Cosmo Pharmaceuticals announces granting of Marketing Authorization in Italy to Rifamycin SV MMX (Stadmycin™) by Italian AIFA

Cosmo Pharmaceuticals announces granting of Marketing Authorization in Italy to Rifamycin SV MMX (StadmycinTM) by Italian AIFA

Dublin, Ireland - 8 July 2020: Cosmo Pharmaceuticals announced today that the Italian Agenzia del Farmaco (AIFA) has granted Marketing Authorization to StadmycinTM (Rifamycin SV MMX), licensed to E.G. S.p.A. (part of the STADA Group), for the treatment of Travelers' Diarrhea. Rifamycin SV MMX is marketed in the US under the brand name Aemcolo® by RedHill Biopharma, in selective European countries under the brand name RelaFalk® by Dr. Falk Pharma and now will be marketed in Italy under the brand name StadmycinTM by E.G.

Cosmo will receive a milestone payment of € 1.5m from E.G. due on the grant of this Marketing Authorization.

About Aemcolo®/RelaFalk®/StadmycinTM

Aemcolo®/RelaFalk®/StadmycinTM is a pharmaceutical drug product containing rifamycin SV formulated with the MMX® technology. Aemcolo®/RelaFalk®/StadmycinTM contains a broad spectrum, semi-synthetic, orally non-absorbable antibiotic, and has been approved in the US and in the EU for the treatment of traveler's diarrhea caused by non-invasive E. coli strains. The application of MMX® technology to rifamycin SV allows the antibiotic to be delivered directly into the colon, avoiding unwanted effects on the beneficial bacterial flora living in the upper portions of the gastro-intestinal tract. The specific dissolution profile of Aemcolo®/RelaFalk®/StadmycinTM tablets is thought to increase the colonic disposition of the antibiotic so that an optimized intestinal concentration is achieved thus avoiding its systemic absorption in the small intestine.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the 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 GI Genius™ its artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo™ to Red Hill Biopharma and is the licensee of BYFAVO™ (Remimazolam) for the U.S. for procedural sedation, which it has sub-licensed to Acacia. For additional information on Cosmo and its products please visit the Company's website: www.cosmopharma.com

Financial calendar

2020 Half-Year Results	July 30, 2020
Investora, Zurich	September 23/24, 2020

Contact

Niall Donnelly, CFO & Head of Investor Relations

Cosmo Pharmaceuticals N.V.

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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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