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Regulatory update – GSK and Valeant respond to FDA on ezogabine

GSK and Valeant Pharmaceuticals International, Inc. submitted on 15 April 2011 the response to the U.S. FDA Complete Response letter received on 30 November 2010 for the NDA for ezogabine.

Issued: London UK, Research Triangle Park, NC & Mississauga, Ontario

GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) submitted on 15 April 2011 the response to the U.S. Food and Drug Administration (FDA) Complete Response letter received on 30 November 2010 for the New Drug Application (NDA) for ezogabine*.

Ezogabine is an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures.

For announcements regarding the regulatory status, including filing and approval information, of ezogabine outside the US (where it is called retigabine*), please visit www.gsk.com and www.valeant.com.

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.

*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.   

GlaxoSmithKline Enquiries:

   

UK Media enquiries:

David Mawdsley

(020) 8047 5502

 

Stephen Rea

(020) 8047 5502

 

Alexandra Harrison

(020) 8047 5502

 

Janet Morgan

(020) 8047 5502

 

David Daley

(020) 8047 5502

 

 

 

US Media enquiries:

Nancy Pekarek

(919) 483 2839

 

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Sarah Alspach

(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

 

Jeff McLaughlin

(215) 751 7002

     

Valeant Enquiries:

Laurie W. Little

(949) 461 6002

       

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 2010.

Valeant Pharmaceuticals Forward-Looking Statement
This press release may contain forward-looking statements, including, but not limited to, statements regarding the initial review and assessment of the complete response letter, the ability to adequately address the issues raised in the complete response letter and the timing of any response to FDA. 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.