- Data Presented at the 4th World Congress of the
World Society for Pediatric Infectious Diseases -
WARSAW, Poland, Sept. 1 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today data from a Phase 1 study demonstrating that
Numax (motavizumab) appears to have an acceptable safety profile in infants
infected with respiratory syncytial virus (RSV) and may have the potential to
help reduce RSV in the upper respiratory tracts of children infected with the
virus. MedImmune is developing Numax as a potential improvement to Synagis(R)
(palivizumab), which it introduced to the market in 1998 and has become the
standard of care for helping to prevent serious RSV disease in high-risk
"Preclinical data have shown that Numax is able to reduce RSV in the upper
and lower respiratory tracts, and this Phase 1 clinical trial has demonstrated
that Numax can reduce RSV in the upper respiratory tract of children infected
with the virus," said Genevieve Losonsky, M.D., senior director, clinical
development. "Based on the increased potency of Numax in preclinical studies
and the safety and pharmacokinetic profile we have observed in children in
Phase 1 and 2 trials conducted to date, we are currently conducting a Phase 3
trial to compare Numax and Synagis for the reduction of hospitalizations due
to serious RSV disease in high-risk children."
Data presented today were from an abstract titled, "Administration of the
Anti-RSV Monoclonal Antibody (MAb), Numax(TM), is Associated with a Reduction
in Upper Airway (UA) RSV Load." The randomized, placebo-controlled study was
conducted in the Northern and Southern Hemispheres and involved 30 children
under the age of two years who were hospitalized with RSV infections. Data
from the trial indicated that Numax was associated with a significant
reduction of RSV in the children's upper respiratory tract.
In preclinical studies, Numax has shown increased potency against RSV when
compared to Synagis. Earlier this year, MedImmune presented this information
and other data from Phase 1 and Phase 1/2 studies at scientific meetings in
the United States and Curacao that provided evidence that Numax was safe and
well-tolerated in high-risk infants. A pivotal Phase 3 efficacy and safety
trial for Numax is currently underway. This head-to-head study comparing
Synagis and Numax is the largest of its kind in these high-risk populations,
and will assess reductions in RSV-related hospitalizations as well as upper
respiratory tract infections such as otitis media.
RSV is the most common respiratory infection in infancy or childhood.
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. Children born prematurely as well as
those with chronic lung disease or congenital heart disease are at highest
risk of severe disease and hospitalization due to RSV.
Numax is an investigational humanized MAb in Phase 3 development to
evaluate its potential to prevent serious lower respiratory tract disease
caused by RSV in pediatric patients at high risk of RSV disease. Phase 1 and
Phase 2 studies have recently been reported showing that Numax appears to have
a similar safety and pharmacokinetic profile to Synagis in infants. By the end
of 2005, there will be three active late-stage clinical trials underway with
Numax involving more than 7,500 children worldwide. These include a pivotal
Phase 3 study initiated in November 2004 comparing the safety and efficacy of
Numax with Synagis in reducing serious RSV disease in high-risk infants; a
second Phase 3 study initiated in November 2004 to assess whether Numax can
reduce the incidence of RSV hospitalization in full-term Native American
infants; and a safety study planned to begin in late 2005 in children with
congenital heart disease.
Synagis is indicated for the prevention of serious lower respiratory tract
disease caused by RSV in pediatric patients at high-risk of RSV disease, which
is prominent in the Northern Hemisphere during the winter months. Synagis is a
humanized MAb given by an intramuscular injection once a month during the RSV
season. Synagis was approved in 1998 by the U.S. Food and Drug Administration
(FDA); in 1999, by the European Medicines Evaluation Agency; and in 2002, by
the Japanese Ministry of Health, Labor and Welfare. In 2003, the FDA expanded
the U.S. label for Synagis for use in young children with hemodynamically
significant congenital heart disease at risk of RSV disease. To date, Synagis
has been approved in 62 countries, including the United States. Synagis has
been used in more than half a million babies since 1998. Adverse events with
Synagis may include upper respiratory tract infection, ear infection, fever,
runny nose, rash, diarrhea, cough, vomiting, gastrointestinal upset and
wheezing. Very rare cases of severe allergic reactions such as anaphylaxis
(less than 1 case per 100,000 patients) have been reported following re-
exposure to Synagis. Rare severe, acute hypersensitivity reactions have also
been reported on initial exposure or re-exposure to Synagis. Synagis should
not be used in patients with a history of a severe prior reaction to Synagis
or its components. For full prescribing information for Synagis, see the
company's website at http://www.medimmune.com/products/synagis/index.asp.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value to
shareholders. 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 2,000 employees
worldwide, MedImmune is headquartered in Maryland. For more information, visit
the company's website at http://www.medimmune.com.
This announcement contains, in addition to historical information, certain
forward-looking statements that involve risks and uncertainties, in
particular, related to the research and development of Numax. 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. There
can be no assurance that such development efforts will succeed, that such a
product will receive required regulatory clearance or that, even if such
regulatory clearance is received, such a product will ultimately achieve
SOURCE MedImmune, Inc.
Peter Vozzo, +1-301-398-4358
all of MedImmune, Inc.