ImClone Announces Changes in Commercial Organization Leadership
2008-07-14 06:00:00
ImClone Announces Changes in Commercial Organization Leadership
Michael P. Bailey Resigns as Senior Vice President, Commercial
Operations;
Joseph I. DePinto Appointed Vice President, Commercial Operations
NEW YORK–(EMWNews)–ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the
development and commercialization of novel antibodies to treat cancer,
today announced that Michael P. Bailey has resigned his position as
Senior Vice President, Commercial Operations, effective August 1, 2008.
Mr. Bailey has resigned to accept a senior level commercial position
with Synta Pharmaceuticals Corp., a New England-based biopharmaceutical
company.
ImClone also announced that it has appointed Joseph I. DePinto as Vice
President, Commercial Operations, effective July 14, 2008. Mr. DePinto,
age 41, will assume responsibility for ImClone’s
Commercial Operations department upon Mr. Bailey’s
departure on August 1, 2008. Mr. DePinto has nearly 20 years of
experience in pharmaceutical sales, marketing and commercial business
strategy for oncology products.
“Joe has a solid track record of delivering
impressive results for the oncology therapeutic franchises he
championed. His proven leadership in sales and marketing will be of
significant value as we aggressively seek to maximize the global
potential of ERBITUX®
and our robust pipeline of novel antibodies in the future,”
said John H. Johnson, Chief Executive Officer of ImClone. “Through
Michael’s leadership of ImClone’s
commercial efforts over the past two years, we are well positioned to
extend the growth of ERBITUX in the years to come. We thank Michael and
wish him continued success as he pursues the next phase of his career.”
Mr. DePinto joins ImClone from Johnson & Johnson Pharmaceutical Services
Inc., where he served as Global Marketing Leader, Oncology Therapeutics
since 2006. In this role, he was responsible for leading the development
and execution of worldwide commercial strategies, market analyses and
forecasts. Previously, Mr. DePinto was with Ortho Biotech Products for
12 years where he took on management positions of increasing
responsibility in oncology sales and marketing and most recently served
as Vice President, Oncology Sales. Prior to joining Ortho Biotech
Products, he held field sales positions at Upjohn Pharmaceuticals from
1990 to 1994. Mr. DePinto has a B.S. degree in Marketing and an M.B.A.
in Pharmaceutical Chemical Studies from Farleigh Dickinson University.
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 ERBITUX inhibits the growth and survival
of tumor cells that express the EGFR. No anti-tumor effects of ERBITUX
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 global
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.
ERBITUX is a registered trademark of ImClone Systems Incorporated.
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.
ImClone Systems Incorporated Henrikson, 908-243-9945 |
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