ImClone Systems Incorporated has received a $3 million payment from Merck KGaA for achieving a clinical development milestone under the Companies’ license agreement for ERBITUX(TM). Upon payment, ImClone Systems issued 150,007 shares of ImClone Systems’ common stock to Merck KGaA, representing the sale of these shares at a ten percent premium to market value as provided in the license agreement.
In December 1998, Merck KGaA licensed from ImClone Systems the right to develop ERBITUX outside of the U.S. and Canada and the co-exclusive right to develop ERBITUX in Japan.
The milestone relates to Merck KGaA’s ability to move forward with the clinical development of ERBITUX in the area of non-small cell lung cancer (NSCLC) based on data from four clinical studies of ERBITUX in combination with chemotherapy in patients with NSCLC.
The data from these studies, which included the Merck KGaA-sponsored Lung Cancer Cetuximab Study (LUCAS) randomized Phase II study, were presented during this year’s American Society of Clinical Oncology Annual Meeting, held in Chicago.
In the LUCAS study, the addition of ERBITUX to cisplatin and vinorelbine increased tumor response rates (53.3 percent vs. 32.3 percent) in 61 evaluable patients with chemotherapy-naive NSCLC.
“We are pleased that data from both ImClone Systems and Merck KGaA Phase II studies of ERBITUX in combination with chemotherapy in patients with non-small cell lung cancer have provided the clinical evidence needed to further the drug development program in this disease type,” stated Daniel S. Lynch, Acting CEO of ImClone Systems Incorporated.
ImClone Systems Incorporated is committed to advancing oncology care by developing a portfolio of targeted biologic treatments, designed to address the medical needs of patients with a variety of cancers.