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news.Dendreon Corporation is to reduce its workforce by 15% and realign its resources to focus on advancing the development of Provenge, its lead investigational immunotherapy for the treatment of prostate cancer.
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The majority of the company’s resources will now be deployed to complete a biologics license application (BLA) and prepare for the commercialization of Provenge.
The 15% reduction in workforce represents 34 employees, primarily in early-stage R&D and in general and administrative functions. The company said that it plans to continue hiring highly specialized and skilled individuals needed to commercialize Provenge.
Provenge has fast track designation and Dendreon plans to begin submitting the BLA to the FDA on a rolling basis by the middle of this year. The company will also apply for priority review upon completion of its BLA submission later in 2006.
The BLA is based on randomized phase III data that showed a statistically significant survival benefit with Provenge in the overall intent-to-treat group of men with advanced prostate cancer.
Dendreon has also announced that Michelle Burris, senior vice president, will be leaving the company. Rick Hamm, senior vice president, corporate development and general counsel will now oversee financial functions and Dr David Urdal, senior vice president and chief scientific officer, will oversee manufacturing operations.
“These changes will allow us to focus on accomplishing the critical activities necessary to see Provenge through the regulatory process and successfully commercialize this novel therapy that we believe could fundamentally change the treatment of patients with late-stage prostate cancer,” said Dr Mitchell Gold, Dendreon’s president and CEO.