See: http://www.dakocytomation.us/
Feb 12, 2004

DakoCytomation Receives FDA Approval for EGFR pharmDx™
CARPINTERIA, CALIF. — DakoCytomation has received approval from the
U.S. Food and Drug Administration for use of its EGFR pharmDx™ kit as
an aid in identifying colorectal cancer patients eligible for
treatment with ERBITUX™ (cetuximab). In parallel, ImClone Systems'
ERBITUXTM (cetuximab) received approval for use in combination with
irinotecan in the treatment of patients with EGFR-expressing,
metastatic colorectal cancer who are refractory to irinotecan-based
chemotherapy, and for use as a single agent in the treatment of
patients with EGFR-expressing, metastatic colorectal cancer who are
intolerant to irinotecan-based chemotherapy.


DakoCytomation's EGFR pharmDx™ kit identifies EGFR in tissue
sections. EGFR is a protein expressed in a variety of cancers,
including colorectal, lung, breast, pancreatic, bladder, prostate,
kidney and head and neck. The kit is a slide-based assay used to
detect expression of EGFR protein in normal and neoplastic tissues.


"Approval of EGFR pharmDx solidifies DakoCytomation's role as the
world leader in providing pharmacoDiagnostic kits that can help
physicians and patients make important treatment decisions regarding
the use of targeted therapies," said Dennis Chenoweth, Corporate Vice
President of Diagnostics for DakoCytomation. The company pioneered
the concept of pharmacoDiagnostics with HercepTest™ — the first
clinical test that helps to assess candidates for a specific targeted
therapy.


DakoCytomation submitted a premarket approval application to the FDA
for EGFR pharmDx in September 2003 in parallel with ImClone Systems'
ERBITUX submission. The approved EGFR pharmDx indication is based on
the results of a pivotal ERBITUX clinical trial that utilized the kit
to aid in identifying patients whose tumors expressed EGFR.


ERBITUX is a monoclonal antibody designed to bind specifically to
EGFR and block certain growth factors from binding and signaling the
cell to promote tumor cell growth, survival and progression. It was
approved by Swiss authorities for use in the treatment of EGFR-
expressing metastatic colorectal cancer patients in December 2003.


EGFR pharmDx is already being used in Switzerland to aid in
identifying patients for ERBITUX therapy.

###


DakoCytomation A/S is headquartered in Copenhagen, Denmark, and has
significant R&D and manufacturing activities in the USA and in
England. It is a leading in vitro diagnostic company specializing in
the identification of cancer markers on samples obtained from tissue
and body fluids. DakoCytomation's cutting-edge technology in
immunochemistry, protein chemistry and instrument development enables
physicians around the world to link diagnostic tests with specific
therapies, thus optimizing patient treatment. The privately held
company, which has operations in 22 sites and distributors in 50
countries, employs more than 1,400 people.


This press release does not constitute an offer of any securities for
sale. It contains certain forward-looking statements with respect to
the positions of both companies in their industries and their plans
if combined. These forward-looking statements are based upon
managements' expectations and beliefs concerning future events.
Forward-looking statements are necessarily subject to risks,
uncertainties and other factors, many of which are outside the
control of the companies, which could cause actual results to differ
materially from such statements. These uncertainties and other
factors include such things as general business conditions; strength
of the economy and growth in the biotech industry; changes in the
companies' relationships with customers and suppliers; changes in
operating costs; and regulatory uncertainties.