This morning, Kenilworth and a bio-similars development subsidiary of the Samsung Japanese entities announced some encouraging Phase III results (prior coverage of that relationship here). Among other things, they announced that the pair’s joint study of a bio-similar to infliximab, the agent branded as Remicade® around the world [and marketed by both J&J and Merck(!)], has shown good results — and will likely allow a filing with non-US, non-EU (i.e., “rest of world“) drug regulators later this year.
This is fascinating. Our readers will likely recall that — as a result of less than perfect lawyering, in the Schering-Plough reverse merger transaction — Merck was forced into an arbitration — against J&J — over the global rights to Remicade. That arbitration ultimately settled with J&J getting US rights, and Merck getting EU, Turkish and Russian rights to market the medicine. That left all the rest of the world as “open territory”. Now Merck is going to sell knockoffs of the stuff, wherever it is not prohibited by license from doing so. I suspect J&J is none too pleased about this development.
Why? It will eat into future market expansion plans of J&J, for the branded product — and (to my eye at least) this is Kenilworth effectively thumbing their collective noses — in the general direction of J&J. [Of course, as we’ve reported, Merck is presently suffering “generic” introductions in parts of the EU, which would lead me to now wonder aloud — whether J&J is quietly “helping out” with that competitive set of efforts.] Hilarious. From the presser then:
. . . .The portfolio includes biosimilar candidates in immunology, oncology and diabetes. There are five candidates in Phase 3 development [Merck partnered territories]:
· SB4 Enbrel (etanercept) [worldwide ex-U.S./EU/Japan]
· SB2 Remicade (infliximab) [worldwide ex-EU/Russia/Turkey]
· SB5 Humira (adalimumab) [worldwide ex-EU/Russia/Turkey]
· SB3 Herceptin (trastuzumab) [worldwide]
· MK-1293 Lantus (insulin glargine) [worldwide]
Each of these five biosimilar candidates is expected to be filed with regulatory authorities around the world between 2015 and 2016. . . .
Do go read all of the FierceBiotech item on the studies, and regulatory filing plans too. Because of the manifold geography limitations, these deals may not turn out to be of much material import, overall — to Merck. Onward we trudge — or forge, depending on our mood. . . missing you. . .