Wednesday, August 13, 2014

Celltrion Files For US FDA Biosimilar License On Infliximab (Remicade®); It Won't Change Merck's Share Price


J&J, on the other hand, should begin to worry about feeling a pinch -- in its Janssen unit (which controls the brand -- and the patents, in the US).

Regular readers will recall that the settlement of the massive (potentially $41 billion deal killing) spat occasioned by Mr. Hassan's mostly-goofy footed attempt at a reverse merger -- to avoid a Remicade® rights "walk-off" by J&J (from Schering-Plough), related to jointly marketed monoclonal antibody products (including Simponi®) -- led to then "New" Merck settling and surrendering all its US rights to a share of those revenues. So, here in the US, the revenue belongs to J&J -- as does this potential downside.

Also here in the US, Celltrion is seeking a declaratory judgment that the Remicade patents are invalid and unenforceable. Here's a bit of that spat (a 27 page PDF file). So -- this morning's Pharma Times report of the FDA biosimilar filing will really only affect J&J's revenue, as Merck already suffered its correlative generics entrance revenue hit, almost exactly a year ago, in the EU and Japan -- when the Celltrion biosimilar product was aproved in those geographies. Celltrion's lower-priced competing anti-inflamatory antibody product is now sold in 50 countries around the globe.

We will keep an eye on this, just the same. By their terms, the relevant patents expire in 2018 -- but a ruling invalidating the patents altogether, here might bring additional competitors into the EU and Japan, beyond the current Hospira and Celltrion biosimilar offerings. This is perhaps Merck's second most important franchise, behind only Januvia®/Janumet®. So, we will monitor that Massachusetts federal District Court litigation. Now, go out and enjoy the bright sunshine -- we've gotcha' covered -- in sunscreens.

2 comments:

Anonymous said...

Check those Persols!

Anonymous said...

Missing you -- wearing my green! Proudly so, too! Smile...