ImClone Systems Incorporated, a global leader in the development and commercialization of novel antibodies to treat cancer, 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 litters at its Branchburg, New Jersey 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 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 tumour 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 tumour 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 signalling pathways that enhance tumour 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.
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.