ImClone Systems says that US regulators have given the go-ahead for the firm’s new facility which will be used to meet demand for the cancer drug Erbitux.
The company has received approval from the Food and Drug Administration for a second facility at its campus in Branchburg, New Jersey to manufacture Erbitux (cetuximab), which is indicated for colon and head-and-neck cancer. The approval to manufacture the drug at a new 250,000-square-foot manufacturing plant, known as BB50, more than doubles ImClone's total available production volume capacity for Erbitux and together with its existing BB36 facility, “enhances the company's ability to meet increasing demand…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”, said Richard Crowley, senior vice president of biopharmaceutical operations. He added that “this now provides us with a great deal of strategic and operational flexibility in pursuing additional commercial opportunities going forward". Construction of BB50 was completed in the fourth quarter of 2005 and is designed to contain three suites with a total capacity of up to 110,000 litres.
Results from the second quarter showed that Erbitux sales actually slowed in the USA but ImClone and partner Bristol-Myers Squibb have recently expanded their alliance to explore further development and commercial opportunities in North America for the drug. This will see investment in Erbitux increase by “up to several hundred million dollars”.