to each other in a general sense.
X: What went through your mind when the results came out in late April?
CH: We had seen the data come out two years ago. Clearly, the FDA’s expert committee had certainly endorsed not only the concept behind the product, but the data they had seen at the time. There were a small minority who wanted more data, but that’s pretty common. Academics always like more data. So repeating it was less surprising. Obviously if the thing works, it should be able to repeat it. I wasn’t surprised. It’s a nice endorsement. Because with the first trial, the numbers were small. When the numbers got larger, the statistical analysis became easier and more convincing.
X: For a very long time, the company was all about a debate over whether the data was convincing or not for Provenge.
CH: Yeah, because the numbers were fairly small. But even from the early days, everything internally was consistent. The patients who did better were the ones with a more pronounced immune response. Everything always held together. It’s just that to make the argument strongly to a skeptical audience, it required the numbers be larger.
X: Now that the numbers are larger, that debate seems to have moved into the past.
CH: That’s right. People are now willing to concede that it works. But if you put it into context, it’s the only cancer vaccine approach that has worked. Cell Genesys and a whole variety of people have tried different approaches for the same issue. This, to date, is the only one that worked. I think that has to speak to the efficiency of the procedure. That is to say that while cumbersome, the process of removing cells, incubating them, and then re-infusing them gives you the best loading with dendritic cells that we’ve been able to achieve.
X: Now that the clinical and development phase for Provenge has passed, what are the top priorities for making this a commercial success?
CH: No. 1 has to be manufacturing, the scale of manufacturing. I don’t doubt that these guys can market it. And in Dave Urdal, they’ve probably got the most experienced manufacturing guy in the entire biotech industry. Dave’s been doing this for 30 years. If there’s anybody I would have faith in for manufacturing, it would be Dave.
X: Is there anything unique about how this company is structured? Is it really rare for them to have made it all the way through Phase III clinical trials without having to sell away half the baby to a Big Pharma company? To have 100 percent ownership worldwide—does this represent some kind of unique commercial opportunity?
CH: No. In fairness, it’s because of the nature of the product, it’s just not in the sweet spot of Big Pharma. The very nature of the manufacturing, and the complication of it, it’s hard for them. Big Pharma is about small molecules. Then reluctantly, they added biotechnology products to their armamentarium, which are large molecules. But this is going a step further. This is cell therapy, another version of cell therapy. The likelihood that Big Pharma would have wanted it, in the company’s early, unproven days, was not high. Now that it’s a proven product, maybe someone would be willing or interested in making that move. It might be more likely to be a large biotech company instead of classic Big Pharma. Or maybe a Japanese company.
X: Do the pharmas not get it?
CH: It’s not that they don’t get it, it’s that it’s complicated for them. It represents
