- New Formulation Offers Improvements for Pediatricians and High-Risk Infants -
GAITHERSBURG, Md., July 26 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) today announced that the U.S. Food and Drug Administration
(FDA) has approved a new liquid formulation of Synagis (palivizumab). In 1998,
the original formulation of Synagis was approved by the FDA to prevent serious
lower respiratory tract disease caused by respiratory syncytial virus (RSV) in
pediatric patients at high risk of RSV disease. Synagis is the first
monoclonal antibody approved for prevention of an infectious disease, and the
first such drug to be safely used in children.
Armando Anido, MedImmune's senior vice president, commercial operations,
stated: "As a leader in the development of drugs to treat or prevent
pediatric infectious disease, MedImmune is excited about the approval of this
new and easier-to-use formulation of our flagship product, Synagis. This is a
significant milestone in the continued development of our RSV product
franchise."
The new liquid Synagis offers healthcare providers, parents and high-risk
infants improved convenience. The original formulation is a freeze-dried
preparation that is reconstituted with sterile water, a process that takes
approximately 20 minutes, from which the final product must be used within the
next six hours. The new liquid formulation of Synagis is already supplied as
a sterile solution ready for injection, thus eliminating the additional
preparatory steps and reducing the time a high-risk infant will spend in a
physician's waiting room among other sick children.
In October 2004, MedImmune plans to end production of the current
formulation for the U.S. and to begin manufacturing liquid Synagis, which
should be available for use in the U.S. for the 2005 - 2006 RSV season.
About RSV and Synagis
RSV is the most common respiratory infection in infancy or childhood,
resulting in over 125,000 hospitalizations in the U.S. annually in children
less than one year of age. 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.
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. Synagis was initially licensed by the FDA
in 1998, and in 2003, its label was expanded to include safety and efficacy
data supporting its use in young children with hemodynamically significant
congenital heart disease to prevent hospitalization caused by RSV. 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 pediatric infectious
diseases, cancer and inflammatory diseases. With approximately 1,800
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 is received, such products will
ultimately achieve commercial success.
SOURCE MedImmune, Inc.
-0- 07/26/2004
/CONTACT: Media: Jamie Lacey, +1-301-398-4035, or Investors: Peter Vozzo,
+1-301-398-4358 or John Filler, +1-301-398-4086, all of MedImmune, Inc./
/Web site: http://www.medimmune.com/
(MEDI)
CO: MedImmune, Inc.; U.S. Food and Drug Administration; FDA
ST: Maryland
IN: MTC HEA BIO
SU: CHI PDT
MB-MV
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2137 07/26/2004 14:52 EDT http://www.prnewswire.com
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