MILAN, ITALY--(Marketwire - May 07, 2010) -
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Recordati announced that it has signed a license agreement with Zambon France, the French subsidiary of the Italian pharmaceutical group Zambon, for the marketing and sales rights in France of Silodyx™ (silodosin), a new compound indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) recently approved by the European Medicines Agency (E.M.A.). Zambon will co-market the product together with Recordati in France.
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 á1 adrenergic receptors. In particular, silodosin has a very high affinity for the á1A receptor. Blockade of the á1A receptor 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 Recordati for its territories, by Watson Pharmaceuticals in North America (where it is available on the market as of 2009) and by Kissei Pharmaceutical Co., Ltd. and its other partners 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 25% in 2009.
“We are delighted to have Zambon as our co-marketer in France for this new drug”, stated Giovanni Recordati, Chairman and CEO. “I am confident that the contribution of Zambon, an important international pharmaceutical company, will be fundamental to the success of this new therapeutic option in France.”
“We are very honoured to have been selected by Recordati for the co- marketing of this new product”, stated Pascal Brossard, GM of Zambon France. “The reasons for this choice are mainly based on our strong and confident knowledge in urology, acquired by the marketing of Monuril®, an antibiotic indicated in the treatment of acute cystitis. This agreement is a major step for the development of our affiliate, based on organic growth but also on launches of new products such as Rhinomaxil® (in 2009) and Silodyx™ today”.
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 € 689.6 million, operating income was € 144.7 million and net income was € 100.4 million.
Zambon S.p.A. is a subsidiary of the Zambon group, which, is controlled by Zambon Company SpA, an industrial holding company. In addition to the pharmaceutical business, the group includes a chemical business unit named ZaCh System, as well as Z-Cube, its industrial incubator. Founded in 1906, Zambon operates in 15 countries and 3 continents (Europe, Asia, North and South America), and employs over 2,500 people with consolidated sales for 2008 of €555 million. Zambon France is the French affiliate of Zambon Spa (Italy). With 200 employees and a domestic turnover of 69.543 Mion € in 2009 (+ 7.8 % versus 2008), this fast growing affiliate is today the third biggest affiliate in the world. Its portfolio includes prescription bound products in three key areas (pain, respiratory and urology) and self-medication brands such as Fluimucil® (respiratory) and Spedifen® (pain).
For further information:
Recordati website: www.recordati.com
Investor Relations Media Relations
Marianne Tatschke Claudio Rossetti (Echo Comunicazione d’Impresa)
(39)0248787393 (39)02 62694736
e-mail: inver@recordati.it e-mail: crossetti@echocom.it
Zambon website: www.zamboncompany.com Public Relations
www.zambon.fr Stefania Torelli
(39)0266524040
e-mail: stefania.torelli@zambongroup.com
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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