Milan, 21 November 2008 - Recordati announces that it has submitted amarketing approval authorization (MAA) request for silodosin, a newcompound indicated for the treatment of the signs and symptoms of benignprostatic hyperplasia (BPH), to the EMEA (European Medicines Agency). Thissubmission will follow the centralized approval procedure with the BritishMHRA acting as Rapporteur and the Italian AIFA as Co-Rapporteur. Approvalis expected in the first half 2010 and the product launch could take placeby end 2010 or beginning 2011.

Benign prostatic hyperplasia (enlargement of the prostate), characterizedby urination difficulties (such as weak stream, increased frequency and asense of urgency, nocturia), is the most frequent reason for patients tosee a urologist. The prevalence of this condition is increasing due to theprogressive ageing of the population. BPH is frequently observed in menover fifty and its symptoms significantly reduce quality of life.

Silodosin is a new drug indicated for the symptomatic treatment of BPH. Itis a powerful antagonist of the á1 adrenergic receptors. In particular,silodosin has a very high affinity for the á1A receptors. Blockade of theá1A receptors leads to a rapid increase in urinary flow-rate and to animprovement in symptoms associated with BPH. The compound was originallydeveloped by Kissei Pharmaceutical Co. Ltd., in Japan and is patentprotected until 2018 (including SPC) in Europe with clinical dataexclusivity until 2020. Silodosin has been obtained under license byRecordati for the whole of Europe (45 countries) and for a further 18countries in the Middle East and Africa. Recordati also has the right toappoint co-marketers where deemed appropriate.

Worldwide development of the drug was conducted jointly by WatsonPharmaceuticals in North America (where approval has already been grantedby the FDA and where launch is expected to take place in early 2009), byRecordati for its territories, and by Kissei Pharmaceutical Co. for therest of the world.

In two Phase III placebo‑controlled clinical trials conducted in theUS by Watson Pharmaceuticals and in one placebo- and active-controlledtrial conducted in Europe by Recordati, over 800 patients receivedsilodosin 8mg once daily. In these studies, patients treated with silodosinhad a significant decrease in BPH symptoms, both irritative (frequency,urgency, nocturia) and obstructive (hesitancy, incomplete emptingintermittency, weak stream). In addition, an improvement in the quality oflife linked to urinary symptoms (measured by the International ProstateSymptom Score, IPSS) was observed with silodosin. Furthermore, in theactive-controlled study conducted in Europe, silodosin 8mg once daily wasnot inferior to tamsulosin 0.4mg once daily, with an adjusted meandifference between treatments in the IPSS Total Score in favour ofsilodosin.

The significant improvement in BPH symptoms was observed within the firstweek of treatment, and was maintained long-term. In addition, significantimprovements in the maximum urine flow-rate (Qmax) were evident within afew hours after the first dose of silodosin, and were also maintainedlong-term.

The safety of silodosin was extensively evaluated in a total of 1600patients. As should be expected for a drug with low affinity for á1Badrenergic receptors, only minimal cardiovascular side-effects wereobserved. No changes were seen in supine blood pressure or heart-rate, andthe incidence of orthostatic hypotension was very low (1.2% with silodosin,versus 1.0% with placebo). Furthermore, no effects on cardiacrepolarization were observed, even at high doses of silodosin. Retrogradeejaculation (i.e., orgasm with reduced semen), due to silodosin's selectivereceptor binding properties, was the most frequent adverse reactionreported. However, this did not represent a safety concern (the dropoutrate due to retrograde ejaculation were very low), and is reversible upondiscontinuation of the treatment.

Urief® (silodosin) is successfully marketed in Japan by Kissei incooperation with Daiichi Sankyo Pharmaceutical Co., Ltd. since May of 2006with annual sales of EUR 86 million and a market share at September 2008of around 20%. The market for the class of drugs to which silodosinbelongs, in the five main European countries where Recordati has marketingrights, is currently of around EUR 800 million per year. Furthermore,within this class of drugs, there are currently no new molecules inadvanced development.

"The introduction of silodosin among our future new corporate products willallow Recordati to consolidate its presence in the therapeutic area ofurology, an area within which it has been present for many years withflavoxate, the first Italian active ingredient to be approved by the FDA inthe U.S.A., and more recently with Kentera®, a drug indicated for thetreatment of urinary incontinence" stated Giovanni Recordati, Chairman andChief Executive Officer. "Recordati has been conducting original innovativeresearch in the area of urology for a long time and has matured specificknow-how that is globally recognized."

Recordati, established in 1926, is a European pharmaceutical group, listedon the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT0003828271),with a total staff of over 2,400, dedicated to the research,development, manufacturing and marketing of pharmaceuticals. It hasheadquarters in Milan, Italy, operations in the main European countries,and a growing presence in the emerging markets of Eastern Europe. AEuropean field force of over 1,300 medical representatives promotes a widerange of innovative pharmaceuticals, both proprietary and under license, ina number of therapeutic areas including a specialized business dedicated totreatments for rare diseases. Recordati's current and growing coverage ofthe European pharmaceutical market makes it a partner of choice for newproduct licenses from companies which do not have European marketingorganizations. Recordati is committed to the research of new drug entitieswithin the cardiovascular and urogenital therapeutic areas in which itsresearch team has proven scientific competence and a track record ofdiscovery and development of original drugs, the most recent of which,lercanidipine, a latest generation calcium channel blocker for thetreatment of hypertension, is the company's leading product. Consolidatedrevenue for 2007 was EUR 628.4 million, operating income was EUR 131.5million and net income was EUR 84.9 million.

For further information:

Recordati website: www.recordati.com

Investor Relations

Marianne Tatschke

(39)0248787393

e-mail: inver@recordati.it

Media Relations

Claudio Rossetti (Echo Comunicazione d'Impresa)

(39)02 62694736

e-mail: crossetti@echocom.it

Statements contained in this release, other than historical facts, are"forward-looking statements" (as such term is defined in the PrivateSecurities Litigation Reform Act of 1995). These statements are based oncurrently available information, on current best estimates, and onassumptions believed to be reasonable. This information, these estimatesand assumptions may prove to be incomplete or erroneous, and involvenumerous risks and uncertainties, beyond the Company's control. Hence,actual results may differ materially from those expressed or implied bysuch forward-looking statements. All mentions and descriptions of Recordatiproducts are intended solely as information on the general nature of thecompany's activities and are not intended to indicate the advisability ofadministering any product in any particular instance.

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