ImClone Systems Incorporated and Bristol-Myers Squibb File New Drug Submission with Health Canada for Use of ERBITUX--cetuximab--for Treatment of EGFR-Expressing Irinotecan-Refractory Metastatic Colorectal Cancer.

Business Editors/Health/Medical Writers

NEW YORK & PRINCETON, N.J.--(BUSINESS WIRE)--Nov. 24, 2003

ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that ImClone Systems has filed a New Drug Submission (NDS) for the use of ERBITUX(TM) (cetuximab) in combination with irinotecan for the treatment of patients with Epidermal Growth Factor Receptor (EGFR)-expressing, irinotecan-refractory metastatic colorectal cancer with the Biologics and Genetic Therapies Directorate (BGTD) of Health Canada. The Companies also announced that the NDS is being reviewed under Priority Review.

"This filing represents a significant step forward in our global regulatory strategy, including our goal of reaching the greatest number of patients with colorectal cancer that may benefit from the use of ERBITUX," stated Daniel S. Lynch, Acting Chief Executive Officer of ImClone Systems. "We are pleased to be able to file the NDS under Priority Review with Health Canada following similar ERBITUX submissions in the U.S., Europe and Australia."

"Advanced colorectal cancer strikes people around the world, and there is tremendous unmet medical need in treating it," said Peter R. Dolan, Chairman and Chief Executive Officer, Bristol-Myers Squibb. "Working with our partners at ImClone Systems, the submission of ERBITUX to Health Canada represents a further important step for Bristol-Myers Squibb in reaching out to people with cancer with innovative oncology therapies."

Health Canada's Priority Review is a status granted to eligible New Drug Submissions. Submissions granted Priority Review status will be subject to the following reduced target timeframes: 25 calendar days for submission screening and 180 calendar days for submission review. Priority Review is granted to drug submissions intended for the treatment, prevention or diagnosis of serious, life-threatening illnesses where there is either no existing drug on the Canadian market or where the new product represents a significant improvement over existing products.

About ERBITUX(TM) (cetuximab)

ERBITUX is an investigational IgG1 monoclonal antibody designed to exclusively target and block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of certain cancer cells in multiple tumor types. ERBITUX is designed to bind to and internalize EGFR and prevent natural ligands called growth factors from binding to the receptor and activating signaling to the tumor. ERBITUX is also being studied in earlier stages of colorectal cancer, as well as in other types of cancer that express the EGF receptor, including lung, pancreatic, ovarian and head and neck cancers. The most common adverse events reported in clinical trials of ERBITUX have been an acne-like rash, asthenia, diarrhea, nausea, abdominal pain and vomiting. Severe, potentially fatal hypersensitivity reactions were observed in a small percentage of patients. Additional information about ERBITUX can be found at www.cetuximab.com.

About 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. The Company's three programs include growth factor blockers, angiogenesis inhibitors and cancer vaccines. ImClone Systems' strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems' headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.

The matters discussed in this news release may include forward-looking statements which involve potential risks and uncertainties. Important factors that may cause actual results to differ materially include, but are not limited to, the risks and uncertainties associated with completing pre-clinical and clinical trials of the company's compounds that demonstrate such compounds' safety and effectiveness; manufacturing losses and risks associated therewith; obtaining additional financing to support the company's operations; obtaining and maintaining regulatory approval for such compounds and complying with other governmental regulations applicable to the company's business; obtaining the raw materials necessary in the development of such compounds; consummating and maintaining collaborative arrangements with corporate partners for product development; achieving milestones under collaborative arrangements with corporate partners; developing the capacity to manufacture, market and sell the company's products, either directly or with collaborative partners; developing market demand for and acceptance of such products; competing effectively with other pharmaceutical and biotechnological products; obtaining adequate reimbursement from third party payers; attracting and retaining key personnel; legal costs and the outcome of outstanding legal proceedings and investigations including but not limited to our investigations pertaining to withholding tax issues; complying with covenants in the indenture for the company's Convertible Subordinated Notes and with the terms of other contractual obligations; obtaining patent protection for discoveries and risks associated with commercial limitations imposed by patents owned or controlled by third parties. The company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

About Bristol-Myers Squibb

Bristol-Myers Squibb is dedicated to the discovery, development and exhaustive exploration of innovative cancer fighting therapies that are designed to extend and enhance the lives of patients living with cancer. More than 40 years ago, Bristol-Myers Squibb built a unified vision for the future of cancer treatment. With expertise, dedication and resolve, that vision led to the development of a diverse global portfolio of anti-cancer therapies that are an important cornerstone of care today. Hundreds of scientists at Bristol-Myers Squibb's Pharmaceutical Research Institute are studying ways to improve current cancer treatments and identify better, more effective medicines for the future.

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, market factors, competitive product development, governmental regulations and legislation, patent positions and litigation. There can be no guarantee that ERBITUX will receive regulatory approval or, if approved, will prove to be commercially successful. For further details and a discussion of these risks and uncertainties, see the company's Securities and Exchange Commission filings, including the company's 2002 annual report on Form 10-K. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.