Phase 3 data Re: Anti-RSV antibody to be presented at Pediatric Academic Societies Annual Meeting

About RSV

Each year, up to 125,000 infants in the U.S. are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections in infants in the United States. RSV is the most common respiratory infection in infancy or childhood. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and hospitalization due to RSV. The virus may also cause severe illness in other high-risk groups such as the elderly, those with underlying respiratory or cardiac disease, and those with compromised immune systems (e.g., bone marrow transplant patients). Otherwise healthy infants in some Native American populations have demonstrated rates of RSV hospitalization that are similar to those among children with underlying medical conditions in the general U.S. population.

About Motavizumab

Motavizumab is an investigational humanized MAb being evaluated for its potential to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease. Phase 1, 2 and 3 study data have been reported showing that motavizumab appears to have a similar safety and pharmacokinetic profile to Synagis® (palivizumab) in infants. Additionally, in early phase studies children treated with motavizumab had reduced RSV replication in the upper respiratory tract. In its pivotal clinical trial, which was a head-to-head comparative trial with Synagis, motavizumab demonstrated non-inferiority with a 26-percent relative reduction in RSV hospitalizations due to RSV, which was its primary endpoint, and a 50-percent relative reduction in the incidence of RSV lower respiratory tract infections requiring outpatient management, one of its secondary endpoints. Rates of adverse events, serious adverse events and study drug discontinuations were balanced between treatment groups.

About Synagis

Synagis (palivizumab) is indicated for the prevention of serious lung infections caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. The first dose of Synagis should be given before RSV season begins. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season. Synagis has been used in more than one million children in the U.S. since its introduction in 1998.