Neurocrine Restructures After FDA Letter

Neurocrine Biosciences announced that it will lay off approximately 130 employees at its San Diego campus, as a part of its restructuring program to prioritize its R&D programs and associated costs and expenses after an FDA delay on insomnia treatment indiplon. Following the firings, Neurocrine will have approximately 120 employees.

One Dec. 13, the FDA issued Neurocrine an “approvable letter” for indiplon, requesting additional clinical and preclinical data on the drug before it will consider approval. The company’s NDA covered 5mg and 10mg doses of the drug. In May 2006, Neurocrine submitted a filing for a 15mg dose of the drug, but the FDA asked for reanalysis of safety and efficacy data; development partner Pfizer pulled out of the project after that. The company is preparing a formal meeting request to the FDA to discuss the most recent approvable Letter.

Gary Lyons, president and chief executive officer of Neurocrine, remarked, “It is with great disappointment that we have to make this difficult decision that will have such an effect on so many of our employees and their families. We are greatly saddened to move in this direction after our employees have continually demonstrated only the highest level of dedication and commitment. However, in order to meet our goals on other high priority programs, we have to refocus our resources as quickly as possible. I want to sincerely thank the departing employees for their tremendous efforts and wish them great success in the future.”