MISSISSAUGA, Ontario, Jan. 21, 2011 /CNW/ -- 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(TM) (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.
UK Media enquiries: David Mawdsley (020) 8047 5502
Claire Brough (020) 8047 5502
Stephen Rea (020) 8047 5502
Harrison (020) 8047 5502
US Media enquiries: Nancy Pekarek (919) 483 2839
Mary Anne Rhyne (919) 483 2839
Kevin Colgan (919) 483 2839
Armstrong (919) 483 2839
European Analyst/Investor enquiries: Sally Ferguson (020) 8047 5543
Gary Davies (020) 8047 5503
Ziba Shamsi (020) 8047 3289
US Analyst/ Investor enquiries: Tom Curry (215) 751 5419
Valeant Enquiries: Laurie W. Little (949) 461 6002
GlaxoSmithKline cautionary statement regarding forward-looking
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.
SOURCE Valeant Pharmaceuticals International, Inc.
For further information: media, UK, David Mawdsley, Claire Brough, or Stephen Rea, or Alexandra Harrison, (020) 8047 5502, or US, Nancy Pekarek, Mary Anne Rhyne, Kevin Colgan, Jennifer Armstrong, +1-919-483 2839, or European Analyst/Investors, Sally Ferguson, (020) 8047 5543, or Gary Davies, or (020) 8047 5503, or Ziba Shamsi, (020) 8047 3289, or US Analyst/ Investors, Tom Curry, +1-215-751 5419, all for GlaxoSmithKline; or Laurie W. Little, +1-949-461- 6002, for Valeant Web Site: http://www.valeant.com http://www.gsk.com/