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Fourteen Abstracts Featuring MedImmune, Inc.'s Influenza and RSV Therapeutic Areas to Be Presented


4/29/2008 7:16:44 AM

GAITHERSBURG, Md., April 28 /PRNewswire/ -- MedImmune today announced that researchers will present results from a host of studies in pediatric infectious disease, featuring FluMist(R) (Influenza Virus Vaccine Live, Intranasal) as well as Synagis(R) (palivizumab) and emerging RSV compounds motavizumab and MEDI-534, at the Pediatric Academic Societies (PAS) Annual Meeting beginning later this week in Honolulu, HI.

"Our rich history in pediatric research is a pillar of our strength at MedImmune and we believe the collective data we share at PAS will help further the understanding of prevention around two important infectious diseases that impact the health of children," said Alexander A. Zukiwski, M.D., senior vice president and chief medical officer. "Ongoing research from our portfolio of current and emerging biologics reflects our commitment to finding important new solutions for pediatric infectious disease prevention."

Immunogenicity of Live Attenuated Influenza Vaccine (LAIV) Compared With Trivalent Inactivated Influenza Vaccine (TIV) in Children 12-35 Months of Age(1) (Harvey BM, et al)

(1) Do not administer FluMist to children less than two years of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials.

Shedding and Safety of Live Attenuated Influenza Vaccine in Healthy Subjects 6 to <60 Months of Age(1) (Block SL, Reisinger KS)

Efficacy, Immunogenicity, and Safety of One Versus Two Doses of LAIV in Young Children (Bracco H, et al)

Cost-Effectiveness of Live Attenuated Influenza Vaccine Versus Inactivated Influenza Vaccine Among Children Aged 24 to 59 Months (Luce B, et al)

Real-Time Assessment of 2007-2008 Influenza Vaccine Coverage Among Practicing Pediatricians (Bhatt P, et al)

Efficacy of Live Attenuated Influenza Vaccine in Children: A Meta-Analysis of 9 Randomized Clinical Trials (Rhorer J, et al)

Early Availability of Influenza Vaccine Could Double In-Office Vaccination Opportunities (Ambrose CS, et al)

Genetic Sequences of Circulating 2004-2005 Influenza Strains and Serum Antibody Responses to LAIV vs. TIV in Young Children (Belshe RB, et al)

RSV-Related Studies

A total of five studies related to MedImmune's respiratory syncytial virus (RSV) marketed and investigational products are scheduled for presentation at the PAS meeting. Among these are two studies related to epidemiology and pharmacoeconomics of RSV, and one each related to Synagis(R) (palivizumab), motavizumab and MEDI-534. Results of these studies are scheduled to be presented as follows:

Seasonality of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Infection (LRI) and Apnea in Infants Presenting to the Emergency Department (ED) (Bonner A, et al)

Phase 1 study of MEDI-534, a Live Attenuated Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy 1-9 Year-Old RSV and PIV3 Seropositive Children (Gomez M, et al)

Lung Function in Healthy Late Preterm Infants Delivered at 33-36 Weeks of Gestation (Venigalla S, et al)

Safety and Efficacy of motavizumab in the Prevention of RSV Disease in Healthy Infants (Chandran A, et al)

About FluMist

FluMist(R) (Influenza Virus Vaccine Live, Intranasal) 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 two years 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 in 10 percent or more of individuals receiving FluMist and at a rate at least five percent higher than in those receiving placebo) are runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees F 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 for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit http://www.flumist.com/prescribing-information.aspx for additional information.

About Synagis

Synagis(R) (palivizumab) is indicated for the prevention of serious lung infections caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. The first dose of Synagis should be given before RSV season begins. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season. Synagis has been used in more than one million children in the U.S. since its introduction in 1998.

Very rare cases (<1 per 100,000 patients) of severe allergic reactions such as anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. These rare reactions may occur when any dose of Synagis is given, not just the first one. Also, rare but serious side effects can occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.

Other side effects with Synagis may include upper respiratory tract infection, ear infection, fever, and runny nose. In children born with heart problems, Synagis was associated with reports of low blood oxygen levels and abnormal heart rhythms. Synagis should not be used in patients with a history of a severe prior reaction to Synagis or its components. Side effects, such as, skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort) can also occur.

Please see complete prescribing information at www.synagis.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 cardiovascular/gastrointestinal disease, neuroscience, oncology, infection, respiratory disease and inflammation. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc . For more information, visit MedImmune's website at www.medimmune.com.

CONTACT: Media: Karen Lancaster, +1-301-398-5864 (influenza), or Tor
Constantino, +1-301-398-8501 (RSV), or Investors: Peter Vozzo,
+1-301-398-4358, all of MedImmune

Web site: http://www.medimmune.com/
http://www.flumist.com/prescribing-information.aspx/
http://www.synagis.com/


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