Neurocrine Biosciences and Mitsubishi Tanabe Pharma Announce Agreement to Develop and Commercialize VMAT2 Inhibitor NBI-98854 for Movement Disorders in Japan and Other Select Asian Markets

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Mar 31, 2015, 10:00 ET

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.