Back at Dendreon, Caggiano takes on Provenge's comeback

Photo credit: Corey Nickols

When the FDA gave Dendreon's prostate-cancer therapy Provenge a thumbs-up in 2010, even the most skeptical observers had a hard time keeping expectations in check. Here was the first immuno-oncology drug, one that offered patients a significant survival benefit with minimal side-effect profile. One analyst predicted annual sales of $4.3 billion by 2020, making all the “blockbuster” chatter seem decidedly non-bombastic.

Then Provenge hit the market, where it promptly tanked, taking Dendreon down with it. The firm filed for bankruptcy protection in November 2014 and was purchased by Valeant the following February, for a mere $495 million (according to one report, the original purchase price of $296 million was upped to secure approval from the bankruptcy court).

Observing the scene from afar, Jim Caggiano, then a VP at Allergan, was stunned. He had witnessed Provenge's birth during an earlier turn at Dendreon and couldn't understand what went wrong. “The drug got approved, then [Dendreon] proved they could execute the logistics, then they secured Medicare reimbursement. Had you told me all three of those things would happen, I would have said, ‘Here's your next blockbuster. Thousands of men are going to be treated with this,'” he says.

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Caggiano's thinking wasn't entirely off the mark. Provenge's slow start was not, he notes, related to a product issue. But in the minds of several analysts, price ($93,000 for a full treatment course) and concerns about its administration (a patient's white blood cells are extracted, blended with vaccine components, then infused back into the patient) proved a heavier lift than expected.

Caggiano didn't think these explanations passed the smell test. They considerably overstated the challenges associated with administration and didn't touch on an initial marketing strategy that was flawed at best.

“I don't say this in regard to the Provenge launch specifically, but sometimes you need to keep things simple,” he says.

So when Valeant called in mid-2015 and asked him to return to Dendreon, Caggiano accepted. Item one on his to-do list, not surprisingly, was to breathe life back into Provenge. Central to that effort was refocusing marketing efforts around urologists, rather than the oncologists who received the most attention the first time.

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“If urologists didn't embrace [Provenge], it wasn't going to reach its potential,” he says. “The urologist should be the quarter­back of prostate-cancer care.”

Caggiano and his team went to work. In the first phase of their efforts, they explained the Provenge administration process to urologists. “What some of them didn't get was that this isn't chemotherapy. They didn't need extra resources. They needed a chair and a pole,” he says. “We had been hearing, ‘Oh, this is going to be a headache.' Once they treated a few patients, they realized it was a simple process.”

After that, Caggiano and company went into teaching mode. They instructed urologists how to identify when patients were at the point in their disease progression where they would benefit most from Provenge. They also provided practice-management assistance when needed, especially in the form of referral programs.

The turnaround has been swift. In 2015, 20% of Provenge enrollments came from urologists; that figure will exceed 50% in 2017. Caggiano says Dendreon “has a shot” of increasing Provenge enrollments by 20% this year.

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Meanwhile, Valeant's sale of Dendreon to Chinese conglomerate Sanpower Group is expected to close sometime this month. The price tag this time around? Approximately $820 million. That represents a neat 66% return on investment for Valeant in fewer than two years.

Caggiano, not surprisingly, is doubling- down on his early belief that Provenge will realize its blockbuster destiny — and restore Dendreon's luster in the process.

“The one thing I want to make sure I convey is that Dendreon is back,” he says. “Between organizational discipline and a change in strategy, we've evolved into an exciting and growing enterprise. We have the people, energy, and resources to make Provenge the world changer it's always had the potential to be.”