ERBITUX(R) Meets Primary Endpoint Of Increasing Survival In Phase III Lung Cancer Study

ImClone Systems
Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY)
today announced that a Phase III study of ERBITUX(R) (Cetuximab) in
combination with platinum-based chemotherapy (vinorelbine plus cisplatin)
met its primary endpoint of increasing overall survival compared with
chemotherapy alone in patients with advanced non-small cell lung cancer
(NSCLC). This large, randomized multi-national study, known as FLEX
(First-Line Treatment for Patients with Epidermal growth factor inhibitor
(EGFR)-EXpressing Advanced NSCLC) was conducted by Merck KGaA, Darmstadt,
Germany and enrolled patients with Stage IIIB or Stage IV NSCLC who had not
previously received chemotherapy.



"Based on the FLEX results, ERBITUX is the only member of the class of
epidermal growth factor inhibitors to demonstrate survival in the
first-line treatment of patients with advanced non-small cell lung cancer.
Previous pivotal trials involving other agents targeting EGFR have failed
to demonstrate a survival advantage for these patients," stated Eric K.
Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone
Systems. "These are important results for lung cancer patients and health
care professionals treating this devastating disease, since there have been
very few treatment advances for lung cancer in recent years."



"Studies have shown that ERBITUX improves overall survival for patients
with certain head and neck cancers, and now, with the FLEX data, for
patients with advanced non-small cell lung cancer," said Martin Birkhofer,
M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers
Squibb. "We look forward to sharing these data with the medical community."



Results from this study will be submitted for presentation at an
upcoming medical conference.



Merck KGaA, Darmstadt, Germany, is ImClone Systems' ERBITUX partner
outside of North America.



About Lung Cancer



The American Cancer Society estimates that in the U.S., more than
213,000 people will be diagnosed with lung cancer in 2007. Lung cancer is
the leading cause of cancer-related death in men and women in the U.S.,
with 160,000 deaths estimated in 2007. Approximately 80 to 85% of these
patients will be diagnosed with non-small cell lung cancer, with the
majority being diagnosed with locally advanced or metastatic disease.



About ERBITUX(R) (Cetuximab)



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
















ERBITUX (Cetuximab), in combination with radiation therapy, is
indicated for the treatment of locally or regionally advanced squamous cell
carcinoma of the head and neck. ERBITUX as a single agent is indicated for
the treatment of patients with recurrent or metastatic squamous cell
carcinoma of the head and neck for whom prior platinum-based therapy has
failed.



ERBITUX is indicated for the treatment of EGFR-expressing, metastatic
colorectal carcinoma (mCRC) in combination with irinotecan for patients who
are refractory to irinotecan-based chemotherapy, and as a single agent for
patients who are intolerant to irinotecan-based therapy. The effectiveness
of ERBITUX for the treatment of EGFR-expressing mCRC 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 mCRC.



For full prescribing information, including boxed WARNINGS regarding
infusion reactions and cardiopulmonary arrest, visit
ERBITUX.



Important Safety Information



Grade 3/4 infusion reactions, rarely with fatal outcome (