New Study in Journal of Pediatrics Suggests Synagis(R) (Palivizumab) May Reduce Subsequent Recurrent Wheezing in Preterm Infants

ABBOTT PARK, Illinois and GAITHERSBURG, Maryland, June 29 /PRNewswire/ --

- Prophylaxis with Synagis Decreases Incidence of Recurrent Wheeze by 
Almost Half

Abbott (NYSE: ABT) and MedImmune today announced results of a new 
study, published in the July issue of Journal of Pediatrics, showing that 
treatment with Synagis(R) (palivizumab) may reduce recurrent wheezing in 
premature infants by almost half.

Specifically, the study showed that premature infants without chronic
lung disease who received Synagis prior to the study had a 49 percent
reduction in the incidence of recurrent wheezing compared to preterm infants
who did not receive Synagis. The two-year study also found a 51 percent
reduction in the incidence of physician-diagnosed recurrent wheezing in the
Synagis group compared to untreated infants.

Wheezing is a whistling sound made by air passing through airways
narrowed by inflammation or muscle spasms. Children who wheeze are frequently
seen by physicians to determine the cause of their wheezing.

Synagis is a biologic therapy known as a monoclonal antibody administered
monthly to premature infants to prevent serious lower respiratory tract
infection caused by respiratory syncytial virus (RSV), a leading cause of
viral respiratory infection among infants.

According to the World Health Organization, 64 million people are
infected with RSV each year, and 160,000 will die from this disease.
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.

'With this new study we see that, by preventing the most serious forms of
RSV infections from progressing to its most serious form, Synagis may help
protect premature children without chronic lung disease from recurrent
wheezing in the first few years of life,' said Eric Simoes, MD, professor,
Department of Pediatric Infectious Diseases, University of Colorado School of
Medicine and lead investigator in the study.

RSV infection usually manifests as an upper respiratory tract infection
with symptoms resembling a cold. In preterm infants, however, the infection
has an increased risk of progressing to a lower respiratory tract infection
that sometimes requires hospitalization, mechanical ventilation and intensive
care. Beyond the acute consequences of infection, epidemiologic data suggest
a link between early RSV-associated hospitalization and chronic respiratory
complications, such as recurrent wheezing and asthma, which may extend into
adolescence.

Synagis, when administered to preterm infants as RSV prophylaxis, has
previously shown a 55 percent reduction in hospitalizations due to RSV.
Researchers in the current study hypothesized that Synagis, by preventing
serious RSV disease, may be responsible for a reduction in recurrent wheezing
later in life.

Clinical Trial Design

The study published today was conducted at 27 locations in Spain,
Germany, The Netherlands, Canada, Poland and Sweden. Researchers
prospectively followed a group of preterm infants (born <35 weeks gestational
age) who received at least three doses of Synagis for RSV prophylaxis during
their first year of life, and a matched group of preterm infants not treated
with Synagis. The Synagis group consisted of 191 preterm infants who were
less than 36 months of age and who were not hospitalized for RSV. The control
group included 230 preterm children who were matched by chronologic and
gestational age: 76 had been hospitalized for RSV and 154 had not. Study
subjects were followed for 24 months beginning at a mean age of 19 months.

The primary endpoint of the study was the incidence of recurrent
wheezing, defined as three or more episodes of wheezing in the preceding 12
months. An episode of wheezing was defined as one or more consecutive days of
wheezing, preceded and followed by a healthy period of at least one week. The
study also evaluated the incidence of physician-diagnosed recurrent wheezing,
defined as three or more episodes of wheezing in the prior 12 months, as
verified by a physician at a physician's office, emergency room or hospital.

Clinical Trial Results

After following these infants for two years, the results showed the
following key findings:

The incidence of recurrent wheezing was 49 percent lower among children
who received Synagis compared to those who did not (13 percent vs. 26
percent, p=0.001). There was also significantly less physician-diagnosed
recurrent wheezing in the group that received Synagis (8 percent vs. 16
percent, p=0.011).

In addition, infants who received Synagis had a significantly longer time
to onset of both recurrent wheezing and physician-diagnosed recurrent
wheezing, compared with the combined non-prophylaxed group.

About Synagis

Synagis is the only monoclonal antibody approved by the U.S. Food and
Drug Administration (FDA) to help prevent an infectious disease. Synagis is
indicated for the prevention of serious lower respiratory tract disease
caused by RSV in children at high risk of RSV disease.

Synagis was approved for use in the United States in 1998, Europe in
1999, and Japan in 2002. Synagis is currently available in 62 countries.

The safety and efficacy of Synagis were established in infants with
bronchopulmonary dysplasia, infants with a history of prematurity (less than
or equal to 35 weeks gestational age), and children with hemodynamically
significant congenital heart disease. The first dose of Synagis should be
administered prior to commencement of the RSV season, which usually starts in
the fall and runs through the spring. Patients, including those who develop
an RSV infection, should continue to receive monthly doses throughout the
season.

Abbott has exclusive rights to Synagis in markets outside the United
States. MedImmune promotes Synagis in the United States.

Important Safety Information

Globally, prescribing information varies; refer to the individual country
product label for complete information. For U.S. safety information, visit
http://www.medimmune.com. Very rare cases (<1 per 100,000 patients) of
anaphylaxis and rare (<1 per 1,000 patients) severe acute 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 1
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.

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 more than 2,500 employees worldwide, MedImmune is
headquartered in Maryland. For more information, visit the company's Web site
at http://www.medimmune.com.

About Abbott

Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs 65,000 people and markets its products in more than 130
countries.

Abbott's news releases and other information are available on the
company's Web site, at http://www.abbott.com.

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