Data From MedImmune Infectious Disease Clinical...

PRAGUE, Czech Republic, October 9 /PRNewswire/ --

    MedImmune today announced that six abstracts have been presented at the
2007 European Society for Paediatric Research (ESPR) Annual Meeting
demonstrating the company's commitment to advancing the science of pediatric
medicine. Data are from studies pertaining to MedImmune's approved and
development-stage products, including both monoclonal antibodies and vaccines
targeting two respiratory infectious diseases: influenza and respiratory
syncytial virus (RSV).



    "MedImmune is pleased to share data with the European medical community
that may help improve the prevention and treatment of infectious diseases in
children," said Frank Malinoski, M.D., Ph.D., senior vice president, medical
and scientific affairs. "We are dedicated to advancing research of our
commercialized products and our robust infectious disease pipeline to
optimize children's health."



    The ESPR meeting, which ran from October 6 to 8, 2007 in Prague, Czech
Republic, featured the following poster and oral data presentations
pertaining to MedImmune's infectious disease programs:


    
    Influenza
    -- School-Based Influenza Vaccination of Elementary Students Reduced
       Countywide School Absenteeism (Poster Presentation) - J. Davis et al,
       Prague Congress Centre (Entrance #4), Poster Walk 10
       BACKGROUND: This Maryland-based study investigated whether mass
       influenza vaccination in elementary schools with live-attenuated
       influenza vaccine (LAIV), or FluMist(R), was associated with a reduced
       rise in absenteeism in elementary, middle, and high schools during the
       influenza outbreak period.

    -- Postmarketing Evaluation of the Safety of Live-Attenuated Influenza
       Vaccine (FluMist) (Poster Presentation) - R. Baxter et al, Prague
       Congress Centre (Entrance #4), Poster Walk 10
       BACKGROUND: LAIV was licensed in 2003 for use in healthy people aged
       five-49 years. As part of a commitment to the FDA, the safety of LAIV
       was evaluated post-licensure through this study.

    -- Prevention of the Influenza B Outbreak During the 2005-06 Influenza
       Season Through a Universal Vaccination Program in Children (Poster
       Presentation) - P. Piedra et al, Prague Congress Centre (Entrance #4),
       Poster Walk 10
       BACKGROUND: A central Texas trial was conducted to determine
       vaccination coverage in children necessary to affect spread of
       influenza.

    -- Efficacy in Children of Live-Attenuated Influenza Vaccine (Oral
       Presentation) - J. Rhorer et al, Prague Congress Centre (Entrance #4),
       Session 10: Infection/Immunity
       BACKGROUND: Nine randomized clinical trials, including approximately
       27,000 children aged six-72 months, evaluated the efficacy of LAIV
       against culture-confirmed influenza. The aim was to determine a 
       precise estimate of vaccine efficacy to aid in evaluating LAIV in 
       young children.

    RSV
    -- RSV Epidemiology in the U.S.: A Two-Year Summary from a Nationwide
       Surveillance Program (2004-2006) (Poster Presentation) - M. Boron et
       al, Prague Congress Centre (Entrance #4), Poster Walk 25
       BACKGROUND: U.S. RSV surveillance data is available through the 
       Centers for Disease Control and Prevention, state health departments 
       and hospital laboratories; however, only regional data is reported. A
       nationwide active surveillance program was established to provide
       information on the epidemiology of RSV outbreaks in local areas, and
       results on local variants will be reported through this study.

    -- Phase 3 Trial of Motavizumab, an Enhanced Potency RSV Specific
       Monoclonal Antibody for the Prevention of Serious RSV Disease in
       High-Risk Infants (Oral Presentation) - E. Simoes et al, Monday,
       October 8, 2007 at 1:57 p.m. CEST, Prague Congress Centre (Entrance
       #4), Session 22: Randomized Controlled Trials
       BACKGROUND: RSV is the predominant cause of serious viral lower
       respiratory tract infection in young children. This study compared the
       safety and efficacy of palivizumab (Synagis(R)), an approved
       RSV-specific humanized monoclonal antibody, and motavizumab, an
       investigational RSV-specific monoclonal antibody, in preterm children
       at high-risk for serious RSV. Outside the United States, Abbott
       International, a global broad-based health care company, has the
       distribution rights to motavizumab.





    Additional information regarding the European Society for Paediatric
Research's Annual Meeting can be found at
http://www.kenes.com/Paediatric-Research/.



About Synagis

    Synagis is indicated for the prevention of serious lower respiratory
tract disease caused by respiratory syncytial virus (RSV) in pediatric
patients at high risk of RSV disease and is administered by intramuscular
injection. Safety and efficacy were established in infants with
bronchopulmonary dysplasia (BPD), infants with a history of premature birth
(less than or equal to 35 weeks gestational age), and children with
hemodynamically significant congenital heart disease (CHD). Synagis has been
used in more than one million children in the U.S. since its introduction in
1998. The first dose of Synagis should be administered prior to commencement
of the RSV season. Patients, including those who develop an RSV infection,
should continue to receive monthly doses throughout the season.



    Very rare cases (less than one per 100,000 patients) of anaphylaxis and
rare (less than one per 1,000 patients) 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 one
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. Please see complete prescribing
information at http://www.medimmune.com.



About FluMist

    FluMist is a live attenuated influenza virus vaccine indicated for active
immunization of individuals two-to-49 years of age against influenza disease
caused by influenza virus subtypes A and type B contained in the vaccine.



    FluMist is contraindicated in individuals with history of
hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or
with life-threatening reactions to previous influenza vaccinations, and in
children and adolescents receiving concomitant aspirin or aspirin-containing
therapy.



    Do not administer FluMist to children less than 24 months of age due to
an increased risk of hospitalization and wheezing that was observed in
clinical trials. FluMist should not be administered to any individual with
asthma and to children less than five years of age with recurrent wheezing
unless the potential benefit outweighs the potential risk. Do not administer
FluMist to individuals with severe asthma or active wheezing.



    If Guillain-Barre syndrome has occurred with prior influenza vaccination
or if an individual is immunocompromised, the decision to give FluMist should
be based on careful consideration of the potential benefits and risks.
FluMist should not be administered to individuals with underlying medical
conditions predisposing them to wild-type influenza infection complications
unless the potential benefit outweighs the potential risk. FluMist should be
given to a pregnant woman only if clearly needed.



    Most common adverse reactions (occurring at greater than or equal to 10
percent in individuals receiving FluMist and at least five percent greater
than in placebo) are runny nose or nasal congestion in recipients of all
ages, fever greater than 100 degrees Fahrenheit in children two-to-six years
of age, and sore throat in adults.



    FluMist may not protect all individuals receiving the vaccine. FluMist is
for intranasal administration only. Please see complete prescribing
information at http://www.medimmune.com.



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.



Web site: http://www.medimmune.com