MedImmune Submits Biologics License Application...

GAITHERSBURG, Maryland, February 4 /PRNewswire/ --

    MedImmune announced today it submitted to the U.S. Food & Drug
Administration (FDA) on January 30 a Biologics License Application (BLA) for
motavizumab, an investigational monoclonal antibody (MAb) derived from
recombinant DNA technology. The motavizumab BLA is supported by clinical
trial data from more than 6,000 patients in which safety and efficacy in
prevention of serious disease caused by respiratory syncytial virus (RSV) in
high-risk pediatric patients were evaluated.


    "We are pleased to submit this BLA for motavizumab, which we believe
represents another tool in the fight against RSV. This marks a significant
milestone for this molecule and further reinforces MedImmune's commitment to
developing anti-RSV biologics for the underserved pediatric patient
population," said Linda J. Peters, senior vice president, regulatory affairs.


    Motavizumab was studied in an active-controlled Phase 3 trial against the
standard of care in pediatric patients at high risk of serious RSV disease.
Primary and secondary endpoints of the study included incidence of RSV
hospitalizations and RSV-specific medically attended outpatient lower
respiratory tract infections. Rates of adverse events, serious adverse events
and study drug discontinuations were balanced between treatment groups. The
most frequently observed reactions versus the active comparator were
cutaneous reactions (overall).


    "Beyond the findings of the various investigational trials for
motavizumab, we believe this molecule will help reinforce the positive role
that MAbs play in RSV prevention within the current clinical body of
evidence. It also reinforces our position as a leader in RSV prevention,"
said Genevieve Losonsky, M.D., vice president, clinical development,
infectious disease.


    RSV is a leading cause of viral respiratory infection among infants. Each
year, up to an estimated 125,000 infants in the United States are
hospitalized with severe RSV infections, the leading cause of infant
hospitalization within the U.S. 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.


    In the United States, RSV causes up to 1.7 million physician office
visits; 400,000 emergency room visits and more than 230,000 hospital
outpatient emergency room visits per year. RSV is the most common respiratory
infection in infancy or childhood. Children born prematurely as well as those
with chronic lung disease (CLD) or congenital heart disease (CHD) are at high
risk for severe disease and hospitalization due to RSV.


    RSV infection usually manifests as an upper respiratory tract infection
with symptoms resembling a cold. Preterm infants, those with chronic lung
disease, and infants with complicated cardiac disease are especially
vulnerable to the infection and have an increased risk of progressing to a
serious lower respiratory tract infection that sometimes requires
hospitalization, mechanical ventilation and intensive care.


    MedImmune intends to commercialize motavizumab through its existing sales
and marketing organization within the U.S., and to co-promote with Abbott in
certain non-U.S. markets if and when the product is approved for marketing by
regulatory authorities. Outside the U.S., Abbott, the global, broad-based
health care company, has marketing and distribution rights for motavizumab.



MedImmune's Commitment to RSV Prevention

    MedImmune is a world leader in the development of innovative therapeutic
biologic products to prevent RSV disease. With the ongoing development of
motavizumab, MedImmune continues to reinforce its commitment to developing
anti-RSV products. 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 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; inflammatory
diseases; cardiovascular and metabolic diseases; pain and central nervous
system disorders and gastrointestinal 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 www.medimmune.com.



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