Dendreon to Turn in Provenge Application to FDA in Mid-November
Dendreon has been saying for months that it plans to file its amended application to the FDA in the fourth quarter, and today it got a little more specific, saying it expects to complete that job by mid-November. That means it should be on target to start selling sipuleucel-T (Provenge) to U.S. prostate cancer patients by the middle of 2010.
That was the closest thing Seattle-based Dendreon (NASDAQ: DNDN) released to news at a relatively ho-hum analyst day this morning in New York. The company is now taking some investors on a tour of its nearby New Jersey factory, where it uses its unique process to create a personalized drug that “teaches” a patient’s own immune system to recognize and fight prostate cancer cells.
Dendreon did release a few more kernels of information this morning, but it didn’t have anything big to say about a commercial partner in Europe or the price projection for its drug—and it didn’t have any new head of sales and marketing to introduce. Those are a few of the big questions on the minds of investors, which the company will surely have to address some other time. The stock was down this morning around 5 percent while the company delivered its presentation.
Here were a few other notable items the company disclosed this morning.
—Dendreon has 290 employees now and will double headcount in time for the Provenge market introduction, said Greg Schiffman, the company’s chief financial officer.
—The company’s New Jersey factory will have room to make $500 million to $1 billion worth of Provenge annually, while the Atlanta and Los Angeles area factories will be smaller, each with the capacity to produce $375 million to $750 million worth of the drug per year.
—Dendreon has a goal of moving forward one new Provenge-like candidate each year, for other cancers, to prove that Provenge isn’t a one-hit wonder—and that it really has a demonstrated an immunotherapy platform approach to cancer. The company plans to go ahead with another clinical trial of lapuleucel-T (Neuvenge) for bladder cancer in late 2010 or early 2011.