Monday, February 10, 2014

Merck Expands BioSimilars Relationship With Samsung Bioepis -- Pushing Into Sanofi's Lantus® (Insulin Glargine) Diabetes Space

Well, this ought to make for some good theatre (so, now cue-up the sure to be looming IP fights -- in the UK, the USA and Japan -- as well as throughout the balance of the EU).

Merck just announced that it has expanded upon its year-ago agreements with Samsung Bioepis. This time, in the pair's sights, though, it seems to be diabetes -- not cancer.

More precisely -- this time, it seems to be a big ole' honking bio-similar construct (see spidery structure at right, with a "Biggest Loser"-style molecular weight, @ 6,000-plus g/mol!), which would compete with Sanofi-Aventis's Lantus® -- Insulin Glargine. The Phase II clinical trial(s) are wrapping up; Phase III (approvability protocols) are to begin, post haste. Here's a bit from the wires, this morning:

. . . .“We look forward to collaborating with Samsung Bioepis on this insulin glargine candidate, as diabetes is a top priority for the company,” said Matt Strasburger, senior vice president, Diabetes, Global Human Health, Merck. “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.”

“Samsung Bioepis is very pleased to extend the partnership with Merck to the field of diabetes,” said Christopher Hansung Ko, Ph.D., CEO of Samsung Bioepis. “This collaboration will bring better access to patients with diabetes worldwide. . . .”

I suppose the $6.4 billion question is whether these biosimilars, when they reach market in 2017 or 2018, will be able to command anything like the margins the Sanofi branded exclusive Lantus® presently commands. Who knows? [Frankly, same question applies to Rituxan®, and Biogen/Idex, announced last February. Indeed, who knows?] In the mean time, this is likely a near $800 million investment collaboration, all in, between Whitehouse Station, and Samsung Bioepis. Stay tuned.

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