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Investigational New Drug Application Filed for Monoclonal Antibody for the Treatment of Lupus

GAITHERSBURG, Md., and PRINCETON, N.J., Oct. 13 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI - News) and Medarex, Inc. (Nasdaq: MEDX - News) 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® 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.

Source: MedImmune and Medarex

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