Merck & Co. and Samsung Bioepis—a joint venture of Samsung and Biogen Idec—said today they have expanded their year-old collaboration in a way that Merck says will support one of its key priorities of building its diabetes drug portfolio.
The joint venture partners said they signed an agreement to develop, manufacture and commercialize MK-1293, an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes. The partners said they will collaborate on clinical development, regulatory filings, and manufacturing, with Merck agreeing to commercialize the drug candidate if approved.
Phase III clinical studies in type 1 and type 2 diabetes will begin “soon,” according to Merck and Samsung Bioepis. Additional details, including the value of the collaboration, were not disclosed.
“This agreement will help build our portfolio across the spectrum of the disease,” Matt Strasburger, svp, diabetes for Merck’s Global Human Health business. “We look forward to collaborating with Samsung Bioepis on this insulin glargine candidate, as diabetes is a top priority for the company.”
Merck identified diabetes as one of its four key therapeutic areas last year, along with oncology, acute hospital care, and vaccines.
One study involving MK-1293 entails a 58-week trial comparing the safety and efficacy of the compound to Sanofi’s blockbuster drug Lantus® in patients with type 1 diabetes, according to the website of Sun Research Institute in San Antonio, which is participating in the study.
And in New Zealand, separate studies of a year in type 1 diabetes patients and six months in type 2 diabetes patients are assessing the safety of MK-1293 in comparison to Lantus, according to the website of P3 Research.
The expansion comes about a year after Merck and Samsung Bioepis entered into their collaboration, saying at the time they would create “multiple pre-specified” undisclosed biosimilars. The collaboration followed separate biosimilars failures by Samsung and Merck in recent years.