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Dendreon May Not Survive Its Success: Q&A with Founder Chris Henney, Part 1

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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 … Next Page »

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    I am very concerned that the alleged corruption surrounding DNDN is very real. “Deep Capture” has presented the facts beautifully and one must take their facts seriously. In sum, I believe Dendreon was indeed railroaded 2 years ago when they did not get FDA approval. Corruption and conflict of interests both at the FDA and other places played an important role in an attempt to kill Dendreon. Yet, as of today, still nothing has been done by the authorities to expose and or punish these criminals. Say what you wish. But, 600+ men have died because of greedy, heartless, money hungry corrupted individuals who obviously do not care about anyones life except theirs.

  • Warlord_2010

    “There were a small minority who wanted more data, but that’s pretty common.” He is being kind! What he should have said is that there was a small minority that was so conflicted they never should have voted, much less been seated on the Advisory Committee! Read http://www.deepcapture.com to see not only how corrupted was the FDA review of Provenge, but how ten hedge funds colluded in a failed attempt to destroy Dendreon. That people provided evidence of this to the SEC and to the HHS IG more than 2 years ago, and that nothing was done, speaks volumes about how ineffective these two agencies are in rooting out corruption…assuming that they even have the least bit of understanding what is going on under their noses. Both the SEC and HHS need a good housecleaning, beginning at the highest. The fact is, nothing has changed in these two agencies…they continue on, business as usual, as they have for the last 9 years. And meanwhile, between May 8, 2007, when the FDA asked for more data, and now, 65,000 men have died of prostate cancer. Many could have been helped by Provenge. And the data the FDA wanted? Well, as seen in the article, it was released on April 28, 2009, and it showed what the FDA knew on March 29, 2007: the drug is safe and effective. Our FDA: what a poor excuse for an agency charged with protecting the health of the American Public. As Joseph Stalin once said: One man’s death is a tragedy, a million is a statistic.” Or was it our FDA?

  • Luke, I am now getting confimation from Chris Henney what I was hearing from David Miller at the Investor Village get together the night before the Dendreon shareholder meeting this year.

    I would prefer to see Dendreon remain independant but these days it is tough. Also big pharma wants to see that a little biotech can not only succeed in phase three but also get the product through the FDA and then be able to produce the product in quanity and finally be able to sell and get reimbursed for it.

    Yes…too complicated. But if Dendreon can do all these things, they will be acquired or have to fight like hell to stay independant.

    Luke, again, thanks for just the facts. So many other media sources just can’t do that.


  • Steven, that’s an interesting point you raise. It sounds like you’re saying that Big Pharma wants to see more risk removed from the equation at Dendreon before it is willing to acquire the company. I’m curious what other readers think those essential steps are: FDA approval, manufacturing scale-up, Medicare reimbursement at the company’s desired price, early sales momentum, or more?

  • Steven is not correct. Just look at the recent J&J acquisition of another prostate cancer company, Cougar Biotech (symbol was CGRB) for $894 million. Cougar has two Phase III trials in process with no results yet. About where DNDN was in early 2006.

  • I asked my boss, you could have gotten that property a lot cheaper, why did you bid so high? he answered, I wanted it. I think Big Pharma with the deepest pockets think the same way. Do your DD and it points to only one high buck phama by far, but M. Gold ain`t sellin`. Get it?