Dublin – May 9 2018 – Cosmo Pharmaceuticals NV (SIX: COPN) today announced that the Company received a letter from the U.S. Food and Drug Administration (FDA) stating that, as part of their ongoing review of the Company’s New Drug Application (NDA) for Methylene Blue MMX, the agency has identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/ commitments at this time.
The letter does not specify the deficiencies identified by the FDA and there has been no further clarification of the deficiencies by the FDA at this time. Cosmo expects receiving further clarification from the FDA on or before the Prescription Drug User Fee Act (PDUFA) date of May 21, 2018. The Company intends to work with the FDA to understand the nature of the deficiencies once identified and resolve them as quickly as possible.
Methylene Blue MMX is a novel application of methylene blue, a coloring agent that is used to stain the mucosa to discover pre-cancerous lesions and polyps in the colon. The objective is to deliver methylene blue along the length of the entire colon via the MMX™ technology thus enabling endoscopists to better detect pre-cancerous and cancerous lesions and polyps throughout the entire colon.
In late 2016, Cosmo has completed an extensive phase III trial in 18 leading centers in North America and Europe. The full analysis set (FAS) covered 1,205 subjects, the per protocol set 1,137. The primary endpoint was to achieve superiority over standard of care, this being high definition white light endoscopy. This primary endpoint was attained by demonstrating that 17.7% more patients with adenomas were detected than in the Standard of Care arm (p value 0.009).
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 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 has developed Eleview™, a medical device for polyp excision and is developing Methylene Blue MMX®, a product for the detection of colon cancer and has a large shareholding in Cassiopea S.p.A., a clinical-stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products. Cosmo’s MMX® products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for Ulcerative Colitis that is licensed globally to Nogra and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in the USA to Santarus/Salix/Valeant and in the Rest of the World 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
Financial Calendar
AGM in Amsterdam 30 May 2018
Contact
John Manieri, Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 (1) 8170 370
Disclaimer
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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