Merck KGaA first with innovative, targeted therapy that offers new treatment
options and brings new hope to colorectal cancer patients - 'This is an
important day in the on-going fight against cancer'
DARMSTADT, Germany, Dec. 1 /PRNewswire-FirstCall/ -- Merck KGaA announced
today that the Swiss Agency for Therapeutic Products (Swissmedic) has approved
the use of Erbitux(TM) (cetuximab) for the treatment of patients with
colorectal cancer who no longer respond to standard chemotherapy treatment
with irinotecan. This is the first approval of Erbitux anywhere in the world.
The Swiss authorization allows doctors to administer Erbitux in
combination with irinotecan. Swissmedic noted in its correspondence with Merck
that the risk-benefit ratio for the combination therapy is favorable.
Based on the convincing efficacy and safety data of Erbitux in the
treatment of this life threatening disease, Swiss authorities approved Erbitux
under an accelerated registration procedure. Upon receiving the Swiss
notification, Merck immediately began shipment of the cancer medicine to
Switzerland.
"We know from inquiries we have been receiving for many months that
patients are desperately waiting for Erbitux," said Professor Bernhard
Scheuble, CEO of Merck KGaA. "This is an important day in the on-going fight
against cancer."
Merck submitted applications at the end of June 2003 for approval of
Erbitux to both Swissmedic and the European Agency for the Evaluation of
Medicinal Products (EMEA). EU marketing authorization is expected in mid-2004.
The Swiss approval was based on a large multi-center clinical trial
conducted in 11 European countries in 57 hospitals with more than 300 patients
diagnosed with advanced metastatic colorectal cancer. In the so-called BOND
(Bowel Oncology with Cetuximab Antibody) study, Erbitux, when used in
combination with irinotecan chemotherapy, benefited more than half of
patients. It shrank tumors in 23% and stopped tumor growth in an additional
33% of these very difficult to treat patients.
"Such response rates usually are associated with a prolongation of life,"
said Professor David Cunningham, M.D., head of the gastrointestinal and
lymphoma units at the Royal Marsden Hospital in London and Surrey, United
Kingdom, and lead investigator for the BOND study.
Professor Cunningham continued: "Erbitux is likely to change the standard
of care for patients with metastatic colorectal cancer as it gives doctors a
powerful new tool for patients whose disease is becoming worse despite
conventional chemotherapy. With this approval, we enter a new era in how
metastatic colorectal cancer is treated."
Erbitux is an IgG1 monoclonal antibody that specifically targets and
blocks the EGFR (Epidermal Growth Factor Receptor), which is expressed in more
than 80% of advanced metastatic colorectal cancers. Erbitux works by blocking
the EGF receptor, reducing both the invasion of normal tissues by tumor cells
and the spread of tumors to new sites (metastasis).
Blocking the receptor also inhibits the ability of tumor cells to repair
the damage caused by chemotherapy and radiotherapy and inhibits the formation
of new blood vessels inside tumors (angiogenesis). This leads to an overall
suppression of tumor growth.
More than 200,000 Western Europeans develop colorectal cancer each year,
with more than half of these already at an advanced stage of the disease at
first diagnosis.
Merck KGaA licensed the right to market Erbitux outside the U.S. and
Canada from ImClone Systems Incorporated of New York in 1998. In Japan, Merck
KGaA has co-exclusive marketing rights with ImClone Systems.
Note to Journalists:
Extensive background information, pictures and illustrations for Erbitux
are available at: http://www.media-highlights.merck.de
Stock Symbols:
Reuters: MRCG
Bloomberg: MRK GY
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With more than 34,500 employees in 53 countries, the Merck Group generated
sales of EUR 7.5 billion in 2002. Founded in 1668 in Darmstadt, Germany, the
company aims to be a world leader within its core businesses of
pharmaceuticals and chemicals. The Merck Group strongly believes the key to
its long-term business success is innovative products created by
entrepreneurial and talented employees. Merck groups its operating activities
under Merck KGaA, in which the Merck family holds 74% and the remaining 26% is
publicly traded. The former U.S. subsidiary, Merck & Co., has been a
completely independent company since 1917.
SOURCE Merck KGaA
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Related links:
http://www.merck.de
CONTACT:
Phyllis Carter, +49-61-51-72-71-44, for Merck
KGaA
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