NEW YORK--(BUSINESS WIRE)--Dec. 7, 2007--ImClone Systems
Incorporated (NASDAQ: IMCL), a global leader in the development and
commercialization of novel cancer therapeutics, today announced that
it has signed a settlement agreement with Yeda Research and
Development Company Ltd. and Sanofi-Aventis to end worldwide
litigation related to U.S. Patent No. 6,217,866 (the "866 Patent") and
its foreign counterparts. All terms of the settlement agreement have
been finalized and the parties will submit stipulations to the
appropriate courts and patent offices in the various jurisdictions.
Under the terms of the settlement agreement, the companies agree
that Yeda is the sole owner of the 866 Patent in the U.S., and Yeda
and Sanofi-Aventis are co-owners of the 866 Patent's foreign
counterparts. Pursuant to the terms of the settlement agreement,
ImClone and Sanofi-Aventis will each pay Yeda $60.0 million in cash
for full and final settlement of the claims and counterclaims in the
matter. ImClone shall be granted a worldwide license to technology
patented under the 866 Patent. ImClone will make a contingent payment
to Yeda of a low single-digit royalty on sales in and outside of the
U.S. and will pay Sanofi-Aventis a low single-digit royalty on sales
outside of the United States. ImClone's worldwide royalty rate for
ERBITUX sales pursuant to the settlement agreement remains unchanged.
"This settlement agreement with Yeda and Sanofi-Aventis further
solidifies our ability to maximize the commercialization of ERBITUX in
the U.S. and abroad going forward," said John H. Johnson, Chief
Executive Officer of ImClone. "With this settlement, we have now
successfully resolved two important patent litigation claims this year
through mutually beneficial agreements that enhance the future
commercial and financial potential for ImClone and ERBITUX."
Yeda Research and Development Company Ltd. is responsible for
technology transfer from the Weizmann Institute of Science, Israel's
leading center of research and graduate education. The Institute's
activities range across the spectrum of contemporary science. Yeda
holds an exclusive agreement with the Institute for the marketing and
commercialization of new developments emerging from the Institute's
laboratories.
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. No anti-tumor effects of
ERBITUX were observed in human tumor xenografts lacking EGFR
expression. 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, as a single agent, is indicated for the treatment of
EGFR-expressing mCRC after failure of both irinotecan- and
oxaliplatin-based regimens. ERBITUX, as a single agent, is also
indicated for the treatment of EGFR-expressing mCRC in patients who
are intolerant to irinotecan-based regimens.
For full prescribing information, including boxed WARNINGS
regarding infusion reactions and cardiopulmonary arrest, visit
http://www.ERBITUX.com.
Important Safety Information
Grade 3/4 infusion reactions occurred in approximately 3% of
patients receiving ERBITUX (cetuximab) in clinical trials with fatal
outcome reported in less than 1 in 1000. Reactions characterized by
rapid onset of airway obstruction (bronchospasm, stridor, hoarseness),
urticaria, hypotension, loss of consciousness, and/or cardiac arrest.
Severe infusion reactions require immediate and permanent
discontinuation of ERBITUX therapy.
Most reactions (90%) were associated with the first infusion of
ERBITUX despite premedication with antihistamines. Caution must be
exercised with every ERBITUX infusion as there were patients who
experienced their first severe infusion reaction during later
infusions. Monitor patients for 1-hour following ERBITUX infusions in
a setting with resuscitation equipment and other agents necessary to
treat anaphylaxis (e.g., epinephrine, corticosteroids, intravenous
antihistamines, bronchodilators, and oxygen). Longer observation
periods may be required in patients who require treatment for infusion
reactions.
Severe cases of interstitial lung disease (ILD), which was fatal
in one case, occurred in 4 of 1570 (less than 0.5%) of patients
receiving ERBITUX in clinical trials. Permanently discontinue ERBITUX
where ILD is confirmed.
In clinical studies of ERBITUX, dermatologic toxicities, including
acneform rash, skin drying and fissuring, paronychial inflammation,
infectious sequelae (eg, S. aureus sepsis, abscess formation,
cellulitis, blepharitis, cheilitis), and hypertrichosis occurred in
patients receiving ERBITUX therapy. Acneform rash occurred in 76-88%
of 1373 patients receiving ERBITUX in clinical trials with severe
acneform rash occurring in 1-17% of patients. Acneform rash usually
developed within the first two weeks of therapy and resolved in a
majority of the patients after cessation of treatment, although in
nearly half, the event continued beyond 28 days. Monitor patients
receiving ERBITUX for dermatologic toxicities and infectious sequelae.
Sun exposure may exacerbate these effects.
In women of childbearing potential, appropriate contraceptive
measures must be used during treatment with ERBITUX and for 6 months
following the last dose of ERBITUX. If ERBITUX is used during
pregnancy or if patients become pregnant while receiving ERBITUX,
patients should be apprised of the potential risk for loss of
pregnancy or potential hazard to the fetus.
Hypomagnesemia occurred in 55% (199/365) of patients receiving
ERBITUX and was severe (NCI CTC grades 3 & 4) in 6-17%. The onset of
hypomagnesemia and accompanying electrolyte abnormalities occurred
days to months after initiation of ERBITUX. Monitor patients
periodically for hypomagnesemia, hypocalcemia and hypokalemia, during
and for at least 8 weeks following the completion of ERBITUX. Replete
electrolytes as necessary.
The most serious adverse reactions associated with ERBITUX in mCRC
patients are infusion reactions, dermatologic toxicity, sepsis, renal
failure, interstitial lung disease, and pulmonary embolus.
The most common adverse reactions with ERBITUX (incidence greater
than or equal to 25% in the ERBITUX + plus best supportive care arm
(BSC)) (n=288) vs. BSC (n=274), respectively, were fatigue (89%, 76%),
rash/desquamation (89%, 16%), abdominal pain (59%, 52%), pain-other
(51%, 34%), dry skin (49%, 11%), dyspnea (48%, 43%), constipation
(46%, 38%), pruritus (40%, 8%), diarrhea (39%, 20%), vomiting (37%,
29%), infection without neutropenia (35%, 17%), headache (33%, 11%),
fever (30%, 18%), insomnia (30%, 15%), cough (29%, 19%),
dermatology-other (27%, 6%), and stomatitis (25%, 10%).
About ImClone Systems
ImClone Systems Incorporated is a fully integrated
biopharmaceutical company committed to advancing oncology care by
developing and commercializing a portfolio of targeted biologic
treatments designed to address the medical needs of patients with a
variety of cancers. The Company's research and development programs
include growth factor blockers and angiogenesis inhibitors. ImClone
Systems' headquarters and research operations are located in New York
City, with additional administration and manufacturing facilities in
Branchburg, New Jersey. For more information about ImClone Systems,
please visit the Company's web site at http://www.imclone.com.
Certain matters discussed in this news release may constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and the Federal securities
laws. Although the company believes that the expectations reflected in
such forward-looking statements are based upon reasonable assumptions
it can give no assurance that its expectations will be achieved.
Forward-looking information is subject to certain risks, trends and
uncertainties that could cause actual results to differ materially
from those currently expected. Many of these factors are beyond the
company's ability to control or predict. Important factors that may
cause actual results to differ materially and could impact the company
and the statements contained in this news release can be found in the
company's filings with the Securities and Exchange Commission,
particularly those factors identified as "risk factors" in the
Company's most recent annual report of Form 10-K and in its quarterly
reports on Form 10-Q and current reports on Form 8-K. For
forward-looking statements in this news release, the company claims
the protection of the safe harbor for forward-looking statements
contained in the Private Securities Litigation Reform Act of 1995. The
company assumes no obligation to update or supplement any
forward-looking statements whether as a result of new information,
future events or otherwise.
CONTACT: Rebecca Gregory
Corporate Communications
ImClone Systems Incorporated
646-638-5058
MEDIA@IMCLONE.COM
or
Tracy Henrikson
Corporate Communications
ImClone Systems Incorporated
908-243-9945
SOURCE: ImClone Systems
