Neurocrine and Pfizer Satisfy Hart-Scott-Rodino
Requirements for Indiplon Collaboration
Requirements for Indiplon Collaboration
SAN DIEGO, Feb. 25 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the expiration of the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act in connection with the global agreement with Pfizer Inc (NYSE: PFE) for the exclusive worldwide development and commercialization of indiplon, Neurocrine's Phase III compound for the treatment of insomnia. The expiration of the waiting period triggers the $100 million initial payment to Neurocrine by Pfizer and allows the two companies to actively begin the collaboration for the clinical development and commercialization of indiplon.
In addition to the $100 million initial payment, Neurocrine will also receive up to $300 million in pre-commercialization milestone payments with Pfizer funding the ongoing development of indiplon and paying royalties on worldwide sales and co-promotion fees in the United States. The companies will co-promote the product in the United States with Pfizer holding an exclusive license to develop and market indiplon outside the United States.
A 200-person Neurocrine sales force, supported by Pfizer, will also be created to reach psychiatrists and sleep specialists. The sales force will detail Zoloft(R) to U.S. psychiatrists after Neurocrine submits the New Drug Application (NDA) for indiplon to the U.S. Food and Drug Administration (FDA). In addition, Pfizer will grant Neurocrine a staged $175 million secured short-term credit facility following the U.S. launch of indiplon.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, stroke, and certain female health disorders. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com .
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward looking statements are risks and uncertainties associated with Neurocrine's indiplon development program and business and finances including, but not limited to, risk that indiplon will not successfully proceed through Phase III clinical trials or that Phase III clinical trials will not show that it is safe and effective in treating humans; determinations by regulatory and governmental authorities; our reliance on corporate collaborators for commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; impact of competitive products and technological changes; availability of capital and cost of capital; and other material risks. A more complete description of these risks can be found in the Company's Form 10K for December 31, 2001 and the quarterly report filed on Form 10-Q for the quarter ended September 30, 2002. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.