02.06.2008 13:30:00
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ImClone Appoints Dr. Bernhard Ehmer Senior Vice President and Managing Director, International Operations
ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the
development and commercialization of novel antibodies to treat cancer,
today announced that it has appointed Bernhard Ehmer, M.D. as Senior
Vice President and Managing Director, International Operations,
effective May 30, 2008.
Dr. Ehmer, age 53, brings to ImClone more than 20 years of experience in
clinical development and global operations in the pharmaceutical
industry, with a majority of his career in senior management positions
overseeing the development of oncology therapeutics. One of the oncology
products that Dr. Ehmer oversaw the development and international
registration of includes ERBITUX®
(cetuximab), during the time he was at Merck KGaA, ImClone’s
ERBITUX partner outside of North America.
"Bernhard was one of the early and most
influential champions of the ERBITUX clinical development and
international registration efforts, and we are delighted to have him
join the ImClone team to help lead this next phase of our global
expansion,” said John H. Johnson, Chief
Executive Officer of ImClone. "Bernhard’s
vast experience in the development of antibodies for oncology and other
therapeutic areas will be of significant value as we continue to pursue
activities to maximize the commercial potential of ERBITUX and our
proprietary pipeline of novel antibodies around the world.”
Mr. Johnson continued, "Concurrent with
Bernhard’s appointment, we are pleased to
announce that we have established operations in Germany, our first
official corporate presence outside of the U.S. We are currently
conducting global clinical trials and this is a key step in furthering
our relationships with key opinion leaders and regulatory agencies
worldwide. Further strengthening our operational capabilities and
international reach are important elements of ImClone’s
overall strategy to be a more fully-integrated global leader in
therapeutic antibodies.”
Dr. Ehmer most recently served as President and Chief Executive Officer
of Fresenius Biotech, a company that is focused on the development and
commercialization of biopharmaceuticals in the fields of oncology and
transplantation medicine. Prior to joining Fresenius Biotech, Dr. Ehmer
served as Managing Director and Chief Executive Officer of Biopheresis
Technologies from May 2006 to April 2007. Biopheresis is focused on the
development and commercialization of the company’s
patented system for immunological cancer treatment.
"I am excited to have the opportunity to
contribute to the development of ImClone’s
promising clinical pipeline aimed at achieving relevant improvements in
treatment outcomes in cancer patients worldwide,”
commented Dr. Ehmer.
Dr. Ehmer was with Merck KGaA for eight years, joining the company in
1998 and taking on positions of increasing responsibility throughout his
tenure, including Head of Clinical R&D Operations, Vice President and
Head of Business Area Oncology and, most recently, Vice President and
Head of Corporate Strategic Planning and Alliance Management. While at
Merck KGaA, he was a key contributor to the clinical development of
ERBITUX, including Phase 3 trials in the drug’s
currently approved indications of colorectal cancer and head and neck
cancer, as well as non-small cell lung cancer, and the regulatory
approval of ERBITUX outside North America. ERBITUX is currently approved
in more than 70 countries.
From 1986 to 1998, Dr. Ehmer was with Boehringer Mannheim, where he held
operational positions of increasing responsibility and most recently
served as Head of the company’s Therapeutics
Regional Office in Singapore. Dr. Ehmer has a medical degree from the
University of Munich and Heidelberg and performed his residency in
Internal Medicine at the Academic Teaching Hospital at the University
from 1983 to 1986. Dr. Ehmer is the author or co-author of approximately
60 scientific publications.
About ERBITUX®
(Cetuximab)
ERBITUX (cetuximab) 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. In
vitro assays and in vivo animal studies have shown that
cetuximab inhibits the growth and survival of tumor cells that express
the EGFR. No anti-tumor effects of cetuximab were observed in human
tumor xenografts lacking EGFR expression.
Squamous Cell Carcinoma of the Head
and Neck (SCCHN)
ERBITUX, in combination with radiation therapy, is indicated for the
initial treatment of locally or regionally advanced squamous cell
carcinoma of the head and neck. ERBITUX, as a single agent, is indicated
for the treatment of patients with recurrent or metastatic squamous cell
carcinoma of the head and neck for whom prior platinum-based therapy has
failed.
Colorectal Cancer
ERBITUX, as a single agent, is indicated for the treatment of
EGFR-expressing metastatic colorectal cancer after failure of both
irinotecan- and oxaliplatin-based regimens. ERBITUX, as a single agent,
is also indicated for the treatment of EGFR-expressing metastatic
colorectal cancer in patients who are intolerant to irinotecan-based
regimens.
ERBITUX, in combination with irinotecan, is indicated for the treatment
of EGFR-expressing metastatic colorectal carcinoma in patients who are
refractory to irinotecan-based chemotherapy. The effectiveness of
ERBITUX in combination with irinotecan is based on objective response
rates. Currently, no data are available that demonstrate an improvement
in disease-related symptoms or increased survival with ERBITUX in
combination with irinotecan for the treatment of EGFR-expressing
metastatic colorectal carcinoma.
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. Serious infusion reactions,
requiring medical intervention and immediate, permanent discontinuation
of ERBITUX, included rapid onset of airway obstruction (bronchospasm,
stridor, hoarseness), hypotension, loss of consciousness, and/or cardiac
arrest. 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 (eg, epinephrine, corticosteroids,
intravenous antihistamines, bronchodilators, and oxygen). Longer
observation periods may be required in patients who require treatment
for infusion reactions. Cardiopulmonary arrest and/or sudden death occurred in 4 (2%) of 208
patients with squamous cell carcinoma of the head and neck treated with
radiation therapy and ERBITUX, as compared to none of 212 patients
treated with radiation therapy alone. Fatal events occurred
within 1 to 43 days after the last ERBITUX treatment. Carefully
consider the use of ERBITUX in combination with radiation therapy in
head and neck cancer patients with a history of coronary artery disease,
congestive heart failure or arrhythmias in light of these risks. Closely
monitor serum electrolytes including serum magnesium, potassium, and
calcium during and after ERBITUX therapy.
Interstitial lung disease (ILD), which was fatal in one case, occurred
in 4 of 1570 (<0.5%) patients receiving
ERBITUX in clinical trials. Interrupt ERBITUX for acute onset or
worsening of pulmonary symptoms. 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. Severe acneform rash
occurred 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.
The safety of ERBITUX in combination with radiation therapy and
cisplatin has not been established. Death and serious
cardiotoxicity were observed in a single-arm trial with ERBITUX,
radiation therapy, and cisplatin (100 mg/m2)
in patients with locally advanced squamous cell carcinoma of the head
and neck. Two of 21 patients died, one as a result of pneumonia
and one of an unknown cause. Four patients discontinued treatment
due to adverse events. Two of these discontinuations were due to cardiac
events. 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 therapy. Monitor
patients periodically for hypomagnesemia, hypocalcemia and hypokalemia,
during, and for at least 8 weeks following the completion of, ERBITUX
therapy. Replete electrolytes as necessary. The overall incidence of late radiation toxicities (any grade) was
higher with ERBITUX in combination with radiation therapy compared with
radiation therapy alone. The following sites were affected: salivary
glands (65%/56%), larynx (52%/36%), subcutaneous tissue (49%/45%),
mucous membranes (48%/39%), esophagus (44%/35%), and skin (42%/33%) in
the ERBITUX and radiation versus radiation alone arms, respectively. The
incidence of grade 3 or 4 late radiation toxicities were similar between
the radiation therapy alone and the ERBITUX plus radiation therapy arms. 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. ERBITUX should only be used during
pregnancy if the potential benefit justifies the potential risk to the
fetus.
The most serious adverse reactions associated with ERBITUX across
all studies were infusion reactions, cardiopulmonary arrest,
dermatologic toxicity and radiation dermatitis, sepsis, renal failure,
interstitial lung disease, and pulmonary embolus.
The most common adverse reactions associated with ERBITUX (incidence =25%)
are cutaneous adverse reactions (including rash, pruritus, and nail
changes), headache, diarrhea, and infection.
The most frequent adverse events seen in patients with carcinomas of the
head and neck receiving ERBITUX in combination with radiation therapy
(n=208) versus radiation alone (n=212) (incidence =50%)
were acneform rash (87%/10%), radiation dermatitis (86%/90%), weight
loss (84%/72%), and asthenia (56%/49%). The most common grade 3/4
adverse events (=10%) included: radiation
dermatitis (23%), acneform rash (17%), and weight loss (11%).
The most frequent adverse events seen in patients with metastatic
colorectal cancer (n=288) in the ERBITUX + best supportive care arm
(incidence = 50%) were fatigue (89%),
rash/desquamation (89%), abdominal pain (59%), and pain-other (51%). The
most common grade 3/4 adverse events (=10%)
included: fatigue (33%), pain-other (16%), dyspnea (16%), abdominal pain
(14%), infection without neutropenia (13%), rash/desquamation (12%), and
gastrointestinal-other (10%).
The most frequent adverse events seen in patients with metastatic
colorectal cancer (n=354) treated with ERBITUX plus irinotecan in
clinical trials (incidence = 50%) were
acneform rash (88%), asthenia/malaise (73%), diarrhea (72%), and nausea
(55%). The most common grade 3/4 adverse events (=
10%) included: diarrhea (22%), leukopenia (17%), asthenia/malaise (16%),
and acneform rash (14%).
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.
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