Tuesday, February 18, 2014

Apparently, Novartis Is Trying To "Buy Itself A Horse" To Enter The Anti-PD-1 Oncology Races -- Thank-Yous Go Out To My Commenters

Again -- my ever-watchful, vigilant and cogent anonymous commenters have provided a nice story idea -- on an otherwise slow Merck news day.

This time, it seems Novartis has belatedly realized what a boon an effective Anti-Programmed (T-Cell) Death Receptor-1 monoclonal antibody would be, in solid organ tumors -- albeit almost at post-time. So, the euro-giant is apparently buying Boston based CoStim Pharmaceuticals (an entrepreneurial little wunderkind), to effectively get at least some horse(s) into this race. [Roche has one too.] Clearly though, none of those companies' progams are at Phase III yet. So our earlier predictions stand, for now: while Merck may get approval for melanoma first, the bulk of the revenue will be in lung and kidney cancers -- and there I have BMS out ahead with later-stage, better data.

So. . . I still think BMS gets two-thirds of the pie, and Merck gets one-third of it, come mid-2015. But it is a perhaps $25 billion a year pie. And now Novartis may nip about five percent of that, off of these two -- if and when its acquired PD-1 candidates reach market. Not that those two will even notice (much) though, because a realistic estimate puts Novartis at a 2017 or 2018 launch date -- in all probability. Here is our comment-box discussion (slightly cleaned up for typos, from yesterday at lunch):

. . . .Anonymous said. . .

Pardon the interruption here, Condor, but another player has entered the PD-1 game. Interesting take in this write up, on where Merck's horse is in the race as well.

February 17, 2014 at 8:45 AM

Condor said. . .

Thank you so much Anon.!

That is interesting. I find it fascinating that Novartis is trying to buy a ticket to/horse in this show.

It is clearly now too late to make one, from scratch.

I also think basing a determination of "leading" -- in the race to market [the article guesses that Merck's lambrolizumab has the lead, given the rolling FDA submission announcement, of early 2014] -- on a rolling FDA submission. . .

. . .is a little unsophisticated.

BMS is likely to have better data in the "bigger burden" cancers, and sooner than Merck will -- and the bigger impact cancers (not just late stage melanoma). . . will drive the market win.

If oncologists will readily and lustily write "off-label", based on an initial clearance/label for melanoma, at FDA -- well, Merck may garner at least a temporary lead (should it actually be the first to clear FDA with a melanoma label) -- but the real question is whether the insurers, exchanges (and Tricare) will pay top dollar for "off-label" prescriptions in solid tumor cancers, like lung or kidney.

I am skeptical about that, so the winner will LIKELY be the one who gets "on label" in lung and solid organ cancers first.

We shall see.

Do stop back! Namaste

February 17, 2014 at 12:16 PM. . . .

As I say -- it will be an entertaining race, once the (latest version of a) starter's bugle sounds -- during the last weekend of May, at the 2014 ASCO conference -- in Chicago's South Loop. I'll pop over for that, now, for certain. Much more actual Phase I/II/III data due -- on all these thoroughbred candidates, then.

1 comment:

Anonymous said...

Off topic but related to Saunders, Fast Freddie's protege: