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EMA Starts Review of Tredaptive, Pelzont, Trevaclyn Medicines

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12/21/2012 | 11:46am CEST

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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Financials ($)
Sales 2017 40 322 M
EBIT 2017 13 713 M
Net income 2017 5 621 M
Debt 2017 4 783 M
Yield 2017 3,01%
P/E ratio 2017 31,24
P/E ratio 2018 18,56
EV / Sales 2017 4,34x
EV / Sales 2018 4,20x
Capitalization 170 241 M
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Number of Analysts 21
Average target price 70,0 $
Spread / Average Target 12%
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Managers
NameTitle
Kenneth C. Frazier Chairman, President & Chief Executive Officer
Robert M. Davis CFO & Executive Vice President-Global Services
Clark Golestani Chief Information Officer & Executive VP
Thomas Henry Glocer Independent Director
Rochelle B. Lazarus Independent Director
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