Data Available From ERBITUX(R) Phase III Study In First-Line Treatment Of Advanced Pancreatic Cancer

ImClone Systems
Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY)
today announced that a Phase III study of ERBITUX(R) (Cetuximab) plus
gemcitabine (a chemotherapy) in patients with locally advanced unresectable
or metastatic pancreatic cancer did not meet its primary endpoint of
improving overall survival.



Conducted by the Southwest Oncology Group (SWOG), a cancer center
network sponsored by the National Cancer Institute, the open-label,
randomized study compared ERBITUX plus gemcitabine to gemcitabine alone in
more than 700 patients with pancreatic cancer in the first-line treatment
setting. The study was conducted in centers throughout the United States
and Canada. It was completed in a significantly shorter time than
projected, providing a timely answer to an important research question.
SWOG has informed ImClone and Bristol-Myers Squibb that the primary study
endpoint of statistically improving overall survival was not met. The three
parties -- SWOG, ImClone, and Bristol-Myers Squibb -- will engage in joint
efforts to fully interpret these results.



"This study was designed to examine the Phase II results we previously
observed for ERBITUX in patients with pancreatic cancer," stated Eric K.
Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone
Systems. "We still consider pancreatic cancer to be of the utmost priority
and we intend to pursue additional evaluations with ERBITUX including a
pilot study of ERBITUX and bevacizumab with or without gemcitabine, as well
as our pipeline agents, to improve the outcome for patients with pancreatic
cancer."



"Pancreatic cancer is a devastating disease with few effective
treatment options, and it is unfortunate that the use of ERBITUX in this
trial has not demonstrated the benefit it has shown in other tumors," said
Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs,
Bristol-Myers Squibb. "We are anxious to understand these data in greater
detail and are committed to exploring the potential benefits that ERBITUX
may provide to cancer patients."



About Pancreatic Cancer



This year in the U.S., approximately 33,700 people will be diagnosed
with cancer of the pancreas. Pancreatic cancer accounts for about six
percent (6%) of all cancer deaths, or about 32,000 deaths per year. The
current 5-year survival rate is about five percent (5%). The number of
deaths from this disease highlights the importance of seeking better
therapies for pancreatic cancer through clinical trials testing novel
drugs. During the past 30 years, the numbers of new cases of pancreatic
cancer (incidence) and deaths (mortality) have changed little.
















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' 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 (