Navigation Links
Neurocrine Advances VMAT2 Inhibitor Program
Date:12/21/2009

SAN DIEGO, Dec. 21 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced their highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, NBI-98854, will be advanced in clinical development.

The first trial in human subjects, NBI-98854-0801, was a single ascending dose trial in healthy male volunteers conducted in Canada under an approved Clinical Trial Application (CTA) with Health Canada. Preliminary data have now been reviewed; NBI-98854 was generally safe and well tolerated. There were no Serious Adverse Events, clinically significant drug-related laboratory abnormalities or clinically significant ECG findings. More critically, the characteristics of the compound met the pre-specified pharmacokinetic requirements: dose proportionality, low maximum concentration (Cmax) with adequate area-under-curve (AUC) for drug exposure, low variability, and a half-life which supports once per day dosing.

"The results of this first clinical trial in our VMAT2 inhibitor are exactly what we were seeking," said Chris O'Brien, Chief Medical Officer of Neurocrine Biosciences. "We will now move NBI-98854 into a multiple repeated dose Phase 1 study and begin preparation for Phase 2 proof of concept trial to be initiated later in 2010."

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 is effective in regulating the levels of 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 the active drug to minimize side effects associated with excessive dopamine depletion.

The next step for this VMAT2 development program is to complete a multiple, repeated dose Phase 1 study in healthy male volunteers after approval of the Canadian CTA submission. Once complete, Neurocrine will approach the FDA regarding the filing of an Investigational New Drug application in the United States with the express purpose of initiating the proof-of-concept study in patients with Tardive Dyskinesia late in 2010. In addition, NBI-98854 may well 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. Our product candidates address some of the largest pharmaceutical markets in the world including endometriosis, anxiety, depression, pain, diabetes, benign prostatic hyperplasia (BPH), irritable bowel syndrome (IBS) 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, 2008 and reports of 10-Q for the quarter ended September 30, 2009. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.

SOURCE Neurocrine Biosciences, Inc.


'/>"/>
SOURCE Neurocrine Biosciences, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Neurocrine Biosciences Reports Fourth Quarter and Year-End 2007 Results
2. Neurocrine Biosciences Reports First Quarter 2008 Results
3. Neurocrine Biosciences Completes Petal Study Treatment Phase for Endometriosis
4. Neurocrine Biosciences Announces Successful Elagolix PETAL Study in Endometriosis
5. Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain
6. Neurocrine Biosciences Presents Elagolix Data
7. Neurocrine Biosciences Announces Conference Call and Webcast to Present Third Quarter 2009 Financial Results
8. Neurocrine Biosciences Reports Third Quarter 2009 Results
9. Neurocrine Biosciences to Present at the 21st Annual Piper Jaffray Health Care Conference
10. Vical Reports Second Quarter 2007 Financial Results, Allowance of Pandemic Influenza IND and Other Advances in Product Development Programs
11. Pre-clinical Data on Recent Advances with HIV VLP Vaccine Presented at AIDS Vaccine 07 Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... , April 28, 2016  ValGenesis, Inc., ... Management Solutions (VLMS) today announced that a ... for sufferers of chronic kidney failure has ... manage their corporate validation process. The global ... software solution to manage their validation processes ...
(Date:4/27/2016)...   , ... le trimestre, soutenu par une croissance de +42% ... de +16% des ventes aux hôpitaux et cliniques  ... (Euronext : MKEA, FR0010609263 ; OTCQX : MKEAY), inventeur de Cellvizio®, ... chiffre d,affaires pour le premier trimestre clos au ...
(Date:4/27/2016)... DELHI , April 27, 2016 ... CSR initiative to save newborns   ... hospital for women & newborns in collaboration with Breast Milk ... launched the first Pasteurized Human Milk Bank, ,Amaara, in Delhi-NCR ... best nutritional food source for infants and should be available ...
Breaking Medicine Technology:
(Date:4/28/2016)... ... April 28, 2016 , ... Horizon Blue ... with doctors and hospitals to make transformative changes in how health care is ... minds this week in discussing breakthroughs in cellular medicine to treat disease. After ...
(Date:4/28/2016)... ... April 28, 2016 , ... Cognizin® Citicoline is one ... Nominated in the Healthy Ageing category, Cognizin® is being considered for this prestigious ... division can include everything from antioxidants, lipids, proteins, and botanicals. NutraIngredients will choose ...
(Date:4/28/2016)... ... April 28, 2016 , ... Amada Senior Care, premier provider of non-medical in-home ... – its San Antonio West location. Prior to entering the senior care industry, Amada ... opening of Amada San Antonio West will take place on Friday, April 29th. ...
(Date:4/28/2016)... ... April 28, 2016 , ... ... Surgery Education and Anzu®, developers of the AnzuMedical™ Knowledge Sharing and Collaboration ... Collaborative Residency Network. The platform is scheduled to launch in July 2016 and ...
(Date:4/28/2016)... ... April 28, 2016 , ... Point ... miniature microphones and headsets announced today that the US Patent Office has approved ... into a structure. This innovative design creates a lightweight and modular audio headset ...
Breaking Medicine News(10 mins):