Cosmo announces successful outcome of phase III clinical trial for LuMeBlue™

Download the PDF version: EN | DE

Dublin – November 10, 2016 – Cosmo Pharmaceuticals N.V. (SIX: COPN) announced that its phase III pivotal clinical trial of LuMeBluefor the detection of adenomas during colonoscopy has successfully met the primary endpoint. The trial completes the data set necessary for the registration of the product both in the US and EU.

The aim of the colonoscopy is to detect adenomas. Not all adenomas turn into cancers, but all cancers were previously adenomas. Therefore, the effectiveness of the colonoscopy depends on the adenoma detection rate. Ultimately, the more adenomas are detected and extracted, the less cancers will subsequently develop. The aim of LuMeBlue™ is to increase the adenoma detection rate versus the white-light high-definition colonoscopy, the current highest standard of care.

LuMeBlue™ is a tablet containing Methylene Blue, a vital dye. 8 tablets are ingested during the colon preparation procedure. LuMeBlue™ stains the entire colon with the dye. The dye penetrates the mucosal cells in such a way that significantly enhances the detection of adenomas by the endoscopist.

The phase III clinical study with LuMeBlue™ was run by Cosmo in 19 top sites in North America and Europe. It enrolled more than 1,200 subjects in an international multi-centre, randomized, double-blind pivotal trial.

A detailed analysis of the data will be presented at Cosmo’s R&D day on November 29, 2016 in Zurich.

Upon its approval, Cosmo will market LuMeBlue™ directly in the USA and intends to establish selective partnerships for the marketing of the product in the Rest of the World.

Alessandro Della Chà, CEO of Cosmo, commented: “This is a fantastic break-through for us. LuMeBlue™ is a tipping point for Cosmo because it addresses a major need in a mass market. Colonoscopies are the only way to detect adenomas and therefore prevent colon cancer, the third cause of death within cancer. LuMeBlue™ has proven to substantially increase the adenoma detection rate and therefore provides a major contribution in colon cancer prevention; and even more so if one considers that the trial was not against a placebo, but against the highest current standard of care. The successful trial positions Cosmo uniquely as a lead player in both endoscopy and GI and we look forward to the exploitation of our pipeline for the benefit of our shareholders”.

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 a medical device for polyp and adenoma excision and is has completed clinical trials of LuMeBlue™, a diagnostic for the detection of colon cancer as well as new chemical entities that are being developed by the associate company Cassiopea S.p.A. for the topical treatment of skin diseases. Cosmo’s MMX® products that have reached 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

 Jefferies Global Healthcare Conference November 16, 2016 in London

Credit Suisse Mid Cap Conference November 17-18, 2016 in Zurich

R&D Day November 29, 2016 in Zurich

Full-year results 2016 reporting March 2017

Annual General Meeting April 2017

Contact

Dr. Chris Tanner, Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 (1) 8170 370
ctanner@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.

Delivered by Investis – link to website (opens in a new window)