UPDATE: Dendreon Announces Increased Capacity and Significant Reimbursement Decisions Supporting Broad Availability of PROVENGE

- FDA Approves Los Angeles Immunotherapy Manufacturing Facility, CMS Announces National Coverage Decision, and Product Specific Q-Code Effective - Dendreon Corporation

today announced significant milestones that support broad availability for on-label use of PROVENGE® (sipuleucel-T), the first autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer (mCRPC). The U.S. Food and Drug Administration (FDA) approved the Los Angeles immunotherapy manufacturing facility on June 29, 2011. The facility includes 36 workstations, and Dendreon will bring these on in a staged approach. In addition, the Centers for Medicare and Medicaid Services (

) issued a final National Coverage Decision (NCD) for PROVENGE on June 30, 2011, requiring Medicare contractors to cover the use of PROVENGE for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. The NCD will standardize coverage processes across the country for all Medicare patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer and provides the local Medicare Administrative Contractors (MACs) specific criteria, consistent with the label, on how PROVENGE should be covered. PROVENGE was issued a product specific Q-code effective July 1, 2011, which allows for electronic submission of claims and is expected to accelerate time to payment for physicians. As part of this expanded access, Dendreon supports programs to provide comprehensive assistance for eligible patients seeking access to treatment with PROVENGE, including through grants to independent foundations and establishment of a patient assistance program for uninsured patients. Dendreon provides grants to independently run foundations providing qualifying patients with financial assistance for co-pays, co-insurance, and treatment-related travel costs. "These significant achievements support broad access to PROVENGE, the foundation of care for men with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "The increased capacity and positive National Coverage Decision by CMS in conjunction with the patient assistance programs will ensure patients who may benefit from treatment with PROVENGE have increased access to it."