Neurocrine Biosciences, Inc. announced 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.
Neurocrine Biosciences, Inc. is a biopharmaceutical company focused on neurological and endocrine diseases and disorders.