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that it can do this in an incredibly reproducible way. The logistics around it [in which blood is shipped from the clinic to Dendreon and back] are different to other therapeutic proteins, but the inherent manufacturing isn’t particularly complex.
X: What are the top three priorities on your to-do list?
HB: To make sure we build a world-class team. The organization is going to grow substantially as we prepare for launch. Bringing in the best of the best is important to us. It’s going well so far, by the way. We just hired a number of district managers that I really believe fit that criteria.
We also need to make sure all the things you need in place for a good commercial launch are in place. We need to educate urologists and oncologists about the clinical data set we have, and the benefits of Provenge.
There are a couple things we clearly need to manage between now and the launch. In the first quarter of this year, we’ll have an inspection from the FDA of our manufacturing plant [in Morris Plains, NJ]. Those are the three major things on the list.
X: What do you want to accomplish in this first year on the job?
HB: The priority, without a doubt, is a successful launch of Provenge. All the other things we just talked about will support a successful launch of Provenge. That’s where I’ll spend all my time.
X: Will you be closely involved in figuring out what the price will be?
HB: Sure. What we’ve said is we’ll price Provenge similarly to other novel biologic drugs that extend lifespan.
X: I’ve heard that before. Can you be a little more specific? Will this be in the Erbitux range or the Avastin range? [Editor’s note: Eli Lilly’s cetuximab (Erbitux) antibody drug for lung cancer costs about $80,000 per patient, while Roche’s bevacizumab (Avastin) antibody for lung cancer costs $8,800 per month, which can cost as much as $100,000.]
HB: I don’t think we’ll say more than that. It wouldn’t be appropriate. We haven’t made a final decision. But that’s the range in which we’re doing our analysis.
X: How has health care reform affected your ability to set the price?
HB: There’s been nothing directly in this round of healthcare reform that will change the process for us. There is no change. But we take the general debate … Next Page »
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