Update: Merck’s Bladder Cancer Med TICE BCG Will Be In Short Supply Into 2020, As Well…

As we reported in early February of this year, back then, the bad news was that TICE BCG (Live) would be “on allocation” — for all of 2019. That’s now been revised and down-dated — to cover all of 2020. So the shortage will stretch at least two years. [Query whether Sanofi could be persuaded to start production again, between now and then?]

I doubt it — Sanofi has very-likely reconfigured its own relevant manufacturing facility significantly (and likely irretrievably), to make an entirely unrelated bio-drug — so no easy fix, to the dire short supply situation will appear in my estimation.

In any event, the most relevant bit of the update, then from the excellent people at FiercePharma, this morning:

. . .Merck says it’s been the sole supplier of TICE BCG, an important bladder cancer med, since 2012 after Sanofi and another drugmaker ran into manufacturing problems. Sanofi never reintroduced its drug, Merck says. In 2016, Sanofi confirmed it was exiting the market.

As the lone supplier, Merck says it has expanded production by more than 100% and cut 40% off its manufacturing time. It’s now at full capacity, producing 600,000 to 870,000 vials annually.

Still, Merck can’t quite keep up. Demand is growing around the world, and Merck still sometimes suffers from issues in a “lengthy and complex” manufacturing process. In January, the company started “proportionally allocating the medicine across countries where the company is the sole or primary supplier, including the United States” based on historical averages. . . .

As we explained before, this is something like baking a huge soufflé, for 100,000 people, all at once. It is a very complicated bio-process — if one batch fails, a reset is required — and Merck cannot now increase its capacity any more, without essentially building entirely new facilities, from the ground up. So people saying “just make more”. . . fundamentally under-appreciate the complexity of the bio-chemistry, involved. Now you know. Onward, to a warm St. Patrick’s weekend here. Smile. . . .


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