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:6/24/2016)... 2016 Epic Sciences unveiled a liquid ... to PARP inhibitors by targeting homologous recombination deficiency ... new test has already been incorporated into numerous ... types. Over 230 clinical trials are ... including PARP, ATM, ATR, DNA-PK and WEE-1. Drugs ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” Partnering with experienced ... this eBook by providing practical tips, tools, and strategies for clinical researchers. , ...
(Date:6/23/2016)... , June 23, 2016 /PRNewswire/ - FACIT has ... Ontario biotechnology company, Propellon Therapeutics Inc. ... and commercialization of a portfolio of first-in-class WDR5 ... targets such as WDR5 represent an exciting class ... in precision medicine for cancer patients. Substantial advances ...
(Date:6/23/2016)... , ... June 23, 2016 , ... ... YM (Yeast and Mold) microbial test has received AOAC Research Institute approval 061601. ... microbial tests introduced last year,” stated Bob Salter, Vice President of Regulatory and ...
Breaking Biology Technology:
(Date:6/21/2016)... Columbia , June 21, 2016 ... to the new role of principal product architect ... named the director of customer development. Both will ... chief technical officer. The moves reflect NuData,s strategic ... in response to high customer demand and customer ...
(Date:6/16/2016)... 2016 The global ... reach USD 1.83 billion by 2024, according to ... Technological proliferation and increasing demand in commercial buildings, ... drive the market growth.      (Logo: ... development of advanced multimodal techniques for biometric authentication ...
(Date:6/9/2016)... , June 9, 2016  Perkotek an innovation leader in attendance control systems ... seamlessly log work hours, for employers to make sure the right employees are actually ... http://photos.prnewswire.com/prnh/20160609/377486LOGO ... ... ...
Breaking Biology News(10 mins):