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Cosmo Pharmaceuticals: Market Launch of LIALDA
Not for release, publication or distribution in
the United States of America,
Canada, Japan or Australia
LIALDA™ (mesalamine) with MMX™ Technology
Now Available
Lainate, Italy – 20 March 2007 –
Cosmo Pharmaceuticals, a specialty pharma company that aims to
become a global leader in optimised therapies for certain gastro
intestinal (GI) diseases, today announced that its most advanced
development product LIALDA™/ MEZAVANT™, is now
available in the US, presently indicated for the induction of
remission in patients with mild-to-moderate ulcerative colitis. The
U.S. Food and Drug Administration (FDA) approved LIALDA™/
MEZAVANT™ on 16 January 2007.
The drug, which is licensed globally to Giuliani and Shire plc,
has been made available by Shire to patients by prescription for
oral administration in dosages of 2.4 g/day and 4.8 g/day, allowing
patients to take as few as two tablets once daily. Other currently
available mesalamines require three to four times daily dosing and
six to 16 pills a day. A study found that patients who are not
compliant with their mesalamine medications have a five-fold
greater risk of disease flares, a serious worsening of symptoms,
than compliant patients.
Mauro Ajani, CEO of Cosmo, commented: “LIALDA™ is
the first drug on the market that utilizes Cosmo’s
proprietary MMX™ technology, which delivers high
concentrations of the active ingredient in a continued and
prolonged release directly to the lumen of the colon - the site of
inflammation. This innovative technology is an important and highly
beneficial development for ulcerative colitis patients.”
About Cosmo Pharmaceuticals
Cosmo is a speciality pharma company that aims to become a global
leader in optimised therapies for certain gastrointestinal
diseases. The company’s proprietary clinical development
pipeline specifically addresses innovative treatments for
inflammatory bowel diseases (IBD), such as ulcerative colitis and
Crohn’s disease, and colon infections. Cosmo’s most
advanced development product is LIALDA™/ MEZAVANT™, a
treatment for mild-to-moderate ulcerative colitis that is licensed
globally to Giuliani and Shire plc. Cosmo’s proprietary
MMX™ technology is at the core of the company’s product
pipeline and was developed from its expertise in formulating and
manufacturing gastrointestinal drugs for international clients at
its GMP (Good Manufacturing Practice) facilities in Lainate, Italy.
More on www.cosmopharmaceuticals.com
For more information please contact
Dr. Chris Tanner, CFO and Head of Investor Relations
Cosmo Pharmaceuticals S.p.A.
Tel: +39 02 9333 7614
Not for release, publication or distribution in
the United States of America,
Canada, Japan or Australia
This document does neither constitute an offer to
buy or to subscribe to shares of COSMO Pharmaceuticals S.p.A. nor a
prospectus within the meaning of the applicable Swiss law.
Investors should make their decision to buy or to subscribe to
shares solely based on the official offering and listing
prospectus. Investors are furthermore advised to consult their bank
or financial adviser.
This publication may contain specific
forward-looking statements, e.g. statements including terms like
"believe", "assume", "expect" or similar expressions. Such
forward-looking statements are subject to known and unknown risks,
uncertainties and other factors which may result in a substantial
divergence between the actual results, financial situation,
development or performance of the company and those explicitly or
implicitly presumed in these statements. Against the background of
these uncertainties readers should not rely on forward-looking
statements. The company assumes no responsibility to update
forward-looking statements or to adapt them to future events or
developments.
This document is not being issued in the United
States of America and should not be distributed or otherwise
transmitted in the United States or to U.S. persons (as defined in
the U.S. Securities Act of 1933, as amended (the Securities Act ))
or publications with a general circulation in the United States.
This document does not constitute an offer or invitation to
subscribe for or purchase any securities. The securities of COSMO
Pharmaceuticals S.p.A. have not been and will not be registered
under the Securities Act and are not being offered or sold in the
United States or to U. S. persons. Securities may not be offered or
sold in the United States or to U.S. persons absent registration or
an applicable exemption from the registration requirements of the
Securities Act.
The information contained herein does not
constitute an offer of securities to the public in the United
Kingdom within the meaning of the Public Offers of Securities
Regulations 1995. No prospectus offering securities to the public
will be published in the United Kingdom.
This document is only being distributed to and is
only directed at (i) persons who are outside the United Kingdom or
(ii) to investment professionals falling within Article 19(5) of
the Financial Services and Markets Act 2000 (Financial Promotion)
Order 2005 (the Order ) or (iii) high net worth entities, and other
persons to whom it may lawfully be communicated, falling within
Article 49(2)(a) to (d) of the Order (all such persons together
being referred to as relevant persons ). The securities are only
available to, and any invitation, offer or agreement to subscribe,
purchase or otherwise acquire such securities will be engaged in
only with, relevant persons. Any person who is not a relevant
person should not act or rely on this document or any of its
contents.
This document constitutes neither an offer to sale
nor an invitation or solicitation to buy securities in Italy and
does not constitute a public offering under the meaning of sections
1, item t) and 94(1) of the Legislative Decree n. 58 of 24 February
1998. The securities referred to herein cannot be offered,
distributed, marketed, promoted or solicited in Italy to investors
other than "Professional Investors" as defined by Articles 25 and
31(2) of Consob s Regulation No. 11522 of 1 July 1998, as amended,
(including, inter alia, investment firms, ("SIMs"), banks
authorized to provide investment services, stockbrokers, SICAVs,
pension funds, insurance companies, entities enrolled in the
register referred to in Articles 106, 107 and 113 of the
Legislative Decree 385 of 1 September 1993, financial salesmen,
individuals possessing the professionalism requirements referred to
in Article 31(2) of the Regulation No. 11522, legal persons stating
to have specific expertise and experience in financial
transactions) without Consob's prior authorization. COSMO
Pharmaceuticals S.p.A. intends neither to carry out a public
offering of the securities in Italy nor to apply for the relevant
Consob's authorization. This press release is not directed to
Italian residents other than Professional Investors as defined
above.
Any offer of securities to the public that may be
deemed to be made pursuant to this communication in any EEA Member
State that has implemented Directive 2003/71/EC (together with any
applicable implementing measures in any Member State, the
Prospectus Directive ) is only addressed to qualified investors in
that Member State within the meaning of the Prospectus
Directive.
The securities described herein will be offered
publicly in Switzerland only. The information contained herein
shall not constitute an offer to sell or the solicitation of an
offer to buy, in any jurisdiction in which such offer or
solicitation would be unlawful prior to registration, exemption
from registration or qualification under the securities laws of any
jurisdiction.
Stabilization/FSA
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