- Company Also Completes Enrollment in Numax Study in Congenital Heart Disease Patients -
GAITHERSBURG, Md., Dec 15, 2005 /PRNewswire-FirstCall via COMTEX News Network/ -- MedImmune, Inc.
(Nasdaq: MEDI) today announced that it has completed enrolling approximately
6,600 high-risk infants in a pivotal Phase 3 study comparing the safety and
efficacy of Numax to Synagis (palivizumab). MedImmune also announced that it
has completed enrollment of more than 620 patients in a separate, late-stage
clinical study with Numax in children with hemodynamically significant
congenital heart disease (CHD). MedImmune is developing Numax as a potential
improvement to Synagis, which was introduced to the market in 1998 and has
become the standard of care for the prevention of serious respiratory
syncytial virus (RSV) disease in these infants.
"MedImmune's commitment to develop medicines to fight pediatric infectious
diseases is evident in its ongoing anti-RSV clinical programs," said Genevieve
Losonsky, M.D., vice president, clinical development, infectious disease. "To
date, Synagis has been used to protect more than 700,000 infants in the United
States from RSV. If the Phase 3 program is successful and Numax is approved,
we may be able to provide enhanced RSV prophylaxis for infants at risk for
serious RSV disease."
The 2005 impact of incremental recruiting and enrollment costs for both
trials is anticipated to be approximately $10 million, which was not included
in MedImmune's previously stated financial guidance for 2005, as issued on
October 20, 2005.
Numax versus Synagis Phase 3 Study
The pivotal Phase 3 study is designed to compare the safety and efficacy
of Numax with that of Synagis for reduction of RSV hospitalization in high-
risk infants. Secondary endpoints include medically attended lower respiratory
tract infections and otitis media (ear infections). The trial is a randomized,
double-blind study involving approximately 6,600 high-risk infants at 300
centers in 24 countries within the Northern and Southern Hemispheres. Study
participants consist of premature infants born at 35 weeks gestational age or
less who were six months of age or younger at randomization, as well as
children with chronic lung disease related to prematurity (CLD), who were 24
months of age or less at randomization. Each child receives an intramuscular
injection of 15 mg/kg of Numax or Synagis each month during the RSV season for
a total of five injections. The participants will be monitored throughout the
trial for safety, medically attended outpatient visits for lower-respiratory-
tract infections and otitis media, and hospitalizations.
Numax CHD Study
This randomized, double-blind, palivizumab-controlled study will evaluate
the safety, tolerability, immunogenicity and pharmacokinetics of Numax in
children with CHD. It is being conducted at approximately 160 sites in the
Northern Hemisphere during the 2005-2006 RSV season. Study participants
include infants with hemodynamically significant CHD who were 24 months of age
or younger at randomization. Approximately 620 patients will receive an
intramuscular injection of either 15 mg/kg of Numax or Synagis each month for
five months. Children will be followed throughout the study for safety. Blood
samples will be collected for assessment of immunogenicity and
pharmacokinetics. Hospitalizations due to RSV will be assessed as a secondary
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 for severe disease and hospitalization due to RSV. The virus may also
cause severe illness in other high-risk groups such as the elderly, those with
underlying respiratory or cardiac disease, and those with compromised immune
systems (e.g., bone marrow transplant patients).
In addition to its Numax clinical program, MedImmune is also studying a
vaccine that could potentially prevent both RSV and parainfluenzavirus type 3
(PIV-3). PIV-3 is another commonly occurring respiratory virus of childhood,
causing bronchitis, bronchiolitis, croup, cough, fever and pneumonia.
Numax is an investigational humanized monoclonal antibody (MAb) being
evaluated for 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.
Additionally, in early phase studies children treated with Numax had reduced
RSV replication in the upper respiratory tract. In light of this latter
finding, MedImmune is studying the potential for preventing upper respiratory
tract infections such as otitis media with Numax in its pivotal Phase 3 trial.
In addition to the two trials mentioned previously in this release, MedImmune
is also conducting a Phase 3 study to assess whether Numax can reduce the
incidence of RSV hospitalization in full-term Native American infants. This
trial will also evaluate the effect of Numax on wheezing in these children.
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.
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 pediatric infectious
diseases, cancer and inflammatory diseases. With more than 2,000 employees
worldwide, MedImmune is headquartered in Maryland. For more information, visit
the company's website at http://www.medimmune.com.
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.
Clarencia Stephen, +1-301-398-4073
Jamie Lacey, +1-301-398-4035
Peter Vozzo, +1-301-398-4358
John Filler, +1-301-398-4086