Earlier this week, Dendreon (NASDAQ:
DNDN ) announced that it has completed the submission of its amended Biologics License Application (
BLA ) for PROVENGE (sipuleucel-T), seeking approval for men with metastatic castrate-resistant prostate cancer (
CRPC ). The amended BLA includes data from the IMPACT 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.
PROVENGE is currently available through several ongoing clinical trials, including OpenACT, an open label trial enrolling men with metastatic CRPC, ProACT, and NeoACT. On 4/28/09, DNDN announced that its experimental cancer vaccine Provenge extended the life of patients with advanced prostate cancer by a median of 4.1 months, which is one month longer than the only other treatment option, Taxotere. The Company will have the manufacturing capacity to generate possible sales of $60-125 million during 2H10 until full capacity is achieved in late 2011. The estimated date for a possible FDA decision is 5/3/10 if a priority (six-month) review is granted by the Agency.
Provenge is poised to become the first FDA approved therapeutic cancer vaccine, which represents a high-risk space for drug development, including public companies such as Favrille, Genitope, and Cell Genesys which have previously failed in late-stage, Phase 3 clinical trials for their therapeutic cancer vaccines. Below is a new index launched last month and tracked at the Investars YOU website for the immunotherapy and vaccine space, including 40 companies on a global basis.
The actively managed HavRx
<font> ImmunoTherapy / Vaccines Index </font> includes companies with market caps below $5 billion at the time of index inclusion which are developing or commercializing any type of immunotherapy, gene therapy, or vaccine product that is designed to stimulate the immune system for the eradication, combination treatment, or prevention of cancer. In addition, the index will track companies which are developing or commercializing any type of vaccine product or vaccine adjuvant for all types of infectious disease such as influenza (flu) and bio-defense applications.
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