GAITHERSBURG, Md., and PRINCETON, N.J., Oct. 13 /PRNewswire-FirstCall/ --
MedImmune, Inc. (Nasdaq: MEDI) and Medarex, Inc. (Nasdaq: MEDX) today
announced the filing of an investigational new drug application (IND) with the
U.S. Food & Drug Administration (FDA) for MEDI-545, a fully human monoclonal
antibody (MAb) targeting interferon-alpha. Preclinical data indicate that
levels of interferon-alpha are elevated in many patients with active systemic
lupus erythematosus (SLE or lupus) and other autoimmune disorders, and may be
associated with disease activity. MEDI-545 binds to interferon-alpha and has
been shown to neutralize its activity in preclinical studies.
"This IND reflects MedImmune's commitment to the development of new
treatments targeting inflammatory and autoimmune diseases, and marks another
milestone in our efforts to advance our pipeline of product candidates," said
Anthony J. Coyle, Ph.D., MedImmune's senior director, research, and head,
inflammation biology. "The growing body of data about the role of interferons
in lupus disease activity supports MedImmune's approach to using this target
for developing therapies that may reduce the effects of SLE, a disease for
which treatment options are currently limited."
In November 2004, MedImmune entered into a collaboration with Medarex to
develop antibodies targeting interferon-alpha and the receptor to type I
interferon, IFNAR1. The collaboration initially was 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 currently fully responsible for all ongoing
development activities.
"We are pleased with the development progress to date for this product
candidate as it advances toward clinical studies," said Donald L. Drakeman,
Medarex's president and chief executive officer. "The entry of this antibody
into a clinical program would mark the twenty-fifth antibody utilizing our
UltiMAb(R) technology in clinical studies, and we are glad to be working with
MedImmune toward this accomplishment."
Additional Information About MEDI-545
MEDI-545 is a fully human antibody that is believed to target multiple
interferon-alpha subtypes. Preclinical data indicate that MEDI-545 may
suppress the abnormal immune activity associated with lupus by binding to the
pattern of multiple interferon-alpha subtypes seen in the serum of lupus
patients. Further, preclinical studies have shown that an inhibition of
interferon-alpha signaling corresponded to decreased autoantibody production
and decreased disease activity, demonstrating the potential key role of
interferon-alpha in a lupus disease animal model.
About Lupus
According to the Lupus Foundation of America, approximately 1.5 million
Americans may suffer from some form of 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 drugs 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 MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value to
shareholders. Dedicated to advancing science and medicine to help people live
better lives, the company is focused on the areas of infectious diseases,
cancer and inflammatory diseases. With more than 2,000 employees worldwide,
MedImmune is headquartered in Maryland. For more information, visit the
company's website at http://www.medimmune.com.
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. Twenty-four of these therapeutic product candidates derived from
Medarex technology are in human clinical testing, with two 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 http://www.medarex.com.
Except for the historical information presented herein, matters discussed
herein may constitute forward-looking statements within the meaning of 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 "potential";
"believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could";
"may"; or similar statements are forward-looking statements. Medarex and
MedImmune disclaim, however, any intent or obligation to update these forward-
looking statements. Risks and uncertainties include risks associated with
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 associated with the collaborative process,
uncertainties related to product manufacturing as well as risks detailed from
time to time in each company's respective public disclosure filings with the
U.S. Securities and Exchange Commission (SEC), including their respective
Annual Reports on Form 10-K for the fiscal year ended December 31, 2004 and
subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
There can be no assurance that such development efforts will succeed, that
such products will receive required regulatory approval or that, even if such
regulatory approval were received, such products would ultimately achieve
commercial success. Copies of public disclosure filings for MedImmune or
Medarex are available from the companies' respective investor relations
departments.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks of
Medarex, Inc. All rights are reserved.
SOURCE MedImmune, Inc.
CONTACT:
Media:
Jamie Lacey, +1-301-398-4035
Kate Barrett,
+1-301-398-4320
Investors:
Peter Vozzo, +1-301-398-4358
John Filler,
+1-301-398-4086
all of MedImmune, Inc.
Media:
Jean Mantuano,
+1-609-430-2880 x2221
Investors:
Laura S. Choi, +1-609-430-2880 x2216,
both of Medarex, Inc.