Milan, le 3 avril 2009 - Recordati annonce avoir signé un accord de licence avec Almirall, société pharmaceutique internationale basée en Espagne, pour le marketing et la vente en Espagne de la silodosine, indiquée pour le traitement des signes et symptômes de l'hyperplasie de la prostate bénigne (HBP). Almirall assurera le co-marketing avec Recordati España, la filiale espagnole du groupe Recordati.
La demande d'autorisation de mise sur le marché de la silodosine a été déposée auprès de l'Agence européenne pour l'évaluation des médicaments (EMEA), dans le cadre de la procédure centralisée de novembre 2008 et l'obtention de l'autorisation est attendue au premier semestre 2010.
Benign prostatic hyperplasia (enlargement of the prostate) is characterized by urination difficulties such as weak stream, increased frequency and a sense of urgency, nocturia. The prevalence of this condition, which is frequently observed in men over fifty, is increasing due to the progressive ageing of the population, and its symptoms significantly reduce quality of life.
Silodosin is a new drug indicated for the symptomatic treatment of BPH. It is a powerful antagonist of the α1 adrenergic receptors. In particular, silodosin has a very high affinity for the α1A receptors. Blockade of the α1A receptors leads to a rapid increase in urinary flow-rate and to an improvement in symptoms associated with BPH. The compound was originally developed by Kissei in Japan and has been obtained under license by Recordati for the whole of Europe and for a number of countries in the Middle East and Africa. Recordati also has the right to appoint co-marketers where deemed appropriate. Worldwide development of the drug was conducted by Watson Pharmaceuticals in North America (where approval has already been granted by the FDA), by Recordati for its territories, and by Kissei Pharmaceutical Co., Ltd. for the rest of the world. Under the brand Urief® silodosin is successfully marketed in Japan since May of 2006 and has achieved a market share of over 20% at the end of December 2008.
"We are delighted to have Almirall as our co-marketer in Spain for this new drug", stated Giovanni Recordati, Chairman and CEO. "I am confident that the contribution of Almirall, the leading Spanish pharmaceutical company, 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 2,900, 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 1,400 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 2008 was E 689.6 million, operating income was E 144.7 million and net income was E 100.4 million.
For further information:
Recordati website: www.recordati.com
Claudio Rossetti (Echo Comunicazione d'Impresa)
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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