CMS(00867) Signed a License Agreement for Innovative Patented Drug Lumeblue (Methylene Blue MMX) with Cosmo
2020-12-04 08:02

China Medical System Holdings Limited (the ¡°Company¡±, together with its subsidiaries, the ¡°Group¡±) is pleased to announce that the Group, through its wholly-owned subsidiary signed a License, Collaboration and Distribution Agreement (the ¡°License Agreement¡±) with Cosmo Technologies Ltd. (¡°Cosmo¡±), a specialty pharma focusing on developing and commercializing the products related to gastrointestinal disorders, for the innovative patented drug Methylthioninium Chloride Cosmo and any line extension thereof (the ¡°Product¡±) on 3 December 2020. The Product currently includes a drug that has been approved by the European Medicines Agency (EMA) to be commercialized in Europe under the trade name Lumeblue™ for the detection of lesions during colonoscopy. Based on a proprietary innovative technology of Cosmo, this oral diagnostic drug has clinically demonstrated its improvement of diagnosis sensitivity in detecting the cancerous/precancerous lesions during colonoscopy for the screening of colorectal cancer.

In accordance with the License Agreement, the Group through its wholly-owned subsidiary will gain an exclusive license to develop and commercialize the Product and use the Product mark in association with the commercialization of the Product in Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan (the ¡°Territory¡±). The License Agreement will commence on the effective date and continue to be valid until (i) the twentieth (20th) anniversary of the first commercial sale of the Product in the Territory, or (ii) the last expiration date of the Product patents of Cosmo, whichever is later. Upon the expiration of the aforementioned term, the License Agreement may be renewable for every single period of three years thereafter as per certain conditions defined in the License Agreement.

Through this collaboration, the Group¡¯s products for digestive system will be further enriched and extended upon the commercialization of the Product in the Territory.

About the Product

Lumeblue™£¨Methylene Blue MMX, EMA approved prescription drug£©

Lumeblue™ is an oral diagnostic drug. The drug is designed to increase the detecting sensitivity of colorectal cancer/precancerous lesions (such as adenomas) by enhancing visualization of the colorectal lesions in adult patients undergoing screening or surveillance colonoscopy. It was firstly approved in Europe on 21 August 2020, following a successful global Phase III trial. Lumeblue™ currently has a granted formation patent in China, valid to 2031.

Colorectal cancer is one of the most common malignant tumour in digestive system, with a high incidence, high motality and poor progress throughout the world. In China, there are 376,000 new cases and 191,000 deaths reported each year, according to 2018 China Cancer Statistics Report. Prevention is better than cure, so the detection and removal of the lesions, such as adenomas, is critical, as survival is significantly better when colorectal cancer is diagnosed early, before it spreads and advances. For that reason, population-based screening for colorectal cancer is widely recommended globally. Colonoscopy remains an important technique and is still regarded as the gold standard in screening for colorectal cancer. Although some new technologies have been developed in colonoscopy last few decades, the clinically meaningful precancerous lesions are often ignored in the practice due to the procedure¡¯s intrinsic detecting sensitivity issue.

Lumeblue™ (Methylene Blue MMX) is a novel oral formulation of the existing liquid colon staining dye methylene blues. The drug is formulated by Cosmo¡¯s proprietary MMX Technology. Taken orally, the tablets deliver the dye in a delayed and controlled way distributing evenly through the full length of the colon. Lumeblue™ is clinically approved to improve the detection of all lesions, including precancerous lesions, such as adenoma, in the colon during endoscopy. The potential to significantly improve the adenoma detection rate (ADR) is important and clinically meaningful, as an improved ADR is inversely related to the risk of developing colorectal cancer and death. The potential benefits of adding Methylene Blue MMX to routine colonoscopy screening procedures appears clear.

About Cosmo

Cosmo is a specialty pharmaceutical company that aims to become a global leader in the market of optimized therapies for selected gastro-intestinal diseases. Cosmo¡¯s proprietary clinical development pipeline specifically addresses innovative treatments for the gastro-intestinal tract, specifically Inflammatory Bowel Diseases (IBD), colon infections and colon diagnosis. For additional information of Cosmo and its products please visit its official website: www.cosmopharma.com.