Dendreon Announces Plans to Make PROVENGE® Commercially Available in Europe
Dendreon Corporation (NASDAQ: DNDN) 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.
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 http://www.dendreon.com/.
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements regarding the expected benefits of the recent and prior restructurings, the timing and elements of the restructurings, the timing and form of related charges, the expected annual operating expense reductions, expectations and beliefs regarding Dendreon's financial position, profitability and Dendreon's ability to break even and achieve improved performance as a result of the restructurings, statements regarding sequencing studies, statements regarding studies to advance understanding of immunotherapy and the treatment of advanced prostate cancer, statements regarding biomarkers, expectations about automation or the early detection study, expectations about advancing our pipeline, expectations regarding reductions of cost of goods sold, expectations regarding reimbursement approvals of PROVENGE® in Europe or Dendreon's ability to launch and commercialize PROVENGE in Europe, expectations regarding the presentation of clinical data, developments affecting Dendreon's U.S. and global business and prospects, beliefs and expectations regarding potential revenue and earnings from product sales, including beliefs regarding Dendreon's ability to grow sales, expectations regarding market size, target market, and market opportunity, beliefs regarding the impact of our direct to consumer advertising, expectations with respect to our sales force execution and effectiveness, progress generally on commercialization efforts for PROVENGE, and expectations about clinical trial enrollments. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Dendreon's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, our inability to achieve and sustain commercial success for PROVENGE; the identification of efficacy, safety or other issues with PROVENGE; a slower than anticipated adoption by treating physicians of PROVENGE for the treatment of patients with advanced prostate cancer for a variety of reasons, including competing therapies, instability in our sales force, the risk that we cannot replace vacant sales positions on a prompt basis, perceived difficulties in the treatment process, delays in obtaining reimbursement or for other reasons; any promotional limitations imposed by the FDA or the EU on our ability to commercialize and market PROVENGE; unexpected difficulties and costs associated with the rapid expansion of our commercial operations to support the commercial launch of PROVENGE; the impact of competing therapies on sales of PROVENGE, the failure to achieve reimbursement approvals in Europe, manufacturing or quality difficulties, the dilution or other effects resulting from capital raising or debt restructuring transactions, disruptions or delays and other factors discussed in the "Risk Factors" section of Dendreon's Annual Report on Form 10-Q for the quarter ended September 30, 2013. All forward-looking statements are qualified in their entirety by this cautionary statement. Dendreon is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
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