Sanofi CEO Bets Outside U.S., Gears Up for Flu Pandemic, and Seeks To Learn From Biotech

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probably propose that. But a pandemic is a different kettle of fish. It’s in a concentrated time frame potentially. So you don’t have time to build a tiered pricing model and everything else. If we really get into a pandemic, there’s going to be a significant amount of competition—we’re already seeing it—for the first doses off the line. From the interest of public health, it would be a mistake to say all the richest countries get the vaccine. This would put [World Health Organization director general] Margaret Chan and the WHO into an untenable position. So, we felt we needed to respond to Margaret Chan’s call to action collectively to provide a stock of vaccine doses that she could deploy on a rapid basis where [the] need is, and to ensure an element of solidarity between all countries and all patients. It’s an exceptional set of circumstances with a pandemic, and that’s why we need exceptional measures, a donation in this case.

X: How much is this costing the company, or hurting the bottom line?

CV: I have to say, I have no idea. At this stage, we don’t even know what the dose is yet. We’re doing clinical trials, so we don’t know what the cost of an individual dose of the vaccine is going to be. But it’s not going to have a negative impact on earnings, because there is no normal market for pandemic flu. If we donate 100 million, we can produce 800 million over a year. There will still be some incremental profit for the company, coming out of pandemic flu vaccine. This just ensures that everybody gets an equitable opportunity to get the vaccine.

X: So to clarify, you can make 800 million doses a year?

CV: Roughly, assuming a 15-milligram dose. That’s the dose of the seasonal flu. What we actually don’t know is what the actual dose [for pandemic flu] vaccine will be. We just all assume it’s the same dose. It could be [different]. We will do clinical trials at 7.5 milligrams, 15 milligrams, and 30 milligrams. That’s all without an adjuvant [an immune-boosting compound], and an adjuvant could potentially reduce the dose further. We’ve just basically said we produce 220 million doses of normal seasonal flu vaccine every year, and that’s with three strains. You’d triple that, because a pandemic flu vaccine will be a monovalent [single-strain] vaccine. Then you have to take into account that we don’t actually produce that seasonal flu vaccine year-round on a 24/7 basis. That gets you from 660 million doses to 800 million on a rough basis.

X: Are you confident this will work against H1N1?

CV: That’s why we’re all busy working on manufacturing clinical trial lots so we can do clinical trials. They won’t necessarily give us efficacy, they’ll give us safety. But if you think about the fact that there’s been four types of H1N1 flu virus in the normal seasonal flu vaccine over the past few years, and although this is a different strain, you’d gain some confidence from being able to produce a seasonal flu vaccine using a strain like that. But of course, we won’t really be able to judge that until we start using it.

X: How does TB fit into the bigger picture of your global health plan?

CV: We have a historical interest because it was one of our former companies, that developed rifampicin, which is the backbone therapy of TB treatment today. We have sales of that product. We also have a new antibiotic, called rifampentine, which we’re developing … Next Page »

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