MILAN, ITALY--(Marketwire - February 03, 2010) -
RECORDATI : SILODOSIN (UROREC®/SILODYX™)
APPROVED BY THE EUROPEAN COMMISSION FOR THE TREATMENT OF THE SIGNS AND
SYMPTOMS OF BPH (BENIGN PROSTATIC HYPERPLASIA)
Milan, 3 February 2010 - Recordati announces that it has been granted
Marketing Authorization by the European Commission for the medicinal
products Urorec® and Silodyx™ 4 mg, 8 mg, hard capsules, intended for
treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Following national post-authorization procedures, as relevant, product
launch could take place by end 2010 or beginning 2011.
Benign prostatic hyperplasia (BPH, enlargement of the prostate) is
characterized by urination difficulties such as weak urine stream,
increased frequency and urgency, nocturia. The prevalence of this condition
is increasing due to the progressive ageing of the male population. BPH is
frequently observed in men over fifty, and its symptoms significantly
reduce quality of life.
The compound was originally developed by Kissei Pharmaceutical Co. Ltd. in
Japan and was 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. Development of the drug was conducted by Recordati for its
territories, by Watson Pharmaceuticals in North America and by Kissei
Pharmaceutical Co. Ltd. for the rest of the world. Silodosin is already
available in North America, in Japan and other countries in Asia.
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 8 mg
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 8 mg once daily was not inferior to
tamsulosin 0.4 mg 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 1B
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 was very low), and is reversible upon
discontinuation of the treatment.
"The authorization to market silodosin confirms the validity of this new
treatment for the symptoms of benign prostatic hyperplasia", declared
Giovanni Recordati, Chairman and CEO. "The product, under the brands
Urorec® and Silodyx™, will be available in all European markets upon
finalization of the national registration procedures. During 2009 a number
of licensing and co-marketing agreements were entered into with leading
pharmaceutical companies for both European and non-European markets which
will allow us to obtain wide coverage and the acceptance of the medical
community for this modern treatment for a condition which increasingly
affects the male population".
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 2,950, 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 1,450 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 EUR 689.6 million, operating income was ÂEUR 144.7 million and net
income was EUR 100.4 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 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.
This information is provided by HUGIN
