Company Reinforces Commitment to Fighting Pediatric Infectious Diseases
GAITHERSBURG, Md., Aug 29, 2005 /PRNewswire-FirstCall via COMTEX/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that it has licensed worldwide rights from
GlaxoSmithKline (NYSE: GSK) to develop certain anti-staphylococcal monoclonal
antibodies (MAbs). The program includes BSYX-A110, which is in Phase 2
clinical development for the prevention of serious bloodstream infections
caused by Staphylococcus in low-birthweight infants. MedImmune will be
responsible for future research and development of BSYX-A110 and any resulting
second-generation MAbs as well as all future sales and marketing activities
Under the terms of the agreement, MedImmune will pay GSK an upfront
payment upon signing as well as potential milestone payments and royalties on
future marketed products. MedImmune has also assumed responsibility for
future milestone and royalty payment obligations to Biosynexus, from which GSK
originally licensed the BSYX-A110 antibody and related rights in 2002.
Biosynexus may continue to provide scientific input regarding future R&D
activities for the program.
"Adding BSYX-A110 into the pipeline provides an opportunity for us to
leverage MedImmune's clinical, regulatory and commercial experience in the
development of monoclonal antibodies in pediatrics," said Edward M. Connor,
M.D., executive vice president and chief medical officer. "BSYX-A110 is
targeted against Staphylococcus, including coagulase negative Staphylococcus
(CONS), which is a leading cause of bloodstream infections among infants in
the neonatal intensive care unit (NICU). If we succeed in bringing this
antibody to market, we may be able to provide pediatricians with a new tool
for protecting the health of these infants."
According to the United States Census Bureau, approximately 43,000 infants
weighing less than 1,250 grams at birth were born in 2001. These low-
birthweight infants are particularly susceptible to hospital-acquired
infections, such as those caused by Staphylococcus. Among infants in the
NICU, hospital-acquired infection rates range from six to 25 percent. Reports
in medical literature suggest that CONS increases an infant's hospital stay by
20 to 40 days at an additional cost of $60,000 to $200,000.
BSYX-A110 is a monoclonal antibody in development for the prevention of
staphylococcal infections in premature infants. BSYX-A110 binds to
staphylococci and promotes ingestion and destruction of the bacteria. Data
acquired from Phase 1 and 2 clinical studies conducted to date with BSYX-A110
suggest that the antibody is well-tolerated in adults and infants. Data are
currently being analyzed from a Phase 2 double-blind, placebo-controlled
safety/pharmacokinetic study in infants and an epidemiological study of the
incidence of bloodstream infections in premature infants.
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 BSYX-A110 and future
related products. Such statements reflect the current views of MedImmune
management 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 the products will receive
required regulatory clearance or, even if such regulatory clearance is
received, that the subsequent products will ultimately achieve commercial
SOURCE MedImmune, Inc.
Jamie Lacey, +1-301-398-4035
Peter Vozzo, +1-301-398-4358 or
John Filler, +1-301-398-4086
all of MedImmune, Inc.