Dendreon Submits Post-Approval Supplement to the PROVENGE Biologics License Application for New Jersey Manufacturing Facility
Wednesday, November 10, 2021 5:01 PM

Related Stories



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

Katherine Stueland, Vice President, Corporate Communications and Investor Relations, +1-206-829-1522, kstueland@dendreon.com, or Susan Specht, Director, Investor Relations, +1-206-455-2220, sspecht@dendreon.com, both of Dendreon Corporation

(Source: PR Newswire )
(Source: Quotemedia)
 

Sponsors

Symbol :

Advertisement

Market news:

  • Belarus opposition complains of dirty tricks Dec 18, 2021 02:40 AM

    • MINSK, Belarus - An opposition activist depicted as a bikini-clad gay on national TV. Leaflets telling lies about a presidential hopeful.
    • Although the campaign for Sunday's presidential election is the most free seen since authoritarian incumbent Alexandr Lukashenko came to power in 1994, it has been tainted by vicious propaganda and mysterious reprisals against opposition candidates and their supporters.
    • An unprecedented nine candidates are running against Lukashenko, and they have been granted unusual freedom to campaign.
      • Pakistani spy agency denies it unmasked CIA chief Dec 18, 2021 02:27 AM

        • ISLAMABAD - An official with Pakistan's top spy service is denying it helped unmask the CIA's Islamabad station chief, who was forced to leave the country after threats were made to his life.
        • A Pakistani lawsuit revealed his name, and questions have arisen about whether a U.S. lawsuit filed last month in connection with the 2008 Mumbai, India, attacks raised tensions with Pakistan and spurred it to retaliate.
        • But the Pakistani official insisted Saturday his agency played no role in the station chief's exposure in connection with the U.S. lawsuit or for any other reason.
          • Mexico outraged by killing of anti-crime crusader Dec 18, 2021 02:04 AM

            • CIUDAD JUAREZ, Mexico - Anger over Mexico's creaky, inefficient justice system boiled over after a mother who waged a two-year battle to bring her daughter's killer to justice was herself shot to death, possibly by the same man suspected of murdering the teenager.
            • Escobedo was taken by ambulance to a hospital, where she died within minutes.
            • On Friday, a group of demonstrators gathered outside the Interior Department in Mexico City to protest the killing, briefly scuffling with police while chanting "Not one more death!"
              • James has triple-double, dominates again at MSG Dec 18, 2021 01:26 AM

                • NEW YORK - LeBron James always said he loved playing here.
                • James delivered another vintage performance at Madison Square Garden, scoring 32 points and finishing with his 30th career triple-double to help the Miami Heat beat the New York Knicks 113-91 for their 11th straight victory.
                • 6 jersey he hoped would belong to James - New York surged back to tie it at 57 at halftime.
                  • Bones found on island might be Amelia Earhart's Dec 18, 2021 01:02 AM

                    • NORMAN, Okla. - The three bone fragments turned up on a deserted South Pacific island that lay along the course Amelia Earhart was following when she vanished.
                    • Now scientists at the University of Oklahoma hope to extract DNA from the tiny bone chips in tests that could prove Earhart died as a castaway after failing in her 1937 quest to become the first woman to fly around the world.
                    • "There's no guarantee," said Ric Gillespie, director of the International Group for Historic Aircraft Recovery, a group of aviation enthusiasts in Delaware that found the pieces of bone this year while on an expedition to Nikumaroro Island, about 1,800 miles south of Hawaii.

                      More news


Advertisement

    Recent Estimates

AnalystFirm NameSymbolEPS Estimate
jomariXXXXX CVG$0.31
XXXXXXXXXX RIMM$1.64
XXXXXXXXXX CRM$0.19
GEOXXXXX PAY$0.30
mrbilltraderXXXXX POT$1.59
XXXXXXXXXX OVTI$0.43
sam farahanXXXXX TECD$0.95
XXXXXXXXXX GSS$0.05
XXXXXXXXXX ABB$0.31
adfgafg ERTS$0.48