FDA agrees with Cosmo's proposed design of phase III trial for Methylene Blue
Lainate, Italy - June 14, 2013 - Cosmo Pharmaceuticals, (SIX:COPN), announced
today that the US Food and Drug Administration (FDA) agrees that the design
and planned analysis of the study proposed by Cosmo adequately address the
objectives necessary to support a regulatory submission for Marketing
authorization of the product. The FDA based its review on the clinical
documentation including the protocol titled "The Safety and Efficacy of
Methylene Blue MMX® modified release tablets administered to subjects
undergoing screening or surveillance colonoscopy" submitted by Cosmo in a
request for a special protocol assessment (SPA).
"Methylene Blue MMX intends to improve adenoma and polyp detection rates in
the more than 30 million colonoscopies that are performed every year. Though
it is a very large market, no drugs are currently available for this. We are
now very pleased that the FDA has agreed to our clinical trial design," said
Mauro Ajani, Chairman and CEO of Cosmo Pharmaceuticals.
Cosmo is now completing the preparations for the phase III clinical trial. EMA
has previously approved the access to the centralized procedure for the future
Marketing Authorization. The trial will be conducted in major North American
and European hospitals.
About Methylene Blue MMX®
CB-17-01, i.e. Methylene Blue MMX® tablet, is an oral colon-release
formulation, in the form of coated tablets. The tablets are formulated using a
patented multimatrix technology, MMX®, that allows the active ingredient to be
spread directly on the whole colonic mucosa. With this technology, the
selected local availability of the active ingredient and, consequently, the
staining and contrasting effect are optimized.
Methylene blue is a vital dye that has the interesting property to stain the
specialized columnar epithelium of the intestine. Methylene blue has been used
with other technologies to screen for colonic neoplasia, to diagnose villous
atrophy and to screen for areas of dysplastic and neoplastic cells.
About Colon Cancer Diagnosis
The American Cancer Society currently states that, because there is a lack of
effective diagnostic tools, fewer than 10% of persons with colon cancer are
diagnosed at the early stage I when patients have a higher likelihood of cure.
The American Cancer Society currently recommends that a flexible sigmoidoscopy
should be done every 5 years or a full colonoscopy every 10 years to detect
lesions and polyps at a precancerous or early cancer stage. Good practice
requires that suspicious polyps and adenomas are excised during colonoscopy.
It is estimated that around 30 million colonoscopies are performed every year
in the 7 major markets.
Optical magnification endoscopy and chromendoscopy have gained renewed
interest as means for the early detection of minute lesions in patients
referred for colonic cancer screening. Chromoendoscopy is a technique in which
different dyes are topically applied to the gastrointestinal mucosa during
endoscopy in order to better characterise and highlight specific changes in
the mucosa. This staining method allows visualization of certain mucosal
features that would otherwise not be evident and, thus, improves the accuracy
of the endoscopic examination.
About Cosmo Pharmaceuticals
Cosmo is a speciality 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 colonic
inflammatory and infective diseases. In addition, the Company is developing a
diagnostic for the detection of colon cancer and a new chemical entity in the
dermatogical area for the topical treatment of Acne, Alopecia and Hirsutism.
Cosmo's first product in the market is Lialda®/Mezavant®/Mesavancol®, a
treatment for mild to moderate Ulcerative Colitis that is licensed globally to
Giuliani and Shire. Cosmo's second product is Uceris(TM)/Cortiment(TM), a
steroid without the typical side effects of systemic steroids, that is
indicated for Ulcerative Colitis patients and is licensed globally to Santarus
and 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 lower part
of intestines. For further information on Cosmo, please visit the Company's
Contact: Cosmo Pharmaceuticals S.p.A.
Dr. Chris Tanner, CFO and Head of Investor Relations
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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