Data Shows Prophylaxis with Synagis Reduces RSV-Related Hospitalizations in High-Risk Infants; Findings Highlight Importance of Early Protection
Gaithersburg, MD, October 22, 2001 -- MedImmune, Inc. (Nasdaq: MEDI) announced today that data on Synagis (palivizumab) and the economic impact of respiratory syncytial virus (RSV) disease were presented at the American Academy of Pediatrics (AAP) 2001 National Conference and Exhibition in San Francisco (October 20-24). Data presented from MedImmune's 2000-2001 Synagis Outcomes Registry reaffirmed that prophylaxis with Synagis reduces the rate of RSV-related hospitalization among high-risk infants, and highlighted the importance of early prophylaxis to prevent hospitalization.
"RSV infection carries a significant health and economic burden here in the U.S. and throughout the world," commented Dr. Robert Hirsch, MedImmune's vice president, medical affairs. "Clinical and real-world data accumulated during the previous RSV seasons continue to suggest that prophylaxis with Synagis can reduce substantially the rate of hospitalization of children at risk of serious disease, and subsequently impact the associated costs of hospitalization."
MedImmune's 2000-2001 Synagis Outcomes Registry was presented in a poster entitled Synagis (Palivizumab) Prophylaxis of Respiratory Syncytial Virus (RSV) Infection-Patient Demographics and Preliminary Results From the 2000-2001 Synagis Outcomes Registry, by Mark Hudak, M.D., et al. A total of 2,116 infants were enrolled in this prospective study that included patients with a broad range of gestational ages and risk factors. Of these patients, 59 (2.9 percent) were hospitalized due to RSV infections, reaffirming the low hospitalization rates seen in retrospective outcomes surveys from previous seasons (2.4 percent in 1999-2000 season and 2.3 percent in 1998-1999 season). Results from all of these outcomes surveys compare favorably to the rates of hospitalization observed in MedImmune's pivotal clinical trial conducted in 1996 and 1997, in which prophylaxis reduced hospitalization from 10.6 percent in the placebo group to 4.8 percent in those children receiving Synagis (The IMpact-RSV Study Group. Palivizumab, A Humanized Respiratory Syncytial Virus Monoclonal Antibody Reduces Hospitalization from Respiratory Syncytial Virus Infection in High-Risk Infants. Pediatrics 1998, 102:531-537).
Highlighting the importance of early protection against RSV, data from the Outcomes Registry showed that 46 percent of the RSV hospitalizations occurred within the first 35 days following the first dose of Synagis. Compliance with recommended monthly injections was also found to be key in that hospitalization rates nearly doubled among infants who either missed or delayed receiving a dose during the RSV season.
Also presented at the AAP meeting were data from two database analyses that highlight the significant health and economic burden of RSV in the United States. These studies, both presented by Shelah Leader, Ph.D. and Kimmie Kohlhase, M.S., were entitled Recent Trends in Respiratory Syncytial Virus (RSV)-Associated U.S. Hospitalizations, 1997-1999, and Respiratory Syncytial Virus (RSV) Coded U.S. Hospitalizations, 1997-1999. In both studies, data from the National Hospital Discharge Survey (NHDS) for 1997-1999 was searched for RSV-related hospital discharges. The first study focused on quantifying the average number of annual RSV-related hospitalizations in infants less than one year of age. The data, which took into account cases specifically coded as RSV, as well as a percentage of all bronchiolitis and pneumonia cases occurring in infants between November and April, indicate that between 134,976 and 163,958 infants under one year of age are hospitalized due to RSV in the U.S. each year. Previous estimates indicated that between 73,400 and 126,300 infants less than one year of age were hospitalized due to RSV annually (David K Shay et al, Bronchiolitis-Associated Hospitalizations Among US Children, 1980-1996, JAMA vol. 282, no. 15, 1999). The second epidemiology study focused on analyzing RSV-associated hospital charges over a three-year period in children five years of age and under, measured by length of hospital stay, patient demographics, and expected payment source. These data showed that hospital charges for children under five with a primary diagnosis of RSV during the three years exceeded $2.3 billion.
RSV is the most common cause of lower respiratory infections in infants and children worldwide. Healthy children and individuals with adequate immune systems often acquire a benign chest cold when infected with RSV. In contrast, certain high-risk infants such as premature infants and children with chronic lung disease (CLD) are at increased risk for acquiring severe RSV disease (pneumonia and bronchiolitis), often requiring hospitalization. Each year in the United States, more than 125,000 infants are hospitalized with RSV disease. There are approximately 315,000 infants at high risk of acquiring severe RSV disease in the United States. Clinical studies have shown a 55-percent reduction in RSV hospitalizations among high-risk pediatric patients receiving Synagis versus those patients receiving placebo. Synagis was safe and generally well tolerated, and the proportions of subjects in the placebo and Synagis groups who experienced any adverse event or any serious adverse event were similar. Synagis is administered by intramuscular injection at 15 mg/kg and is given once per month during anticipated periods of RSV prevalence in the community. In the Northern Hemisphere, the RSV season typically commences in September and lasts through April or May.
MedImmune, Inc. is a biotechnology company focused on developing and marketing products that address medical needs in areas such as infectious disease, immune regulation and cancer. Headquartered in Gaithersburg, Maryland, MedImmune has manufacturing facilities in Frederick, Maryland and Nijmegen, the Netherlands.
This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in the company's filings with the U.S. Securities and Exchange Commission. The company is developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success.