SAN FRANCISCO, October 26, 2007 – MedImmune, Inc. today announced it will present three abstracts at the American Academy of Pediatrics (AAP) 2007 National Conference & Exhibition, adding to the company’s growing body of research into the prevention of respiratory syncytial virus (RSV), a leading cause of hospitalization among infants.
“MedImmune is pleased to present data that provide key insights into how we can optimize the fight against RSV,” said Jessie R. Groothuis, M.D., vice president, medical and scientific affairs, infectious disease. “Cost-effectiveness data help insurers, governments, and families understand the benefits of RSV prophylaxis and the potential impact of not taking preventive measures. Surveillance data help us understand local variants in RSV outbreaks, which can inform and improve RSV prevention guidelines.”
MedImmune abstracts to be presented at AAP include:
- Cost-Effectiveness of Respiratory Syncytial Virus Prophylaxis with Palivizumab Among Preterm Infants After Valuing a Reduction in Persistent Wheezing (Poster #P14) – Mark J. Polak, M.D., Saturday, October 27th, 2007 from 12:15 – 1:00 p.m.
BACKGROUND: Recent trials have suggested that Synagis® (palivizumab), a monoclonal antibody (MAb) that is the standard of care in RSV prevention, reduced the incidence of persistent wheezing in studied populations. Researchers conducted a cost-effectiveness analysis of prophylaxis with Synagis compared with no prophylaxis among preterm infants less than 32 weeks and between 32 and 35 weeks gestation, factoring in the quality of life associated with a reduction in persistent wheezing.
- A Nationwide Hospital RSV Surveillance Program: Interim Assessment of the 2006-2007 RSV Season (Poster #P25) – Marnie L. Boron, PharmD, Saturday, October 27th, 2007 from 12:15 – 1:00 p.m.
BACKGROUND: Due to limited uniformity in RSV testing and local surveillance reporting, nationwide RSV prevention programs are not optimal. A nationwide surveillance program was initiated to track and report RSV activity at the local level in a timely manner. This abstract includes an interim report of the data collected to date.
- Regional Respiratory Syncytial Virus Surveillance Data for Georgia and Implications for Prophylactic Administration of Palivizumab (Poster #P32) – Mark Eggleston, PharmD, MBA, Saturday, October 27th, 2007 from 12:15 – 1:00 p.m.
BACKGROUND: The Georgia Division of Public Health initiated an RSV surveillance program in mid-2000 to monitor RSV activity within four regions of the state. This study aimed to identify the onset, duration, and peak month of the RSV season in each of the four regions and evaluate whether national guidelines for RSV prophylaxis with Synagis are sufficient or whether recommendations should be based on local RSV virology data.
Additional information about the 2007 AAP National Conference & Exhibition can be found at http://www.aap.org/nce/.
MedImmune’s Commitment to RSV Prevention
MedImmune is a world leader in the development of innovative therapeutic biologic products to prevent RSV disease. In 1996, MedImmune launched the first anti-RSV drug, RespiGam® (respiratory syncytial virus immune globulin intravenous (human) (RSV-IGIV)), which was a polyclonal antibody administered via four-hour intravenous infusion. In 1998, MedImmune introduced Synagis, which was a significant product improvement as a monthly intramuscular injection for the prevention of severe RSV, as well as being the first MAb to receive U.S. Food and Drug Administration (FDA) approval for an infectious disease. With the ongoing development of motavizumab, 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 U.S. are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections in infants in the United States. 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 such as the elderly, those with underlying respiratory or cardiac disease, and those with compromised immune systems (e.g., bone marrow transplant patients).
About Synagis® (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 fall and runs through the spring. Synagis is administered by intramuscular injection. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the season. Abbott has exclusive rights to Synagis in markets outside the United States. MedImmune promotes Synagis in the United States.
Important Safety Information
Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information, visit http://www.medimmune.com.
Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) severe acute 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.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is dedicated to advancing science and medicine to help people live better lives and is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website at http://www.medimmune.com.