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

- Numax Achieves Primary Endpoint Among High-Risk Infants Versus Current Standard of Care and Shows Reduction of Medically Attended Outpatient RSV- Related Lower Respiratory Infections -

TORONTO, May 08, 2007 /PRNewswire-FirstCall/ -- MedImmune, Inc. today announced positive results from a large prospective trial conducted for prevention of respiratory syncytial virus (RSV). The trial compared motavizumab, the investigational monoclonal antibody (MAb) also known as Numax(R), with Synagis(R) (palivizumab), the standard of care for preventing RSV hospitalization in high-risk infants. In the Phase 3 study involving 6,635 pre-term infants at high risk for RSV, with a primary endpoint of non- inferiority, motavizumab demonstrated overall 26-percent fewer RSV hospitalizations compared with Synagis (p<0.01 for non-inferiority). Additionally, motavizumab demonstrated a statistically significant 50 percent reduction in the incidence of RSV-specific medically attended outpatient lower respiratory infections (LRIs) (p<0.01) compared with Synagis. These findings were presented today in a poster entitled, Phase 3 Trial of Motavizumab, an Enhanced Potency RSV-Specific MAb for the Prevention of Serious RSV Disease in High-Risk Infants, at the Pediatric Academic Societies' Annual Meeting in Toronto, Canada.

"As RSV continues to be the leading cause of lower respiratory tract infections in infants in the United States, we are very encouraged by the results of this Phase 3 trial, which suggest that motavizumab may help to reduce the chance that our most vulnerable babies will have serious RSV disease," said Edward M. Connor, M.D., chief medical officer and executive vice president. "Data from the study showed that motavizumab was statistically superior to Synagis for the secondary endpoint of outpatient medically attended LRI caused by RSV, and thus may reduce the overall burden of RSV disease compared to the current stan
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