ImClone Systems Issues Statement Regarding European Commission Approval for ERBITUX(R) for the Treatment of Head and Neck Cancer

"The approval of ERBITUX by the European Commission is asignificant advancement for patients with head and neck cancer,"stated Joseph L. Fischer, Interim Chief Executive Officer of ImCloneSystems. "Designed to inhibit the function of the epidermal growthfactor receptor (EGFR), ERBITUX is the first and only monoclonalantibody approved for head and neck cancer. This approval was based ondata demonstrating an improvement in overall survival. This benefitwas achieved in one of the largest studies ever conducted in head andneck cancer, which is part of a broad, evidence-based development planfor ERBITUX aimed at demonstrating the therapy's potential in treatinghuman cancers."

With the European Commission's approval, ERBITUX will be availablefor the treatment of head and neck cancer in all 25 member states ofthe European Union as well as Iceland and Norway in accordance withlocal legal regulations. ERBITUX is already licensed in 53 countriesfor metastatic colorectal cancer after failure of irinotecan-basedchemotherapy.

The license application is based on the results from a randomized,international phase III trial (IMCL-9815), conducted by ImCloneSystems and Merck KGaA, which examined the impact of combining ERBITUXwith radiation on overall survival and locoregional control in 424patients with locally or regionally advanced SCCHN.

ERBITUX was granted approval by SwissMedic in December 2005 foruse in combination with radiotherapy in the treatment of patients withpreviously untreated advanced SCCHN. On March 1, 2006, the FDAapproved ERBITUX for use in combination with radiotherapy for thetreatment of locally or regionally advanced SCCHN and as a singleagent in recurrent or metastatic SCCHN where prior platinum-basedchemotherapy has failed.

About Head and Neck Cancer

In Europe alone, around 100,800 people are diagnosed with head andneck cancer and almost 40,000 die from the disease every year.(1) Headand neck cancer is the sixth most frequently occurring cancerworldwide.(2) Head and neck cancer includes cancers of the tongue,mouth, salivary glands, pharynx, larynx, sinus, and other siteslocated in the head and neck area. About 90 percent of head and neckcancers are of the squamous cell variety(3) and nearly all expressepidermal growth factor receptor (EGFR), which is critical for tumorgrowth.(4)

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.

ERBITUX (Cetuximab), in combination with radiation therapy, isindicated for the treatment of locally or regionally advanced squamouscell carcinoma of the head and neck. ERBITUX as a single agent isindicated for the treatment of patients with recurrent or metastaticsquamous cell carcinoma of the head and neck for whom priorplatinum-based therapy has failed. ERBITUX is indicated for thetreatment of ERGFR-expressing, metastatic colorectal carcinoma incombination with irinotecan for patients who are refractory toirinotecan-based chemotherapy, and as a single agent for patients whoare intolerant to irinotecan-based therapy. The effectiveness ofERBITUX in EGFR-expressing mCRC cancer is based on objective responserates. Currently, no data are available that demonstrate animprovement in disease-related symptoms or increased survival withERBITUX.

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. These reactions werecharacterized by rapid onset of airway obstruction (bronchospasm,stridor, hoarseness), urticaria, hypotension, and/or cardiac arrest.Severe infusion reactions require immediate and permanentdiscontinuation 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. ERBITUX in combination withradiation therapy should be used with caution in patients with knowncoronary artery 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 (e.g. 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 safety of ERBITUX in combination with radiation therapy andcisplatin has not been established. Death and serious cardiotoxicitywere observed in a single-arm 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. Four patientsdiscontinued treatment due to adverse events.

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. Patients receiving ERBITUX therapy should be periodicallymonitored for hypomagnesemia, and accompanying hypocalcemia andhypokalemia during, and up to 8 weeks following the completion of,ERBITUX therapy.

The most serious adverse reactions associated with ERBITUX incombination with radiation therapy in patients with head and neckcancer were infusion reaction (3%), cardiopulmonary arrest (2%),dermatologic toxicity (2.5%), mucositis (6%), radiation dermatitis(3%), confusion (2%) and diarrhea (2%).

The most serious adverse reactions associated with ERBITUX in mCRCclinical trials (N=774) were infusion reaction (3%), dermatologictoxicity (1%), interstitial lung disease (0.4%), fever (5%), sepsis(3%), kidney failure (2%), pulmonary embolus (1%), dehydration (5% inpatients receiving ERBITUX with irinotecan, 2% in patients receivingERBITUX as a single agent), and diarrhea (6% in patients receivingERBITUX with irinotecan, 0.2% in patients receiving ERBITUX as asingle 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 arms.

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 patients receiving ERBITUXwith irinotecan (n=354) or ERBITUX as a single agent (n=420) wereacneform 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%).
References

1. www-dep.iarc.fr. April 2002.

2. Hunter KD et al. Profiling early head and neck cancer. Nat Rev
Cancer. 2005 Feb; 5 (2): 127-35.

3. Bourhis J and Pinto H. Redefining 'State of the Art' in Head and
Neck Cancer. Oral presentation, 6th International Conference on
Head and Neck Cancer 7-11 August 2004.

4. Forastiere A, Koch W, Trotti A, Sidransky D, et al. Head and neck
cancer. N Engl J Med 2001:345(26), 1890-1900.

About ImClone Systems Incorporated

ImClone Systems Incorporated is committed to advancing oncologycare by developing and commercializing a portfolio of targetedbiologic treatments designed to address the medical needs of patientswith a variety of cancers. The Company's research and developmentprograms include growth factor blockers and angiogenesis inhibitors.ImClone Systems' strategy is to become a fully integratedbiopharmaceutical company, taking its development programs from theresearch stage to the market. ImClone Systems' headquarters andresearch operations are located in New York City, with additionaladministration and manufacturing facilities 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 Commissionincluding 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.