Client News
Dendreon CEO sees clear path to Provenge approval
Reuters UK
May 12th, 2009
NEW YORK, May 12 (Reuters) - The risk of Dendreon Corp's (DNDN.O: Quote, Profile, Research) Provenge prostate cancer vaccine failing to win U.S. approval in its second attempt is "low," the biotechnology company's CEO said on Tuesday.
The U.S. Food and Drug Administration stunned investors in May 2007 when it demanded more data before approving Provenge, despite an earlier recommendation in favor of the product from an FDA advisory panel.
Dendreon CEO Mitchell Gold believes that positive data unveiled last month from a clinical trial will be sufficient.
"I think the regulatory risk for Provenge is low at this time," Gold said at a Bank of America health care conference, which was broadcast over the Internet.
Gold said the FDA was specific in its feedback two years ago when it said it wanted additional data demonstrating Provenge prolonged survival, and the criteria for success of the clinical trial was clearly defined.
The results of the so-called Impact study found that Provenge improved three-year survival of patients with advanced prostate cancer by 38 percent, compared with a placebo.
Dendreon shares have nearly tripled to $20 since the company first announced on April 14 that Provenge worked in the Impact study. They were at $20.02 in early afternoon Nasdaq trading, down $1.01.
The company plans to seek approval for Provenge in the fourth quarter and expects a six-month review by the FDA, Gold said.
BREAKTHROUGH
Provenge stands to be a breakthrough for tens of thousands of men who suffer from prostate cancer and the first approved therapeutic vaccine for any type of cancer.
Unlike traditional vaccines that prevent disease, Provenge treats it by stimulating the body's own immune system to attack cancer cells.
Gold said the company had yet to determine a price for Provenge but that he expects it to be priced similarly to other biologics — drugs derived from living cells or proteins — that prolong survival.
Even with Provenge's delay, Gold said, word of the potential treatment has spread.
"The regulatory delay actually allowed us to create more brand awareness for the product," he said. "I think that physicians are extremely aware of this product and what it means for their patients."
Significant bearish sentiment had built up in Dendreon's stock for many months, as reflected by the large short position, but that may be on the wane.
Dendreon saw the second-largest decrease in its short interest last month in terms of volume of all Nasdaq-traded stocks, according to Nasdaq data released on Monday.
Short interest in Dendreon fell 42 percent to 12.48 million shares from April 15-30. About 12.4 percent of Dendreon's shares are now held short.