Recordati : EMEA/LE COMITE DES MEDICAMENTS A USAGE HUMAIN (CHMP) A EMIS UNE RECOMMENDATION POSITIVE POUR LA SILODOSINE (MARQUES UROREC® ET SILODYX®)
23/11/2009 | 09:30 Milan, le 20 novembre 2009 - Recordati annonce que le comité des médicaments à usage humain a émis le 19 novembre 2009 une recommandation positive pour l′octroi d′une autorisation de mise sur le marché pour les produits Urorec® et Silodyx® 4 mg, 8 mg, en gélules, indiqués pour le traitement des signes et symptômes de l′hyperplasie de la prostate bénigne (HBP). L´autorisation commerciale est attendue dans 67 jours, présumant que la EMEA adopte l´avis du CHMP.
The active substance of Urorec® and Silodyx® is silodosin, a urological medicinal product (ATC code G04CA04). Silodosin is a selective antagonist of the á1A-adrenoreceptors. Blockade of these receptors causes smooth muscle in the prostate, urinary bladder base and neck, prostatic capsule and prostatic urethra to relax, thus decreasing the bladder outlet resistance associated with BPH.
The compound was originally developed by Kissei Pharmaceutical Co. Ltd. in Japan and has been obtained under license by Recordati for the whole of Europe (45 countries) and for a further 18 countries in the Middle East and Africa. Development of the drug was conducted by Recordati for its territories, by Watson Pharmaceuticals in North America and by Kissei Pharmaceutical Co. Ltd. for the rest of the world. Silodosin is already available in North America, in Japan and other countries in Asia.
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 2,950, 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 over 1,450 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 2008 was E 689.6 million, operating income was E 144.7 million and net income was E 100.4 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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