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MedImmune Announces Positive Clinical Results at PAS Annual Meeting,From Large Prospective Trial in Prevention of Serious RSV Disease

dard of care."

The Phase 3 study was designed to compare the safety and efficacy of motavizumab with that of Synagis, which was first launched by MedImmune in 1998, in reducing serious RSV disease in high-risk infants in the inpatient and outpatient settings. As defined in the study, infants who are at high risk for RSV include those who were born at 35 weeks gestation or less as well as those who have chronic lung disease (CLD) due to being born prematurely. The primary endpoint was to assess the incidence of RSV hospitalizations with motavizumab compared to Synagis. Motavizumab met the primary endpoint, demonstrating non-inferiority to Synagis with 26 percent fewer RSV hospitalizations in motavizumab-treated infants. The overall RSV attack rate was low in both treatment groups: 1.4 percent for infants who received motavizumab, compared with 1.9 percent for those who received Synagis [RR: 0.740, 95 percent CI: (0.503, 1.083)]. The p-value for non-inferiority was p<0.01, demonstrating a significant finding.

Analysis of the data also showed that motavizumab reduced the incidence of RSV-specific medically attended outpatient LRIs (the study's RSV-related secondary endpoint) by approximately 50 percent compared with Synagis. The overall RSV-specific medically attended LRI rate was 2.0 percent for infants who received motavizumab compared with 3.9 percent for those who received Synagis (p<0.01). There were no significant differences in other non-RSV- specific endpoints.

"I am very pleased with the study results for motavizumab," said Xavier Carbonell, M.D., Ph.D., lead study author, chairman of neonatology, Barcelona Hospital Clinic, and vice president, Spanish Neonatal Society. "As a practicing neonatologist, I look forward to the potential to use this next- generation antibody to help reduce RSV-related hospitalizations and LRIs in the outpatient setting."

Data from this trial demonstrate that both study drugs were well tolerated. The incid
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