Navigation Links
Neurocrine Biosciences Announces Notice of Allowance for Composition of Matter Patent on VMAT2 Inhibitor
Date:6/23/2011

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."

About NBI-98854

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.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Neurocrine Biosciences Announces Successful Phase IIa Clinical Trial for VMAT2 Inhibitor
2. Neurocrine Biosciences to Present at the Cowen & Co. 31st Annual Health Care Conference
3. Neurocrine Biosciences Reports Fourth Quarter and Year End 2010 Results
4. Neurocrine Biosciences Announces Conference Call and Webcast to Report Third Quarter 2010 Financial Results
5. Abbott and Neurocrine Announce Global Agreement to Develop and Commercialize Elagolix for the Treatment of Endometriosis
6. Neurocrine Biosciences Announces Conference Call and Webcast on Worldwide Agreement With Abbott on Elagolix
7. Neurocrine Biosciences to Present at the Jefferies 2010 Global Life Sciences Conference and the 9th Annual Needham Healthcare Conference
8. Neurocrine Biosciences Announces Conference Call and Webcast to Present First Quarter 2010 Financial Results
9. Neurocrine Biosciences, Inc. Announces Exercise of Over-Allotment Option for Common Stock Offering
10. Neurocrine Biosciences to Present at the Roth 22nd Annual OC Growth Conference
11. Neurocrine Biosciences Announces the Appointment of William H. Rastetter to Its Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... October 12, 2017 , ... ... States multicenter, prospective clinical study that demonstrates the accuracy of the FebriDx® ... identifying clinically significant acute bacterial and viral respiratory tract infections by testing ...
(Date:10/11/2017)... N.C. (PRWEB) , ... October 11, 2017 , ... ... ARCS® Foundation President Andi Purple announced Dr. Suneel I. Sheikh, the co-founder, ... ( ASTER Labs ), Inc. has been selected for membership in ARCS ...
(Date:10/11/2017)... BALTIMORE, Md. (PRWEB) , ... October 11, 2017 ... ... for digital pathology, announced today it will be hosting a Webinar titled, “Pathology ... of  Advanced Pathology Associates , on digital pathology adoption best practices and how ...
(Date:10/11/2017)... ... October 11, 2017 , ... A ... pregnancy rates in frozen and fresh in vitro fertilization (IVF) transfer ... age to IVF success. , After comparing the results from the fresh and ...
Breaking Biology Technology:
(Date:5/23/2017)... 23, 2017  Hunova, the first robotic gym for the rehabilitation and ... launched in Genoa, Italy . The first 30 robots ... the USA . The technology was developed and patented ... the IIT spin-off Movendo Technology thanks to a 10 million euro investment ... please click: ...
(Date:4/19/2017)... , April 19, 2017 ... its vendor landscape is marked by the presence of ... is however held by five major players - 3M ... these companies accounted for nearly 61% of the global ... leading companies in the global military biometrics market boast ...
(Date:4/11/2017)... BEACH GARDENS, Fla. , April 11, 2017 ... identity management and secure authentication solutions, today announced ... contract by Intelligence Advanced Research Projects Activity (IARPA) ... for IARPA,s Thor program. "Innovation has ... onset and IARPA,s Thor program will allow us ...
Breaking Biology News(10 mins):