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MedImmune Submits Biologics License Application to FDA for Motavizumab

GAITHERSBURG, Md., Feb. 4 /PRNewswire/ -- MedImmune announced today it submitted to the U.S. Food & Drug Administration (FDA) on January 30 a Biologics License Application (BLA) for motavizumab, an investigational monoclonal antibody (MAb) derived from recombinant DNA technology. The motavizumab BLA is supported by clinical trial data from more than 6,000 patients in which safety and efficacy in prevention of serious disease caused by respiratory syncytial virus (RSV) in high-risk pediatric patients were evaluated.

"We are pleased to submit this BLA for motavizumab, which we believe represents another tool in the fight against RSV. This marks a significant milestone for this molecule and further reinforces MedImmune's commitment to developing anti-RSV biologics for the underserved pediatric patient population," said Linda J. Peters, senior vice president, regulatory affairs.

Motavizumab was studied in an active-controlled Phase 3 trial against the standard of care in pediatric patients at high risk of serious RSV disease. Primary and secondary endpoints of the study included incidence of RSV hospitalizations and RSV-specific medically attended outpatient lower respiratory tract infections. Rates of adverse events, serious adverse events and study drug discontinuations were balanced between treatment groups. The most frequently observed reactions versus the active comparator were cutaneous reactions (overall).

"Beyond the findings of the various investigational trials for motavizumab, we believe this molecule will help reinforce the positive role that MAbs play in RSV prevention within the current clinical body of evidence. It also reinforces our position as a leader in RSV prevention," said Genevieve Losonsky, M.D., vice president, clinical development, infectious disease.

RSV is a leading cause of viral respiratory infection among infants. Each year, up to an estimated 125,000 infants in the United States are hospitalized with severe RSV infections, the leading cause of infant hospitalization within the U.S. 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.

In the United States, RSV causes up to 1.7 million physician office visits; 400,000 emergency room visits and more than 230,000 hospital outpatient emergency room visits per year. RSV is the most common respiratory infection in infancy or childhood. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at high risk for severe disease and hospitalization due to RSV.

RSV infection usually manifests as an upper respiratory tract infection with symptoms resembling a cold. Preterm infants, those with chronic lung disease, and infants with complicated cardiac disease are especially vulnerable to the infection and have an increased risk of progressing to a serious lower respiratory tract infection that sometimes requires hospitalization, mechanical ventilation and intensive care.

MedImmune intends to commercialize motavizumab through its existing sales and marketing organization within the U.S., and to co-promote with Abbott in certain non-U.S. markets if and when the product is approved for marketing by

regulatory authorities. Outside the U.S., Abbott, the global, broad-based health care company, has marketing and distribution rights for motavizumab.

MedImmune's Commitment to RSV Prevention

MedImmune is a world leader in the development of innovative therapeutic biologic products to prevent RSV disease. With the ongoing development of motavizumab, MedImmune continues to reinforce its commitment to developing anti-RSV products. 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 MedImmune

MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases; cancer; inflammatory diseases; cardiovascular and metabolic diseases; pain and central nervous system disorders and gastrointestinal diseases. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website at

SOURCE MedImmune
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