Healthy Skepticism Library item: 11487

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Publication type: news

Perrone M.
Ahead of the Bell: Dendreon Protest
Associated Press 2007 Sep 18
http://biz.yahoo.com/ap/070918/dendreon_ahead_of_the_bell.html?.v=1

Full text:

Protest to Support Approval of Dendreon’s Provenge Unlikely to Speed FDA Review Process

WASHINGTON (AP) — The profile of Dendreon’s cancer treatment, Provenge, could rise Tuesday as a group of protesters — made up of patients and investors — urge the government to clear the drug.
Demonstrations calling for the approval of a single drug are extremely rare and analysts said the effort is unlikely to speed up the Food and Drug Administration’s review. But with more than 15 years of research completed and a loss of over $90 million last year, Dendreon has a lot riding on the success — or failure — of Provenge.

While the demonstration to take place outside FDA’s offices in Rockville, Md., will include many cancer patients, Dendreon investors also are expected to attend.

“Unlike your typical big pharma company, Dendreon doesn’t have any other products on the market, so this is their one shot at gold,” said analyst Paul Latta of Seattle-based research firm McAdams, Wright and Ragen. “As a result there are probably many investors willing to go above and beyond to see this drug through.”

In recent months Dendreon investors have donated money to several cancer patient groups pushing for approval of Provenge. In one case, investors helped pay for an ad in The Washington Post, criticizing FDA’s handling of the drug.

But the FDA is unlikely to yield to the pressure.

The agency is already under investigation by Congress for several food and drug safety issues, and FDA scientists are unlikely to push through a novel cancer vaccine before it has been completely vetted.

Shares of the Seattle-based company soared more than 200 percent in late March the day after a panel of FDA advisers gave Provenge a positive review. But in May shares plunged almost 60 percent when government scientists said they want more patient data before approving the treatment.

Scott Riccio, founder of the group A Right to Live, said he expects about 200 people to participate in the protest. A Right to Live is funded by donations, according to Riccio, though he said he does not screen donations to see whether they come from people with a stake in the company.

Provenge is an experimental vaccine that functions like a cancer-fighting drug. If approved it would be the first in a new class of treatments designed to stimulate a patient’s immune system against cancer. An estimated 232,000 new cases of prostate cancer are diagnosed each year in the U.S., and more than 30,000 men die from prostate cancer each year. Treatment typically involves surgery, radiation therapy and chemotherapy, depending on when the cancer is detected.

FDA’s outside panelists voted unanimously that the vaccine was safe and 13-4 that it appeared effective against advanced prostate cancer.

Despite that positive opinion by FDA’s advisers, Dendreon’s studies of Provenge were not conclusive. Both of the small studies submitted to FDA by the company failed to meet preset goals of slowing cancer progression. Only in post analysis did Dendreon find that patients treated with its drug lived about 4.5 months longer than those taking a dummy pill.

Dendreon’s management hopes mid-stage results from a study due out next year will convince FDA of Provenege’s effectiveness.