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

ract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease and is administered by intramuscular injection. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (less than or equal to 35 weeks gestation age), and children with hemodynamically significant CHD. Synagis has been used in more than one million children in the U.S. since its introduction in 1998. The first dose of Synagis should be administered prior to commencement of the RSV season. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the season.

Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reaction occurs, caution should be used on re-administration of Synagis.

In clinical trials, the most common adverse events occurring at least 1 percent more frequently in Synagis-treated patients than controls were upper respiratory infection, otitis media, fever and rhinitis. Cyanosis and arrhythmia were seen in children with CHD.

For full prescribing information for Synagis, see the company's website at: www.medimmune.com/products/synagis/index.asp.

About MedImmune, Inc.

MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the ar
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