"PROVENGE provides patients with a clinically meaningful survival
benefit, a manageable side effect profile, and a short duration of
therapy. We believe that the improved reimbursement landscape and our
comprehensive plan to educate physicians, coupled with the meaningful
clinical benefit that PROVENGE provides to patients, creates a strong
market opportunity," said
"With the addition of
Conference Call Information
Dendreon will host a conference call on September 8, 2011 at 4:30 p.m. ET. To access the live call, dial 1-877-548-9590 (domestic) or +1-720-545-0037 (international); the conference ID number is 97761940. The call also will be audio webcast and will be available from the Company's website at http://www.dendreon.com under the "Investor/Webcasts and Presentations" section. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-855-859-2056 or +1-404-537-3406 for international callers; the conference ID number is 97761940. The replay will be available from 7:30 p.m. ET on September 8 until 11:59 p.m. ET on September 15. In addition, the webcast will be archived for on-demand listening for 30 days at http://www.dendreon.com.
PROVENGE Indication and Safety
PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
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.
To fulfill a post marketing requirement and as a part of the company's
ongoing commitment to patients,
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. 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/.
This news release contains forward-looking statements that are
subject to risks and uncertainties. Factors that could affect
these forward-looking statements include, but are not limited to,
developments affecting Dendreon's business and prospects, including
progress on the commercialization efforts for PROVENGE. Information
on the factors and risks that could affect Dendreon's business,
financial condition and results of operations are contained
in Dendreon's public disclosure filings with the U.S. Securities and
Exchange Commission, which are available at www.sec.gov.
Vice President, Corporate Communications and Investor Relations
News Provided by Acquire Media