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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 ImClones

Commercial Operations department upon Mr. Baileys

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

Michaels leadership of ImClones

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 Companys 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 Companys

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 Companys 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
Corporate Communications
Tracy

Henrikson, 908-243-9945
or
Rebecca Gregory, 646-638-5058
or
[email protected]

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