LA PROCEDURE DE RECONNAISSANCE MUTUELLE POUR L'APPROBATION DU NOUVEAU PRODUIT ANTIHYPERTENSEUR DE RECORDATI EST ACHEVEE DANS 28 PAYS EUROPEENS
Milan, le 12 mars 2008 - Recordati a annoncé l'achèvement de la procédure de reconnaissance mutuelle pour l'approbation du nouveau produit antihypertenseur basé sur une combinaison fixe de lercanidipine et d'énalapril dans L'Union Européenne, en Norvège et en Islande. L'Allemagne, qui a agi comme Etat membre de référence, et les 28 états membres concernés ont reconnu l'approbation accordée en 2006 par l'agence allemande du médicament (BfArM) à ce nouveau produit qui existe sous deux formes de dosage : lercanidipine 10mg/énalapril 10mg et lercanidipine 10mg/énalapril 20mg. Ce produit est sur le marché allemand depuis 2007.
Fixed combinations of more than one antihypertensive agent will play a significant and increasing role in the future hypertension market. Most hypertensive patients, especially those with other risk factors, require the administration of more than one drug to keep their blood pressure at desired levels. Fixed combinations as opposed to the administration of separate treatments provide advantages for both doctors and patients. The combined dosages of the drugs, which were proven to be efficacious and well tolerated in clinical trials, are precisely those broadly used by the physician. Furthermore, the reduction of the number of pills a patient must take, especially in the elderly, increases patient compliance which in turn increases the probability of obtaining the desired therapeutic effect.
"We are very pleased to be able to announce the positive outcome of the mutual recognition process for the approval of our new antihypertensive specialty throughout Europe" declared Giovanni Recordati, Chairman and CEO. "We will initiate launches in all these countries, in which lercanidipine has already obtained the physicians' appreciation, gradually as from the second half of the year. The extension of our therapeutic offering will allow us to consolidate our position in the antihypertensives market. The new product will be sold directly by our marketing organizations in most of the European pharmaceutical market."
Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, isin IT 0003828271), dedicated to the research, development, manufacturing and marketing of pharmaceuticals, with headquarters in Milan, Italy, operations in the main European countries, and a total staff of over 2,200. A European field force of over 1,100 medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas. 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 of new drug entities within the cardiovascular and urogenital therapeutic areas in which its research TEAM has proven scientific competence and a track record of discovery and development of original drugs, the most recent of which, lercanidipine, a latest generation calcium channel blocker for the treatment of hypertension, is the company's leading product. Consolidated revenue for 2007 was E 628.4 million, operating income was E 131.5 million and net income was E 84.9 million.
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Marianne Tatschke Claudio Rossetti (Echo Comunicazione d'Impresa)
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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.