Wednesday, February 20, 2013

Samsung Subsidiary "Dials Up" A Merck BioSimilars Commercialization "Hook-Up"

A few observations, if I may: (1) While financial terms were not disclosed, we may safely assume this is a pretty significant collaboration -- because these two very large multinationals issued a joint press release. Merck does that (on its front page) for only the largest of its deals. Note that Merck didn't do so for the now $650 million relationship with Lycera I mentioned on Monday. So it's likely big.

(2) But, how big? Well, it almost certainly cannot be over $2.5 billion. At that level, it would approach five percent of Merck's yearly sales -- and would be arguably "material" (a magic word, that), and thus the projected amount would be have to be disclosed, under applicable SEC rules, and case law. It may well be north of the $650 million figure we mentioned on Lycera, though -- we shall see. Even so, it may well run into the high hundreds of millions, or (perhaps somewhat fancifully) not too far under $2 billion. But, to be clear, that is all just educated conjecture -- on my part.

(3) The most fascinating story-line here, though (Oops! I buried my lead!) -- for my money -- is the accelerating shift toward biosimilars, by once "branded-only" pharma multinationals. Merck is offering to be the market muscle behind what used to be derisively called -- at Whitehouse Station -- the "generic copies" made by "thieves". Or so (used to say) the branded pharma "innovators". Now, these same companies are seeing that there is much money to be made by selling biologically similar agents -- and competing against branded biological agents. Oh, how the world turns. Those nasty patent cliffs will do that, right?

In any event, here is a bit of Samsung Bioepis version of the the release:
. . . .Under the agreement, Samsung Bioepis will be responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration. Merck will be responsible for commercialization. Samsung Bioepis will receive an upfront payment from Merck, product supply income and will be eligible for additional payments associated with pre-specified clinical and regulatory milestones. Further financial terms were not disclosed. . . .

Personally, I think they could have just txted it. More seriously, we will keep you posted. [This is the 3,000th post on this blog. Woot!]

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