Navigation Links
Neurocrine Biosciences and Dainippon Sumitomo Pharma (DSP) Announce Agreement to Develop and Commercialize Indiplon in Japan
Date:11/1/2007

SAN DIEGO, Nov. 1 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) 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.


'/>"/>
SOURCE Neurocrine Biosciences, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Perscitus Biosciences secures $250K Commerce loan
2. Wisconsin biosciences rise to the challenge
3. Quintessence Biosciences advances cancer drug
4. Quintessence Biosciences names new president
5. Caden Biosciences may signal critical mass
6. Wisconsin start up Primorigen Biosciences corrals out-of-state investment
7. WARF signs licensing pact with BD Biosciences
8. Fisher Biosciences contracts with Madison-based GenTel BioSurfaces
9. State awards QRG Biosciences development grant
10. EMD Biosciences partners with European biotech company
11. Quintessence Biosciences forms cancer therapeutic advisory board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... FL (PRWEB) , ... February 10, 2016 , ... ... in regenerative medicine, has announced a new agreement with Singapore-based Global Stem Cells ... physicians from the Philippines, Thailand and Singapore in the latest adipose and bone ...
(Date:2/10/2016)... ... February 09, 2016 , ... ... current winner of the Highest Overall Customer Rating Award from Circuits Assembly ... its business units across the USA, Canada, Mexico and China. , The EMS ...
(Date:2/9/2016)... LITTLE FALLS, N.J. , Feb. 9, 2016 ... ), a biotechnology company specializing in the development ... the health of damaged tissues and organs, recently ... milestones for the first quarter of 2016. ... Regenicin began the new 2015 fiscal year in ...
(Date:2/9/2016)... ... February 08, 2016 , ... Net-Translators, an industry-leading ... launch of its revamped and improved website. In an on-going effort to further ... website will better communicate how the company designs and delivers thorough, high-quality results ...
Breaking Biology Technology:
(Date:2/2/2016)... , Feb. 2, 2016 Checkpoint ... that Rising Market Are you interested in ... forecasts revenues for checkpoint inhibitors. Visiongain,s report gives ... submarket, product and national level. Avoid falling ... what progress, opportunities and revenues those emerging cancer ...
(Date:2/1/2016)... YORK , Feb. 1, 2016  Today, the ... Association (AHA) announced plans to develop a first of ... computing power of IBM Watson. In the first application ... AHA, IBM (NYSE: IBM ), and Welltok will ... and health assessments with cognitive analytics, delivered on Welltok,s ...
(Date:1/25/2016)... Software, the world-leading supplier of image data management solutions ... data management solution OMERO Plus for the newly established ... Photo - http://photos.prnewswire.com/prnh/20160125/325328LOGO ... analysis measures the characteristics and behavior of cells, tissues ... as health and disease, the presence or absence of ...
Breaking Biology News(10 mins):