MedImmune Announces Phase 2 Safety Data For Anti RSV Antibody And National RSV Surveillance Results

Main Category: Respiratory / Asthma
Also Included In: Infectious Diseases / Bacteria / Viruses;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 05 Oct 2007 - 0:00 PDT

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MedImmune, Inc. announced results from two important studies presented at the 2007 Infectious Diseases Society of America (IDSA) 45th Annual Meeting adding to the body of knowledge about respiratory syncytial virus (RSV). RSV is a viral pathogen that produces annual outbreaks usually between fall and spring. While RSV typically manifests cold-like symptoms in healthy children, it can prove to be a very serious respiratory illness for premature infants and is the leading cause of respiratory infections for newborns each year. MedImmune has long been committed to developing and improving products for prevention of RSV disease and to enhancing the body of knowledge about RSV epidemiology.

"MedImmune continues to forge ahead with its aggressive strategy to help combat RSV disease," said Edward M. Connor, M.D., executive vice president and chief medical officer. "We are pleased to present new Phase 2 data at IDSA regarding motavizumab, a key investigational monoclonal antibody (MAb) within our product development portfolio that we are currently preparing for regulatory submission in the United States."

Connor added, "We will also present data regarding RSV surveillance at IDSA. These data show regional variability of RSV in the community, particularly in the southernmost United States. We believe that a better understanding of the regional variation in the timing of RSV may help inform decisions about timing of RSV prophylaxis for children at risk for serious RSV disease."

Data pertaining to MedImmune's anti-RSV initiatives that will be presented during the IDSA meeting include:

Safety, Tolerability, and Immunogenicity of Motavizumab in Young Children After a Second Season of RSV Prophylaxis (Poster Presentation #233) - Katia G. Abarca, M.D., Infectious Diseases and Molecular Virology Laboratory, Universidad Catolica de Chile,

-- Friday, October 5, 2007; 12:30 - 2:00 p.m. in Poster Halls G-H.

-- This study assessed the safety and immunogenicity of motavizumab, an investigational anti-RSV MAb, in young children with a history of prematurity who received two sequential seasons of the antibody.

RSV Surveillance: Retrospective and Current Data on the Variance in Season Onsets and Offsets (Poster Presentation #719) - Jessie R. Groothuis M.D., MedImmune,

-- Saturday, October 6, 2007; 12:15 - 1:45 p.m. in Poster Halls G-H. -- A nationwide active surveillance program was established to evaluate the variability of the RSV season temporally and geographically in the United States. Laboratory results from a three-year period were analyzed by month and by geographic region.

Additional information regarding the IDSA 45TH Annual Meeting can be found at http://www.idsociety.org/Meetingshome.aspx?id=238.

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(R) (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(R) (palivizumab), which was the first MAb to receive U.S. Food and Drug Administration (FDA) approval for an infectious disease. With the development of motavizumab, MedImmune continues to reinforce its commitment to developing anti-RSV products. In a head-to-head comparative Phase 3 trial with Synagis, motavizumab met its primary endpoint of reducing RSV-related hospitalizations in high-risk pediatric patients and met a secondary endpoint of reducing medically attended, outpatient respiratory tract infections in that patient group. 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 Motavizumab

Motavizumab, formerly known as Numax(R), is an investigational humanized MAb being evaluated for its potential to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease. Phase 1 and Phase 2 study data have been reported showing that motavizumab appears to have a similar safety and pharmacokinetic profile to Synagis (palivizumab) in infants. Additionally, in early phase studies children treated with motavizumab had reduced RSV replication in the upper respiratory tract. In its first pivotal trial, which was a head-to-head comparative trial with Synagis (palivizumab), motavizumab met its non-inferiority objective by demonstrating a 26-percent relative reduction in RSV hospitalizations and also showed a statistically significant 50-percent relative reduction in the incidence of RSV lower respiratory tract infections requiring outpatient management, a secondary endpoint.

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 and inflammatory 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 http://www.medimmune.com.

MedImmune, Inc.
http://www.medimmune.com