SAN DIEGO and PORTO, Portugal, Feb.
9, 2017 /PRNewswire/ -- Neurocrine Biosciences, Inc.
(NASDAQ: NBIX) and BIAL today announced that they have entered into
an exclusive licensing agreement for the development and
commercialization of opicapone in North
America. ONGENTYS® (opicapone) is a once-daily,
peripherally-acting, highly-selective catechol-O-methyltransferase
inhibitor (COMT inhibitor) that was approved in June 2016 by the European Commission as an
adjunct therapy to preparations of levodopa/DOPA decarboxylase
inhibitors for adult patients with Parkinson's disease and
end-of-dose motor fluctuations who cannot be stabilized on those
combinations.
"Securing the commercial rights to opicapone in the United States and Canada is another important step in expanding
our movement disorders franchise," said Kevin C. Gorman, Chief Executive Officer of
Neurocrine Biosciences. "Opicapone is a significant late stage
asset with outstanding clinical data and a long period of
exclusivity. Upon FDA approval, it will allow us to further
leverage our commercial infrastructure and bring much needed relief
to the one million people in the United
States suffering from the symptoms of Parkinson's
disease."
"We are pleased to have Neurocrine as our partner in developing
and commercializing opicapone," said Antonio Portela, Chief Executive Officer of
BIAL. "We believe this partnership is another landmark for BIAL.
Neurocrine has extensive experience in developing therapies for
movement disorders and shares our long-term vision for opicapone,
we look forward to bringing this important new treatment option to
Parkinson's patients in the United
States."
"Opicapone potentially addresses two significant needs for
individuals with Parkinson's disease; extending the timeframe when
motor symptoms are adequately controlled as well as once-daily
dosing which greatly simplifies the treatment regimen," said
Christopher O'Brien, Chief Medical
Officer of Neurocrine Biosciences. "We look forward to working with
the FDA to bring this novel therapy to Parkinson's patients."
Under the terms of the agreement, Neurocrine will be responsible
for development and commercialization of opicapone in the United States and Canada. Neurocrine will make an upfront
payment of $30 million and will fund
all development activities necessary for U.S. Food and Drug
Administration (FDA) approval. BIAL is eligible to receive
additional milestone payments of approximately $115 million from Neurocrine for the achievement
of certain development, regulatory and commercial milestones. In
addition, Neurocrine will pay BIAL a percentage of net sales in
exchange for the manufacture and supply of opicapone drug
product.
Upon the completion of technology transfer from BIAL, Neurocrine
intends to meet with the FDA to discuss a potential New Drug
Application submission.
Conference Call and Webcast at 4:30 PM
Eastern Time
Neurocrine will host a live conference call and webcast to
discuss this press release today at 4:30pm
Eastern Standard Time (EST)/ 1:30pm
Pacific Standard Time (PST). Participants may access the
live conference call by dialing 877-876-9177 (U.S.) or 785-424-1666
(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 800-757-4761 (U.S.) or
402-220-7215 (International) using the conference ID NBIX. The call
will be archived for one month.
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 COMT inhibitor to
levodopa.
About Opicapone
Opicapone is a novel, once-daily, peripherally-acting,
highly-selective COMT inhibitor proposed for use as
adjunct therapy to levodopa 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 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-
and increase in on-time periods that was demonstrated
during the double-blind placebo-controlled portion of the
studies.
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.
About BIAL
Founded in 1924, BIAL's mission is to discover, develop and
provide therapeutic solutions within the area of health. In recent
decades, BIAL has strategically focused on quality, innovation and
internationalization.
BIAL has channeled more than 20% of its annual turnover into
research and development within neurosciences and the
cardiovascular system.
In 2009 BIAL launched ZEBINIX® (eslicarbazepine
acetate) that is partnered with Eisai in Europe for the treatment of epilepsy. In the
U.S. it was launched in 2014 as APTIOM® (eslicarbazepine
acetate) in a partnership with Sunovion. At the end of 2016
BIAL launched ONGENTYS® (opicapone) for Parkinson's
disease. Already available in Germany and in the United Kingdom, it will be introduced in the
remaining European countries throughout 2017.
Currently representing around two thirds of its turnover, BIAL
will continue to strengthen its international presence based in its
own innovative medicines, particularly in the most important
European pharmaceutical markets, Spain, Germany, United
Kingdom and Italy, where
the company is already present with its own affiliates.
For more information about BIAL, please visit www.bial.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 opicapone development and
commercialization. Specifically, the risks and uncertainties the
Company faces include risks that the benefits of the agreement with
BIAL may never be realized; 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 tech transfer, 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 as to whether and
when any of the milestone payments or royalties under our agreement
with BIAL will ever be paid by the Company; 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 that the Company will be
unable to raise additional funding, if required, to complete
development of or commercialize opicapone; risks and uncertainties
relating to competitive products and technological changes that may
limit demand for opicapone; and other risks described in the
Company's quarterly 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-and-bial-announce-exclusive-north-american-licensing-agreement-for-opicapone-300405152.html
SOURCE Neurocrine Biosciences, Inc.