Dendreon Sees Full Provenge Capacity by Mid-2011

by Deena Beasley | Reuters | 01.11.2010

Dendreon Corp (DNDN.O) expects to reach full manufacturing capacity for experimental prostate cancer drug Provenge by mid-2011, and will immediately launch sales of the drug when it is approved by U.S. regulators, the company's chief executive said on Monday.

Speaking at the JP Morgan healthcare conference here, CEO Mitchell Gold said an existing manufacturing plant in New Jersey is at 25 percent capacity, and will be up to full capacity -- supporting annual sales of $500 million to $1 billion -- by the first half of 2011.

Two other plants -- one in Southern California and another in Atlanta, each able to support sales of $375 million to $750 million -- are expected to be online by mid-2011.

The U.S. Food and Drug Administration is slated to decide whether to approve the drug by May 1.

Provenge, a therapeutic vaccine designed to activate a patient's own immune system, is produced by taking cells from a patient's tumor, incorporating them into a vaccine, then returning them to a physician to be injected back into the patient.

Gold said Provenge will be priced "in line with other biologics that prolong survival."

The company reported last April that Provenge extended survival in men with advanced prostate cancer. An outside advisory panel of doctors had recommended in March 2007 that the FDA approve Provenge, based on favorable efficacy and safety results from an earlier Phase III study, but the agency had declined to approve the medicine until data was shown to confirm earlier trends.

Gold said on Monday that the FDA has shown "no indication" that it would convene another advisory panel to review Provenge.

The CEO said Seattle-based Dendreon, which raised $410 million in a stock offering in December, has about $600 million in cash.

The company plans to commercialize Provenge on its own in the United States, but is looking for a partner to develop the drug in overseas markets.

Gold said Dendreon is in discussions with several potential overseas marketing partners, some of which had been seeking a share of the U.S. market for Provenge.

"We don't feel a lot of pressure to enter into a deal," he said.

The CEO also said Dendreon is "looking at" the use of Provenge in earlier-stage prostate cancer as well as other cancer types.

Copyright Reuters 2010