Neurocrine, Pfizer end collaboration on indiplon, Neurocrine to develop independently

New York, June 22 - Neurocrine Biosciences, Inc. and Pfizer Inc. said they have terminated their collaboration agreement to develop and co-promote indiplon.

Neurocrine will reacquire all worldwide rights for indiplon capsules and tablets and will now independently develop indiplon for approval and commercialization.

Neurocrine added that it will meet with the Food and Drug Administration to finalize development plans for the resubmissions of each indiplon NDA and said it plans to commercialize indiplon as quickly as possible upon approval.

The company plans to review various business and commercial alternatives to expedite successful commercialization of indiplon. As part of the termination provisions of the agreement, Pfizer will continue to support indiplon for a period of up to 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," said Gary A. Lyons, president and chief executive officer of Neurocrine.

"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."

Lyons added that the company believes indiplon has "significant commercial value."

On May 16 Neurocrine said that the FDA had issued a not approvable letter for its 15 mg XR indoplin tablets for insomnia.

Neurocrine said in a news release that the FDA indicated that it did not have an opportunity to review all of the information submitted during the New Drug Application review cycle.

Neurocrine is a product-based biopharmaceutical company based in San Diego.

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