Erbitux

On Feb 12, 2004, ImClone Systems Incorporated and Bristol-Myers Squibb Company announced that the FDA approved the Erbitux (cetuximab) Injection for use in combination with irinotecan in the treatment of certain colorectal cancer patients. Particularly, Erbitux has been approved for patients with Epidermal Growth Factor Receptor (EGFR) expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. Erbitux is a chimeric monoclonal antibody (MAb), which features a structure of approximately one-third mouse protein sequence and two-thirds human protein sequence, that binds to EGFR. Over expression of EGFR is common in a number of solid-tumor cancers, and Erbitux may block epidermal growth factor and transforming growth factor-alpha (TGF-alpha) from binding to this receptor, thereby potentially slowing tumor growth. ImClone has estimated that over 70% of advanced stage colorectal cancer cases express EGFR.

The American Cancer Society estimates that 147,500 new cases of colorectal cancer will be diagnosed in the United States in 2003. This makes colorectal cancer the third most commonly diagnosed cancer and the second leading cause of cancer death in the United States.

The FDA submission included data from a randomized two-arm Phase II clinical study conducted by Merck KGaA which evaluated Erbitux as a single agent and the combination of Erbitux and irinotecan in 329 patients with EGFR-expressing metastatic colorectal cancer who were refractory to irinotecan-based chemotherapy. The findings showed that Erbitux given in combination with irinotecan (n=218) had an objective response rate of 22.9 percent, a median duration of response of 5.7 months and a median time to disease progression of 4.1 months. Results of the Erbitux single agent study (n=57) showed a 9 percent objective response rate and a median duration of response of 4.2 months.

Our research indicates that Wall Street analysts are forecasting a wide range of possible gross sales numbers for Erbitux ranging from 200 million to 1.5 billion dollars per year. Most analysts are using the 15,000 to 20,000 dollar per patient per treatment assumption in their models.

Erbitux represents the first EGFR blocker/inhibitor to receive regulatory approval and represents true innovation. We have designated Erbitux as a High Impact emerging health technology and recommend preliminary assessment activities.

Technology Details
Target Disease / Indication: Metastatic Colon Cancer
Technology Classification: Drug – Chimeric Monoclonal Antibody (EGFR inhibitor)
Body System: Gastrointestinal System
Program Area: Medicine/Oncology
Regulatory Status: Approved
BioHorizon Impact Score: 68/100 – High