SEATTLE, WA USA (Press Release) (BUSINESS WIRE) - March 3, 2014 - Dendreon Corporation today announced that it plans to make PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) available in Europe, beginning with Germany and the United Kingdom.
Dendreon will make PROVENGE commercially available to patients within the approved label through Centers of Excellence using its Contract Manufacturing Organization, PharmaCell. Centers of Excellence are institutions where a high volume of prostate cancer patients are treated by leading prostate cancer experts. These centers will be located in larger cities, which will allow for convenient patient access. In some cases, a Center of Excellence may be a co-op group of institutions. Following the implementation of automation, which will enable Dendreon to manufacture more cost effectively, the Company will explore opportunities to make PROVENGE more broadly available in Europe and other world markets.
"Bringing PROVENGE commercially to Europe marks a major milestone for Dendreon," said John H. Johnson, chairman, president and chief executive officer of Dendreon. "Both urology and oncology key opinion leaders in Europe have expressed a desire to have PROVENGE available to their patients and it is evident that there is pre-market demand as the first - and only - personalized immunotherapy approved for the treatment of mCRPC. We are pleased to be able to make PROVENGE available to oncologists and urologists and their prostate cancer patients in this important market."
"As the first personalized immunotherapy approved for the treatment of mCRPC in Europe, PROVENGE provides a new therapeutic option for advanced prostate cancer patients with a different mechanism of action than existing therapies," said Andrew S. Sandler, M.D., executive vice president and chief medical officer at Dendreon. "We have a commercially-favorable label in Europe, including PSA quartile analysis and positive correlation between immune response and overall survival. These data will allow for early positioning and strong messaging for our reimbursement dossiers."
PROVENGE is approved 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. Dendreon received marketing authorization for PROVENGE from the European Commission in September 2013, which provides approval for the commercialization of PROVENGE in all 28 countries of the EU as well as Norway, Iceland and Liechtenstein.
Important Safety Information for PROVENGE
PROVENGE is intended solely for autologous use and should under no circumstances be administered to other patients.
The safety evaluation of PROVENGE was based on data from 601 prostate cancer patients in four randomized clinical trials and post-marketing surveillance.
PROVENGE should be delayed in patients with active systemic infection until resolution and used with caution in patients with a history of embolic and thrombotic events, including cerebrovascular disease and cardiovascular disorders.
Serious adverse reactions reported include acute infusion reactions (occurring within 1 day of infusion), catheter sepsis, staphylococcal bacteremia, myocardial infarction and cerebrovascular events.
The most commonly reported adverse reactions were chills, fatigue, pyrexia (fever), nausea, arthralgia (joint ache), headache, and vomiting.
About Dendreon
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. 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 www.dendreon.com/.
Dendreon Corporation
Corporate Communications
Lindsay Rocco, 862-596-1304
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