Dublin – March 21, 2018 – Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that its subsidiary Cosmo Technologies Ltd. has entered into a license agreement with EA Pharma Co., Ltd. Japan. With the agreement Cosmo Technologies Ltd. grants EA Pharma an exclusive license for the development and commercialization of Methylene Blue MMX, Eleview and an option to further license Qolotag for Japan and South Korea.
Subject to a confirmatory due diligence process, Cosmo Pharmaceuticals N.V. will receive an upfront payment as well as additional development and commercial milestone payments upon reaching certain annual net sales thresholds, plus royalties once the products are approved.
“We are very happy to have signed this contract with EA Pharma, who is a leading GI player in Japan. This agreement will entitle us to introduce our innovative GI products in these untapped markets” said Alessandro Della Chà, Chief Executive Officer of Cosmo Pharmaceuticals. “We are sure that EA Pharma will be a great partner for us.”
“EA Pharma is pleased to have this new collaboration with Cosmo Pharmaceuticals as we aim to provide wide solutions to meet various needs for patients and their family who suffer from gastrointestinal disease. This could also be the first step for EA Pharma on medical device field in addition to pharmaceuticals and is expected to further contribute to the GI disease area after the contract becomes effective.” said Yuji Matsue, Representative Director, President & CEO of EA Pharma.
Eleview, designed for easy and safe resection, increases visibility of target lesion margins and lowers the risk of perforation. It is appropriate for challenging polyps, regardless of size, location, or type and the immediate, long-lasting cushion can hold for up to 45 minutes. Developed by Cosmo, Eleview improves margin visualization and helps decrease the risk of gastrointestinal perforation and damage to the external muscular layer, which can lead to gastrointestinal perforation. Furthermore, it decreases the time needed to resect a lesion while reducing both reinjections required and piecemeal excisions, as compared to saline.
Methylene Blue MMX is a first-in-class drug candidate based on Cosmo Pharmaceutical’s proprietary MMX delivery technology, which highlights the lesions prior to colonoscopy thus enhancing the detection of abnormal or dysplastic areas in the colon. In the phase III clinical trial, Methylene Blue MMX attained the statistically significant primary endpoint (p-value: 0.009) by identifying 17.71% more patients with adenomas or carcinomas than HDWL (High Definition White Light) colonoscopy, the most advanced standard of care today. Adenomas were found in 56.3% of all subjects when using Methylene Blue MMX, in contrast to 47.8% with HDWL. The NDA is expected to show that Methylene Blue MMX helps to increase the Adenoma Detection Rate (ADR) substantially beyond the current standard of care in endoscopic procedures. This increase has an important clinical relevance: it’s known from scientific literature that for each 1% increase in ADR, a 3% decline in incidence of interval cancer and a 5% decline in incidence of fatal colorectal cancer (CRC) should be expected.
Qolotag is a liquid, blue coloured emulsion developed by Cosmo as an enema formulation to be used for the mechanical cleansing, and simultaneous staining, of the sigmoid colon and rectum. It cleanses and stains with methylene blue the sigmoid colon and rectal mucosa to aid visualization of mucosa structure and mucosal lesions by the endoscopist during the sigmoidoscopy.
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. 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 Eleview™, a medical device for polyp excision and is developing Methylene Blue MMX®, a product for the detection of colon cancer and has a large shareholding in Cassiopea S.p.A., a clinical-stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products. Cosmo’s MMX® products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for Ulcerative Colitis that is licensed globally to Nogra and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in the USA to Santarus/Salix/Valeant and in the Rest of the World to Ferring. 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
About EA Pharma Co., Ltd.
EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, was established in April 2016 by integration of the gastrointestinal business unit with more than 60 years’ history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma is a gastrointestinal specialty pharma with a full value chain covering R&D, logistics and sales & marketing. For more information on EA Pharma Co., Ltd., please see http://www.eapharma.co.jp/en/
Financial Calendar
2017 Full Year Results 26 March 2018
Contact
John Manieri, Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 (1) 8170 370
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.