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.

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3 responses to “Dendreon to Turn in Provenge Application to FDA in Mid-November”

  1. Bob Smith says:

    Will that Neuvenge trial be a Phase 1 trial? Or since they already had some phase 1 trials for it for another cancer, will it be Phase 2?

  2. Luke TimmermanLuke Timmerman says:

    Bob–I didn’t catch which phase of trial Dendreon has in mind for Neuvenge, although the earlier work was in breast cancer, and this is for bladder. I would guess this will be another Phase 1.–Luke

  3. jerzee says:

    Luke ….
    Should Mitch and company prove true to form, that is, to hold out for a peer attended event to release pertinant new data – and should historical track records mean anything at all then perhaps a quick review of old news releases may suggest a more narrow mid November date to focus in on.

    On the last go round Dendreon put forth the following headline with story on Monday November 13, 2006: “Dendreon Completes Submission of Biologics License Application to FDA for PROVENGE in Hormone Refractory Prostate Cancer”
    Just three days earlier, on Friday November 10 the company set the stage with: “Dendreon Announces New Data Analysis Presented at Chemotherapy Foundation Symposium”. These headlines book ended the Symposium dates.

    If one were to be looking to narrow “mid-November” down to a feasible guesstimated date … with the Chemotherapy Foundation Symposium “Innovative Cancer Therapy for Tomorrow” being convened this year in New York from November 10 – 14 ….. somewhere around there might prove to be a good time to start checking for press released top line data numbers and completion of the aBLA submission headlines.