NYC-PC

Why Sales Estimates for Dendreon's Provenge Are Too Low

Michael, 33,000 patients/year out of 50-60,000 eligible is do-able, but it probably represents pretty high market penetration. I don't do these kind of projections, so I don't know what's a 'typical' penetration figure. As for off-label use--let me ask you, who's going to pay for it? 3rd party payers are not going to pony up for an unapproved indication--at least that's my understanding. And virtually no patients are going to pay out of pocket for a $45-80,000 therapy unless maybe they feel they will be cured and there's zero evidence to support that. And while the rest of the analysts may stay behind the curve, I have to think that your sweeping statement that '[t]he technology should work on any solid tumor cancer...' is the new definition of irrational exuberance. Have you forgotten that no other therapeutic vaccine has ever worked in cancer? And what antigens will they use in breast, colon, head & neck and other cancers? I think Dendreon would appreciate your guidance on the last question.

Why Sales Estimates for Dendreon's Provenge Are Too Low

I didn't quibble with your projection at all, just your 'facts'. Although that's not to say, I accept your projections either. I guess the market size all depends on how you (or Mitch Gold) define 'potential' market size. Provenge was tested in patients with hormone-refractory metastatic PC and will get a label limited to hormone-refractory metastatic disease, maybe narrower. He may be including in 'potential' off-label use or the expectation that they will later get approval in an earlier stage setting. But the incidence of HR, met PC in the US is +/- 55,000 patients/year. As for $80,000 per patient--I personally think that would cause a backlash and MDs would not prescribe it--i know i would not at that price.

Why Sales Estimates for Dendreon's Provenge Are Too Low

There are a number of errors in your column. 1st, the current incidence of PC in the US is 192,000 [www.cancer.gov/cancert...], not the 230,000 you quote. In addition, the observation that 80-85% will become hormone-refractory is grossly wrong. It is estimated that about 1/3 of newly diagnosed patients will fail management of their localized disease. This translates to estimates of 50-60,000 people failing surg and/or radiation therapy yearly and these are the people who may go on to become hormone-refractory--well below your figure of 180,000. I don't know the source of the Merrill Lynch estimate of 140,000 but that is also way off. You indicate that Provenge is given in '2 simple infusions over 3 weeks'--also wrong. It was actually given as 3 infusions every other week. It requires a leukophoresis [white blood cell removal from the patient], shipment of the cells to a processing facility and shipment back to the infusion center followed by the 'simple infusion' you mention. Not a big deal, perhaps, but you ought to get your information correct. Lastly, you comment "we know that the survival advantage over Taxotere, the current standard for metastatic prostate cancer, is a quite robust six weeks." Please tell me where a study was done that compared Provenge to taxotere? The fact is that no such study has been done. I would hope that if you had the 'expertise' to comment on biomedical issues/clinical trials that you should know that you cannot directly compare results of 2 separate studies--that's called a 'historical' comparison but it holds little weight beyond being 'hypothesis-generating'. From my perspective, you've made numerous errors and I have to question whether you are really qualified to draw the conclusions that you do. At least check your facts with someone who knows the field before you put them out to the general public.