SAN DIEGO, June 23, 2011 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the Company's proprietary Vesicular Monoamine Transporter 2 inhibitor (VMAT2), NBI-98854. The Notice of Allowance indicates that a composition of matter patent on NBI-98854 will have an initial patent term extending to May 2029.
Additionally, on June 17, 2011, the Company held a Pre-Investigational New Drug Application (Pre-IND) meeting with the United States Food and Drug Administration (FDA) Division of Psychiatry Products. As a result of this positive meeting, the Company will submit the final Investigational New Drug Application to the FDA in mid July 2011, followed by the initiation of a second Phase II trial of NBI-98854 in tardive dyskinesia patients later in the third quarter of 2011. The Company has also initiated three-month pre-clinical toxicology studies of NBI-98854 to permit longer duration of treatment in patients.
"We are very pleased with both the patent office decision and the successful pre-IND meeting with the FDA," said Kevin C. Gorman, Chief Executive Officer of Neurocrine Biosciences. "The composition of matter patent will provide us with the maximum commercial timeframe of up to fourteen years for NBI-98854, and the successful FDA meeting confirmed that FDA is very interested in a safe and effective therapy for tardive dyskinesia."
VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) among nerve cells. NBI-98854, developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines thereby reducing the likelihood of "off target" side effects.NBI-98854 is designed to provide low, sustained, plasma and brain concentrations of active drug to minimize side effects associated with excessive dopamine depletion.
NBI-98854 may be useful in other disorders such as Huntington's chorea, schizophrenia, Tourette's syndrome, and tardive dystonia.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. is a biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world, including endometriosis, stress-related disorders, pain, diabetes, insomnia, and other neurological and endocrine-related diseases and 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 may contain 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 business and finances in general, as well as risks and uncertainties associated with the Company's VMAT2 program and Company overall. Specifically, the risks and uncertainties the Company faces with respect to the Company's VMAT2 program include, but are not limited to; risk that NBI-98854 will not proceed to later stage clinical trials and risk that the Company's clinical trials will fail to demonstrate that NBI-98854 is safe and effective. With respect to its pipeline overall, the Company faces risk that it will be unable to raise additional funding required to complete development of all of its product candidates; risk relating to the Company's dependence on contract manufacturers for clinical drug supply; risks associated with the Company's dependence on corporate partners for development, commercial manufacturing and marketing and sales activities for the Company's partnered programs; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company's products; and the other risks described in the Company's report on Form 10-K for the year ended December 31, 2010 and report on Form 10-Q for the quarter ended March 31, 2011. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
|SOURCE Neurocrine Biosciences, Inc.|
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