Wednesday, June 25, 2014

With This Flawlessly-Designed Phase III Study Stoppage -- BMS Is Ready To Submit Nivolumab To FDA; Will It Do So In July?

As I said as ASCO wrapped up in the first few days of June -- BMS has positioned itself to take the best market share, overall -- in the class of anti-PD-1 receptor oncology candidates -- even if Merck receives a slightly-prior approval date in the melanoma indication.

That is so, because, frankly, the BMS studies were more thoughtfully designed (vis-a-vis Merck, and the others, in the space) -- with eventual approvability being the first goal. With a view toward speedy submissions (and approvals, at FDA and EMA) -- once efficacy became evident. It is now quite thoroughly evident. Smartly strategic, in clinical trial management and expenditures. That's a hallmark of the new BMS. So -- I still see nivolumab as garnering the bulk of the overall oncology market share here (for squamous-cell lung cancer, too). BMS is up 3 per cent on the NYSE.

Why? Because. . .

. . .overnight, we learned that BMS is the first to be able to show Phase III melanoma survivablity data worthy of FDA submission. I expect the company will submit nivolumab (as a complete FDA packet) very shortly. Here is Bloomberg on it:

. . . .Bristol-Myers Squibb Co. (BMY) said it stopped a late-stage study of a top experimental drug after skin cancer patients showed “superior overall survival” with the medicine compared with a group on chemotherapy alone.

Patients in the chemotherapy group were “unblinded” and allowed to take the experimental drug, called nivolumab, after an analysis by the trial’s independent data monitoring committee, Bristol-Myers said today in a statement. . . .

The study of patients whose skin cancer had spread “represents the first well-controlled, randomized Phase 3 trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit,” Michael Giordano, head of the New York-based company’s oncology development, said in the statement. . . .

Merck may get there at about the same time, but BMS is now better positioned to pivot the data into FDA approvable letters for at least six other cancers. That represents a $35 billion to $40 billion market. We will keep an eye on it.

Separately -- the Australian deal Merck signed is only a guaranteed $20 million. So, I'll likely not cover it. Waifsh (even though some MSM outlets are reciting the larger, contingent on milestones' acheived figures).

Now, if you believe the boards at CafePharma -- the Merck US sales teams will learn which of their managers and team leads (and higher ups) are without jobs; and which regions are being consolidated and or eliminated, altogether -- come tomorrow by noon. So -- stay tuned for that. A slew of such individuals heard on Monday, that they has been let go -- the ones that do not have seats in the new regional structure, at Merck.

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