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MedImmune's Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study
Date:8/23/2007

GAITHERSBURG, Md., Aug. 23 /PRNewswire/ -- MedImmune, Inc. today announced that in a Phase 3 study, motavizumab was shown to reduce hospitalizations due to respiratory syncytial virus (RSV) by 83 percent as compared to placebo (8.3 percent in placebo arm vs. 1.4 percent in motavizumab; p<0.001), as the trial's primary endpoint. In addition, the trial showed a 71-percent reduction in the incidence of RSV-specific lower respiratory infections (LRIs) requiring outpatient management (9.5 percent in placebo group and 2.8 percent in the motavizumab group; p<0.001), which was a secondary endpoint.

Motavizumab is an investigational monoclonal antibody (MAb) being evaluated for its potential to prevent serious disease caused by RSV in high-risk pediatric patients. This Phase 3 trial involved 1,410 full-term infants less than six months of age in two Native American populations. In previous medical studies these populations were shown to have high rates of hospitalization due to RSV.

The randomized (2:1), double-blind study was designed to compare monthly intramuscular injections of motavizumab against placebo. After an interim analysis conducted by an independent data safety monitoring committee, the study was unblinded early due to statistical evidence demonstrating that motavizumab reduced RSV hospitalizations and LRIs requiring outpatient medical management within this population. Kate O'Brien, M.D., associate professor at the Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, served as the study's principal investigator.

"We are pleased with the results of this study which support the positive results seen in our Phase 3 pivotal trial comparing motavizumab and Synagis(R) (palivizumab) that were previously reported at the Pediatric Academic Societies meeting in May 2007," said Genevieve Losonsky, M.D., vice president, clinical development, infectious disease, MedImmune.

Motavizumab was well tolerated in these
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SOURCE MedImmune, Inc.
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