Good News -- But Entering A Crowded, Highly-Competitive Field... In Type 2 Diabetes

This combo falls in the "adult onset", or type 2 diabetes space, for the two companies -- which as we reported four and three-quarters years ago -- involves a 60/40 split, in favor of Kenilworth, on this next gen diabetes drug-pairing.

As we've long intoned, this cooperative effort is running well behind the Lilly offering (in fact, we speculated that the entire "risk sharing" venture was born of Lilly's clear lead, back in the Spring of 2013).

With Glyxambi^TM (the Lilly offering) already on-market and at least arguably showing some cardio-protective data, if this new combination treatment is going to gain real traction, it too will need to show some cardio-protective benefit. We shall see -- but here is MDMag's coverage -- as well as SeekingAlpha, with some more of yesterday afternoon's coverage of the FDA approval letter:

. . . .The US Food and Drug Administration has approved ertugliflozin for the treatment of glycemic control in patients with type 2 diabetes (T2D).

Ertugliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor from Merck & Co. and Pfizer, was approved as both a single therapy and fixed-dose combination therapy with dipeptidyl peptidase-4 inhibitor sitagliptin (Januvia^TM) or common first-line therapy metformin. The combination therapies will carry the brand names Steglujan and Segluromet, respectively.

Merck and Pfizer previously announced successfully-met endpoints for the combination therapies in 2 phase 3 trials (VERTIS MET, VERTIS SITA) in June.

VERTIS MET, a 26-week study which evaluated the safety and efficacy of 5 mg and 15 mg ertugliflozin with metformin, compared the combination therapy at both doses, with placebo and metformin in adult patients with uncontrolled T2D currently taking metformin monotherapy. . . .

Steglujan^TM will compete head-to-head with Boehringer Ingelheim and Eli Lilly's Glyxambi^TM (empagliflozin/linagliptin). . . .

Now you know. This combo-package is unlikely to move the needle very much, for either mega-pharma. Each is just too. . . big. [And, as an update to the "I was wrong" tax story (about which I'll have another post coming shortly), there may be a "Pay as You Go" fly, in Mr. Trump's tax package soup, that will as soon as January 2018 further curtail the measure. These guys just don't really think. . . anything all the way through, it seems.]

Still scantly sleeping, As sleep fails to find me -- once again. . . but smiling at long-ago tight curls, just the same. . . .

नमस्ते