Conference call scheduled for tomorrow, Tuesday, December 11, 2007 at 8:45
am ET
PRINCETON, N.J., Dec. 10 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) and Bristol-Myers Squibb Company (NYSE: BMY) today announced
top-line data from the three registrational trials (008, 022, 007) that
constitute the monotherapy program for ipilimumab -- an investigational
immunotherapy -- in patients with metastatic melanoma. The results from
study 008, conducted under Special Protocol Assessment (SPA), did not meet
the primary endpoint, which was to rule out a best objective response rate
of less than 10 percent. However, the totality of data from the
registrational program included a clear dose response effect observed in
study 022 and best objective response rates across the three studies
ranging from mid-single digits to mid-teens as determined by independent
radiology review.
The objective responses were consistent with previous observations and
included complete and partial responses. The majority of the responses were
ongoing at the end of the observation period. In contrast to standard
cytotoxic therapy, responses at the highest doses were noted to evolve over
time; these patterns of response appear potentially unique to this form of
therapy.
Given the importance of these findings and the limited treatment
options for this patient population, Medarex and Bristol-Myers Squibb are
planning to meet with regulatory agencies in the near future. Pending these
discussions, the companies aim to submit a regulatory filing to the U.S.
Food and Drug Administration (FDA) in the first half of 2008.
Overall, the safety results from the three studies were generally
consistent with data from previously reported clinical trials of ipilimumab
and, as expected, the most common immune related adverse events (greater
than five percent) consisted of rash, diarrhea, and hepatitis. Safety data
from the 10 mg/kg cohorts were consistent with results from similar or
lower doses of previously reported clinical data.
About the Ipilimumab Registrational Monotherapy Program
The registrational, monotherapy program evaluated ipilimumab in 487
patients with advanced Stage III or Stage IV metastatic melanoma from three
clinical trials conducted at multiple centers across North America, Europe,
South America and Africa. The trials included an open-label, single arm
trial (008) evaluating overall response rate in 155 patients who progressed
on or following standard treatment; a randomized, double-blind trial (022)
evaluating the efficacy of three dose levels of ipilimumab in 216 patients
who were previously treated, relapsed or failed to respond to experimental
treatment or were unable to tolerate currently approved therapies; and a
randomized, double-blind, placebo-controlled trial (007) in 116 patients
comparing the safety of ipilimumab, with or without prophylactic oral
budesonide (primarily evaluating the rate of grade 2+ diarrhea). All
patients enrolled in these trials were diagnosed with advanced Stage III or
Stage IV malignant melanoma.
All three studies were designed to capture clinical activity and
kinetics of response at specific time points, beginning with an initial
assessment at 12 weeks. Objective response determinations were verified by
an independent radiology committee. Active follow-up of patients is
ongoing, and many patients enrolled in the three studies are continuing to
be treated with maintenance therapy.
Initiation of the ipilimumab registrational monotherapy program
reviewed under SPA with the FDA was announced in March 2006. Following the
March 2006 announcement, enrollment of 487 patients was completed in less
than one year and in line with timeline expectations. In December 2006,
ipilimumab received Fast Track designation from the FDA for use as a
monotherapy in previously treated patients with metastatic melanoma.
About Ipilimumab
Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T
lymphocyte-associated antigen 4), a molecule on T-cells that plays a
critical role in regulating natural immune responses. The absence or
presence of CTLA- 4 can augment or suppress the immune system's T-cell
response in fighting disease. Ipilimumab is designed to block the activity
of CTLA-4, thereby sustaining an active immune response in its attack on
cancer cells.
Comprehensive Clinical Trial Program for Ipilimumab
Ipilimumab is being developed through a joint partnership between
Bristol- Myers Squibb and Medarex. Based on nonclinical and clinical
studies showing that antibody blockade of CTLA-4 plays an important role in
sustaining an active immune response to fight cancer, Bristol-Myers Squibb
and Medarex are pursuing a broad clinical development program with
ipilimumab evaluating its potential use in advanced metastatic melanoma, as
well as prostate, lung, pancreatic, bladder, breast, lymphoma and leukemia
cancers. More than 2,000 patients have been treated with ipilimumab as a
monotherapy or in combination with other agents in clinical trials.
For further information about ipilimumab clinical trials, please visit
http://www.clinicaltrials.gov.
About Advanced Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled
growth of pigment-producing cells (melanocytes) located in the skin. As
with many cancers, it is more difficult to treat once the disease has
spread beyond the skin to other parts of the body by way of the bloodstream
or the lymphatic system (metastatic disease). Melanoma accounts for about
three percent of skin cancer cases, but it causes most skin cancer deaths.
The American Cancer Society estimates that in 2007 there will be 59,940 new
cases of melanoma in the U.S., and about 8,110 people will die of this
disease.
Conference Call Details for Tomorrow, December 11, 2007 at 8:45 am ET
Medarex will hold a public conference call on Tuesday, December 11,
2007 at 8:45 am Eastern Time to discuss the top-line results of the
registrational program. To access the call live, please dial 1-888-713-4214
within the U.S. or 1-617-213-4866 outside the U.S. The conference call
passcode number is 37954707. The live webcast of the conference call can be
accessed at http://www.medarex.com/Investor/Webcasts.htm. An archive of the event
will be available for a limited period following the call and may be
accessed at http://www.medarex.com or by dialing 1-888-286-8010 within the U.S. or
1-617-801-6888 outside the U.S. The archive conference call passcode number
is 71497127.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery,
development and potential commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
cancer, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing experience to generate, support and potentially commercialize
a broad range of fully human antibody product candidates for itself and its
partners. More than 30 of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates
currently in Phase 3 clinical trials or the subject of regulatory
applications for marketing authorization. Medarex is committed to building
value by developing a diverse pipeline of antibody products to address the
world's unmet healthcare needs. For more information about Medarex, visit
its Web site at http://www.medarex.com.
Medarex Statement on Cautionary Factors: Except for the historical
information presented herein, matters discussed herein may constitute
forward- looking statements that are subject to certain risks and
uncertainties that could cause actual results to differ materially from any
future results, performance or achievements expressed or implied by such
statements. Statements that are not historical facts, including statements
preceded by, followed by, or that include the words "potential"; "believe";
"plan"; "expect"; "estimate"; "could"; "may"; or similar statements are
forward- looking statements. Medarex disclaims, however, any intent or
obligation to update these forward-looking statements. Risks and
uncertainties include risks associated with whether future clinical trials
will result in the same outcomes as these clinical trials and whether the
regulatory authorities will interpret the data from these clinical trials
in the same manner, as well as risks detailed from time to time in
Medarex's public disclosure filings with the U.S. Securities and Exchange
Commission (SEC), including its Annual Report on Form 10-K for the fiscal
year ended December 31, 2006 and its quarterly reports on Form 10-Q. There
can be no assurance that such development efforts will succeed or that
other developed products will receive required regulatory clearance or
that, even if such regulatory clearance were received, such products would
ultimately achieve commercial success. Copies of Medarex's public
disclosure filings are available from its investor relations department.
About Bristol-Myers Squibb
Bristol-Myers Squibb is dedicated to the discovery, development and
exhaustive exploration of innovative cancer fighting therapies designed to
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 and 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 development of biological products and the submission of
applications to market such products. 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. Among other
risks, there can be no guarantee that the development of the product
described in this release will be successful or that the clinical studies
described in this release will support the filing of a Biological License
Application (BLA) with the U.S. Food and Drug Administration (FDA).
Furthermore, there can be no assurances that if a BLA is filed with the
FDA, that it will be filed in the timeframe described in this release or
that the BLA for the product described in this release will receive
regulatory approval. There can be no assurances that if approved, the
product described in this release will be commercially successful.
Forward-looking statements in the 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, its Quarterly Reports on Form 10-Q, and
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 Bristol-Myers Squibb Company; Medarex, Inc.
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Related links:
http://www.bms.com
http://www.medarex.com http://www.clinicaltrials.gov
CONTACT:
Media, Jean Mantuano, +1-609-430-2880, Ext.
2221, or Investor Relations, Laura Choi, +1-609-430-2880, Ext.
2216, both of Medarex; or Media, Madeline Malia, +1-609-252-3347
or +1-609-651-1323, Madeline.Malia@bms.com, or Investors, John
Elicker, +1-212-546-3775, John.Elicker@bms.com, both of
Bristol-Myers Squibb
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