Navigation Links
Dendreon Receives FDA Acknowledgement of Complete Response
Date:11/20/2009

SEATTLE, Nov. 20 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

The FDA considers this to be a complete, Class 2 Resubmission following the action letter the company received in 2007. The BLA includes data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC. The resubmission also contains the remaining information requested by the FDA pertaining to chemistry, manufacturing and controls section of the BLA for PROVENGE.

If approved by the FDA, PROVENGE would represent the first product in a new therapeutic class known as active cellular immunotherapies.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters 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 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 the FDA's actions with respect to the BLA and whether the FDA determines to convene an advisory committee to review the BLA; progress on the commercialization efforts for PROVENGE, including the expansion of Dendreon's manufacturing capacity and other necessary infrastructure; success in the hiring of additional personnel to support business growth and expansion; the outcome of pre-approval inspection of Dendreon's expanded manufacturing facility; and requisite receipt of FDA licensure for marketing of PROVENGE and the risk that additional capital could be needed in the future for the potential 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


'/>"/>
SOURCE Dendreon Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Dendreon Reports Third Quarter 2009 Financial Results and Continuing Progress Toward PROVENGE Commercialization
2. Dendreon Completes Submission of Biologics License Application for PROVENGE
3. Dendreon Announces Webcast Presentations at Upcoming Investor Conferences
4. Dendreon Announces Webcast Presentations at Upcoming Investor Conferences
5. Dendreon Announces Analyst Day Webcast Presentation to be Held on September 24, 2009
6. Dendreon Reports Second Quarter 2009 Financial Results
7. Dendreon Signs Lease for New Manufacturing Facility in Atlanta
8. Dendreon to Hold Conference Call on Tuesday, August 11, 2009 at 11:30 AM ET
9. Dendreon Announces Webcast Presentations at Upcoming Investor Conferences
10. Dendreon Corporation CEO Mitchell H. Gold, M.D. Named Ernst & Young Entrepreneur of the Year(R) 2009 Award Finalist in the Pacific Northwest
11. Dendreon Announces Closing of Common Stock Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2017)... Toronto, Canada (PRWEB) , ... May 23, 2017 ... ... of Firmex FileSend, a cloud-based file transfer solution that makes it easy for ... firewall without having to worry about cumbersome FTP software or email file size ...
(Date:5/23/2017)... ... May 22, 2017 , ... ... row in the Aragon Research Globe™ for Corporate Learning, 2017. , Aragon Research ... and market demand, and effectively perform against those strategies. NetDimensions’ ranking as a ...
(Date:5/23/2017)... , ... May 23, 2017 , ... ... as Vice President of Clinical Operations. She brings years of expertise in ... Therapeutics. From her professional foundation as a licensed occupational therapist, through a variety ...
(Date:5/22/2017)... ... May 22, 2017 , ... Stratevi, a boutique firm that ... East Coast. It has opened an office in downtown Boston at 745 Atlantic Ave. ... increasingly more important to generate evidence on the value they provide, not just to ...
Breaking Biology Technology:
(Date:3/30/2017)... LOS ANGELES , March 30, 2017  On ... Hack the Genome hackathon at ... This exciting two-day competition will focus on developing health ... experience. Hack the Genome is ... has been tremendous. The world,s largest companies in the ...
(Date:3/27/2017)... March 27, 2017  Catholic Health Services (CHS) ... Systems Society (HIMSS) Analytics for achieving Stage 6 ... sm . In addition, CHS previously earned a ... using an electronic medical record (EMR). ... level of EMR usage in an outpatient setting.  ...
(Date:3/22/2017)... 2017   Neurotechnology , a provider of ... announced the release of the SentiVeillance 6.0 ... facial recognition using up to 10 surveillance, security ... The new version uses deep neural-network-based facial detection ... utilizes a Graphing Processing Unit (GPU) for enhanced ...
Breaking Biology News(10 mins):