SAN DIEGO, March 31, 2015 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced that it has
entered into an exclusive collaboration and licensing agreement for
the development and commercialization of its VMAT2 inhibitor,
NBI-98854, in Japan and other
select Asian markets with Mitsubishi Tanabe Pharma Corporation
(TSE: 4508). Mitsubishi Tanabe intends to initially develop
NBI-98854 in Japan for the chorea
associated with Huntington's disease and tardive dyskinesia.
Neurocrine retains full commercial rights to NBI-98854 in
North America, Europe and other countries outside of
Asia.
Under the terms of the agreement, Neurocrine will receive an
initial payment of $30 million and is
eligible to receive up to $85 million
in additional milestone payments associated with the development
and commercialization of NBI-98854 in Asia. Upon commercialization, Neurocrine will
receive royalties on product sales from Mitsubishi Tanabe
territories in Asia. Neurocrine
will also support Mitsubishi Tanabe's clinical efforts in
developing NBI-98854 for patients suffering from the chorea
associated with Huntington's disease and tardive dyskinesia.
"We are excited to have one of the leading pharmaceutical
companies in Japan as our
commercialization partner for NBI-98854 in Asia. Importantly, Mitsubishi Tanabe has a
proven track record of developing innovative pharmaceuticals, which
we believe will optimize NBI-98854's full potential in the growing
Asian movement disorders market," said Kevin Gorman, President and Chief Executive
Officer of Neurocrine Biosciences. "We have recently initiated the
build of our North American commercial infrastructure and the
signing of this international partnership meaningfully extends that
commercial reach. Additionally, the economics of this agreement,
given the significant milestones and substantial royalty rate,
confirm the value of NBI-98854 in movement disorders."
In addition to Japan,
Mitsubishi Tanabe's territory also includes China, South
Korea, Philippines,
Indonesia, Taiwan, Singapore, Malaysia, Thailand, and Hong
Kong.
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 a wholly owned 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.
Mitsubishi Tanabe Pharma Corporation (MTPC) is a research-driven
pharmaceutical company based in Osaka,
Japan. MTPC is taking on the challenge of drug discovery in
the fields of autoimmune disorders, central nervous system
diseases, diabetes and kidney diseases, and vaccines. To those
ends, MTPC is strengthening its R&D pipeline. MTPC contributes
to the healthier lives of people around the world through the
creation of pharmaceuticals. http://www.mt-pharma.co.jp/e.
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 the development of NBI-98854 by Mitsubishi
Tanabe, and the Company overall. Specifically, the risks and
uncertainties the Company faces include dependence on
Mitsubishi Tanabe for development and commercialization of
NBI-98854 in certain Asian countries; risks that clinical
development activities may not be completed on time or at
all, may be delayed for regulatory or other reasons, may not be
successful or replicate previous clinical trial results, may
fail to demonstrate that our product candidates are safe and
effective, or may not be predictive of real-world results or
of results in subsequent clinical trials; risks that regulatory
submissions may not occur or be submitted in a timely
manner; risks that NBI-98854 may not obtain regulatory approval
in Mitsubishi Tanabe's territory or that regulatory authorities
outside the U.S. may make adverse decisions regarding
NBI-98854; risks that NBI-98854 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, manufacturing and marketing and
sales activities; risk and uncertainties relating to
competitive products and technological changes that may
limit demand NBI-98854; and other risks described in the
Company's annual report on Form 10-K for the year ended
December 31, 2014. 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.