase III study for
opicapone prior to the NDA filing. As a result, Neurocrine will
proceed with plans to file the NDA for opicapone during the first
half of 2019.
"We had a very productive meeting with the FDA and are pleased
that we can proceed with the NDA submission based on the robust
clinical data that already exists for opicapone," said Eiry W.
Roberts, M.D., Chief Medical Officer at Neurocrine. "We have a
tremendous amount of work ahead of us as we compile the
FDA-required datasets to prepare for the NDA filing, which we plan
to have completed during the first half of 2019. As part of our
commitment to helping patients with movement disorders, we are
eager to continue advancing this important medicine for the nearly
one million patients suffering from Parkinson's disease in
the United States."
Opicapone, an investigational drug in the U.S., is a once-daily,
peripherally-acting, highly-selective catechol-o-methyltransferase
(COMT) inhibitor being developed as an adjunct therapy to
preparations of levodopa/DOPA decarboxylase inhibitors for adult
patients with Parkinson's disease and motor fluctuations.
In February 2017, Neurocrine
entered into an exclusive licensing agreement with BIAL for the
development and commercialization of opicapone in the United States and Canada. Under the terms of the agreement,
Neurocrine is responsible for development and commercialization of
opicapone in the United States and
Canada. As a result of the FDA
guidance for the NDA filing, Neurocrine will pay a $10 million milestone payment to BIAL.
About Parkinson's Disease
Parkinson's disease is a
chronic and progressive movement disorder that affects
approximately one million people in the
United States. The disease is characterized by a loss of
neurons in the substantia nigra, the area of the brain where
dopamine is produced. Dopamine production and synthesis is
necessary for coordination and movement. As Parkinson's progresses,
dopamine production steadily decreases resulting in tremor, slowed
movement (bradykinesia), impaired posture and balance, and speech
and writing problems. There is no present cure for Parkinson's
disease and management consists of controlling the motor symptoms
primarily through administration of levodopa therapies. While this
improves the control of Parkinson's symptoms, the disease
progresses and the beneficial effects of levodopa begin to wear
off, symptoms worsen and patients experience end-of-dose motor
fluctuations. These end-of-dose motor fluctuations are improved
with the addition of a catechol-o-methyltransferase (COMT)
inhibitor to levodopa.
About Opicapone
Opicapone is a novel, once-daily,
peripherally-acting, highly-selective catechol-o-methyltransferase
(COMT) inhibitor proposed for use as adjunct therapy to
levodopa/DOPA decarboxylase inhibitors in Parkinson's
patients. Opicapone works by prolonging the duration of effect of
levodopa through decreasing its conversion rate into
3-O-methyldopa, thereby reducing the off-time period of Parkinson's
and extending the on-time period. A novel compound discovered
in the BIAL laboratories, it is designed to provide patients and
physicians with a once-daily treatment option without the
deleterious side-effects and complicated dosing regimen of other
COMT inhibitors.
In June 2016, the European
Commission authorized ONGENTYS® (opicapone) as an
adjunct therapy to preparations of levodopa/DOPA decarboxylase
inhibitors (DDCIs) in adult patients with Parkinson's disease and
end-of-dose motor fluctuations who cannot be stabilized on those
combinations. This European approval was based on data from a
clinical development program that included 28 clinical studies of
more than 900 patients treated with opicapone in 30 countries
worldwide. Opicapone is an investigational drug, not approved for
use in the United States or
Canada.
The two pivotal Phase III studies utilized for European
approval, BIPARK-I and BIPARK-II, demonstrated that opicapone
once-daily achieved a statistically significant decrease in
off-time periods for Parkinson's patients compared to placebo. The
BIPARK-I study was a placebo-controlled study of approximately 600
patients that also included entacapone as an active comparator. The
results of this study showed that once-daily opicapone was
non-inferior to entacapone dosed multiple times per day. The
BIPARK-II study was a placebo-controlled study of approximately 400
patients that also showed a significant decrease in off-time
periods for Parkinson's patients. In both studies, opicapone was
associated with significant improvements in both patient and
clinician global assessments of change. The data from these two
Phase III trials also demonstrated that opicapone improved motor
fluctuations in levodopa-treated patients regardless of concomitant
dopamine agonist or monoamine oxidase type B inhibitors used.
Opicapone was generally well tolerated and was not associated with
relevant electrocardiographic or hepatic adverse events.
Both of the BIPARK Phase III trials included a one-year
open-label extension where opicapone sustained the decrease in
off-time and increase in on-time periods that was demonstrated
during the double-blind placebo-controlled portion of the
studies.
About Neurocrine Biosciences, Inc.
Neurocrine
Biosciences is a San Diego based biotechnology
company focused on neurologic, psychiatric and endocrine related
disorders. The Company markets INGREZZA® (valbenazine)
capsules in the United States for the treatment of adults
with tardive dyskinesia. INGREZZA is a novel, selective
vesicular monoamine transporter 2 (VMAT2) inhibitor, and is the
first FDA approved product indicated for the treatment of adults
with tardive dyskinesia. The Company's three late-stage
clinical programs are: elagolix, a gonadotropin-releasing hormone
antagonist for women's health that is partnered with AbbVie
Inc.; opicapone, a novel, once-daily, peripherally-acting,
highly-selective catechol-o-methyltransferase inhibitor under
investigation as adjunct therapy to levodopa in Parkinson's
patients; and INGREZZA, a novel, once-daily, selective VMAT2
inhibitor under investigation for the treatment of Tourette
syndrome.
Neurocrine Biosciences, Inc. news releases are available through
the Company's website at http://www.neurocrine.com.
Forward-Looking Statements
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 opicapone development and commercialization. Specifically, the
risks and uncertainties the Company faces include risks that
opicapone may not obtain regulatory approval from the FDA or such
approval may be delayed or conditioned; risks that opicapone
development activities may not be completed on time or at all;
risks associated with the Company's dependence on BIAL for
development and manufacturing activities related to opicapone;
risks that ongoing or future opicapone clinical trials may not be
successful or replicate previous clinical trial results, or may not
be predictive of real-world results or of results in subsequent
clinical trials; risks that the FDA or regulatory authorities
outside the U.S. may make adverse decisions regarding opicapone;
risks that opicapone may be precluded from commercialization by the
proprietary rights of third parties, or have unintended side
effects, adverse reactions or incidents of misuse; risks and
uncertainties relating to competitive products and technological
changes that may limit demand for opicapone; and other risks
described in the Company's periodic reports filed with the
Securities and Exchange Commission, including without limitation
the Company's annual report on Form 10-K for the year ended
December 31, 2017. 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.