Dendreon Receives Positive Opinion for PROVENGE® in the European Union
SEATTLE-- June 28, 2013--Dendreon Corporation (Nasdaq: DNDN) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T) be granted marketing authorization in the European Union (EU), for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. The CHMP's recommendation follows a positive recommendation by the Committee for Advanced Therapy (CAT).
"We are pleased with this outcome and look forward to a final regulatory decision by the European Commission later this year," said Mark Frohlich, Executive Vice President of Research and Development and Chief Medical Officer of Dendreon. "By using the body's own immune system to fight cancer, PROVENGE is a novel therapy that addresses a genuine unmet patient need. If approved, PROVENGE would help extend the lives of appropriate prostate cancer patients in Europe."
The CHMP will make a final recommendation to the European Commission (EC) within the coming months on the marketing authorization application for PROVENGE in the EU. A regulatory decision is anticipated from the EC in the second half of this year.
"PROVENGE is the first immunotherapy to have demonstrated an overall survival improvement in prostate cancer. The positive CHMP opinion for PROVENGE is great news for advanced prostate cancer patients and physicians in Europe, and we look forward to the European Commission's final decision on this novel treatment option," said Prof. Karim Fizazi, M.D., Ph.D. Head of the Department of Cancer Medicine, The Institut Gustave Roussy, Villejuif, and Full Professor in Oncology, the University of Paris, France.
John H. Johnson, Dendreon's chairman, president and chief executive officer, said, "This recommendation represents a significant milestone for Dendreon as we advance the global market opportunity for PROVENGE. We are finalizing our plans for a capital-efficient launch in Europe, including evaluating our partnering options. We look forward to bringing the innovative treatment of PROVENGE to patients around the world."
Important U.S. Label Safety Information for PROVENGE
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
For more information on PROVENGE, please see the full prescribing information at http://www.provenge.com or call 1-877-336- 3736.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington, and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.
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