Dendreon Announces Strategic Realignment to Focus on PROVENGE BLA and Commercialization

24-Jan-2006

Dendreon Corporation announced the Company has realigned its resources to focus on advancing PROVENGE® (sipuleucel-T), its lead investigational active cellular immunotherapy for the treatment of prostate cancer, toward the market as expeditiously as possible. In addition, Michelle Burris, senior vice president and chief financial officer, will be leaving the Company. Rick Hamm, senior vice president, corporate development and general counsel will now oversee financial functions and David Urdal, Ph.D., senior vice president and chief scientific officer, will oversee manufacturing operations.

The majority of the Company's resources will be deployed to complete the Biologics License Application (BLA) and prepare for the commercialization of PROVENGE. PROVENGE has Fast Track designation and the Company plans to begin submitting the BLA to the U.S. Food and Drug Administration (FDA) on a rolling basis by the middle of this year. The Company will apply for Priority Review upon completion of its BLA submission later this year. The BLA is based on randomized Phase 3 data that showed a statistically significant survival benefit with PROVENGE in the overall intent-to-treat group of men with advanced prostate cancer. In addition, the Company will also focus on completing an ongoing Phase 3 study, known as the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, for the potential treatment of patients with metastatic, androgen-independent prostate cancer.

As a result of this realignment, Dendreon reduced its workforce by 15 percent or 34 employees, primarily in early-stage research and development and in general and administrative functions. The Company plans to continue hiring highly specialized and skilled individuals needed to commercialize PROVENGE, particularly at its manufacturing plant in East Hanover, NJ.

https://www.bionity.com/en/news/51771/dendreon-announces-strategic-realignment-to-focus-on-provenge-bla-and-commercialization.html