SEATTLE, June 13, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that Mitchell H. Gold, M.D., President and Chief Executive Officer received the Ernst & Young Entrepreneur Of The Year® 2011 Pacific Northwest Award in the Emerging Sciences category.
Dr. Gold has served as CEO of Dendreon since 2003, and under his leadership the company last year received U.S. Food and Drug Administration approval for PROVENGE® (sipuleucel-T) the first autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
"This has been an extraordinary year for Dendreon, for our dedicated employees, but most importantly for patients as we have begun to deliver on our longstanding promise to improve the lives of men with prostate cancer," said Dr. Gold. "This is just the beginning for Dendreon, as we seek to apply our active cellular immunotherapy technology to different tumor types to serve more patients with cancer."
The award recognizes outstanding entrepreneurs who demonstrate excellence and extraordinary success in such areas as innovation, financial performance and personal commitment to their businesses and communities. Dr. Gold was selected by an independent panel of judges.
The Ernst & Young Entrepreneur Of The Year Awards Program celebrates its 25th anniversary this year. Past award winners have included Howard Schultz of Starbucks Coffee Company, Arthur M. Blank of AMB Group, LLC (Home Depot, Atlanta Falcons), Pierre Omidyar of eBay, Inc., Ruth Fertel of Ruth's Chris Steak House, Inc., Maxine Clark of Build-a-Bear Workshop, Tom Adams of Rosetta Stone Inc., Matt Szulik of Red Hat, Inc., and last year's national winner, Howard Lutnick, Chairman and CEO of Cantor Fitzgerald and BGC Capital Partners, Inc.
As a Pacific Northwest award winner, Dr. Gold is now eligible for consideration for the Ernst & Young Entrepreneur Of The Year 2011 National Award. Award winners in several national categories, as well as the overall Ernst & Young Entrepreneur Of The Year National Award winner, will be announced at the annual awards gala in Palm Springs, California, on November 12, 2011. The awards are the culminating event of the Ernst & Young Strategic Growth Forum®, the nation's most prestigious gathering of high-growth, market-leading companies, which will be held November 9–13, 2011.
Founded and produced by Ernst & Young LLP, the Entrepreneur Of The Year Awards are pleased to have the Ewing Marion Kauffman Foundation as a national sponsor.
In the Pacific Northwest, local sponsors include ADP, Union Bank, Seattle Business, The Big Picture Film Video & Arts, and Scherzer International.
PROVENGE Indication and Safety
PROVENGE is an autologous cellular immunotherapy 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 procedure. The most common adverse events (incidence greater than or equal to 15%) reported in patients in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in patients 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, Dendreon will conduct a registry of approximately 1,500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
For more information on PROVENGE, please see the full Prescribing Information at www.provenge.com or call Dendreon ON Call at 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/.
About Ernst & Young Entrepreneur Of The Year®
Ernst & Young Entrepreneur Of The Year® is the world's most prestigious business award for entrepreneurs. The unique award makes a difference through the way it encourages entrepreneurial activity among those with potential, and recognizes the contribution of people who inspire others with their vision, leadership and achievement. As the first and only truly global award of its kind, Entrepreneur Of The Year celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional, national and global awards programs in more than 140 cities in more than 50 countries.
About Ernst & Young
Ernst & Young is a global leader in assurance, tax, transaction and advisory services. Worldwide, our 141,000 people are united by our shared values and an unwavering commitment to quality. We make a difference by helping our people, our clients and our wider communities achieve their potential.
Ernst & Young refers to the global organization of member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young LLP is a client-serving member firm of Ernst & Young Global Limited operating in the US. For more information about our organization, please visit www.ey.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 commercialization of 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. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
|SOURCE Dendreon Corporation|
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