NEW YORK, Oct. 17 /PRNewswire-FirstCall/ -- ImClone Systems
Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY)
today announced that they have established an agreement with Merck KGaA for
the co-development and co-commercialization of ERBITUX(R) (cetuximab) in
Japan. Under the terms of the agreement, ImClone Systems, Bristol-Myers
Squibb and Merck KGaA will collaborate on a joint effort to develop and,
following regulatory approval, market ERBITUX in Japan for the treatment of
epidermal growth factor receptor (EGFR)-expressing metastatic colorectal
cancer (mCRC), as well as for the treatment of any other cancers the
parties agree to pursue. Bristol-Myers Squibb and Merck KGaA will utilize
their respective sales forces in Japan, and the three companies will share
profits/losses realized as a result of the agreement. Merck Serono Japan
will distribute the product and record the sales for the collaboration.
The terms of this new agreement provide that Merck KGaA will receive 50
percent of the profit/loss from sales in Japan, and ImClone Systems and BMS
will each receive 25 percent. The sharing of profit/loss reflect the co-
exclusive rights to ERBITUX in Japan, previously granted by ImClone Systems
to Merck KGaA and Bristol-Myers Squibb. In addition to its percentage of
profits, ImClone Systems will receive from Merck KGaA a royalty equal to
4.75 percent of total net sales in Japan.
ImClone Systems, Bristol-Myers Squibb and Merck KGaA of Darmstadt,
Germany submitted an application in Japan earlier this year for the use of
ERBITUX in treating patients with EGFR-expressing mCRC. The submission is a
result of a development collaboration among the three companies and is
based on results from studies conducted in North America, Europe and Japan.
ERBITUX is the first monoclonal antibody that inhibits EGFR to be submitted
for marketing authorization in Japan.
"We are pleased to have established this agreement with our ERBITUX
partners Bristol-Myers Squibb and Merck KGaA. Doing so puts the companies
in a solid position to make ERBITUX available to EGFR-expressing metastatic
colorectal cancer patients in Japan upon a final decision from Japanese
regulatory officials," said John H. Johnson, Chief Executive Officer of
ImClone Systems.
"This agreement further strengthens our partnership with ImClone
Systems and Merck KGaA as we focus on maximizing the global potential of
ERBITUX," said Lamberto Andreotti, Executive Vice President and Chief
Operating Officer, Worldwide Pharmaceuticals, Bristol-Myers Squibb. "If
approved in Japan, ERBITUX would be an important new addition to the
treatments available to Japanese patients with EGFR-expressing metastatic
colorectal cancer."
About Colorectal Cancer
In Japan, the incidence of colorectal cancer has increased markedly
during the last 50 years. Among men and women in Japan, the incidence is
higher than for lung cancer (95,651 per year vs 66,453) and second to
stomach cancer (95,651 per year vs 109,779). In terms of mortality, the
ranking is slightly different; colorectal cancer is now the third largest
cancer threat in Japan after lung and stomach cancer (38,206, 56,367 and
54,423 people per year, respectively). Approximately 25 percent of
colorectal cancer patients present with metastatic disease or cancer that
has spread to other organs. EGFR is expressed in 60-80 percent of
colorectal cancer tumors.
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. While the mechanism of ERBITUX's anti- tumor effect(s) in vivo is
unknown, all of these processes may contribute to the overall therapeutic
effect of ERBITUX. 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, metastatic colorectal carcinoma (mCRC) 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 regimen.
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
Interstitial lung disease (ILD), which was fatal in one case, occurred
in 4 of 1570 (<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 ERBIUTX in clinical trials. Swith 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
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 in mCRC patients 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.
ERBITUX(R) 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 projected. 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, including quarterly
reports on Form 10-Q, current reports on Form 8-K and annual reports on
Form 10-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.
About Bristol-Myers Squibb
Bristol-Myers Squibb is dedicated to the discovery, development and
exhaustive exploration of innovative cancer fighting therapies that extend
and enhance the lives of patients living with cancer. More than 40 years
ago, Bristol-Myers Squibb built a unified vision for the future of cancer
treatment. With expertise, dedication and resolve, that vision led to the
development of a diverse global portfolio of anti-cancer therapies that are
an important cornerstone of care today. Hundreds of scientists in
Bristol-Myers Squibb's Research & Development organization are studying
ways to improve current cancer treatments and identify better, more
effective medicines for the future.
Bristol-Myers Squibb is a global pharmaceutical and related health care
products company whose mission is to extend and enhance human life.
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding the commercialization of ERBITUX in Japan. Such forward-looking
statements are based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change any of
them, and could cause actual outcomes and results to differ materially from
current expectations. No forward-looking statement can be guaranteed. There
can be no guarantee that the application to market ERBITUX in Japan will be
approved. Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect Bristol-Myers
Squibb's business, particularly those identified in the cautionary factors
discussion in Bristol- Myers Squibb's Annual Report on Form 10-K for the
year ended December 31, 2006, in our Quarterly Reports on Form 10-Q and our
Current Reports on Form 8- K. Bristol-Myers Squibb undertakes no obligation
to publicly update any forward-looking statement, whether as a result of
new information, future events or otherwise.
SOURCE ImClone Systems Incorporated; Bristol-Myers Squibb Company
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Related links:
http://www.imclone.com
http://www.bms.com http://www.ERBITUX.com
CONTACT:
Rebecca Gregory, +1-646-638-5058,
Rebecca.Gregory@imclone.com, Tracy Henrikson, +1-908-243-9945,
Tracy.Henrikson@imclone.com, both of ImClone Systems
Incorporated, Corporate Communications; or Media, Madeline Malia,
+1-609-252-3347, Madeline.Malia@bms.com, Tony Plohoros,
+1-609-252-7938, Tony.Plohoros@bms.com, or Investors, John
Elicker, +1-212-546-3775, John.Elicker@bms.com, all of
Bristol-Myers Squibb
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