Medarex, Inc.
(Nasdaq: MEDX) today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation for ipilimumab (also known as MDX-
010) used in combination with chemotherapy (dacarbazine) in previously
untreated (first-line) metastatic melanoma patients. The FDA also has
granted Fast Track designation for ipilimumab used as a monotherapy in
previously treated (second-line) metastatic melanoma patients.
Under the FDA Modernization Act of 1997, designation as a Fast Track
product for a new drug or biological product means that the FDA has
determined that the drug or biologic is intended for the treatment of a
serious or life- threatening condition and demonstrates the potential to
address unmet medical needs for such a condition, and that the FDA will
facilitate the clinical development and expedite the review of a Biologics
License Application for the product.
"We are pleased with the Fast Track designations as we continue to work
with our partner Bristol-Myers Squibb to advance the development of
ipilimumab, and we believe that ipilimumab has the potential to play an
important role in the fight against cancer," said Irwin Lerner, Chairman of
the Board of Directors and Interim President and CEO of Medarex.
About ipilimumab
Ipilimumab is an investigational fully human antibody against human
CTLA- 4, a molecule on T cells that is believed to be responsible for
suppressing the immune response. Medarex and Bristol-Myers Squibb are
investigating the potential of ipilimumab to enable the immune systems of
cancer patients to help suppress or eradicate cancer tumors. Ipilimumab is
currently under investigation in several registrational clinical trials
under Special Protocol Assessment agreements with the FDA for the treatment
of metastatic melanoma -- as a first-line treatment in combination with
dacarbazine, as a second-line monotherapy (enrollment expected to be
completed this year) and as a second- line treatment in combination with
MDX-1379 (a melanoma peptide vaccine). The combination with MDX-1379 was
previously granted Fast Track designation. Ipilimumab is also being
evaluated in multiple Phase II clinical trials to investigate the product's
potential activity in other tumor types, as well as in combination studies
with chemotherapy, immunotherapy and vaccines. Further information
regarding Medarex's and Bristol-Myers Squibb's ipilimumab program can be
found in Medarex's public disclosure filings with the U.S. Securities and
Exchange Commission (SEC).
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. Thirty-four of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with six of the most advanced product candidates currently
in Phase III clinical trials. 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
website at medarex.
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;" "anticipate;" "intend;" "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 ipilimumab will help the immune systems of cancer
patients to suppress or eradicate cancer tumors, product discovery and
development, uncertainties related to the outcome of clinical trials,
slower than expected rates of patient recruitment, unforeseen safety issues
resulting from the administration of antibody products in patients,
uncertainties related to product manufacturing 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, 2005 and subsequent
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.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved.
Medarex, Inc.
medarex