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Dendreon Announces Plans to Seek Marketing Authorization for PROVENGE in Europe
Date:1/7/2011

clinical data described in its U.S. Biologics License to file its marketing authorization application (MAA) to the European Medicines Agency (EMA) in late 2011/early 2012.
  • To accelerate the regulatory timeline, initially PROVENGE will be manufactured through a Contract Manufacturing Organization (CMO) while Dendreon concurrently builds an immunotherapy manufacturing facility in Europe.
  • The company anticipates a regulatory decision in the first half of 2013.

  • DN24-02 IND Filing

    • Dendreon filed an Investigational New Drug (IND) application in December 2010 with the U.S. Food and Drug Administration (FDA) for DN24-02 for the treatment of invasive bladder cancer.
    • The randomized Phase 2 study will evaluate the safety and efficacy of DN24-02 in patients with HER2+ invasive transitional cell carcinoma (TCC) of the bladder following cystectomy.
    • The primary endpoint is to evaluate overall survival. Approximately 180 patients will be enrolled at clinical sites throughout the U.S.  

    Conference Call Information

    Dendreon will host a conference call today at 6:00 a.m. PT, 9:00 a.m. ET. To access the live call, dial 1-877-548-9590 (domestic) or +1-720-545-0037 (international). The call will also be audio webcast and will be available from the Company's website at www.dendreon.com under the "Investor/Webcasts and Presentations" section. A phone replay of the call will be available for 3 days by calling 1-800-642-1687 (domestic) or +1-706-645-9291 (international); Passcode: 35063654.

    PROVENGE Indication and Safety

    PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

    PROVENGE is intended solely for autologous use and is not routinely teste
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    SOURCE Dendreon Corporation
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