COSMO PHARMACEUTICALS N.V. Cosmo Pharmaceuticals signs with EA Pharma Co., Ltd.
Exclusive License Agreement for Japan and South Korea
for Methylene Blue MMX and Eleview
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
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