ImClone Systems Inc (formerly IMCL)

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FDA Approves ImClone Systems' New State-of-the-Art Manufacturing Facility
-- "BB50" Facility to Serve as Second Manufacturing Source for ERBITUX(R) --

IMCL31.59, +0.44, +1.4%) , a leader in the development and commercialization of novel cancer therapeutics, today announced that it has received approval from the Food and Drug Administration for a second facility to manufacture ERBITUX(R). The approval to manufacture ERBITUX in this new 250,000-square-foot multi-suite manufacturing facility, referred to as "BB50", more than doubles ImClone's total available production volume capacity for ERBITUX. This approval, in conjunction with ImClone's existing "BB36" manufacturing facility, enhances the Company's ability to meet increasing demand for ERBITUX in the worldwide market.
"The FDA approval of BB50 represents the culmination of ImClone's efforts over the last several years to establish this state-of-the-art facility. This now provides us with a great deal of strategic and operational flexibility in pursuing additional commercial opportunities going forward," said Richard P. Crowley, Senior Vice President, Biopharmaceutical Operations of ImClone Systems. "Together, our two manufacturing facilities provide us with the capacity to produce ERBITUX and future products for worldwide development and commercialization, and serve to support our initiatives for the long-term growth and success of ImClone."
Construction of BB50 was completed in the fourth quarter of 2005. This facility is designed to contain three distinct suites with a total future production volume capacity of up to 110,000 liters. The commissioning and initial validation of one of the suites was completed during the second quarter of 2006 and the Company began producing ERBITUX in this suite in June 2006. The other two suites at this facility will enable ImClone in the future to produce ERBITUX, additional ImClone products, or third-party products under contract manufacturing agreements. Both BB50 and BB36 are located on ImClone's Branchburg, N.J. campus.
About ERBITUX(R) (Cetuximab)
ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, ERBITUX can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. While the mechanism of ERBITUX's anti-tumor effect(s) in vivo is unknown, all of these processes may contribute to the overall therapeutic effect of ERBITUX. EGFR is part of a signaling pathway that is linked to the growth and development of many human cancers, including those of the head and neck, colon and rectum.
ERBITUX (Cetuximab), in combination with radiation therapy, is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. ERBITUX as a single agent is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.
ERBITUX is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) in combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy, and as a single agent for patients who are intolerant to irinotecan-based therapy. The effectiveness of ERBITUX for the treatment of EGFR-expressing mCRC cancer is based on objective response rates.
For full prescribing information, including boxed WARNINGS regarding infusion reactions and cardiopulmonary arrest, visit http://www.ERBITUX.com.
Important Safety Information