Cosmo announces granting of first patent in USA for Methylene Blue MMX® and
EMA approval for phase III clinical trial
*EMA approved phase III clinical trial design
*Poster presentation on phase II at EUGW in Berlin
*Phase III to start in November
Lainate, Italy - October 8, 2013 - Cosmo Pharmaceuticals, (SIX:COPN),
announces today that the USPTO has issued its patent application under
reference US 8,545,811. This patent was filed in 2010.
Following the approval of the special protocol assessment (SPA) by the FDA,
the European Medicines Agency (EMA) has approved the clinical trial protocol
and confirmed the application of the centralized procedure for registration.
The phase III clinical trial is scheduled to start in November treating
approximately 1270 patients in 14 large US, CA and EU hospitals.
A poster presentation with the results of Phase II clinical trials is to be
posted at the EUGW in Berlin next week.
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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