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Can Dendreon’s new Provenge data help ignite a turnaround for the faded cancer star?

Two years ago, when Valeant bought Dendreon and its prostate cancer cell therapy Provenge out of bankruptcy for $400 million, observers marked it as another step down a long and bumpy spiral for a treatment that had once been celebrated as a historic breakthrough. Valeant was the sole bidder and a bad match.

Then CEO J. Michael Pearson called the acquisition an effective way to launch Valeant into the cancer field — but Pearson wasn’t headed anywhere. A year later, the CEO was out the door and Valeant was in utter disarray as its business model of buying drugs and jacking the price became a radioactive source of controversy.

Provenge, though, has survived the latest chapter of its troubled history. A Chinese company, Sanpower Group, struck a deal to buy the cell therapy — built from cells extracted from patients — for $820 million, looking to penetrate the huge Chinese cancer drug market.  And the executive crew that runs Dendreon released new “real world” data over the weekend to underscore its effectiveness among African-American men, pushing to expand the market and awareness for a drug that had been eclipsed by Xtandi and Zytiga.

When the FDA approved Provenge 7 years ago, it required Dendreon to set up a patient registry to track its impact. And now Dendreon, looking to stage a comeback, has posted some of the new data they’ve drawn from the registry to underscore its potential for a subset of African-American patients primed to deliver the best outcomes.

Comparing African-Americans and whites with similar baseline characteristics, Dendreon notes that they tracked an overall survival benefit of 9.3 months compared with Caucasians (37.3 months vs 28.0 months, respectively). And if you restrict to patients with PSA levels below median amounts, “African-American patients demonstrated an additional OS benefit of nearly two additional years (20.9 months) compared with Caucasian patients (54.3 months vs. 33.4 months, respectively).”

The data were presented over the weekend at the 112th American Urological Association Annual Meeting in Boston by lead author A. Oliver Sartor.

Jim Caggiano

Jim Caggiano, president of Dendreon, says the data underscore the value of using Provenge at an early stage of the disease, particularly among African-American men who suffer from a significantly higher risk of death from prostate cancer.

“Dendreon is back and better than ever,” Caggiano told me ahead of the data review. “These findings are important for all men.”

These new data mark a big step toward expanding the market for Provenge, says Caggiano, who was originally hired into Dendreon by former CEO Mitch Gold back in 2004 as the head of its sales effort.

Gold, now back at work as a biotech entrepreneur, also outlined some huge sales forecasts that caused quick and painful trouble for Dendreon. With new, more easily administered drugs rivaling Provenge, the autologous cell therapy never had a chance to compare well.

Caggiano, though, says that the drug is being used by a growing group of patients. Last year about 4,000 men were treated with Provenge, he says, up from about 3,500. And Sanpower’s willingness to pay more than twice what Valeant needed to pluck it out of bankruptcy underscores the growing attraction.

Sanpower should complete the buyout soon, says Caggiano, and that will set the stage for new studies to test Provenge with surgery and radiation, looking for evidence that an aggressive combination can be curative.

Provenge is a long way from dying out, says the Dendreon president with all the enthusiasm of a head cheerleader. And he intends to try. But not everyone at the meeting was impressed.

 


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