June 28 (Bloomberg) -- Dendreon Corp. rose after winning the backing of European Union regulators for the prostate cancer treatment Provenge, the company’s only marketed product.
Dendreon gained about 1 percent to $4.12 at the close in New York. The Seattle-based company’s shares have declined 22 percent this year.
Provenge was approved in 2010 as the first therapy in the U.S. that trains the body’s immune system to attack cancer cells as if they were a virus. Possibilities for partnerships for the drug in Europe are being evaluated, Dendreon said today in a statement. The European Medicines Agency’s Committee for Medicinal Products for Human Use today recommended that marketing authorization for Provenge be approved with a final decision by the European Commission expected later this year, Dendreon said.
“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, Geoffrey Porges, an analyst at Sanford C. Bernstein & Co., wrote today in a note. Provenge may not reach the EU market until the third quarter of 2015, said Porges, who has an outperform rating on the shares.
The committee recommended that Provenge be cleared to treat prostate cancer with no or little symptoms in adult males for whom chemotherapy isn’t yet clinically indicated.
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