Regulatory update - GSK and Valeant receive positive opinion in Europe from the CHMP for Trobalt (retigabine)
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: |
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UK Media enquiries: |
David Mawdsley |
(020) 8047 5502 |
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Claire Brough |
(020) 8047 5502 |
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Stephen Rea |
(020) 8047 5502 |
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Alexandra Harrison |
(020) 8047 5502 |
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US Media enquiries: |
Nancy Pekarek |
(919) 483 2839 |
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Mary Anne Rhyne |
(919) 483 2839 |
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Kevin Colgan |
(919) 483 2839 |
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Jennifer Armstrong |
(919) 483 2839 |
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European Analyst/Investor enquiries: |
Sally Ferguson |
(020) 8047 5543 |
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Gary Davies |
(020) 8047 5503 |
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Ziba Shamsi |
(020) 8047 3289 |
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US Analyst/ Investor enquiries: |
Tom Curry |
(215) 751 5419 |
Valeant Enquiries: |
Laurie W. Little |
(949) 461 6002 |
*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.


