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FDA Approves Liquid Formulation of Palivizumab

GAITHERSBURG, Md., July 26 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI) today announced that the U.S. Food and Drug Administration (FDA) has approved a new liquid formulation of Synagis (palivizumab). In 1998, the original formulation of Synagis was approved by the FDA to prevent serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease. Synagis is the first monoclonal antibody approved for prevention of an infectious disease, and the first such drug to be safely used in children.

Armando Anido, MedImmune's senior vice president, commercial operations, stated: "As a leader in the development of drugs to treat or prevent pediatric infectious disease, MedImmune is excited about the approval of this new and easier-to-use formulation of our flagship product, Synagis. This is a significant milestone in the continued development of our RSV product franchise."

The new liquid Synagis offers healthcare providers, parents and high-risk infants improved convenience. The original formulation is a freeze-dried preparation that is reconstituted with sterile water, a process that takes approximately 20 minutes, from which the final product must be used within the next six hours. The new liquid formulation of Synagis is already supplied as a sterile solution ready for injection, thus eliminating the additional preparatory steps and reducing the time a high-risk infant will spend in a physician's waiting room among other sick children.

In October 2004, MedImmune plans to end production of the current formulation for the U.S. and to begin manufacturing liquid Synagis, which should be available for use in the U.S. for the 2005 - 2006 RSV season.

About RSV and Synagis
RSV is the most common respiratory infection in infancy or childhood, resulting in over 125,000 hospitalizations in the U.S. annually in children less than one year of age. 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 or congenital heart disease are at highest risk of severe disease and hospitalization due to RSV.

Synagis is marketed for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease, which is prominent in the Northern Hemisphere from October through May. Synagis is a humanized monoclonal antibody given through a simple intramuscular injection once a month during the RSV season. Synagis was initially licensed by the FDA in 1998, and in 2003, its label was expanded to include safety and efficacy data supporting its use in young children with hemodynamically significant congenital heart disease to prevent hospitalization caused by RSV. For full prescribing information for Synagis, see the company's website at

Source: MedImmune, Inc.

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