ImClone Systems' State-of-the-Art Manufacturing Facility Receives FDA Approval for Multi-Product Biologics Production
Approval Significantly Expands Production Capacity for ImClone's Proprietary Pipeline Antibodies
NEW YORK--(BUSINESS WIRE)--ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that it has received approval from the Food and Drug Administration for its state-of-the-art "BB50" manufacturing facility to manufacture multiple products. This approval significantly expands ImClone's total available production volume capacity for its proprietary pipeline of novel antibodies, which are now entering late-stage clinical development.
"This multi-product FDA approval of BB50 significantly enhances ImClone's operational flexibility as we scale up production of our robust pipeline of proprietary antibodies for the growing number of Phase 2 and Phase 3 trials that will be commencing in the next year," said Richard P. Crowley, Senior Vice President, Biopharmaceutical Operations of ImClone. "ImClone has one of the largest biologic production capacities in the world and this approval is an important milestone in our efforts to maximize the global potential of both ERBITUX® and our portfolio of novel fully-human antibodies, which together represents one of the deepest pipelines in oncology today."
ImClone's 250,000-square-foot multi-suite BB50 facility received FDA approval to manufacture ERBITUX (cetuximab) in August 2007. Together with the Company's "BB36" manufacturing facility, ImClone has a total production volume capacity of up to 140,000 liters at its Branchburg, N.J. campus. This is among the largest antibody manufacturing capacities in the biotechnology industry and is a key component of ImClone's fully integrated operations supporting the development and commercialization of the Company's antibodies.
ImClone's Proprietary Pipeline Antibodies
ImClone has established one of the deepest pipelines in oncology therapeutics. In addition to the blockbuster cancer drug ERBITUX, ImClone has a robust pipeline of proprietary monoclonal antibodies in clinical development. The Company is developing these pipeline antibodies with the hope of optimizing efficacy and safety by targeting specific tumor receptors, by developing fully human antibodies, and by developing IgG1 antibodies which may have the potential to increase efficacy through an antibody cell-mediated cytotoxicity. Three of these antibodies are now entering late stage clinical development, with the first commencing a Phase 3 trial earlier this year.
IMC-1121B targets the vascular endothelial growth factor receptor-2 (VEGFR-2) to deprive tumor blood vessels of the nutrients they need for further growth. Phase 2 studies of IMC-1121B are underway for metastatic melanoma, liver, non-small cell lung, ovarian, prostate and renal cancers. A Phase 3 study of IMC-1121B in metastatic breast cancer is enrolling patients, and Phase 3 testing in gastric cancer may begin in 2009.
IMC-A12 targets the insulin-like growth factor-1 receptor (IGF-1R) to block signaling pathways that enhance tumor cell proliferation and survival. Phase 2 studies of IMC-A12 are underway in breast, prostate, pancreatic, colorectal, liver and head and neck cancers, as well as sarcoma, with Phase 3 trials planned to begin in 2009. IMC-A12 has the potential to work with other targeted agents.
IMC-11F8 is a potent, fully human IgG1 monoclonal antibody that targets the epidermal growth factor receptor (EGFR). It is currently in Phase 2 testing for metastatic colorectal cancer with one or more Phase 3 trials planned to begin in 2009.
About ImClone Systems
ImClone Systems Incorporated is a fully integrated global biopharmaceutical company committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. The Company's research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems' headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey. For more information about ImClone Systems, please visit the Company's web site at http://www.imclone.com.
Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those currently expected. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission, particularly those factors identified as "risk factors" in the Company's most recent annual report of Form 10-K and in its quarterly reports on Form 10-Q and current reports on Form 8-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.