Dublin, Ireland – November 28, 2018 – Cosmo Pharmaceuticals N.V. (SIX: COPN) announces that its licensee Dr. Falk Pharma has received today approval in the European Decentralized Procedure (DCP) for Relafalk (Rifamycin SV MMX) for the treatment of Travelers’ Diarrhea. This approval follows the approval of AEMCOLO (Rifamycin SV MMX) by the FDA on November 16 for the same indication.
The DCP concerned the following Member States: Germany, United Kingdom, Spain, Denmark, Greece, Finland, Hungary, Norway, Portugal, Poland, Sweden and Bulgaria.
“We are very happy with this further approval, which opens up the European Market for the exploitation of this MMX oral dosage form of the antibiotic Rifamycin SV in the gastrointestinal infections. We are thankful to our partner Dr. Falk Pharma for the successful outcome of the DCP”, said Alessandro Della Chà, CEO of Cosmo Pharmaceuticals N.V.
About RELAFALK
Relafalk (Rifamycin SV MMX) is an orally administered, minimally absorbed antibiotic approved for the treatment of Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli in adults. Relafalk is the first antibiotic engineered with Cosmo Pharmaceuticals’ Multi Matrix Technology (MMX®) which allows for the colonic release of active ingredient. Relafalk was approved based on data from two randomized, multi-center, controlled Phase 3 clinical trials. In both trials Relafalk was dosed at 400mg twice daily for three days. Relafalk demonstrated superiority to placebo and non-inferiority to Ciprofloxacin for the primary endpoint (time to last unformed stool).
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. On November 16 2018 the FDA has also approved Aemcolo, Cosmo’s first oral antibiotic for the treatment of Travelers’ Diarrhea. 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 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: +353 1 817 03 70
jmanieri@cosmopharma.com
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.