-- ImClone Systems and FDA discuss approach for resubmission of Erbitux
Biologics license application
DARMSTADT, Germany, Feb. 27 /PRNewswire/ -- Merck KGaA confirmed today
that it was represented at the Tuesday meeting between its strategic partner
ImClone Systems Inc., Bristol-Myers Squibb Co. and the U.S. Food and Drug
Administration (FDA).
The purpose of the meeting was to discuss the FDA's letter refusing to
file ImClone Systems' Biologics License Application (BLA) for Erbitux(TM)
(cetuximab) in the treatment of irinotecan-refractory colorectal cancer, and
to seek guidance on how to proceed.
Merck KGaA shares the opinion of ImClone Systems that the meeting in
Washington, D.C., was productive. Under terms of the 1998 licensing agreement,
Merck will provide ImClone Systems with available European clinical data.
Erbitux (known as C225 in Europe) is an investigational monoclonal
antibody designed to target and block the Epidermal Growth Factor Receptor
(EGFR), which is expressed on the surface of certain cancer cells.
With more than 34,000 employees in 55 countries, the Merck Group generated
sales of EUR 7.5 billion in 2001. Founded in 1668 in Darmstadt, Germany, the
company aims to be a world leader in 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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CONTACT: Phyllis Carter of Merck KGaA, +49-61-51-72-7144
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