GAITHERSBURG, Md., Sep 16, 2003 /PRNewswire-FirstCall via COMTEX/ -- MedImmune, Inc.
(Nasdaq: MEDI) today announced that the U.S. Food & Drug Administration (FDA)
has approved the addition of new safety and efficacy data to the prescribing
information of Synagis(R) (palivizumab). In what is the largest study
conducted in children with complex congenital heart disease, investigators'
findings supported the drug's use in young children with hemodynamically
significant CHD to prevent hospitalization caused by respiratory syncytial
virus (RSV). RSV is the most common cause of lower tract respiratory
infections in infants and children worldwide, typically occurring during the
fall and winter months.
"Infants and young children with significant CHD are at high risk of
serious RSV disease," said Dr. Edward M. Connor, MedImmune's senior vice
president, clinical development. "We are pleased that the FDA has expanded
the label for Synagis to help protect these patients from a potentially life-
threatening RSV infection."
Congenital heart defects are structural problems of the heart that are
present at birth, having occurred during development. Approximately 32,000
children are born in the U.S. each year with CHD, of which there are many
different types with varying degrees of severity. Children born with serious
CHD who have decreased cardiac or pulmonary reserve appear to be at highest
risk of serious RSV infection. These children have been shown to require
intensive care and use mechanical ventilation with RSV infection more
frequently than children who do not have CHD. Further, children with CHD who
are hospitalized with RSV have a fatality rate that is two to six times
greater than those without CHD.
Synagis is a humanized monoclonal antibody licensed by the FDA in 1998 to
prevent serious lower respiratory tract disease caused by RSV in pediatric
patients at high risk of RSV disease. MedImmune submitted data to the FDA in
November 2002 from its large, multinational Phase 3 clinical study indicating
that Synagis was safe and effective in preventing RSV-related hospitalizations
in young children with hemodynamically significant CHD.
"Synagis is an important preventative option for children with significant
congenital heart disease," said Dr. Henry M. Sondheimer, professor of
pediatrics, University of Colorado Health Sciences Center and clinical
director of Pediatric Cardiology at The Children's Hospital, Denver.
"Children with CHD who are hospitalized with RSV have substantially higher
rates of morbidity and mortality than those children who do not have CHD.
With the FDA's approval of CHD information in the Synagis label, pediatricians
and pediatric cardiologists will have a better understanding of those
vulnerable children who will most benefit from RSV prophylaxis with Synagis."
The regulatory submission was based on a four-year, double-blind, placebo-
controlled study assessing 1,287 children less than two years of age with
serious CHD. In the study, children were randomized to receive monthly
intramuscular injections (15 mg/kg) of either Synagis (n=639) or placebo
(n=648) during four consecutive RSV seasons. The study was conducted at 76
centers in North America, France, Germany, Poland, Sweden, and the United
Kingdom and was completed in 2002. The Synagis group had 45 percent relative
reduction in hospitalizations due to RSV (p=0.003) compared to the placebo
group, with a total of 34 patients compared to 63 patients requiring
hospitalization. The adverse events reported in the two treatment groups were
For children with chronic lung disease, premature infants who are less
than 36 weeks gestational age, and children with significant CHD, clinical
studies now have demonstrated that Synagis is safe and effective at preventing
serious RSV-related hospitalizations.
In July 2003, Abbott Laboratories, international distributor for Synagis,
announced that the European Agency for the Evaluation of Medicinal Products
had granted a positive opinion for Synagis use in young children born with CHD
to prevent respiratory tract infection caused by RSV.
About MedImmune, Inc.
MedImmune is a leading biotechnology company focused on researching,
developing and commercializing products to prevent or treat infectious
disease, autoimmune disease and cancer. MedImmune actively markets four
products, Synagis(R) (palivizumab), FluMist(TM) (Influenza Virus Vaccine Live,
Intranasal), Ethyol(R) (amifostine) and CytoGam(R) (cytomegalovirus immune
globulin intravenous (human)), and has additional products in clinical
testing. MedImmune employs approximately 1,700 people, is headquartered in
Gaithersburg, Maryland, and has additional operations in Frederick, Maryland,
as well as Pennsylvania, California, the United Kingdom and the Netherlands.
For more information on the company, visit MedImmune's website at
This announcement may contain, in addition to historical information,
certain forward-looking statements that involve risks and uncertainties. Such
statements reflect management's current views and are based on certain
assumptions. Actual results could differ materially from those currently
anticipated as a result of a number of factors, including risks and
uncertainties discussed in MedImmune's filings with the U.S. Securities and
Exchange Commission. The company is developing several products for potential
future marketing. There can be no assurance that such development efforts
will succeed, that such products will receive required regulatory clearance or
that, even if such regulatory clearance were received, such products would
ultimately achieve commercial success.
SOURCE MedImmune, Inc.
Media: Jamie Lacey, +1-240-632-4035, or Investors: Will
Roberts, +1-301-527-4358, both of MedImmune, Inc.