DARMSTADT, Germany, Jan. 24 /PRNewswire/ -- Merck KGaA today confirmed
that its European studies for the cancer treatment C225 (cetuximab,
Erbitux(TM)) are continuing as planned.  Merck has a license to the rights for
C225 outside of North America, except for Japan where Merck KGaA,
Bristol-Myers Squibb and ImClone Systems Incorporated (Nasdaq: IMCL) have
development and commercialization rights.
    ImClone Systems announced in December that it had received a "Refusal to
File" (RTF) letter from the U.S. Food and Drug Administration (FDA) for its
application for approval of C225 to treat refractory colorectal cancer.  As a
consequence of the FDA's RTF letter, the U.S. launch of C225 may be delayed.
Merck's application for approval of C225 in Switzerland, expected to be its
first in Europe, also could be slightly delayed as the filing was to be based
on ImClone Systems' U.S. application.
    "Merck KGaA is conducting its own multi-center, controlled studies with
C225 in Europe," said Matthew Emmens, Merck's head of Ethical Pharmaceuticals.
"These are designed to determine the safety and efficacy of the drug in both
head-and-neck and colorectal cancer.  We continue to feel that C225 is a
promising agent that may offer a valuable therapeutic option for patients with
certain types of cancer.  Our studies and the application process generally
remain on schedule."
    Merck KGaA currently is conducting a multi-center European development
program for C225.  The program includes pivotal clinical trials of the drug in
patients who are refractory (resistant) to the standard treatments of
cisplatinum in head-and-neck cancer and irinotecan in colorectal cancer.
    The pivotal trial in head-and-neck cancer (Merck 001) evaluates the
effects of C225 added to cis- or carboplatinum in patients who have shown
progression of the cancer on the same dose and schedule of the platinum
compound.  The trial requires that patients have documentation of progression
either by computerized tomography (CT) or magnetic resonance imaging (MRI)
prior to inclusion.  Pre-study CTs and MRIs are collected for all patients and
are independently reviewed to assure appropriateness of patient selection.
Likewise, all imaging studies documenting the therapeutic benefit of C225 are
collected and reviewed by an independent expert panel.  This trial has
completed recruitment and is undergoing final evaluation.  Supportive data
concerning the single agent activity of C225 in patients with
platinum-refractory head-and-neck cancer are generated in an ongoing trial
(Merck 016), which uses the same strict inclusion criteria and quality control
measures as trial 001.
    To support the filing for colorectal cancer, Merck KGaA began enrolling
patients in a large randomized multi-center trial in patients with
irinotecan-refractory colorectal cancer during July 2001.  Strict inclusion
criteria, including collection and review of all pre-study CTs or MRIs, are
used for this trial.  Patients are randomized to receive either single agent
C225 or C225 plus the same dose and schedule of irinotecan to which the
patient was refractory.  A total of 225 patients will be recruited for this
trial.
    Additional supportive data from two ongoing phase I/II studies in
colorectal cancer patients are being conducted using C225 as first-line
therapy (combined with irinotecan/folinic acid and 5-FU).  There also are data
from an ongoing pharmacokinetic study, which specifically investigates
possible pharmacokinetic interaction between C225 with the activation of
irinotecan to SN38.

    Headquartered in Darmstadt,Germany, the Merck Group generated sales of
EUR 6.7 billion in 2000 in the fields of Pharmaceuticals, Specialty Chemicals,
Lab Products and Lab Distribution.  Founded in 1668, the Merck Group is
represented today by more than 200 companies in 52 countries and employs
34,300 people worldwide.  The company groups its operating activities under
Merck KGaA, in which E. Merck, as a general partner, holds the Merck family's
74 percent equity interest in Merck KGaA.  The Merck Group strongly believes
that promotion of its employees' self-initiative and self-responsibility,
application-oriented research and development and close customer relationships
in the markets are the keys to long-term corporate success.

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