Neurocrine Biosciences and Dainippon Sumitomo Pharma (DSP) Announce Agreement to Develop and Commercialize Indiplo...( SAN DIEGO Nov. 1 /- Neurocrine Bi...)

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
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