Cosmo unveils new product addressing major unmet need in colonoscopies
targeted for launch in early 2015
Lainate, Italy - June 3, 2014 - Cosmo Pharmaceuticals S.p.A. (SIX: COPN) today
presents its new product SIC 8000 at the Jefferies Global Health Care
Conference in New York.
SIC stands for Submucosal Injectable Composition and allows an easier and
faster removal of polyps/adenomas/early cancers during colonoscopies.
Colon Cancer is one of the four most frequent cancers in the world. It is
believed that all colon cancers were previously polyps which then mutate to
adenomas and subsequently full cancer. Of all cancers, colon cancer can be
most reduced by early diagnosis, if polyps are detected and removed early on.
During colonoscopy, endoscopists strive to identify all polyps and remove
those potentially dangerous. Removal of polyps can be challenging, especially
if the polyp is flat or positioned in difficult areas. Endoscopists have
therefore constantly been looking for a device that would lift the polyp,
making its removal easier and thus reducing the risk of colon perforation.
SIC 8000 is injected during colonoscopy under the polyp. It creates a lasting
cushion elevating the polyp thus separating it from the underlying colonic
wall. In order to allow better recognition of tissues and polyp margins and
diminish colon perforation risk SIC 8000 is additionally dyed with Methylene
SIC 8000 is classified as a medical device with a very short regulatory
approval path. Cosmo expects therefore to be able to launch this product in
North America and the EU in H1 2015.
Currently, no FDA-approved products are available for such purpose. Cosmo
believes that the availability of a new, long-lasting, FDA-approved product
will cover a significant unmet need, greatly improving effectiveness and
safety of polyp removal.
Approximately, 32 million colonoscopies are performed every year in the USA &
EU. Polyps/adenomas/cancerous lesions are found in approximately 20% of all
colonoscopies and up to 35% of these lesions may require removal with a
sub-mucosal injectable composition.
Alessandro Della Chà, CEO, commented: "Cosmo works hand-in-hand with some of
the leading KOLs in endoscopy and together we specifically target unmet needs.
This is why I believe SIC 8000 will be warmly welcomed by endoscopists, as it
will make their life easier. I also see the opportunity of the combination
between Methylene Blue MMX® and SIC 8000. Cosmo will help: on one hand, to
identify precancerous lesions with Methylene Blue MMX®; on the other hand, to
remove them with SIC 8000. This should greatly assist endoscopists in their
quest for colon cancer reduction at the lowest possible cost. I am proud that
all this has been developed in-house".
The presentation is available for download at:
About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company that aims to become a global
leader in the field of optimized therapies for selected Gastrointestinal and
topically treated Skin Disorders. The company's proprietary clinical
development pipeline specifically addresses innovative treatments for IBD,
such as Ulcerative Colitis and Crohn's Disease, and Colon Infections. In
addition, the Company is developing a diagnostic for the detection of colon
cancer and a medical device for polyp excision as well as a new chemical
entity for the topical skin treatment. Cosmo's MMX® products that have reached
the market are Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is
licensed globally to Giuliani and Shire Limited and Uceris®, the first
glucocorticosteroid indicated for the induction of remission in active, mild
to moderate ulcerative colitis, licensed in US to Salix and in the Rest of the
World except for Japan to Ferring. 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. The technology is designed to deliver active ingredients in a
targeted manner in the colon. For further information on Cosmo, please visit
the Company's website: www.cosmopharma.com
Half-year results 2014 30 July 2014
Dr. Chris Tanner, CFO and Head of Investor Relations
Cosmo Pharmaceuticals S.p.A.
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
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