2020

02.04.2020 – COSMO Pharmaceuticals N.V.

Cosmo Pharmaceuticals Methylene Blue MMX regulatory update: filing of protocol for confirmatory phase III trial for Methylene Blue

Cosmo Pharmaceuticals Methylene Blue MMX regulatory update: filing of protocol for confirmatory phase III trial for Methylene Blue

Dublin, Ireland – April 2, 2020 - Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that it has filed for final comment the protocol and related statistical analysis plan with the U.S. FDA for the confirmatory phase III trial 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.

The FDA has agreed to expedite review of the protocol upon receipt and to provide feedback within a 30 to 60 day timeframes. Notwithstanding the main elements have already been previously aligned with the agency, it is possible that this deadline will be impacted by the pandemic disruptions. Cosmo plans to commence the confirmatory phase III trial in H2, subject to acceptance of the protocol by the FDA and subject to normal clinical operations resuming to ordinary standards.

Cosmo will provide further 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 U.S. 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

Calendar

Full Year Results 2019

April 3, 2020

Annual General Meeting

May 28, 2020

Contact:

Niall Donnelly, Chief Financial Officer & Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 1 817 03 70

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.

This communication is not an offer of securities of any issuer. Securities may not be offered or sold in the United States absent registration or an exemption from the registration requirement of the US Securities Act of 1933.

This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. The offer will be made solely by means of, and on the basis of, a securities prospectus to be published. An investment decision regarding the securities to be publicly offered should only be made on the basis of the securities prospectus.

This press release is made to and directed only at (i) persons outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. Any person who is not a relevant person should not act or rely on this press release or any of its contents.

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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