SOURCE: Recordati S.p.A.

September 26, 2007 04:09 ET


MILAN, ITALY--(Marketwire - September 26, 2007) - Recordati announced that it has successfully completed the double-blind portion of the phase III study of silodosin, an alpha-blocker for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) licensed from Kissei. The trial was conducted in 11 European countries with 1128 patients (977 randomized) enrolled in 70 clinical centres.

The study was designed to show superiority of silodosin over placebo and non-inferiority to tamsulosin following a treatment period of 12 weeks. The primary end point was to demonstrate relief from BPH symptoms as measured by the IPSS (International Prostate Symptom Score) and other efficacy parameters. Safety and tolerability were assessed as secondary end points.

Silodosin 8mg dosed once daily was found to be significantly superior to placebo in all parameters, with scores that were always equal to or better than those of tamsulosin. There were no safety issues. The overall discontinuation rate due to adverse events was low and similar in all groups, although ejaculation with little or no semen (expected with highly uroselective alpha blockers) was somewhat greater in the silodosin group.

Silodosin is a selective alpha blocker for the treatment of symptoms associated with benign hypertrophy of the prostate, a condition affecting millions of male patients across the world. Such symptoms, both obstructive and irritative, can have a significant negative impact on the patient's quality of life. The drug is already on the market in Japan and has completed phase III studies in the US. Recordati is completing the long- term portion of the phase III study and plans to file for approval in Europe, and in other countries of the licensed territory, during the last quarter of 2008.

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 2006 was EUR 576.2 million, operating income was EUR 120.3 million and net income was EUR 74.0 million.

Kissei Pharmaceutical Co., Ltd., headquartered in Matsumoto, Nagano prefecture, founded in 1946, is a Japanese pharmaceutical company that develops, manufactures, markets, sells and distributes brand pharmaceutical products. Kissei is primarily focused on three important fields of new drug research: urogenital, endocrinology & metabolism and immunology & allergy.

For further information:

Recordati website:

Investor Relations

Marianne Tatschke



Media Relations

Claudio Rossetti (Echo Comunicazione d'Impresa)

(39)02 62694736


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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