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FOR IMMEDIATE RELEASE
–First
and Only Approved Monoclonal Antibody for New York, NY & Princeton, NJ – March 1, 2006 – ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved ERBITUX® (Cetuximab), an IgG1 monoclonal antibody, for use in the treatment of squamous cell carcinoma of the head and neck. Designed to inhibit the function of the epidermal growth factor receptor (EGFR) – a molecular structure linked to tumor growth – ERBITUX is the first and only monoclonal antibody to be approved for the treatment of head and neck cancer. With this approval, ERBITUX is now indicated for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed. These indications are based on a Phase III study – one of the largest studies ever conducted in head and neck cancer patients –that demonstrated a survival and loco regional control advantage when ERBITUXwas added to radiation therapy, and a Phase II study, where ERBITUX therapy alone reduced tumor size. “This is an important milestone as ERBITUX is the first FDA approved therapy for head and neck cancer patients in more than 30 years,” said Kie-Kian Ang, M.D.,Ph.D., Professor, Radiation Oncology, Deputy Chair, Radiation Oncology, Deputy Division Head, Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. “For patients with locally or regionally advanced disease, ERBITUX in combination with radiation therapy has demonstrated a clinically significant improvement in survival and loco regional control.” Ina pivotal, international, randomized Phase III trial of 424 patients with locally or regionally advanced squamous cell carcinoma of the oropharynx, hypopharynx or larynx with no prior therapy, the addition of ERBITUX to radiation (n=211) when compared to radiation alone (n=213) resulted in a 9.5-month improvement in median duration of loco regional control [24.4 months versus 14.9 months, p = 0.005, hazard ratio, 0.68, 95% Confidence Interval (0.52-0.89)]. ERBITUX was dosed weekly, starting one week before radiation and for the duration of radiation therapy. The median number of ERBITUX doses administered in the clinical study was eight (1-11 infusions). Results also showed a 19.7-month improvement in median survival [49.0 months versus 29.3 months, p=0.03, hazard ratio, 0.74, 95%Confidence Interval (0.57-0.97)]. Another principal trial was a single-arm, multi center, Phase II trial studying the effects of ERBITUX as a single-agent treatment. The study analyzed 103patients with recurrent or metastatic SCCHN not suitable for further local therapy and who had failed platinum-based chemotherapy. ERBITUX was administered until disease progression or unacceptable toxicity. The median number of doses was 11 (range 1-45 infusions). Patients demonstrated a clinically meaningful objective response rate of 13 percent (95% Confidence Interval 7%-21%). The median duration of response was 5.8months (range 1.2-5.8 months). Pretreatment assessment for evidence of EGFR expression is not required for patients with squamous cell carcinoma of the head and neck. “This approval is a significant advancement for ImClone Systems and its partners,” said Joseph L. Fischer, Interim Chief Executive Officer, ImClone Systems Incorporated. “We continue to support abroad, evidence-based development plan for ERBITUX with the goal of fully demonstrating the therapy’s potential in treating human cancers.” “ERBITUX represents an important new option for potentially thousands of patients fighting head and neck cancer, a serious disease for which there is significant unmet medical need," said Peter R. Dolan, Chief Executive Officer, Bristol-Myers Squibb. "These new indications for ERBITUX are another step forward in our company's commitment to helping patients with cancer, and building on our decades-long legacy of researching, developing and providing innovative anti-cancer therapies to patients around the world." This is the second indicated tumor type for ERBITUX, previously approved by the FDA for use in combination with irinotecan for patients with EGFR-expressing metastatic colorectal cancer who are refractory to irinotecan therapy and as a single-agent for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are intolerant to irinotecan therapy. The effectiveness of ERBITUX for the treatment of EGFR-expressing metastatic colorectal cancer is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX for the treatment of EGFR-expressing metastatic colorectal cancer. ERBITUX was granted approval by Swiss Medic in December 2005 for use in combination with radiation in the treatment of patients with previously untreated advanced head and neck cancer. A similar marketing application was recommended for approval by a European Medicines Agency scientific advisory panel. The incidence of Grade 3 or 4 late radiation toxicities were generally similar between the radiation therapy alone and the ERBITUX plus radiation therapy arms. The most common adverse events seen in patients with carcinomas of the head and neck receiving ERBITUX in combination with radiation therapy (n=208) versus radiation alone (n=212) were mucositis-stomatitis (93%/94%), acneform rash (87%/10%), radiation dermatitis (86%/90%), weight loss (84%/72%), xerostomia (72%/71%), dysphagia (65%/63%), asthenia (56%/49%), nausea (49%/37%), constipation (35%/30%) and vomiting (29%/23%). The most common adverse events seen in patients with carcinomas of the head and neck receiving ERBITUX as a single agent (N=103) were acneform rash (76%), asthenia (45%), pain (28%), fever (27%) and weight loss (27%). The most common adverse events seen in patients with mCRC receiving ERBITUX with irinotecan (n=354) or ERBITUX as a single agent (n=420) were acneform rash (88%/90%), asthenia/malaise (73%/48%), diarrhea (72%/25%), nausea (55%/29%), abdominal pain (45%/26%), vomiting (41%/25%), fever (34%/27%), constipation (30%/26%), and headache (14%/26%). About ImClone Systems 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 research and development programs include growth factor blockers and angiogenesis inhibitors. 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. Certain matters discussed in this news release may constitute forward- looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission, including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement 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 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 "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including risk factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in the Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2006 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. SOURCE: ImClone Systems; Bristol-Myers Squibb CONTACT: Media - Rebecca Gregory Corporate Communications for ImClone Systems Incorporated +1-646-638-5058 media@imclone.com Madeline Malia +1-609-252-3347 Madeline.Malia@bms.com Tony Plohoros +1-609-252-7938 tony.plohoros@bms.com Investors - John Elicker +1-212-546-3775 John.Elicker@bms.com all of Bristol-Myers Squibb
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