FDA Approves ERBITUX(R) (Cetuximab) for Treatment of Head and Neck Cancer; First and Only Approved Monoclonal Antibody for Squamous Cell Carcinoma of the Head and Neck

With this approval, ERBITUX is now indicated for use incombination with radiation therapy for the treatment of locally orregionally advanced squamous cell carcinoma of the head and neck(SCCHN) and as a single agent in recurrent or metastatic SCCHN whereprior platinum-based chemotherapy has failed. These indications arebased on a Phase III study - one of the largest studies ever conductedin head and neck cancer patients - that demonstrated a survival andlocoregional control advantage when ERBITUX was added to radiationtherapy, and a Phase II study, where ERBITUX therapy alone reducedtumor size.

"This is an important milestone as ERBITUX is the first FDAapproved therapy for head and neck cancer patients in more than 30years," said Kie-Kian Ang, M.D., Ph.D., Professor, Radiation Oncology,Deputy Chair, Radiation Oncology, Deputy Division Head, RadiationOncology, The University of Texas M. D. Anderson Cancer Center,Houston, Texas. "For patients with locally or regionally advanceddisease, ERBITUX in combination with radiation therapy hasdemonstrated a clinically significant improvement in survival andlocoregional control."

In a pivotal, international, randomized Phase III trial of 424patients with locally or regionally advanced squamous cell carcinomaof the oropharynx, hypopharynx or larynx with no prior therapy, theaddition of ERBITUX to radiation (n=211) when compared to radiationalone (n=213) resulted in a 9.5-month improvement in median durationof locoregional control (24.4 months versus 14.9 months, p = 0.005,hazard ratio, 0.68, 95% Confidence Interval (0.52-0.89)). ERBITUX wasdosed weekly, starting one week before radiation and for the durationof radiation therapy. The median number of ERBITUX doses administeredin the clinical study was eight (1-11 infusions). Results also showeda 19.7-month improvement in median survival (49.0 months versus 29.3months, p=0.03, hazard ratio, 0.74, 95% Confidence Interval(0.57-0.97)).

Another principal trial was a single-arm, multicenter, Phase IItrial studying the effects of ERBITUX as a single-agent treatment. Thestudy analyzed 103 patients with recurrent or metastatic SCCHN notsuitable for further local therapy and who had failed platinum-basedchemotherapy. ERBITUX was administered until disease progression orunacceptable toxicity. The median number of doses was 11 (range 1-45infusions). Patients demonstrated a clinically meaningful objectiveresponse rate of 13 percent (95% Confidence Interval 7%-21%). Themedian duration of response was 5.8 months (range 1.2-5.8 months).

Pretreatment assessment for evidence of EGFR expression is notrequired for patients with squamous cell carcinoma of the head andneck.

"This approval is a significant advancement for ImClone Systemsand its partners," said Joseph L. Fischer, Interim Chief ExecutiveOfficer, ImClone Systems Incorporated. "We continue to support abroad, evidence-based development plan for ERBITUX with the goal offully demonstrating the therapy's potential in treating humancancers."

"ERBITUX represents an important new option for potentiallythousands of patients fighting head and neck cancer, a serious diseasefor which there is significant unmet medical need," said Peter R.Dolan, Chief Executive Officer, Bristol-Myers Squibb. "These newindications for ERBITUX are another step forward in our company'scommitment to helping patients with cancer, and building on ourdecades-long legacy of researching, developing and providinginnovative anti-cancer therapies to patients around the world."

This is the second indicated tumor type for ERBITUX, previouslyapproved by the FDA for use in combination with irinotecan forpatients with EGFR-expressing metastatic colorectal cancer who arerefractory to irinotecan therapy and as a single-agent for thetreatment of EGFR-expressing metastatic colorectal cancer in patientswho are intolerant to irinotecan therapy. The effectiveness of ERBITUXfor the treatment of EGFR-expressing metastatic colorectal cancer isbased on objective response rates. Currently, no data are availablethat demonstrate an improvement in disease-related symptoms orincreased survival with ERBITUX for the treatment of EGFR-expressingmetastatic colorectal cancer.

ERBITUX was granted approval by SwissMedic in December 2005 foruse in combination with radiation in the treatment of patients withpreviously untreated advanced head and neck cancer. A similarmarketing application was recommended for approval by a EuropeanMedicines Agency scientific advisory panel.

About Head and Neck Cancer

According to the American Cancer Society, nearly 40,000 Americanswere diagnosed with head and neck cancer in 2005, including cancers ofthe tongue, the rest of the mouth, the salivary glands and inside thethroat, the voice box and the lymph nodes in the upper neck. Inaddition, it is estimated that more than 11,000 Americans died fromthe disease last year. Head and neck cancer most often affects peopleover the age of 50, and men are twice as likely to be diagnosed aswomen. The most common risk factors are tobacco and excessive alcoholuse.

About ERBITUX(R) (Cetuximab)

ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibitthe function of a molecular structure expressed on the surface ofnormal and tumor cells called the epidermal growth factor receptor(EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studieshave shown that binding of ERBITUX to the EGFR blocks phosphorylationand activation of receptor-associated kinases, resulting in inhibitionof cell growth, induction of apoptosis, and decreased matrixmetalloproteinase and vascular endothelial growth factor production.In vitro, ERBITUX can mediate antibody-dependent cellular cytotoxicity(ADCC) against certain human tumor types. While the mechanism ofERBITUX' anti-tumor effect(s) in vivo is unknown, all of theseprocesses may contribute to the overall therapeutic effect of ERBITUX.EGFR is part of a signaling pathway that is linked to the growth anddevelopment of many human cancers, including those of the head andneck, colon and rectum.

For full prescribing information, including boxed WARNINGS forERBITUX, visit http://www.ERBITUX.com.

Important Safety Information

Grade 3/4 infusion reactions, rarely with fatal outcome (less than1 in 1000), occurred in approximately 3% (46/1485) of patientsreceiving ERBITUX (Cetuximab) therapy, characterized by rapid onset ofairway obstruction (bronchospasm, stridor, hoarseness), urticaria,hypotension, and/or cardiac arrest. Severe infusion reactions requireimmediate and permanent discontinuation of ERBITUX therapy.

Most reactions (90%) were associated with the first infusion ofERBITUX despite the use of prophylactic antihistamines. Caution mustbe exercised with every ERBITUX infusion as there were patients whoexperienced their first severe infusion reaction during laterinfusions. A 1-hour observation period is recommended following theERBITUX infusion. Longer observation periods may be required inpatients who experience infusion reactions.

Cardiopulmonary arrest and/or sudden death occurred in 2% (4/208)of patients with squamous cell carcinoma of the head and neck treatedwith radiation therapy and ERBITUX as compared to none of 212 patientstreated with radiotherapy alone. ERBITUX in combination with radiationtherapy should be used with caution in patients with known coronaryartery disease, congestive heart failure and arrhythmias.

Close monitoring of serum electrolytes, including serum magnesium,potassium, and calcium during and after Cetuximab therapy isrecommended.

Severe cases of interstitial lung disease (ILD), which was fatalin one case, occurred in less than 0.5% of 774 patients with advancedcolorectal cancer (mCRC) receiving ERBITUX. There was one case (n=796)of ILD reported in patients in head and neck clinical trials withERBITUX.

In clinical studies of ERBITUX, dermatologic toxicities, includingacneform rash, skin drying and fissuring, and inflammatory andinfectious sequelae (eg, blepharitis, cheilitis, cellulitis, cyst)were reported. Severe (Grade 3/4) acneform rash was reported in 17% of208 patients with head and neck cancer treated with ERBITUX plusradiation and in 1% of 103 patients treated with ERBITUX as a singleagent as well as 11% of 774 patients with mCRC treated with ERBITUX.Sun exposure may exacerbate these effects. A related nail disorder,occurring in 12% (0.4% Grade 3) of patients, was characterized as aparonychial inflammation.

The incidence of hypomagnesemia (both overall and severe (NCI CTCGrades 3 & 4)) was increased in patients receiving ERBITUX alone or incombination with chemotherapy as compared to those receiving bestsupportive care or chemotherapy alone based on ongoing, controlledclinical trials in 244 patients. Approximately one-half of thesepatients receiving ERBITUX experienced hypomagnesemia and 10-15%experienced severe hypomagnesemia. Electrolyte repletion was necessaryin some patients and in severe cases, intravenous replacement wasrequired.

The safety of ERBITUX in combination with radiation therapy andcisplatin has not been established. Death and serious cardiotoxicitywere observed in a single-am trial with ERBITUX, delayed, accelerated(concomitant boost) fractionation radiation therapy, and cisplatin(100 mg/m2) conducted in patients with locally advanced squamous cellcarcinoma of the head and neck. Two of 21 patients died, one as aresult of pneumonia and one of an unknown cause. Four patientsdiscontinued treatment due to adverse events. Two of thesediscontinuations were due to cardiac events (myocardial infarction inone patient and arrhythmia, diminished cardiac output, and hypotensionin the other patient).

Additional serious adverse events associated with ERBITUX incombination with RT in patients with head and neck cancer weremucositis (6%), radiation dermatitis (3%), confusion (2%) and diarrhea(2%). Additional serious adverse events associated with ERBITUX inmCRC clinical trials (N=774) were fever (5%), sepsis (3%), kidneyfailure (2%), pulmonary embolus (1%), dehydration (5% in patientsreceiving ERBITUX with irinotecan, 2% in patients receiving ERBITUX asa single agent), and diarrhea (6% in patients receiving ERBITUX withirinotecan, 0.2% in patients receiving ERBITUX as a single agent).

The overall incidence of late radiation toxicities (any grade) washigher in ERBITUX in combination with radiation therapy compared withradiation therapy alone. The following sites were affected: salivaryglands (65%/56%), larynx (52%/36%), subcutaneous tissue (49%/45%),mucous membranes (48%/39%), esophagus (44%/35%), skin (42%/33%), brain(11%/9%), lung (11%/8%), spinal cord (4%/3%), and bone (4%/5%) in theERBITUX and radiation versus radiation alone arms, respectively.

The incidence of Grade 3 or 4 late radiation toxicities weregenerally similar between the radiation therapy alone and the ERBITUXplus radiation therapy.

The most common adverse events seen in patients with carcinomas ofthe head and neck receiving ERBITUX in combination with radiationtherapy (n=208) versus radiation alone (n=212) weremucositis-stomatitis (93%/94%), acneform rash (87%/10%), radiationdermatitis (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 adverseevents seen in patients receiving ERBITUX as a single agent (n=103)were acneform rash (76%), asthenia (45%), pain (28%), fever (27%) andweight loss (27%). The most common adverse events seen in patientsreceiving 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%), andheadache (14%/26%).

About ImClone Systems

ImClone Systems Incorporated is committed to advancing oncologycare by developing a portfolio of targeted biologic treatmentsdesigned to address the medical needs of patients with a variety ofcancers. The Company's research and development programs includegrowth 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 inNew York City, with additional administration and manufacturingfacilities in Branchburg, New Jersey.

Certain matters discussed in this news release may constituteforward-looking statements within the meaning of the PrivateSecurities Litigation Reform Act of 1995 and the Federal securitieslaws. Although the company believes that the expectations reflected insuch forward-looking statements are based upon reasonable assumptionsit can give no assurance that its expectations will be achieved.Forward-looking information is subject to certain risks, trends anduncertainties that could cause actual results to differ materiallyfrom those projected. Many of these factors are beyond the company'sability to control or predict. Important factors that may cause actualresults to differ materially and could impact the company and thestatements contained in this news release can be found in thecompany's filings with the Securities and Exchange Commission,including quarterly reports on Form 10-Q, current reports on Form 8-Kand annual reports on Form 10-K. For forward-looking statements inthis news release, the company claims the protection of the safeharbor for forward-looking statements contained in the PrivateSecurities Litigation Reform Act of 1995. The company assumes noobligation to update or supplement any forward-looking statementswhether as a result of new information, future events or otherwise.

About Bristol-Myers Squibb

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

Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance humanlife.