MILAN, ITALY--(Marketwire - July 15, 2010) -
Recordati announces the positive outcome of
the Decentralized Procedure for the approval of pitavastatin (Livazo®,
Alipza® and other brands) in Europe following the communication from the
Reference Member State (MHRA, Medicines and Healthcare products Regulatory
Agency, UK) and the agreement of all the Concerned Member States which was
received by Kowa. Pitavastatin, 1mg, 2mg and 4mg tablets, is indicated for
the reduction of elevated total cholesterol (TC) and LDL-C, in adult
patients with primary hypercholesterolaemia and combined (mixed)
dyslipidaemia when response to diet and other non-pharmacological measures
is inadequate.
Pitavastatin is a statin licensed by Recordati from the European subsidiary
of Kowa Company Limited, the Japanese pharmaceutical company, in the
majority of the European market. It has been available on the market in
Japan since 2003 and was recently launched in the U.S. by Kowa
Pharmaceuticals America and its US co-promotion partner Eli Lilly. This
medicinal product promises to be an effective new treatment for
dyslipidemia, a condition characterized by altered levels of blood
cholesterol and other lipids and associated with an increased risk for
heart disease and stroke.
In controlled clinical trials, run by Kowa Pharmaceutical in Europe,
involving more than 1,600 patients it was shown that pitavastatin induces a
reduction in LDL-cholesterol (the "bad" cholesterol that contributes to
formation of atherosclerotic plaques) and an increase in HDL-cholesterol
(the "good" cholesterol that is removed from the arterial walls), a dual
effect that should be regarded as highly relevant, since it appears to
reduce the relative risk for cardiovascular complications. It has been
shown that pitavastatin is minimally metabolized by the enzymes of the
Cytochrome P-450 family, enzymes that play a key role in the metabolism of
many drugs, thus minimizing the potential risk for unpredictable responses
to treatment or for interaction with drugs metabolized by this pathway.
Pitavastatin has an excellent safety profile and represents a new effective
and safe treatment for dyslipidemia.
"The favourable conclusion of the regulatory process in Europe for the
approval of pitavastatin confirms the validity of this new treatment for
hypercholesterolaemia" declared Giovanni Recordati, Chairman and CEO. "The
product, under the brand Livazo® and Alipza® represents a new and
interesting therapeutic option for a condition which constitutes one of the
risk factors for cardiovascular disease".
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 2,800, 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 around 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 2009 was € 747.5 million, operating income was € 162.2
million and net income was € 110.6 million.
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
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
