Cosmo Pharmaceuticals Methylene Blue MMX Regulatory Update: new appeal filing – Next steps

Cosmo Pharmaceuticals Methylene Blue MMX Regulatory Update: new appeal filing - Next steps

Dublin, Ireland - December 21, 2018 - Cosmo Pharmaceuticals N.V. (SIX: COPN) today provided a regulatory update for Methylene Blue MMX, an investigational new drug product for visualization of lesions in patients undergoing colonoscopy to improve overall detection of adenomas and carcinomas.

After the initial appeal was denied by the FDA's Office of Drug Evaluation IV (ODE IV), as released on November 1, Cosmo is now in the process of filing a new appeal to the Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER).

Upon receipt of the appeal, the OND is expected to act within 30 days to either grant or deny the appeal or request a meeting or additional information. Cosmo has requested the OND to schedule a Type A meeting. If the meeting request is granted, the timeline for response to the appeal will likely shift in order to allow the meeting to take place. Cosmo will promptly provide updates on the process and will continue to work closely with the agency on a favourable resolution of this matter.

Cosmo remains fully committed to bring this potential improvement to existing standard of care for colonoscopy screening to the health care system as soon as possible, to help reduce the overall incidence of life-threatening colon cancer.

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 and Endoscopic Procedures. 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 and launched Eleview, a medical device for polyp and adenoma excision, in the U.S. and it has filed the NDA for Methylene Blue MMX, a diagnostic drug for the detection of colon cancer. In addition, new chemical entities are being developed by its associate company Cassiopea S.p.A. for the topical treatment of skin diseases. Cosmo's MMX drugs already on the market are Lialda/ Mezavant/Mesavancol, a treatment for IBD that is licensed globally to Giuliani and Shire Limited and Uceris, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in US to Santarus/Salix/Valeant and in the Rest of the World to Ferring as Cortiment. 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

Next events

Full-year results 2018 reporting	March 2019
Annual General Meeting	May 2019

Contact:

John Manieri, Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: [phone]

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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.

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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