Diosynth Biotechnology (Research Triangle Park) Enters Long-Term Commercial Supply Agreement With Dendreon Corporation
Published: Mar 02, 2006
RESEARCH TRIANGLE PARK, N.C., March 2 /PRNewswire/ -- Diosynth Biotechnology announced today that it has entered into a long-term commercial supply agreement with Dendreon Corporation (Nasdaq: DNDN - News) for the manufacture of the recombinant antigen component of PROVENGE® (sipuleucel-T), Dendreon's investigational active cellular immunotherapy for prostate cancer.
The product will be manufactured for market launch and commercial sale in the Diosynth Biotechnology state-of-the-art facility in North Carolina, US. Subsequent manufacturing may also be done at the large-scale cell culture facilities of Diosynth in the Netherlands.
This agreement reflects a continuing collaboration between Dendreon and Diosynth Biotechnology beginning with the initial agreement for process development and scale-up through the more recent manufacture of conformance lots.
"We value the ongoing confidence Dendreon has in Diosynth, entrusting us to provide commercial supply for Dendreon's leading product candidate," said Frank Tielens, President, Diosynth Biotechnology. "In addition to our industry-leading custom process development, analytical characterization and cGMP manufacturing of recombinant molecules, Diosynth contributes significant value through its expertise in scale-up and cGMP manufacturing with the Baculovirus expression system."
Dendreon's unique therapy has the potential to significantly improve the prospects of millions of men who suffer from prostate cancer, the third most common cancer worldwide. PROVENGE is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicities. Dendreon's proprietary Antigen Delivery Cassette(TM) technology utilizes a recombinant form of an antigen found in approximately 95 percent of prostate cancers, prostatic acid phosphatase (PAP), to stimulate a patient's own immune system. PROVENGE is in late-stage clinical development for the treatment of patients with early-stage and advanced prostate cancer.
Mr. Tielens further commented, "This contract demonstrates the strength of our recombinant biotech manufacturing facilities and capabilities which position us as one of the world leaders in innovative process development and biopharmaceutical manufacturing."
Diosynth Biotechnology supplies contract manufacturing services for the global biotechnology industry. The company has an 80-year heritage in biologics manufacturing and is a global leader in technology-driven process development and cGMP manufacturing of recombinant proteins, monoclonal antibodies and peptides. We help our customers succeed by developing scalable and robust processes and by driving products efficiently, rapidly and cost- effectively from preclinical development to market supply. Diosynth Biotechnology serves pharmaceutical and biopharmaceutical customers globally and operates FDA-, Health Canada- and EMEA-inspected cGMP manufacturing facilities in Research Triangle Park, NC, USA, and Oss, the Netherlands. Diosynth Biotechnology is a division of Akzo Nobel's human healthcare business unit Organon.
The Akzo Nobel Safe Harbor Statement (below) applies to this press release. For more information: http://www.diosynthbiotechnology.com
Diosynth Safe Harbor Statement*
This press release may contain statements which address such key issues as the Akzo Nobel growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements, including but not limited to the "Outlook", should be carefully considered and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. These factors also include changes in regulations or interpretations related to the implementation and reporting under IFRS, decisions to apply a different option of presentation permitted by IFRS, and various other factors related to the implementation of IFRS, including the implementation of IAS 32 and 39 for financial instruments. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more complete discussion of the risk factors affecting our business please refer to the Akzo Nobel Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the Akzo Nobel website.
* Pursuant to the U.S. Private Securities Litigation Reform Act 1995.
Source: Diosynth Biotechnology