MILAN, ITALY -- 11/20/09 --
Recordati announces that on 19
November 2009 the Committee for Medicinal Products for Human Use
(CHMP) adopted a positive opinion, recommending to grant a
Marketing Authorization 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). The
European Commission Decision is normally issued within 67 days
from adoption of the CHMP Opinion.
The active substance of Urorec® and Silodyx® is silodosin, a
urological medicinal product (ATC code G04CA04). Silodosin is a
selective antagonist of the á1A-adrenoreceptors. Blockade of these
receptors causes smooth muscle in the prostate, urinary bladder
base and neck, prostatic capsule and prostatic urethra to relax,
thus decreasing the bladder outlet resistance associated with BPH.
The compound was originally developed by Kissei Pharmaceutical Co.
Ltd. in Japan and 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. 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.
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 EUR 144.7 million and net income
was EUR 100.4 million.
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
For further information:
Recordati website: www.recordati.com
Investor Relations
Marianne Tatschke
(39)0248787393
e-mail: Email Contact
Media Relations
Claudio Rossetti (Echo Comunicazione d'Impresa)
(39)02 62694736
e-mail: Email Contact
