Pioneering prostate cancer drug approved

By Andrew Jack in London

Published: Last updated: April 30 2010 02:29

US regulators on Thursday approved a pioneering treatment for prostate cancer, lifting the value of Dendreon, its Seattle-based developer, by more than 25 per cent.

Sipuleucel-T, known by its brand name Provenge, dubbed by some the world’s first therapeutic cancer vaccine, is an injectable treatment designed to tackle the disease once it has been contracted.

The approval could pave the way for new approaches to tackling a range of cancers using immunotherapy, sparking fresh investment and research by rival companies. It would also mark a boost to the biotech sector in the northwest of the US, extending the corridor of growing companies that stretches from San Diego in the south and Los Angeles northwards, through the industry’s traditional US hub in the San Francisco area.

Provenge works by stimulating the body’s own immune response, in contrast both to traditional vaccines, which build defences ahead of infection, and to existing cancer drugs that passively trigger an immune response.

George Farmer, an analyst with Canaccord Adams, said Provenge had the potential to bring in $4.3bn in annual sales by 2020. “Demand will be very high given the simplicity and convenience of administration combined with the extremely benign safety profile,” Mr Farmer said.

Dendreon ended $10.56, or 26.7 per cent, higher at $50.18. The shares have gained 51 per cent this year as investors looked ahead to the FDA decision. The approval follows nearly two decades of development costing Dendreon nearly $800m, and a series of regulatory setbacks including a demand in 2007 for additional clinical studies from the company.

Karen Midthun, acting director of the FDA’s centre for biologics evaluation and research, said in a statement: “The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available.”

The results approved by the agency showed an increase of just over four months in overall survival in 512 patients with advanced prostate cancer, most with only mild or moderate side effects. Median survival was 25.8 months compared with 21.7 months for those not receiving the treatment.

The company will need to overcome concerns by health insurers in persuading them to use its product, given both the relatively short proven extra benefit and the high cost. Analysts have estimated treatment will be priced at around $75,000.

Some specialists believe the use of the drug could ultimately be extended to provide earlier stage treatment, offering the prospects for greater efficacy.

Copyright The Financial Times Limited 2010.