Synagis Also Awarded the German Prix Galien For
Outstanding Pharmaceutical Product
GAITHERSBURG, Md., Jan. 24 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq:
MEDI) announced today that Synagis(R) (palivizumab) was approved on January 17,
2002 by the Japanese Ministry of Health, Labor, and Welfare (MHLW).
MedImmune also announced that Synagis was recently awarded the prestigious 2001
German Prix Galien for outstanding pharmaceutical product. The Prix Galien is
the highest accolade for research and development in the Biomedical Industry in
"The approval of Synagis in Japan and its receipt of the German Prix Galien
represent significant advances in the international acceptance for the product,"
commented Armando Anido, senior vice president of sales and marketing for
MedImmune. "We are particularly pleased with the relative speed with which Japan
approved Synagis, and are honored by the recognition bestowed upon Synagis by
Germany, identifying it as an important advance in the protection of children at
risk of serious respiratory infections."
The New Drug Submission (NDS) for Synagis was submitted to the Japanese Ministry
of Health, Labor and Welfare on December 26, 2000 by Abbott International,
MedImmune's international distribution partner for the product. Abbott is now
seeking the appropriate reimbursement and pricing approvals for Synagis in
Japan, following which, they will begin marketing the product.
Synagis was approved on August 13, 1999 by the European Medicines Evaluation
Agency (EMEA) and has been available in Germany since September 1999. It remains
the only product available for prevention of lower respiratory tract disease
caused by RSV; there is no immunization against the virus, and previously no
convenient prophylaxis was available.
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 two-thirds 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 or with chronic lung disease are at highest risk of severe disease
and hospitalization due to RSV.
Synagis is a humanized monoclonal antibody approved and available for the
prevention of serious lower respiratory tract disease caused by respiratory
syncytial virus in pediatric patients at high risk of RSV disease (see full
prescribing information at http://www.medimmune.com/products/synagis/index.asp).
It is administered by intramuscular injection at 15 mg/kg and is given once per
month during anticipated periods of increased RSV prevalence in a given
community. In the Northern Hemisphere, the RSV season typically commences in
September and lasts through April or May.
MedImmune is a leading biotechnology company focused on researching, developing
and commercializing products to prevent or treat infectious diseases, autoimmune
diseases and cancers. MedImmune currently markets three products, Synagis(R)
(palivizumab), Ethyol(R) (amifostine) and CytoGam(R) (cytomegalovirus immune
globulin intravenous (human)), and has 12 products in clinical testing.
MedImmune employs over 1,400 people, is headquartered in Gaithersburg, Maryland,
and has additional operations in Frederick, Maryland, Pennsylvania, California,
The United Kingdom and the Netherlands. For more information on MedImmune, 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 the
company'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.
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SOURCE MedImmune, Inc.
CONTACT: Lori Weiman, Senior Director, Corporate Communications,
+1-301-527-4321, or William Roberts, Manager, Investor Relations,
+1-301-527-4358, both of MedImmune, Inc.
Copyright (C) 2002 PR Newswire. All rights reserved.