SAN DIEGO, Nov. 1 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. today announced that it has entered into an exclusive licensing agreement for the development and commercialization of indiplon in Japan with Dainippon Sumitomo Pharma Co, Ltd. (DSP). Neurocrine has submitted its New Drug Application (NDA) for indiplon in the US for the treatment of insomnia. The NDA is currently under review by the FDA with a PUDFA action date of December 12, 2007.
Under the terms of the agreement, Neurocrine will receive an initial payment of $20 million and an additional $10 million payment upon FDA approval of indiplon. Neurocrine is eligible to receive additional milestone payments associated with the successful development and commercialization of the indiplon immediate release formulation in Japan. Upon commercialization of indiplon, Neurocrine will receive royalties from DSP based on sales in Japan. DSP also has a right to develop and commercialize the modified release formulation of indiplon in Japan which would result in additional milestone payments and royalties to Neurocrine.
“We are excited to have a leading multi-national pharmaceutical company in Japan with one of the highest and most aggressive sales records in the Japanese market as our commercialization partner for indiplon. Importantly, DSP has a proven track record, which we believe will optimize indiplon’s full potential in the growing Japanese insomnia market,” said Gary Lyons, President and Chief Executive Officer of Neurocrine Biosciences, “the economics of this agreement, given the significant milestones and substantial royalty rate, confirm the value of indiplon.”
In 2006, the sedative hypnotic market in Japan was valued at approximately $500 million. An estimated 24 million people in Japan experience insomnia, but only 7 to 8 million are currently being treated.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. The product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, endometriosis, irritable bowel syndrome, pain, and diabetes. Indiplon was licensed from DOV Pharmaceuticals in 1998. Neurocrine Biosciences, Inc. news releases are available through the Company’s website via the Internet at http://www.neurocrine.com.
Dainnipon Sumitomo Pharma Co’s Corporate Mission is to broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide. Dainippon Sumitomo Pharma Co’s news releases are available through the website via the Internet at http://www.ds-pharma.co.jp/english.
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 Neurocrine’s business and finances and research programs in general including, but not limited to, risk and uncertainties associated with the Company’s indiplon program and planned commercialization activities, risk that regulatory authorities may find our resubmission of the indiplon capsule NDA incomplete or insufficient or otherwise unapprovable or that approval may be delayed; risk that following approval of indiplon capsules, commercialization may be delayed for any of a number of reasons including market conditions and product supply; risk that we will not be able to independently commercialize indiplon capsules or find a marketing partner on reasonable terms or at all; risk that the indiplon capsule labeling granted by regulatory authorities may limit the commercial success of indiplon capsules; and risk relating to market acceptance of indiplon capsules following marketing approval; and the other risks described in the Company’s report on Form 10-K for the year ended December 31, 2006 and most recent report on Form 10-Q filed for the for the quarter ended June 30, 2007. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
CONTACT: Elizabeth Foster of Neurocrine Biosciences, +1-858-617-7600
Web site: http://www.neurocrine.com//
