21.01.2020 – COSMO Pharmaceuticals N.V.

Cosmo Pharmaceuticals Methylene Blue MMX regulatory update:; Substantial alignment reached with FDA on second phase III study features – next steps

Cosmo Pharmaceuticals Methylene Blue MMX regulatory update:

Substantial alignment reached with FDA on second phase III study features – next steps

Dublin, Ireland – January 21, 2020 - Cosmo Pharmaceuticals N.V. (SIX: COPN) today provided a regulatory update for Methylene Blue MMX, an investigational new drug product developed as an aid for the detection of colorectal lesions in patients undergoing routine screening and surveillance of colonoscopies.

In a face-to-face meeting with the U.S. Food and Drug Administration (FDA), the company received positive feedback and achieved substantial alignment on the proposed trial design and endpoints of the second Phase III protocol and associated statistical analysis plan. This alignment is reflected in the minutes received from the FDA. The next step will be the submission of the complete protocol and statistical analysis plan (expected in Q1 2020) for final comment by the FDA before the start of the trial, which Cosmo hopes to begin within H1 2020.

Cosmo will promptly provide updates on the process and remains fully committed to bringing this potential improvement to existing standards of care for colonoscopy screening and surveillance to the health care system as soon as possible. Effective screening and surveillance are critical to the prevention of colorectal cancer and the reduction in the overall incidence of life-threatening colorectal cancer.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused in treating selected Gastrointestinal Disorders and Endoscopy. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, Colonic Infections and detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of its novel Artificial Intelligence device to be used in coloscopies and GI procedures. Further, Cosmo has licensed Aemcolo to Red Hill Biopharma and is the licensee for US of the novel agent for procedural sedation, Remimazolam, which it has sub-licensed to Acacia. For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com


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Niall Donnelly, Chief Financial Officer & Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 1 817 03 70


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