Dendreon revving up drug plants ahead of FDA decision
Dendreon will have three plants to make its Provenge prostate cancer drug by mid-2011, said Chief Executive Officer Mitchell Gold.
Dendreon will have three plants to make its Provenge prostate-cancer drug by mid-2011, said Chief Executive Officer Mitchell Gold.
The Seattle-based company will also have a sales force of 125 people to market the drug, he said at a Biotechnology Industry Organization conference in New York.
U.S. regulators are slated to make a decision on the drug on May 1, and Gold said that if Dendreon gets the go-ahead, "Within one year of potential approval, we'll be at full capacity."
Provenge, designed to treat the second-leading cause of cancer death in men, could be worth more than $1.5 billion in 2016 in U.S. sales, wrote Eric Schmidt, an analyst for Cowen & Co., in a note to investors on Feb. 2.
The plants, in New Jersey, Atlanta and Orange County, Calif., will produce at full capacity $1.2 billion to $2.5 billion in sales, Gold said.
The New Jersey plant will be working first, he said. It is currently at 25 percent capacity and will be at full capacity in the first half of 2011.
Dendreon has $600 million in cash as of Dec. 31, 2009, and is looking for a partner to help market Provenge outside the U.S., Gold said.
Dendreon rose 55 cents to close at $29.44 on Tuesday.
Provenge, if approved, would be the first drug to train the body's immune system to attack cancer cells like a virus. It could provide a new treatment option for a disease that kills about 27,000 men a year, according to the National Cancer Institute.
Provenge extended the lives of men with prostate cancer that had spread to other organs by four months, according to a study released by the company on April 28. The therapy involves extracting infection-fighting white blood cells from patients, mixing them with the vaccine and injecting that combination to attack tumors.
Dendreon won a 13-4 vote in favor of approving Provenge at a meeting of cancer advisers to the U.S. Food and Drug Administration in March 2007. But the FDA in May 2007 rejected Provenge, requesting another study.
This time the FDA is "90 percent or more likely" to approve the drug this year, Cowen's Schmidt wrote in his note.
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