Dendreon's Provenge gets recommendation in Europe

Dendreon ($DNDN) today got the best news it has had in a long time for its prostate cancer vaccine Provenge, a thumbs up from the Europe's Committee for Medicinal Products for Human Use (CHMP) for approval in Europe.

The treatment has yet to get expected traction in the U.S., forcing Dendreon to lay off staff to cut costs and try a bag of tricks to boost sales. CHMP recommended Provenge for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. It said the therapy has been able to improve the overall survival by 4.1 months over a placebo and, because it is an immunotherapy, it is less toxic than the therapies currently available for this fatal condition. Its recommendations are usually accepted by the European Medicines Agency within a couple of months.

"This recommendation represents a significant milestone for Dendreon as we advance the global market opportunity for Provenge," CEO John Johnson said. "We are finalizing our plans for a capital-efficient launch in Europe, including evaluating our partnering options."

The question will be whether the drug catches on any better in the EU than it has in the U.S. Dendreon has been struggling to get U.S. docs to use Provenge since its 2010 approval by the FDA. Its high price, $93,000/year, as well as competition from Johnson & Johnson's ($JNJ) oral treatment Zytiga, have made it a rough go. Dendreon has tried a list of ways to pump up sales, remaking its doctor-detailing program, doing more DTC advertising and working with reluctant payers. To cut costs it has laid off hundreds of employees and sold off a plant. It brought in Johnson last year to replace then-CEO Mitchell Gold, who had clouded the market by overpromising. The cost cutting has helped but Provenge continues to languish. In May, Dendreon laid out the results of another bad quarter, with Provenge sales actually down 17% to $67.6 million.

A side distraction for Dendreon has been a report in April that the SEC is investigating whether Gold acted on insider information when he sold shares ahead of a company announcement in 2011 that Provenge would not hit its sales forecasts.

- here's the Dendreon press release
- read the EMA release

Special Report: Provenge - 10 top drug launch disasters

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