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Supplemental Application for Cetuximab Expands its Use to First-Line Treatment of Head and Neck Cancer

NEW YORK--(BUSINESS WIRE)--ImClone Systems Incorporated (NASDAQ: IMCL - News) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of Erbitux (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). The application, submitted on August 29, 2008, was prepared in conjunction with Bristol-Myers Squibb Company, ImClone’s partner for Erbitux in North America. ImClone has requested Priority Review of the application, which, if granted, means that the FDA would make a decision on the application within six months. The FDA will notify ImClone whether it has accepted the submission by the end of October.

Erbitux was approved by the FDA in March 2006 for use in combination with radiation therapy for the treatment of locally or regionally advanced SCCHN, and as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. In that approval, the FDA noted that Erbitux was the first drug ever approved for head and neck cancer that showed a survival benefit in locally or regionally advanced SCCHN. If approved, the submitted label would extend the use of Erbitux for treatment of patients with recurrent and/or metastatic SCCHN in combination with platinum-based chemotherapy.

“As the first new therapy to be approved for head and neck cancer in the last 45 years, the additional approval of Erbitux in the first-line setting would represent a real breakthrough in the treatment of this disease,” said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone. “This submission is an important milestone in ImClone’s ongoing efforts to maximize the potential of Erbitux and provide cancer patients with new treatment options.”

The submission is based on data from the EXTREME study(1) (Erbitux in first-line Treatment of REcurrent or MEtastatic head and neck cancer) investigating the efficacy of Erbitux in combination with platinum-based chemotherapy in the first-line setting in patients with recurrent and/or metastatic SCCHN. The EXTREME study, conducted by Merck KGaA, Darmstadt, Germany, ImClone’s Erbitux partner outside of North America, showed that Erbitux , when added to current standard platinum-based chemotherapy, significantly increased the overall survival time for patients.

The Phase 3 randomized EXTREME study involved 442 patients with previously untreated recurrent and/or metastatic SCCHN who were treated with either Erbitux plus platinum-based chemotherapy (cisplatin or carboplatin plus infusional 5-fluorouracil [5-FU]) or platinum-based chemotherapy alone. The study met the primary endpoint of significantly increasing overall survival. The median overall survival for patients in the Erbitux plus platinum-based chemotherapy arm was 10.1 months, and 7.4 months for patients treated with platinum-based chemotherapy alone (Hazard Ratio [HR], 0.797 [p = 0.036]). Erbitux plus platinum-based chemotherapy also conferred increased progression-free survival (PFS) and a higher response rate compared with chemotherapy alone. The median PFS values were 5.6 months and 3.3 months (HR = 0.538 [p The toxicity profile of Erbitux in combination with platinum-based chemotherapy was manageable.

Merck KGaA submitted an application to the European Medicines Agency (EMEA) in June 2008 to broaden the use of Erbitux to include first-line treatment of patients with recurrent and/or metastatic SCCHN.

About Head and Neck Cancer
According to the American Cancer Society, there will be an estimated 47,500 new cases of head and neck cancer in the U.S. in 2008, with 11,200 people dying from the disease. Head and neck cancer is the sixth most frequently occurring cancer worldwide. About 40% of patients suffering from head and neck cancer are in the recurrent/metastatic state. Head and neck cancer includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinus, and other sites located in the head and neck area. About 90% of head and neck cancers are of the squamous cell variety and nearly all express epidermal growth factor receptor, or EGFR, which is critical for tumor growth. Although there have been significant improvements in chemotherapy and surgical techniques, the disease is particularly challenging to treat since most patients present with advanced disease, have secondary tumors and suffer from other co-morbidities. The disease most often affects people over the age of 50, and men are twice as likely to be diagnosed as women. The most common risk factors are tobacco and excessive alcohol use. Additionally, infection with certain strains of the Human Papilloma Virus (HPV) is known to increase risk of oropharyngeal cancers.

Source: ImClone Systems Incorporated

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