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CNBC ON DIGG

Pharma's Market

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Aug.23

1:40 PM ET

Thursday, 23 Aug 2007

Dendreon's Provenge Backers Want Action: Marching On FDA

Posted By:Mike Huckman

Topics:FDA | Medicine | Pharmaceuticals

Sectors:Health Care Equipment and Services | Health Care | Pharmaceuticals

Companies:Dendreon Corp

AP
In case you hadn't heard September is Prostate Cancer Awareness Month. It's the #2 cancer killer of American men behind lung cancer. The American Cancer Society estimates nearly 220,000 men will be diagnosed with the disease this year. And as the emails coming into our inboxes indicate, it's going to be a busy month for those who are trying to get more money, research and drugs to help fight it.

Sept. 5th-8th the Department of Defense's Prostate Cancer Research Program will hold its conference called the 2007 Innovative Minds in Prostate Cancer Today, or IMPaCT for short, in Atlanta.

On Sept. 27th and 28th the National Prostate Cancer Coalition will hold its annual Advocacy Day (actually, it's two days) in Washington, DC.

And on September 18th Provenge proponents announced today that they will be holding "A Right To Live Day" at Food and Drug Administration headquarters in Rockville, MD. On its Web site, www.arighttolive.com, the organization says it's an "all-volunteer advocacy group", but doesn't divulge whether its base is made up of patients, their advocates, and/or investors. Scott Riccio, the founding member of Right to Live, told me over the phone the group is made up of all three stakeholders. He says he does not own DNDN shares.

The group will be protesting the FDA's controversial delay in the potential approval of Dendreon's [DNDN Loading... () ] Provenge. Riccio is quoted in a press release saying, "It has become very clear over the past few years that the FDA has instituted a decelerated approval process for cancer therapies....There has never been such an incredible, irrational and unjustifiable denial of rights of dying patients by such a dysfunctional agency."

This protest follows two small demonstrations in Washington and in Chicago at the American Society of Clinical Oncology meeting last June.

The FDA says it makes decisions about whether to approve or reject drugs based solely on the scientific evidence--the clinical trial data. In the case of Provenge, the agency has asked for the results of an ongoing, larger study aimed directly at determining if the drugs extends patients' lives and, if so, by how much. The preliminary data are expected, at the earliest, the middle of next year.

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