Pfizer said it would return development and marketing rights for the developmental insomnia treatment Indiplon to Neurocrine Biosciences.
As a result, Neurocrine will independently develop Indiplon, the San Diego-based biotech company said in statement.
In May, the FDA delayed approval of 5 mg. and 10 mg. versions of the drug and issued a rejection for the 15 mg dose.
Neurocrine said it plans to meet with the FDA to finalize development plans for the resubmissions of each indiplon NDA and plans to commercialize Indiplon as quickly as possible upon approval.
Neurocrine also plans to review various business and commercial alternatives related to Indiplon, including possible future partnerships.
“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 Lyons, Neurocrine CEO, in a statement. “We believe that full rights to indiplon, together with our R&D pipeline which is advancing several Phase II products, provides additional value and partnering opportunities.”
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