RECORDATI DEPOSE UNE DEMANDE D'ENREGISTREMENT EUROPEENNE A L'EMEA
Milan, le 21 novembre 2008 - Recordati annonce avoir déposé la demande d'autorisation de mise sur le marché de la silodosine indiquée pour le traitement des signes et symptômes de l'hyperplasie de la prostate bénigne (HBP), auprès de l'Agence européenne pour l'évaluation des médicaments (EMEA). Cette demande d'autorisation a été déposée dans le cadre d'une procédure centralisée où l'Agence britannique de régulation des médicaments et produits de santé (MHRA) et l'agence italienne du médicament (AIFA) seront respectivement rapporteur et co-rapporteur. L'obtention de l'autorisation est attendue au premier semestre 2010 et le lancement du produit pourrait avoir lieu fin 2010 ou début 2011.
Benign prostatic hyperplasia (enlargement of the prostate), characterized by urination difficulties (such as weak stream, increased frequency and a sense of urgency, nocturia), is the most frequent reason for patients to see a urologist. The prevalence of this condition is increasing due to the progressive ageing of the population. BPH is frequently observed in men over fifty 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 á1 adrenergic receptors. In particular, silodosin has a very high affinity for the á1A receptors. Blockade of the á1A 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 Pharmaceutical Co. Ltd., in Japan and is patent protected until 2018 (including SPC) in Europe with clinical data exclusivity until 2020. Silodosin 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. Recordati also has the right to appoint co-marketers where deemed appropriate.
Worldwide development of the drug was conducted jointly by Watson Pharmaceuticals in North America (where approval has already been granted by the FDA and where launch is expected to take place in early 2009), by Recordati for its territories, and by Kissei Pharmaceutical Co. for the rest of the world.
In two Phase III placebo‑controlled clinical trials conducted in the US by Watson Pharmaceuticals and in one placebo- and active-controlled trial conducted in Europe by Recordati, over 800 patients received silodosin 8mg once daily. In these studies, patients treated with silodosin had a significant decrease in BPH symptoms, both irritative (frequency, urgency, nocturia) and obstructive (hesitancy, incomplete empting intermittency, weak stream). In addition, an improvement in the quality of life linked to urinary symptoms (measured by the International Prostate Symptom Score, IPSS) was observed with silodosin. Furthermore, in the active-controlled study conducted in Europe, silodosin 8mg once daily was not inferior to tamsulosin 0.4mg once daily, with an adjusted mean difference between treatments in the IPSS Total Score in favour of silodosin.
The significant improvement in BPH symptoms was observed within the first week of treatment, and was maintained long-term. In addition, significant improvements in the maximum urine flow-rate (Qmax) were evident within a few hours after the first dose of silodosin, and were also maintained long-term.
The safety of silodosin was extensively evaluated in a total of 1600 patients. As should be expected for a drug with low affinity for á1B adrenergic receptors, only minimal cardiovascular side-effects were observed. No changes were seen in supine blood pressure or heart-rate, and the incidence of orthostatic hypotension was very low (1.2% with silodosin, versus 1.0% with placebo). Furthermore, no effects on cardiac repolarization were observed, even at high doses of silodosin. Retrograde ejaculation (i.e., orgasm with reduced semen), due to silodosin's selective receptor binding properties, was the most frequent adverse reaction reported. However, this did not represent a safety concern (the dropout rate due to retrograde ejaculation were very low), and is reversible upon discontinuation of the treatment.
Urief® (silodosin) is successfully marketed in Japan by Kissei in cooperation with Daiichi Sankyo Pharmaceutical Co., Ltd. since May of 2006 with annual sales of E 86 million and a market share at September 2008 of around 20%. The market for the class of drugs to which silodosin belongs, in the five main European countries where Recordati has marketing rights, is currently of around E 800 million per year. Furthermore, within this class of drugs, there are currently no new molecules in advanced development.
"The introduction of silodosin among our future new corporate products will allow Recordati to consolidate its presence in the therapeutic area of urology, an area within which it has been present for many years with flavoxate, the first Italian active ingredient to be approved by the FDA in the U.S.A., and more recently with Kentera®, a drug indicated for the treatment of urinary incontinence" stated Giovanni Recordati, Chairman and Chief Executive Officer. "Recordati has been conducting original innovative research in the area of urology for a long time and has matured specific know-how that is globally recognized."
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 2,400, 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 emerging markets of Eastern Europe. A European field force of over 1,300 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 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.
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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