- Pivotal Phase 3 Efficacy Trial for Numax(TM) Underway -
WASHINGTON, May 14, 2005 /PRNewswire-FirstCall via COMTEX/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today data from a Phase 1/2 study demonstrating that
Numax appears to be safe and well tolerated, with an acceptable
pharmacokinetic profile, in infants at high risk of respiratory syncytial
virus (RSV) disease. 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 protecting high-risk infants against RSV. To
date, Synagis has successfully helped to reduce the incidence of serious lower
respiratory tract illness in more than 700,000 high-risk infants.
"Numax has been shown in preclinical studies to be more potent than
Synagis in reducing RSV replication in both the lower and upper respiratory
tract," said Genevieve Losonsky, M.D., senior director, clinical development.
"Our development goals for Numax are to fully assess its safety and to
evaluate if the increased potency seen in preclinical studies can be
translated into better efficacy against RSV hospitalizations, medically
attended lower respiratory tract illness and upper respiratory tract disease,
such as otitis media (middle ear infections)."
An abstract presented today at the annual meeting of the Pediatric
Academic Societies in Washington, DC was entitled "Phase 1/2 Trial in High-
Risk Infants of MEDI-524 (Numax(TM)) an Enhanced Potency Respiratory Syncytial
Virus (RSV) Specific Monoclonal Antibody." The dose-escalation trial was
conducted in North and South America and included 217 preterm infants (32-35
weeks gestational age) and infants with chronic lung disease of prematurity
two years of age or younger. Each participant received up to five monthly
intramuscular injections of Numax and had completed evaluations through 90
days after the final dose for safety, immunogenicity and pharmacokinetics.
In March, MedImmune presented results from Phase 1 and 2 studies of Numax,
including data that showed Numax was present in the nasal secretions of
patients receiving the antibody and inhibited viral replication in the nose.
These results were presented at the 7th International Symposium on Respiratory
Viral Infections in Curacao. More recently, MedImmune also initiated a Phase
2, second-season study to determine the safety of re-dosing children who
received Numax in a prior RSV season.
RSV is the most common respiratory infection in infancy or childhood,
resulting in more than 125,000 hospitalizations in the U.S. annually in
children less than one year of age. 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 a humanized monoclonal antibody currently being developed to
potentially prevent serious lower respiratory tract disease caused by RSV in
pediatric patients at high-risk of RSV disease. In November 2004, MedImmune
initiated a pivotal worldwide Phase 3 study comparing the safety and efficacy
of Numax in reducing RSV disease in high-risk infants to that of Synagis. A
Phase 3 study is also underway to evaluate the safety and efficacy of Numax in
healthy Native American infants.
Synagis is marketed 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 through 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. The adverse reactions most commonly observed in Synagis-treated
patients have been upper respiratory tract infection, ear infection, fever,
runny nose, rash, diarrhea, cough, vomiting, gastroenteritis and wheezing.
Very rare cases of severe allergic reactions such as anaphylaxis (less than
one case per 100,000 patients) and hypersensitivity reactions have been
reported. 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.
About MedImmune, Inc.
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, Numax will
receive required regulatory clearance or, even if such regulatory clearance is
received, that Numax will ultimately achieve commercial success.
SOURCE MedImmune, Inc.
Clarencia Stephen, +1-301-398-4073
Pete Vozzo, +1-301-398-4358
John Filler, +1-301-398-4086
all of MedImmune, Inc.