GAITHERSBURG, Md., April 15, 2005 /PRNewswire-FirstCall via COMTEX/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that is has begun dosing adult volunteers in a
Phase 1 clinical trial with its respiratory syncytial virus (RSV) vaccine
candidate. The vaccine was developed using an attenuated parainfluenza virus
type-3 (PIV-3), which was previously evaluated in a Phase 1 clinical trial in
infants and recently modified to induce immunity to RSV. Data from preclinical
studies indicate that the vaccine protects against both RSV and PIV-3.
"Our vaccine candidate is unique because it leverages MedImmune's novel
intranasal technology to target RSV, and possibly PIV-3, through a single
intranasal immunization," said Edward M. Connor, M.D., chief medical officer.
"If successfully developed and approved, this vaccine may offer pediatricians
an intranasal option to protect children broadly against respiratory disease
caused by two important respiratory pathogens. These pathogens are responsible
for significant illnesses in children and significant healthcare expenditures
The Phase 1 clinical study is designed to evaluate the vaccine's safety,
tolerability, and immunogenicity. It is a randomized, double-blind, placebo-
controlled, dose-escalation study in approximately 120 healthy men and women
between the ages of 18 and 40 years. MedImmune filed an investigational new
drug application with the U.S. Food and Drug Administration (FDA) for the
vaccine candidate in January 2005.
The combination vaccine is expected to offer ease of administration for
pediatricians and their patients, and may help reduce RSV/PIV-3-associated
illnesses and hospital costs in the United States. RSV and PIV-3 are viruses
that cause serious respiratory disease. RSV is the most common cause of lower
respiratory tract infections in infants and children worldwide, typically
occurring during the fall and winter months. There are approximately 125,000
RSV-associated hospitalizations each year in the United States. Lower
respiratory tract disease due to PIV-3 is responsible for as many as 50,000
hospitalizations annually in the United States with approximately half of
those in infants less than one year old.
The advancement of MedImmune's vaccine candidate into a Phase 1 clinical
study underscores the company's efforts to leverage the latest vaccine
technologies with its proven experience in developing options for the
prevention of respiratory infectious disease. MedImmune products have helped
to protect children from RSV since 1996. Now the standard of care for the
prevention of RSV in high-risk infants, Synagis(R) (pavilizumab) was the first
monoclonal antibody approved by the FDA to combat an infectious disease. To
date, Synagis has helped protect more than 700,000 premature and/or high-risk
infants against RSV disease. MedImmune is also the developer and manufacturer
of FluMist(R) (Influenza Virus Vaccine Live, Intranasal), the first FDA-
approved intranasal influenza vaccine in the United States.
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 from October through May. Synagis is
a humanized monoclonal antibody given through a simple intramuscular injection
once a month during the RSV season. The adverse reactions most commonly
observed in Synagis-treated patients were 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.
FluMist was approved by the FDA in June 2003. It is the first live,
attenuated influenza vaccine in the U.S. that is indicated for active
immunization for the prevention of disease caused by influenza A and B viruses
in healthy children and adolescents, 5 to 17 years of age, and healthy adults,
18 to 49 years of age. There are risks associated with all vaccines including
FluMist. Like any vaccine, FluMist does not protect 100 percent of
individuals vaccinated. In placebo-controlled clinical trials, the most
common solicited adverse events in the indicated population of 2,762 included
runny nose/nasal congestion, headache, cough, sore throat, tiredness/weakness,
irritability, decreased activity and muscle aches. For full prescribing
information for FluMist, see the company's website at
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 a potential RSV/PIV-3
combination vaccine product. 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 commercial success.
SOURCE MedImmune, Inc.