- MedImmune Has Co-Promotion Rights for Numax
in Seven Ex-U.S. Markets -
GAITHERSBURG, Md., Feb. 28 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that it has amended its ex-U.S. distribution
agreement with Abbott for monoclonal antibodies (MAb) against respiratory
syncytial virus (RSV). Under the amended agreement, Abbott will distribute
and market Numax(TM), MedImmune's investigational second-generation anti-RSV
MAb currently in Phase 3 development, upon approval outside of the United
States. Additionally, Abbott will continue to distribute and market
Synagis(R) (palivizumab), MedImmune's first-generation anti-RSV MAb. As a
part of the amendment, MedImmune has the option to co-promote Numax with
Abbott in up to seven countries outside of the United States. As previously
stated, MedImmune intends to market and sell Numax on its own in the United
"Abbott has been our exclusive distributor of Synagis outside of the U.S.
and, since its launch in 1999, the product has experienced significant
growth," said David M. Mott, chief executive officer and president of
MedImmune. "Expanding our relationship with Abbott to include Numax enables
us to build on the success they are already having with Synagis. This new
agreement provides MedImmune with a larger portion of the economics from our
RSV franchise outside of the U.S., and longer term, provides us with the
opportunity to participate directly in the commercialization of Numax outside
the United States."
"We're pleased to build on the success we've realized with Synagis and
this agreement expands and extends Abbott's RSV franchise outside of the
U.S.," said Holger Liepmann, senior vice president, International Operations,
Abbott. "Furthermore, this agreement demonstrates Abbott's continued long-
term commitment to bringing advanced RSV prevention options to physicians and
Numax is a humanized MAb 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, the current standard of
care for reducing RSV hospitalizations in this population. The Numax
comparative Phase 3 trial is designed to assess if the increased potency seen
in preclinical studies can be translated into better efficacy against lower
respiratory tract illness in high-risk children and to assess the effect of
Numax on upper respiratory tract disease, such as otitis media.
Additional Synagis Information
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 a simple 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. For full prescribing information for Synagis, see the company's
website at http://www.medimmune.com.
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 of severe disease and hospitalization due to RSV.
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. Such
statements reflect management's current views and are based on certain
assumptions. In particular, in addition to risks related to product
development, regulatory approval, manufacturing and commercialization
discussed in MedImmune's filings with the U.S. Securities and Exchange
Commission, the success of Numax outside of the U.S. is likely to be dependent
in large part to commercialization efforts that are not within MedImmune's
direct control. There can be no assurance that such development efforts will
succeed, that Numax will receive required regulatory clearance or that, even
if such regulatory clearance is received, there will be any significant market
for Numax or that Numax will ultimately achieve commercial success.
SOURCE MedImmune, Inc.
CONTACT: Media: Jamie Lacey +1-301-398-4035 or Clarencia Stephen
+1-301-398-4073 Investors: Peter Vozzo +1-301-398-4358 or John Filler
+1-301-398-4086 all of MedImmune, Inc.