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Dendreon: The Revenge of Provenge

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Biotech firm may make huge leap in battling prostate cancer.

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When Dendreon (DNDN) halted trading last night and announced it was going to release the results of its IMPACT Phase III trial of Provenge for late-stage prostate cancer, the butterflies started. Despite being exhausted after walking a few miles late last night while volunteering for a count of homeless folks in Seattle, I confess I didn't get much sleep last night.

My firm first met with Dendreon management in 2000. We've been bullish on the company during that time span, believing their active immunotherapy drug Provenge was a winner. There's been more than a little drama along the way, and I've taken my share of bruises for this bullish stance. This morning's announcement that IMPACT met the demands of the FDA's Special Protocol Assessment (SPA) and would be resubmitted for approval is making for a pretty darn good day.

Provenge, for those unfamiliar with the story, is a unique drug. It takes a man's immune-system cells and trains them to recognize a standardized "antigen" called PAP. This antigen is a marker for prostate cancer cells in men who have relapsed (progressed) after their prostatectomy and hormone-therapy treatments. These patients are said to have metastatic, Hormone-Refractory Prostate Cancer (HRPC, sometimes called CRPC or AIPC).

In an earlier Phase III trial, this drug posted a survival benefit higher than ever seen for men with HRPC. Out of many ways of expressing this, I believe the most telling is that 3 years out, guys who got Provenge had a 34% chance of being alive versus less than 10% for those who didn't.

The most exciting part about this drug is the side effects are fevers and chills. This drug trains men's immune systems to work better, so the side effects are similar to the side effects a person gets as their body mounts a significant immune response against the flu. Also, a man gets the drug 3 times - and that's it. Three doses over 6 weeks and he's done.

Contrast this to the other approved drugs in the space. Taxotere -- a chemotherapy drug that has a smaller survival benefit -- has significant side effects. Anywhere from 1%-2% of patients who take the drug die from the side effects and not from their disease.

In patient surveys, over 50% of men say they/ll never take Taxotere, even though it's the only therapy approved for their disease. Sales figures and the inability of academics to convince men to sign up for clinical trials looking to take Taxotere into earlier-stage prostate cancer prove these surveys accurately depict real-world attitudes.

Dendreon will re-submit their BLA to the FDA in the fourth quarter of 2009. In 6 months or less after the submission date, I expect the FDA to approve the drug. My firm projects peak sales in the US in excess of a billion dollars per year.

The company needs to sign a European partner to get the drug approved and sold over there - something I expect to happen in the next year. If EU regulators don't require new clinical data -- which I'll have a better opinion on after we see more data from Dendreon at the end of the month -- then the drug could be on the market in Europe in 2011.

I've spent a great deal of time talking to urologists, urological oncologists and patients about this drug. Urologists and patients will readily adopt this drug. Good urological oncologists will too. But old-school oncologists -- who have a hard time believing chemotherapy is no longer the best, first treatment -- will resist. That's ok - I'm sure people kept buying buggy-whip stocks after the automobile came on the scene.

Manufacturing of Provenge is different, but easily scalable. Their existing facility in New Jersey will be scaled much faster than your typical biologics manufacturing plant. In any case, its size is sufficient for early launch needs. Manufacturing will be a little more expensive than the average biologic, but not prohibitively so.

I believe today's event will have a positive effect on the overall biotech market, but I'm not prepared to call an all-clear quite yet. The overall macro market is sketchier than in the biotech bust of 2001-2002, so we'll see.
Position in DNDN

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