SOURCE: Recordati

December 23, 2010 03:11 ET

Recordati Signs Co-Marketing Agreement With Merck Serono in France for Pitavastatin

MILAN, ITALY--(Marketwire - December 23, 2010) -

Recordati announced that it has signed a license agreement with Merck Serono, a division of Merck DgaA, Darmstadt, Germany, for the marketing and sales in France of pitavastatin. Pitavastatin is a novel "statin" for the treatment of hypercholesterolemia. Merck Serono will co- market the product together with Bouchara Recordati, the group's French subsidiary. During July 2010 the Decentralized Procedure for the approval of pitavastatin (Livazo®, Alipza® and other brands) in Europe was concluded positively.

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 launched in the U.S.. This drug has the potential 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.

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.

Statements contained in this release, other than historical facts, are "forward- looking statements" (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are based on currently available information, on current best estimates, and on assumptions believed to be reasonable. This information, these estimates and assumptions may prove to be incomplete or erroneous, and involve numerous risks and uncertainties, beyond the Company's control. Hence, actual results may differ materially from those expressed or implied by such forward-looking statements. All mentions and descriptions of Recordati products are intended solely as information on the general nature of the company's activities and are not intended to indicate the advisability of administering any product in any particular instance.


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Source: RECORDATI via Thomson Reuters ONE


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