MedImmune Presents New Pharmaco-Economic Data at American Academy of Pediatrics Regarding Infants at High Ri...(d and Drug Administration(FDA) approval ...),Health

Date:10/29/2007

d and Drug Administration (FDA) approval for an infectious disease. MedImmune continues to reinforce its commitment to developing anti- RSV products with the ongoing development of its next potential anti-RSV antibody, motavizumab, for which the company is planning to submit a Biologic License Application around the beginning of 2008. MedImmune is also developing a small-molecule product candidate to prevent RSV as well as a vaccine against RSV, both of which are in Phase 1 clinical trials.

About RSV

Each year, up to 125,000 infants in the United States are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections in U.S. infants. 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.

About Synagis(R) (palivizumab)

Synagis is the only monoclonal antibody approved by the FDA to help prevent an infectious disease. Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease. Synagis was approved for use in the United States in 1998, Europe in 1999, and Japan in 2002. Synagis is currently available in 62 countries. The safety and efficacy of Synagis were established in infants with bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease. The first dose of Synagis should be administered prior to commencement of the RSV season, which usually starts in the fal
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