How Sanofi’s discontinuation of BCG affects patients, clinicians
Urology Times: What short-term and long-term implications does this announcement have for patients?
Dr. Davies: I think in the short term, it’s a challenge to predict. We may well see a decrease in supply in the near term, although it’s a bit of a challenge to know if that’s true or not. I think long term, we’ll actually have a little bit easier time predicting that we’re going to have real supply difficulties with BCG. I think it’s fair to say that barring any change or any new announcement, that’s likely to happen. The reason I say that is because we know that Merck has had challenges in the past in increasing supply of the drug, and that was around 2012 into 2013. That’s probably a product of it being a challenging drug to make. You can imagine that this is not the type of drug where it’s chemical XYZ joins chemical ZYX in a pot and it’s spit out into pills. This is a biologic drug that has to grow under very careful medium conditions, and one mistake in temperature, one contamination into the growth medium, and the whole drug can be spoiled. That can mean up to 5,000 to 10,000 doses can go bad day to day. So it’s a challenging drug to make, and we know that it can be a challenge for one manufacturer to really hold the supply of America in good faith.
And I would say in Merck’s defense, it’s not really good for Merck to be the only supplier in America of a drug that’s very challenging to make. You can imagine from a market perspective that that’s not the way we want to be. We want to have multiple people making challenging drugs, biologics in general, because that way we know the drug will be available. If Merck’s one plant in North Carolina goes down, even for reasons of which it really has no ability to control, what do we do? It’s a real big problem. So I say in summary to that question, short term, we don’t know, we may be okay for the next few months, next 6 months. Long term, I think we have a serious problem.