Dublin - 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.

Contact:

Niall Donnelly

Tel: +353 1 817 03 70

Email: ndonnelly@cosmopharma.com

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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This press release does not constitute an 'offer of securities to the public' within the meaning of Directive 2003/71/EC of the European Union (the 'Prospectus Directive') of the securities referred to in it (the 'Securities') in any member state of the European Economic Area (the 'EEA'). Any offers of the Securities to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities.

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