PRIORITY REVIEW GRANTED FOR ERBITUX

The FDA has granted priority review to ImClone Systems' supplemental biologics license application (sBLA) for Erbitux, which seeks approval to sell the drug as a treatment for head and neck cancer.

The sBLA seeks U.S. marketing approval of Erbitux (cetuximab) in combination with radiation for locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN), and as monotherapy in patients with recurrent and/or metastatic SCCHN where prior platinum-based chemotherapy has failed or where platinum-based therapy would not be appropriate. ImClone filed the application in conjunction with Bristol-Myers Squibb, which owns approximately 17 percent of the biotech firm.

Under the priority review designation, the FDA has six months to review the application. The firms submitted the sBLA Aug. 30, meaning a decision should come in late February.

Erbitux generated roughly $261 million in revenues in 2004, but its growth is expected to skyrocket in coming years, particularly if it gains the indication for head and neck cancer, analysts say.

Standard & Poor's Equity Research recently forecasted that Erbitux sales will reach $402 million in 2005, $557 million in 2006 and $1.4 billion by 2012.