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Cosmo Pharmaceuticals reports positive preliminary Phase II/III data with Rifamycin MMX™ in Infectious Diarrhoea
-- Primary endpoint achieved --
Lainate, Italy – July 4, 2007 –
Cosmo Pharmaceuticals SpA (SWX:COPN) announced today positive
preliminary results from its phase II/III study with CB-01-11
(Rifamycin SV MMX™) in infectious diarrhoea. CB-01-11 is a
broad spectrum, semi-synthetic antibiotic that is not absorbed when
taken in tablet form. Through the use of Cosmo’s MMX™
technology, which delivers the active ingredient into the colon,
bacteria in the gastro intestinal tract that are important for
vitamin synthesis are not sterilized. Given that it is practically
not absorbed CB-01-11 is potentially applicable for the treatment
of long term infections in the colon.
In the placebo controlled, randomized, double blind trial 120
patients in 8 sites in South Africa were treated with a 200mg
tablet, 4 times per day for 3 days. The trial assessed
non-inferiority versus Normix® (rifaximin) and the primary
endpoint was the time from first ingestion of tablet to the last
unformed stool. According to the preliminary reports CB-01-11 met
this primary endpoint.
Mauro Ajani, CEO of Cosmo Pharmaceuticals, commented: ”We
are very encouraged about these preliminary results since many of
the needs of patients are not adequately met with products
currently on the market. Infections of the colon affect many more
persons than colon inflammations and this is consequently a
substantially larger market. We believe that our proprietary
MMX™ technology will enable us to improve a range of products
in colon infections and thus better meet patients’
requirements.”
Further analysis of the data is ongoing.
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 IBD, such
as ulcerative colitis and Crohn’s disease, and colon
infections. Cosmo’s first MMX™ product that has reached
the market is LIALDA™ / MEZAVANT™, a treatment for IBD
that is licensed globally to Giuliani and Shire Pharmaceuticals.
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. For further information on Cosmo,
please visit the Company’s website: www.cosmopharmaceuticals.com
Contact:
Dr. Chris Tanner, CFO and Head of Investor Relations
Cosmo Pharmaceuticals SpA
Tel: +39 02 9333 7614
Some of the information contained in this press
release contains forward-looking statements. Readers are
cautioned that any such forward-looking statements are not
guarantees of future performance and involve risks and
uncertainties, and that actual results may differ materially from
those in the forward-looking statements as a result of various
factors. Cosmo undertakes no obligation to publicly update or
revise any forward-looking statements.
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