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EMA Starts Review of Tredaptive, Pelzont, Trevaclyn Medicines

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12/21/2012 | 11:46am CET

LONDON--The European Medicines Agency, or EMA, Friday said it has started a review of the safety and efficacy of Tredaptive, Pelzont and Trevaclyn, identical medicines that are used to treat adults with dyslipidaemia, particularly combined mixed dyslipidaemia and primary hypercholesterolaemia.

MAIN FACTS:

-Review was triggered because the Agency was informed by the pharmaceutical company Merck, Sharp & Dohme of the preliminary results of a large, long-term study comparing the clinical effects of adding these medicines to statins (standard medicines used to reduce cholesterol) with statin treatment alone.

-Study raises questions about the efficacy of the medicine when added to statins, as this did not reduce the risk of major vascular events compared with statin therapy alone.

-Preliminary results saw a higher frequency of non-fatal but serious side effects in patients taking the medicines than in patients only taking statins.

-Pharmacovigilance Risk Assessment Committee (>> PRODUCTIVITY TECHS CORP) will assess the data and make a recommendation to the Committee on Medicinal Products for Human Use (>> Champion Industries, Inc.), which will issue an opinion on the regulatory action required.

-Opinion is expected in January 2013.

-Write to Tapan Panchal at tapan.panchal@dowjones.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

Stocks mentioned in the article : PRODUCTIVITY TECHS CORP, Champion Industries, Inc.
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Sales 2016 39 897 M
EBIT 2016 13 686 M
Net income 2016 5 904 M
Debt 2016 4 610 M
Yield 2016 3,03%
P/E ratio 2016 29,54
P/E ratio 2017 17,53
EV / Sales 2016 4,35x
EV / Sales 2017 4,32x
Capitalization 168 820 M
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Kenneth C. Frazier Chairman, President & Chief Executive Officer
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