EU decision a rare positive for Dendreon

It is almost two years since cancer vaccine maker Dendreon ($DNDN) sent its share price into a precipitous decline by pulling the forecast on its debut drug, Provenge. Since then, bad news has mounted up. Weak sales drove shares down 30% last year, and the slide has continued in 2013.

At the end of last week Dendreon got a rare piece of good news, though. Europe's Committee for Medicinal Products for Human Use (CHMP) gave Provenge its backing, putting Dendreon a step closer to selling the vaccine in the region. Dendreon has struggled to grow Provenge sales in the U.S., with revenue from the drug falling almost 20% last quarter in the face of competition for the prostate cancer market. In the past year, the FDA has approved Johnson & Johnson's ($JNJ) Zytiga and Medivation's ($MDVN) Xtandi.

Dendreon is now looking to Europe to return the drug to growth. A final decision by the European Commission is expected later this year, but further work will then be needed to bring Provenge to market. While an approval will be European Union-wide, national and subnational payers hold the budgets to cover the $93,000-a-year drug. Negotiations will take time. "Whether Dendreon can find a partner or decides to launch the drug alone in Europe, we expect there will be a significant lag time between EU approval [and being on the market]," Sanford C. Bernstein analyst Geoffrey Porges wrote in a note seen by Bloomberg. Porges thinks it could take Dendreon until the third quarter of 2015 to bring Provenge to market.

Whenever Provenge arrives, it will face competition. Zytiga and Xtandi are both approved in Europe and have a head start on Provenge. In its favor, the CHMP release said Provenge is considered less toxic than available therapies because it is an immunotherapy.

- here's the Bloomberg article
- check out the AP's take
- read FiercePharma's coverage