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

Xconomy Seattle — 

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 »

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17 responses to “Dendreon Saga Heads Toward Climax, As Cancer Drug Aims to Prove It Prolongs Lives”

  1. This will be one of the more interesting days in biotech in 2009. I expect the conference room in Chicago where the data are to be presented to be absolutely packed.

    David Miller

  2. eric newland says:

    Hussain – if I remember – had a conflict of interest as he was involved in support of a competing prostate drug – and his vote was detrimental in the approval process.

  3. Mike Scott says:

    With the deepest respect to Eric Newland …

    (a) Dr. Hussain is a “she”, not a “he” and she has been involved in clinical research on nearly every significant prostate cancer drug that is or has recently been in development. That’s her job. She’s a specialized clinical researcher in prostate cancer! That’s not a conflict of interest. That IS her interest, and I have profound respect for her integrity.

    (b) More than half the panel at the CBER hearings had conflicts of interest because their future research funding was tied to the development of immunotherapeutics for treatment of cancer (but no one seems to recognize that that might bias their opinions). Mr Timmerman has pointed out in his article that one member of the panel did effectively admit that after the meeting.

  4. Paul Sanders says:

    What will be the extended life expectancy as a result of using Provenge and what will be its costs?

  5. Bob says:

    Another company betting the Easter egg basket on Prostate Cancer…

    I know the Federal Govt. is looking at these expensive treatments, that, at best increase life-span by a few months…

  6. mason says:

    will DNDN succeed in spite of itself? lol history tells me to bet against it. The company has issues, even if the science does not. Everything since they FDA shot them down has been last bid attempts to salvage stock market value, asking for another recount, if you will. They are snake oil IMHO.

  7. bob denver says:
  8. p3analyze says:

    nice summary but for a necessary correction:

    The interim analysis penalized hurdle of success for the upcoming final anlaysis of the ongoing IMPACT trial is a 22% improvement in median survival.