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Dendreon Statement on CMS National Coverage Analysis
Date:6/30/2010

SEATTLE, June 30 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) announced that the Centers for Medicare and Medicaid Services (CMS) today initiated a National Coverage Analysis (NCA) of PROVENGE® (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). PROVENGE is the first in a new therapeutic class known as autologous cellular immunotherapies.

In CMS's announcement of the NCA, CMS is requesting public comments on the effects of PROVENGE on health outcomes in patients with prostate cancer.  It is not a change in Medicare coverage policy. 

NCAs do not impact existing coverage decisions, nor do they restrict local Medicare contractors from covering PROVENGE.  Therefore, Medicare beneficiaries are still able to access PROVENGE and private payers can also still cover PROVENGE.

Dendreon welcomes the opportunity to continue our discussions with CMS about how PROVENGE will be provided to Medicare beneficiaries, particularly given the survival benefit and safety profile of PROVENGE.  We plan on continuing to work closely with CMS during this process to ensure patients with advanced prostate cancer have broad access to PROVENGE.

Clinical Trial Results Supporting U.S. Food and Drug Administration (FDA) Approval

Three Phase 3 studies involving 737 patients were submitted to FDA to support licensure. The pivotal study was the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial (D9902B), a 512-patient, multi-center, randomized, d
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Related medicine technology :

1. Dendreon Announces Presentation of PROVENGE Data at the American Urological Association Annual Meeting
2. Dendreon Presents Updated IMPACT Results Confirming PROVENGE Improves Overall Survival in Patients With Metastatic Castrate-Resistant Prostate Cancer
3. Dendreon Reports Fourth Quarter and 2009 Year End Financial Results
4. Dendreon Announces Election of Ian Clark and Pedro Granadillo to Board of Directors
5. Dendreon Reports PROVENGE Regulatory and Commercialization Progress and Future Pipeline Plans at Analyst Event
6. Dendreon Presents Preclinical Data Demonstrating Activity of TRPM8 Agonist, D-3263, in Benign Prostatic Hyperplasia
7. Dendreon Initiates Phase 1 Clinical Trial of Small Molecule Targeting TRPM8 in Cancer
8. Dendreon to Hold a Conference Call Tomorrow at 9:00 AM ET to Discuss Final Results of Phase 3 PROVENGE IMPACT Trial
9. Dendreon Presents Integrated Analysis of Clinical Data from NEUVENGE Trials at Chemotherapy Foundation Symposium
10. Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial
11. Dendreon to Hold a Conference Call Today at 9:00 AM ET to Provide an Update on Interim Results of Phase 3 PROVENGE IMPACT Trial
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