Merck, Samsung Bioepis to develop diabetes biosimilar

MK-1293 is an insulin glargine candidate for the treatment of types 1 and 2 diabetes

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WHITEHOUSE STATION, N.J. and SEOUL, South Korea—Merck, also known as MSD outside of the United States and Canada, and Samsung Bioepis Co., Ltd. have announced the expansion of their collaboration in the form of an agreement to develop, manufacture and commercialize MK-1293, an insulin glargine candidate for treating type 1 and type 2 diabetes. Phase 3 clinical studies of the compound will begin soon for both types of diabetes.
Per the terms of this agreement, Samsung Bioepis and Merck will collaborate on the clinical development, regulatory filings and manufacturing of the compound. Should it successfully attain market approval, Merck will be responsible for commercializing MK-1293.
“Samsung Bioepis is very pleased to extend the partnership with Merck to the field of diabetes,” Christopher Hansung Ko, Ph.D., CEO of Samsung Bioepis, commented in a statement. “This collaboration will bring better access to patients with diabetes worldwide.”
This expansion builds on the agreement established by the partners a year ago. In February 2013, Samsung Bioepis and Merck began an agreement for the development and commercialization of multiple pre-specified biosimilar candidates. Under the terms of the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing clinical trials and registration of the candidates, while Merck is responsible for commercialization. Though specific financial terms were not disclosed, Samsung Bioepis received an upfront payment from Merck, as well as product supply income and potential additional payments if clinical and regulatory milestones were met. Rich Murray, Ph.D., senior vice president of Biologics and vaccines research at Merck, noted in a press release regarding the original agreement that the deal “positions the two companies well to increase access to biosimilars to improve human health.”
“We look forward to collaborating with Samsung Bioepis on this insulin glargine candidate, as diabetes is a top priority for the company,” Matt Strasburger, senior vice president of Diabetes, Global Human Health at Merck, said in a press release regarding the agreement. “Merck is strengthening its leadership in diabetes through our own work and in collaboration with others, and this agreement will help build our portfolio across the spectrum of the disease.”
Glargine is the generic name for Lantus, a long-acting form of insulin marketed by Sanofi for the treatment of diabetes mellitus. Eli Lilly and Co. is also developing a biosimilar of the diabetes drug, which currently nets Sanofi approximately $7 billion each year.
This is just some of the most recent work in biosimilars for Samsung Bioepis. Last December, the company made an announcement, along with Biogen Idec, that the latter had exercised its right to enter into an agreement to commercialize anti-tumor necrosis factor biosimilar product candidates in Europe. Samsung Bioepis is a joint venture established by Samsung and Biogen Idec in December 2011 for the development, manufacture and marketing of biosimilars.

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