SEATTLE, Nov. 10, 2010 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that it has completed the submission of the post-approval supplement to the PROVENGE® (sipuleucel-T) Biologics License Application for the Morris Plains, New Jersey manufacturing facility. Dendreon is requesting licensure for an additional 36 workstations to manufacture PROVENGE. The standard U.S. Food and Drug Administration (FDA) review for a post-approval supplement to a Biologics License Application is typically four months.
"The submission requesting licensure for additional capacity of the New Jersey manufacturing facility is an important milestone as we work to make PROVENGE more widely available to the many patients who may benefit from it," said Mitchell H. Gold, M.D., president and chief executive officer.
Dendreon's manufacturing facility in Morris Plains, New Jersey is currently operating at 25 percent capacity, with 12 workstations available to manufacture PROVENGE. With the FDA approval of the post-approval supplement to the Biologics License Application, the facility will have a total of 48 workstations. PROVENGE is the first in a new therapeutic class known as autologous cellular immunotherapies.
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 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. 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