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Merck's Biosimilar Version of Lantus Tops Phase III Studies
Merck & Co. Inc. (MRK - Free Report) announced encouraging data from two phase III studies on its insulin glargine candidate, MK-1293, for the treatment of type I and type II diabetes.
The two randomized, active-controlled, open-label studies evaluated the safety and efficacy of MK-1293, in comparison to Sanofi’s (SNY - Free Report) Lantus (insulin glargine).
Data from the studies revealed that MK-1293 demonstrated non-inferiority in change from baseline A1C (average blood glucose) and had a similar safety profile as Lantus after 24 weeks in patients with type I and type II diabetes, thereby achieving the primary endpoint. In addition, the studies met the pre-specified secondary efficacy endpoints of statistical A1C equivalence to Lantus, thereby establishing that the investigational treatment was similar, within a certain range, to the current therapy.
Results were presented at the Scientific Sessions of the American Diabetes Association.
Merck is developing MK-1293 in collaboration with Samsung Bioepis. Under the agreement terms, Merck is responsible for clinical development, manufacturing and commercialization while Bioepis is partially funding development.
Currently, an application for regulatory approval of MK-1293 for the treatment of patients with type I and type II diabetes is under review in the EU. The company expects to submit a regulatory filing for the candidate in the U.S. this year.
We note that the diabetes market is heavily crowded and several companies are working on bringing new and improved treatments to market.
We remind investors that Eli Lilly and Company (LLY - Free Report) is already marketing a biosimilar version of Lantus in the EU, which is expected to hit U.S. markets after Dec 15, 2016.
Merck currently carries a Zacks Rank #3 (Hold). Bristol-Myers Squibb Co. (BMY - Free Report) , with a Zacks Rank #1 (Strong Buy), is a better-ranked stocks in the health care sector.
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