Navigation Links
Regulatory Update - GSK and Valeant Receive Positive Opinion in Europe From the CHMP for Trobalt (Retigabine)
Date:1/21/2011

MISSISSAUGA, Ontario, Jan. 21, 2011 /PRNewswire/ -- GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for Trobalt (retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalisation in adults aged 18 years and above with epilepsy.

Retigabine received a preliminary approval from the Swiss Agency for Therapeutic Products, Swissmedic, in December 2010.

Retigabine, referred to as ezogabine in the US, is being jointly developed by GSK and Valeant.

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) - is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.  More information about Valeant can be found at www.valeant.com.GlaxoSmithKline Enquiries:UK Media enquiries:

David Mawdsley

(020) 8047 5502Claire Brough

(020) 8047 5502Stephen Rea

(020) 8047 5502Alexandra Harrison

(020) 8047 5502US Media enquiries:

Nancy Pekarek

(919) 483 2839Mary Anne Rhyne

(919) 483 2839Kevin Colgan

(919) 483 2839Jennifer Armstrong

(919) 483 2839European Analyst/Investor enquiries:

Sally Ferguson

(020) 8047 5543Gary Davies

(020) 8047 5503Ziba Shamsi

(020) 8047 3289US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419Valeant Enquiries: Laurie W. Little

(949) 461 6002GlaxoSmithKline cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.Valeant Pharmaceuticals Forward-Looking Statement This press release may contain forward-looking statements, including statements regarding the development or approval of ezogabine. Forward-looking statements may be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the company's most recent annual or quarterly report filed with the Securities and Exchange Commission ("SEC") and other risks and uncertainties detailed from time to time in the Company's filings with the SEC and the Canadian Securities Administrators ("CSA"), which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.

*Editor's note: Ezogabine is the non-proprietary name adopted by the United States Adopted Name Council for use in the U.S. and Canada. Retigabine is the non-proprietary name adopted by the International Nonproprietary Name for Pharmaceuticals Substances Program for use in the rest of the world.  

(Logo: http://photos.prnewswire.com/prnh/20101025/LA87217LOGO)


'/>"/>
SOURCE Valeant Pharmaceuticals International, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. EpiCept Reports Regulatory Progress on Ceplene(TM)
2. Wyeth Presents New Phase 3 Data and Updates Regulatory Timing for NDA Filing of Bazedoxifene/Conjugated Estrogens
3. Anesiva Defines Regulatory Pathway for Adlea with FDA
4. Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
5. EpiCept Provides Update on Clinical and Regulatory Progress with Ceplene(TM) and EpiCept(TM) NP-1 Cream
6. Northwestern Offers Clinical Research and Regulatory Administration Graduate Certificate Program
7. Gen-Probe Submits U.S. Regulatory Application for Additional Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
8. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
9. PulmoBioTech Announces Details of Its Regulatory Approval Experiments
10. Morria Biopharmaceuticals Plc Announces Regulatory Approval to Commence Phase II Clinical Study of MRX-4 in Allergic Rhinitis
11. XTENT Announces European Regulatory Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... 2016 Since its commercial introduction ... essential life science tool for conducting genetic studies in ... reveals in its new report that the industry sits ... powered by a range of new applications in the ... http://photos.prnewswire.com/prnh/20140723/694805 ) , Since the ...
(Date:5/25/2016)... GERMANTOWN, Maryland , May 25, 2016 /PRNewswire/ ... Frankfurt Prime Standard: QIA) today announced that the company has ... GmbH to develop and commercialize predictive assays in oncology. An ... a marker to predict effectiveness of anthracycline treatment in triple ... are pleased to partner with Therawis, which developed the PITX2 ...
(Date:5/25/2016)... As illustrated by the Spring ... the numbers and momentum of cannabis in the US ... billions, more research and development push the sector forward. ... Legal Marijuana Markets Report  from from ArcView Market Research ... the increase in sector is attributed to adult use ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... Development Team of Pixel Film Studios Announced ... "This new layered style transition tool will keep a consistent flow to your project ... Film Studios. , TranSweep is an all new layered style transition tool for ...
(Date:5/26/2016)... ... May 26, 2016 , ... Dalton Pharma Services, ... has successfully completed another Health Canada inspection and has received a compliant rating ... resulted from a Good Manufacturing Practices (GMP) inspection conducted at Dalton’s facility during ...
(Date:5/26/2016)... ... 26, 2016 , ... Women’s athletic apparel company GRACEDBYGRIT is ... shop for three consecutive weekends. The pop-up shop is a great way to ... community full of women who appreciate the most premium goods and vibrant events. ...
(Date:5/26/2016)... ... 26, 2016 , ... Bunion Bootie is a great option for ... save. For a limited time only (offer expires May 31, 2016) customers can save ... by using the promo code "Memorial" at checkout. The more Bunion Booties purchased, the ...
(Date:5/25/2016)... ... May 25, 2016 , ... ... Association/American Stroke Association's Get With The Guidelines®-Stroke Gold Plus Achievement Award with ... second for Memorial Healthcare System, recognizes its commitment to emergency stroke care ...
Breaking Medicine News(10 mins):