Cosmo Pharmaceuticals provides Methylene Blue MMX
regulatory update

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).


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