Key Developments For Dendreon Corp
Dendreon Corp (DNDN.O) (Consolidated Issue listed on NASDAQ Global Market)
Dendreon Corporation Receives FDA Acknowledgement Of Complete Response
Dendreon Corporation announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC). The FDA considers this to be a complete, Class 2 Resubmission following the action letter the Company received in 2007. The BLA includes data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC. The resubmission also contains the remaining information requested by the FDA pertaining to chemistry, manufacturing and controls section of the BLA for PROVENGE.
Dendreon Corporation Completes Submission Of Biologics License Application For PROVENGE
Dendreon Corporation announced that it has completed the submission of the amended Biologics License Application (BLA) for PROVENGE (sipuleucel-T), to the United States Food and Drug Administration (FDA). Dendreon Corporation is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC). If approved by the FDA, PROVENGE would represent the first product in the new therapeutic class known as active cellular immunotherapies.
Dendreon Corporation To Seek Provenge Approval In November-Reuters
Reuters reported that Dendreon Corporation plans to seek U.S. approval for its Provenge prostate cancer vaccine in November and expects regulators to act on the application by the middle of next year, the Company said. The Company previously said it would submit an application for Provenge in the fourth quarter.
Dendreon Corporation Signs Lease For New Manufacturing Facility In Atlanta
Dendreon Corporation announced that it has signed a lease agreement with Majestic Realty Co. to build a 160,000 square-foot manufacturing facility in Union City, Ga., where it expects to manufacture PROVENGE (sipuleucel-T) for patients with advanced prostate cancer.
Dendreon Corporation Hires Adviser For International Pact-Reuters
Reuters reported that Dendreon Corporation hired JPMorgan Chase & Co as an adviser to help it find an international licensing partner for its prostate cancer vaccine Provenge, a source familiar with the situation said. Dendreon is not looking to sell itself outright, but instead wants a partner for Provenge sales outside the United States, the source said. Dendreon and JPMorgan could not be immediately reached for comment.
