Merck and Samsung Bioepis expand biosimilars pact

Companies will develop and commercialize a biosimilar version of diabetes therapy Lantus

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WHITEHOUSE STATION, N.J.—South Korean corporate giant Samsung isn’t a name that leaps to mind when one thinks about life sciences, but rather when one thinks of smart phones and television sets. However, the company has been positioning itself to be a player in the pharma and biotech markets and, to that end, Samsung Bioepis in February announced a deal with U.S.-based Merck & Co., known as MSD outside the United States and Canada, to develop, manufacture and commercialize MK-1293, an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes.
The candidate would essentially be a biosimilar version of Sanofi’s Lantus, with Merck and Samsung Bioepis planning for Phase 3 clinical studies of their candidate in type 1 and type 2 diabetes patients to “begin soon.”
Samsung Bioepis is actually a joint venture between Samsung and Cambridge, Mass.-based Biogen Idec, and this isn’t the first time the joint venture and Merck have signed a deal. Nearly a year earlier, Merck and Samsung Bioepis agreed “to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.”
Presumably, other biosimilars will eventually follow, but the diabetes candidate seems to be the first out of the starting gate and, given that the companies say this collaboration “builds upon” their earlier agreement, MK-1293 seems not to have been part of the original scope of their deal inked in 2013.
Under the terms of the agreement, the companies will collaborate on clinical development, regulatory filings and manufacturing of MK-1293, and if it gains regulatory approval, Merck will commercialize the candidate.
“Samsung Bioepis is very pleased to extend the biosimilar partnership with Merck to the field of diabetes,” said Dr. Christopher Hansung Ko, CEO of Samsung Bioepis. “This collaboration will bring better access to patients with diabetes worldwide.”
Matt Strasburger, senior vice president of diabetes for Global Human Health at Merck, expresses his own eagerness to begin the new work with Samsung Bioepis, “as diabetes is a top priority for the company. 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.”
Looking more broadly, Dr. Rich Murray, senior vice president of biologics and vaccines research at Merck Research Laboratories, said of the original and wider deal that “The combination of Merck's global commercial presence with Samsung Bioepis’ biologic development and manufacturing capabilities positions the two companies well to increase access to biosimilars to improve human health.”
The larger biosimilars deal called for Samsung Bioepis to be responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration, with Merck responsible for commercialization. Samsung Bioepis received an upfront payment from Merck, product supply income and will be eligible for additional payments associated with prespecified clinical and regulatory milestones. No specific financial details were shared about the more recent diabetes deal, however.
As regards that current diabetes agreement, analysts at Bernstein Research noted on Feb. 10, “The relevance of today's announcement to Sanofi is the potential for greater price erosion and market share loss from two ‘generic’ Lantus.’ We currently model ‘generic’ erosion of Lantus in our Sanofi model in the mid-2016 timeframe. This erosion could accelerate more quickly now that a second player is likely to enter in the 2016 timeframe.”
The “first player” suggested by the Bernstein wording is most likely the duo of Eli Lilly and Co. and Boehringer Ingelheim, which co-developed the insulin glargine biosimilar candidate LY2963016. In January, Sanofi filed a patent infringement suit in the U.S. courts claiming that Lilly’s marketing submission to the U.S. Food and Drug Administration for LY2963016infringes four of the Sanofi’s patents.
Samsung’s journey into biopharmaceuticals began officially in November 2011 when the ground was broken for Samsung Biologics—which had been established as a corporate entity in April 2011—in Incheon, South Korea, with full-scale operation set to begin by January 2013. Then, a month later, Biogen Idec and Samsung announced an agreement under which they would invest $300 million to establish the  joint venture Samsung Bioepis for the development, manufacture and marketing of biosimilars, with Samsung holding the leading role in the joint venture and Biogen Idec contributing its experience in protein engineering and biologics manufacturing.
Per the 2011 agreement, Samsung agreed to put forward $255 million in funding, providing it with an 85-percent stake in the joint venture, while Biogen Idec contributed $45 million for a 15-percent stake. The joint venture is based in Korea and would contract for technical development and manufacturing services with both Biogen Idec and Samsung Biologics.
In December 2013, as we reported in our Daily News section on the DDNews website, Biogen Idec and Samsung announced that through Samsung Bioepis, Biogen Idec had exercised its right to enter into an agreement for the commercialization of anti-tumor necrosis factor biosimilar product candidates in Europe. This included biosimilars of therapies for conditions such as rheumatoid arthritis and Crohn’s disease.
Despite the flurry of activity, however, it remains unclear how successful this joint venture’s biosimilar efforts—or those of other companies—will be in the short run based on past recent experiences. A 2012 report by McKinsey & Co. on emerging biosimilars suggested that the estimated market could be anywhere from $2 billion to $20 billion by 2020, but also noted, “Copying [monoclonal antibodies] is inherently more complicated, and there will be greater uncertainty over whether small deviations will have any meaningful clinical effect. The probability of success in developing these molecules is also like to be lower. Both Teva and Samsung have recently had difficulties in developing biosimilar rituximab [Remicade].”

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