Healthcare Industry News: hypercholesterolemia
News Release - April 7, 2010
Recordati Signs Co-Marketing Agreement With Esteve in Spain for PitavastatinMILAN, ITALY, April 7--(HSMN NewsFeed) - Recordati announced that it has signed a license agreement with Esteve, a leading pharmaceutical company in the Spanish market, for the marketing and sales in Spain of pitavastatin. Pitavastatin is a novel "statin" for the treatment of hypercholesterolemia. Esteve will co-market the product together with Recordati Espaņa, the Spanish subsidiary of the Recordati group. The drug is currently being evaluated by the UK Medicines and Healthcare products Regulatory Agency (MHRA), and is expected to be launched in Europe in the second half of 2010.
Pitavastatin is a statin licensed by Recordati from the Japanese pharmaceutical company Kowa for the European market. It has been available on the market in Japan since 2003 and was recently approved by the U.S. FDA. This drug promises to be an effective new treatment for dyslipidemia, a condition characterized by altered levels of blood cholesterol and other lipids and associated with an increased risk for heart disease and stroke.
In controlled clinical trials involving more than 1,600 patients it was shown that pitavastatin induces a reduction in LDL-cholesterol (the "bad" cholesterol that contributes to formation of atherosclerotic plaques) and an increase in HDL-cholesterol (the "good" cholesterol that is removed from the arterial walls), a dual effect that should be regarded as highly relevant, since it appears to reduce the relative risk for cardiovascular complications. It has been shown that pitavastatin is minimally metabolized by the enzymes of the Cytochrome P-450 family, enzymes that play a key role in the metabolism of many drugs, thus minimizing the potential risk for unpredictable responses to treatment or for interaction with drugs metabolized by this pathway. Pitavastatin has an excellent safety profile and represents a new effective and safe treatment for dyslipidemia.
"We are delighted to have Esteve as our co-marketer in Spain for this new drug" stated Giovanni Recordati, Chairman and CEO. "I am confident that the contribution of Esteve, a leading pharmaceutical company in the Spanish market, will be fundamental to the success of this new therapeutic option in Spain".
Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271),with a total staff of over 2,800, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. It has headquarters in Milan, Italy, operations in the main European countries, and a growing presence in the new markets of Central and Eastern Europe. A European field force of around 1,400 medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati's current and growing coverage of the European pharmaceutical market makes it a partner of choice for new product licenses from companies which do not have European marketing organizations. Recordati is committed to the research and development of new drug entities within the cardiovascular and urogenital therapeutic areas and of treatments for rare diseases. Consolidated revenue for 2009 was EUR 747.5 million, operating income was EUR 162.2 million and net income was EUR 110.6 million.
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Recordati website: www.recordati.com
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