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Pfizer, Neurocrine Terminate Collaboration

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pfizer is returning to Neurocrine Biosciences the development and marketing rights for Indiplon, a medicine in development to treat insomnia. This includes both the collaboration to develop and co-market Indiplon in the U.S. as well as Pfizer’s exclusive license to develop and market Indiplon outside of the U.S.

As a result, Neurocrine will reacquire all worldwide rights for indiplon and will develop indiplon for approval and commercialization. Neurocrine will meet with the FDA to finalize development plans for the resubmissions of each NDA and plans to commercialize indiplon as quickly as possible upon approval. As part of the termination provisions of the agreement, Pfizer will continue to support indiplon for a period of 180 days to ensure a smooth transition.

“While we are disappointed that we will not be working with Pfizer for the commercialization of indiplon, Neurocrine is fully committed and prepared to develop and commercialize this product. With the clinical, regulatory and commercial investment we have received from Pfizer coupled with our experience in conducting the indiplon clinical development program, we are well-positioned to complete development of this product to secure FDA approval and we anticipate a seamless transition of responsibility,” said Gary A. Lyons, president and chief executive officer of Neurocrine Biosciences.

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