Medarex to Receive Milestone Payment from MedImmune
PRINCETON, N.J., Aug. 12 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) announced today that its partner MedImmune, Inc. has
initiated a Phase 2A multi-dose clinical trial of MEDI-545 for the
potential treatment of systemic lupus erythematosus (SLE or lupus).
MEDI-545 is a fully human antibody generated by Medarex's UltiMAb Human
Antibody Development System(R). Under the terms of the agreement, Medarex
will receive a milestone payment of an undisclosed amount.
The Phase 2A clinical trial is designed to evaluate the safety and
tolerability of multiple subcutaneous dose schedules of MEDI-545 or placebo
in adult patients with moderate to severe active lupus. The study will also
assess the effects of MEDI-545 on disease activity in lupus patients. This
randomized, double-blind, placebo-controlled trial is expected to enroll 80
patients and will be conducted at 20 sites in the United States.
MedImmune is also conducting a Phase 1 clinical trial for MEDI-545 in
idiopathic inflammatory myositis, an immunological disease that involves
chronic muscle inflammation, pain and weakness.
"Data from an earlier reported placebo-controlled Phase 1 study
suggested therapeutic activity with single doses in patients with lupus and
demonstrated an acceptable safety profile," said Geoffrey M. Nichol,
M.B.Ch.B., Senior Vice President of Product Development at Medarex. "We are
very excited about the role of the interferon alpha inflammatory pathway
and look forward to exploring its potential in treating patients with lupus
and other autoimmune diseases."
About MEDI-545
MEDI-545 (previously known as MDX-1103) is a fully human monoclonal
antibody targeting interferon-alpha. Published data indicate that levels of
interferon-alpha are elevated in many patients with active SLE and other
autoimmune disorders, and may be associated with disease activity.
Preclinical data from animal models suggest that MEDI-545 may suppress the
abnormal immune activity associated with lupus by binding to multiple
interferon-alpha subtypes seen in the serum of lupus patients.
In November 2004, MedImmune entered into a collaboration with Medarex
to focus on two specific antibodies, one of which was MDX-1103 (now known
as MEDI-545). Under the terms of the agreement, MedImmune is responsible
for all ongoing clinical development activities. Prior to the beginning of
pivotal studies, Medarex may elect to co-develop the products in return for
the opportunity to co-promote and to receive a share of the commercial
profits in the United States. In all other cases, Medarex will be entitled
to receive milestone payments and royalties.
About Lupus
Approximately 350,000 individuals in the United States are affected
with lupus, a chronic inflammatory disease that causes the body to attack
its own tissues and organs, including the skin, joints, blood and kidneys.
Treatments for lupus include anti-inflammatory drugs, antimalarials,
corticosteroids and drugs approved for other purposes, such as
immunosuppressive agents given to cancer patients undergoing chemotherapy
or medicines developed to treat arthritis patients. Lupus occurs about 10
times more frequently in adult females than adult males, and is two to
three times more common among African Americans, Hispanics, Asians and
Native Americans.
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 40 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 website at http://www.medarex.com.
Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein may constitute forward-looking statements, as defined in
the Private Securities Litigation Reform Act of 1995, 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
"expect"; "potential" or "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
uncertainties related to the outcome of clinical trials, slower than
expected rates of patient recruitment, unforeseen safety issues resulting
from the administration of MEDI-545 in patients, 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, 2007 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.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved.
SOURCE Medarex, Inc.
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Related links:
http://www.medarex.com
http://www.prnewswire.com/comp/108265.html/
CONTACT:
Laura S. Choi, Investor Relations,
+1-609-430-2880 ext. 2216, or Nichol Harber, Corporate
Communications (media), +1-609-430-2880 ext. 2214, both of
Medarex
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