Dendreon Saga Heads Toward Climax, As Cancer Drug Aims to Prove It Prolongs Lives

Luke Timmerman4/3/09Follow @ldtimmerman

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Dendreon has all the ingredients of a Hollywood thriller: Life and death on the line. Millions of dollars at stake. Fast money in the stock market. Cutting-edge technology that aspires to achieve the impossible.

The Seattle biotech company (NASDAQ: DNDN) has gone through a riveting set of twists and turns over the past two years, and the story may reach its climax within weeks. One day this month, Dendreon plans to rip off the blind from a clinical trial that it hopes will offer convincing proof that its experimental drug helps men with terminal forms of prostate cancer live longer, with minimal side effects.

If this trial of 500 men is successful, Dendreon will dash off to the FDA for permission to start selling this product, called Provenge, in the U.S., possibly by the end of this year. Analysts will rhapsodize about a new drug with $1 billion annual sales potential. Scientists will talk about a new paradigm of cancer treatment that stimulates the immune system to fight cancer cells like a virus. Patient advocates will cheer, as about 30,000 men in the U.S. who die of prostate cancer each year will have a new kind of treatment option. Dendreon stock will rocket from its current plateau of a little more than $4 to more than $20 a share, says Seattle-based biotech analyst David Miller.

If the trial fails, though, things will get ugly. Layoffs will likely follow, and the company’s promising immune-therapy technology will probably go on the back burner. Dendreon will likely fall back on a more conventional small-molecule pill for cancer that’s just entering clinical trials and has years to go before proving its worth. People will be inclined to write off the whole field, given that Dendreon would join a growing list of companies that failed to live up to the promise of cancer vaccines, including Cell Genesys, Genitope, and Favrille.

If there are shades of gray in the Dendreon data, all bets are off.

“We are going to see fireworks,” Miller says.

Like any good story, Dendreon’s tale has a beginning, a middle, and an end (which we haven’t quite gotten to yet). The company was founded in 1992, formed out of technology from Stanford University. From the start, it had a powerful pull on the imagination of scientists, doctors, patients, investors, and journalists. I first started following Dendreon in 2001 while at The Seattle Times.

Dendreon has worked all those years, and burned through more than $563 million of investor money, to develop its active immunotherapy, or cancer vaccine, technology. It doesn’t work like a traditional chemotherapy … Next Page »

Luke Timmerman is the National Biotech Editor of Xconomy. E-mail him at ltimmerman@xconomy.com Follow @ldtimmerman