ImClone Systems, Inc. received approval from the FDA for a second facility to manufacture Erbitux. This new 250,000-sq.-ft. multi-suite manufacturing facility, referred to as “BB50”, more than doubles the company’s total production capacity for Erbitux.

“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 4Q2005. This facility is designed to contain three distinct suites with a total future production capacity of as much as 110,000 liters. The initial validation of one of the suites was completed during 2Q2006 at which point the company began producing Erbitux. The other two suites at this facility will enable the company to produce Erbitux, ImClone products, or third-party products under contract manufacturing agreements, down the road. Both BB50 and BB36 are located on ImClone’s Branchburg, N.J. campus.