Imclone Gets Greenlight from FDA for Increased ERBITUX Production in New Jersey

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Industrial Info Resources (Sugar Land, Texas)— Imclone Systems Incorporated (NASDAQ:IMCL) (New York City, New York) has been approved by the Food and Drug Administration (FDA) for a second manufacturing facility to produce ERBITUX, an oncology drug. The new facility, known as “BB50”, added 150,000 square feet of manufacturing space, more than doubling the size of the existing 100,000 square foot facility, which is called “BB36”, and also produces ERBITUX. ERBITUX is approved to treat patients that suffer from neck and head cancer that has reoccurred in the same spot of the body or spread to different parts of the body.

The FDA approval is the final step of the $260 million invested to more than triple the site’s production capacity from 30,000 liters to 110,000 liters. Construction began in 2004, and was finished and ready to go in early 2006. Binsky and Snyder, headquartered out of Piscataway, New Jersey, were in charge of construction for this expansion. The company in charge of engineering and project management was Kvaerner, which has locations all around the globe, with its home office in Norway, and domestic headquarters in Houston. The new plant has three manufacturing suites, all currently scheduled to produce ERBITUX, with the eventual introduction of other drug products.

Imclone Systems Incorporated was founded in 1984 and opened its first facility in 1986, in New York City. At this time the company’s focus was on infectious disease vaccines and diagnostics, later the focus shifted to the area of oncology. Imclone has two sites, its executive offices in New York City and the manufacturing site in Branchburg, New Jersey. Branchburg is home to both “BB36” and “BB50”.

Imclone is remembered by many as the company that brought entrepreneur Martha Stewart some trouble. In 2004, Stewart was accused and convicted of insider trading, through her friendship with one of Imclone’s founders Samuel Waksal. In 2001, she sold her shares the day before the stock tumbled when the FDA postponed approval for ERBITUX. Stewart avoided a loss of over $50,000 by selling 4,000 shares. Stewart and her former stockbroker, Peter Bacanovic, were both found guilty on four counts of making false statements to the government related to her sale of the Imclone stock. The pair were both sentenced to five months in jail, with two years probation. Stewart was fined $30,000 while Bacanovic got away with paying $4,000.

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