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Dendreon Reports PROVENGE Regulatory and Commercialization Progress and Future Pipeline Plans at Analyst Event
Date:9/24/2009

SEATTLE and NEW YORK, Sept. 24 /PRNewswire-FirstCall/ -- At its analyst event today, Dendreon Corporation (Nasdaq: DNDN) provided updates on its regulatory and commercialization progress for PROVENGE(R) (sipuleucel-T), the Company's investigational product candidate for men with advanced prostate cancer.

"2009 has been a transformational year for the company as we prepare to commercialize PROVENGE by the middle of next year and make it available to the many men with metastatic castrate-resistant prostate cancer who currently have few appealing treatment options. We are on track to complete the submission of our Biologics License Application (BLA) amendment to the U.S. Food and Drug Administration (FDA) by the middle of November," said Mitchell H. Gold, M.D., president and chief executive officer. "After FDA approval we will implement a deliberate, stepwise launch to ensure the highest quality standards, patient delivery and experience with this completely new approach that could change the way prostate cancer and eventually other cancers are treated."

In addition to this regulatory progress, Dendreon provided the following updates today during its Analyst Day meeting in New York:

Manufacturing and Commercialization Preparation

  • The existing capacity at Dendreon's New Jersey manufacturing facility represents 25 percent of the total future capacity at this facility. After FDA approval, the Company expects to launch PROVENGE from this existing portion of the New Jersey facility in mid-2010 and to continue to make the product available in a gradual stepwise fashion as the Company ramps up to full capacity at this facility.
  • The Company expects to have 48 workstations in production at the New Jersey facility by the
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SOURCE Dendreon Corporation
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Related medicine technology :

1. Dendreon Presents Preclinical Data Demonstrating Activity of TRPM8 Agonist, D-3263, in Benign Prostatic Hyperplasia
2. Dendreon Initiates Phase 1 Clinical Trial of Small Molecule Targeting TRPM8 in Cancer
3. Dendreon to Hold a Conference Call Tomorrow at 9:00 AM ET to Discuss Final Results of Phase 3 PROVENGE IMPACT Trial
4. Dendreon Presents Integrated Analysis of Clinical Data from NEUVENGE Trials at Chemotherapy Foundation Symposium
5. Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial
6. 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
7. Dendreon Expects Interim Data Analysis for Phase 3 PROVENGE IMPACT Trial in October
8. Dendreon Initiates Phase 2 Trial of PROVENGE in Patients With Localized Prostate Cancer Prior to Surgery
9. Dendreon Presents Preclinical Data Demonstrating Activity of Trp-p8 agonist, D-3263, in Benign Prostatic Hyperplasia
10. Dendreon Presents Data Correlating the Cumulative Potency of PROVENGE(R) to Overall Survival
11. Dendreon Completes Target Enrollment of 500 Patients in Phase 3 IMPACT Study of Provenge(R) For Advanced Prostate Cancer
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