Plans for regulatory filing of Erbitux

ImClone Systems and Bristol-Myers Squibb have established a plan FDA for the filing of a supplemental Biologics License Application (sBLA) to seek approval for use of Erbitux (Cetuximab) Injection, an IgG1 monoclonal antibody, as a single agent and in combination with radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN).

Based on the outcome of discussions with the FDA, the companies intend to submit an sBLA in the second quarter of 2005 and will request priority review at the time of filing. The FDA has provided written notification that the following clinical trials could form the basis of an sBLA together with other supportive data:

a randomised, international phase III trial (IMCL-9815) conducted by ImClone Systems and Merck KGaA presented at the American Society of Clinical Oncology (ASCO) annual meeting in June examining the impact of combining Erbitux with radiation on locoregional control and overall survival in 424 patients with locally advanced SCCHN, and

a multicentre phase II trial (EMR-016) conducted by Merck KgaA presented at the ASCO annual meeting in June evaluating the response rate of ERBITUX as a single agent in 103 patients with advanced recurrent and/or metastatic SCCHN not suitable for further local therapy and who have failed platinum-based chemotherapy.

'Patients with this disease have been without any significant advancements in approved treatments for over a decade,' stated Daniel Lynch, chief executive officer of ImClone Systems. 'We were pleased to be able to present clinical trial data in head and neck cancer at this year's ASCO annual meeting, including the late-breaking Phase III study IMCL-9815. We look forward to working diligently with our partners to assemble and analyse all the data from the studies that will comprise this submission.'

'Delivering to patients novel approaches to the treatment of cancer is part of Bristol-Myers Squibb's legacy and aligns with our comprehensive strategy to focus on areas of significant medical need, in this case the treatment of head and neck cancer,' said Dr Andrew G. Bodnar, senior vice president strategy and medical & external affairs, Bristol-Myers Squibb. 'We will continue to work with our partners to conduct a thorough clinical development program to explore the use of Erbitux in various tumour types.'

About Head and Neck Cancer

According to the American Cancer Society, approximately 40,000 Americans will be diagnosed with oral, head and neck cancer this year, including cancers of the tongue, mouth, pharynx, and larynx. More than 11,000 will die from the disease in 2004.