- Initial Focus on Monoclonal Antibody Targeting IL-5 Receptor in
Phase 1 Trials with Asthma Patients -
GAITHERSBURG, Md., and PRINCETON, N.J., Dec. 19 /PRNewswire-FirstCall/ --
MedImmune, Inc. (Nasdaq: MEDI) and BioWa, Inc. announced today that they have
entered into a licensing and collaboration agreement to develop and
commercialize new inflammatory disease therapies targeting the interleukin-5
(IL-5) receptor. Initially, the companies will focus on developing BIW-8405, a
monoclonal antibody (MAb) currently in Phase 1 clinical studies in patients
with asthma.
BIW-8405 has been developed utilizing BioWa's POTELLIGENT(TM) technology
platform for the development of antibody-dependent cellular cytotoxicity
(ADCC) enhanced antibodies. The molecule aims to directly deplete eosinophils,
a class of white blood cells implicated in the pathology of asthma and other
inflammatory diseases. Additionally, BIW-8405 has the potential to neutralize
the activity of IL-5, which is believed to play a key role in the growth and
development of eosinophils.
"The IL-5 receptor program is an excellent strategic fit for MedImmune as
we continue to expand our research and development pipeline with promising
targets that are consistent with our areas of therapeutic focus and scientific
expertise," said Barbara White, M.D., MedImmune's senior director, clinical
development, inflammatory disease. "We are excited to have three therapies
targeting inflammatory diseases in clinical trials, in addition to our robust
preclinical portfolio, and we will continue to advance or adopt programs and
technologies that may address unmet medical needs in this area."
According to the terms of the agreement, BioWa will receive an undisclosed
upfront payment, milestone payments and royalties on any future marketed
products. BioWa will have exclusive marketing rights in Japan and certain
countries in Asia for potential products developed as a result of the
agreement. MedImmune will have exclusive marketing rights to these products
for the United States, Europe and all other countries.
"Outlicensing the development and commercialization rights to the anti IL-
5 receptor antibody is a hallmark for BioWa, reinforcing our corporate mission
to discover and develop high value proprietary ADCC enhanced therapeutic
products through the use of POTELLIGENT(TM), our core technology," said Dr.
Nobuo Hanai, president and CEO of BioWa. "We are pleased to build upon our
partnership with MedImmune, a leader in antibody development and
optimization."
About the IL-5 Receptor and BIW-8405IL-5 is a cytokine involved in the
growth and development of eosinophils. Because IL-5 function and expression of
its receptor are largely limited to eosinophils in humans, targeting IL-5 and
its receptor may provide a selective approach to eosinophil depletion.
BIW-8405 is a humanized MAb targeting the IL-5 receptor. In preclinical
studies, BIW-8405 has been shown to neutralize IL-5 activity and to deplete
eosinophils. Preclinical research also suggests that depletion of eosinophils
by inhibiting IL-5 may result in reduced airway inflammation, airway hyper-
responsiveness (AHR) and mucous secretion.
About Asthma
Asthma is a chronic disease of the airways that may cause wheezing,
breathlessness, chest tightness and coughing. According to the U.S. Centers
for Disease Control and Prevention (CDC), more than 20 million Americans
reported having asthma in 2001, including more than six million children. In
2000, the CDC reported that there were more than 10 million asthma-related
outpatient visits to private physician offices and hospital clinics (nearly 5
million of these involved children under 18). The National Institutes of
Health (NIH) have estimated asthma-related healthcare costs in the U.S. at $14
billion annually.
About POTELLIGENT(TM) Technology
ADCC activity is an important function of the human immune system, whereby
immune cells can kill target cells, e.g. cancer cells. Several anti-cancer
therapeutic antibodies that are on the market today have ADCC activity as one
of their mechanisms for the killing of tumor cells. Enhancement of this
activity is one promising approach in the next generation of antibody
technologies.
POTELLIGENT(TM) technology involves the reduction of the amount of fucose
in the carbohydrate structure of an antibody using a proprietary
fucosyltransferase-knockout CHO cell line as a production cell. Research shows
that POTELLIGENT(TM) technology significantly enhances ADCC activity of an
antibody in vitro, thereby increasing the potential for improved activity in
vivo.
About BioWa, Inc.
BioWa is a wholly owned subsidiary of Kyowa Hakko Kogyo Co., Ltd., Japan's
leading pharmaceutical and largest biotech company, and is the exclusive
worldwide licensor of POTELLIGENT(TM) technology, which creates high ADCC
monoclonal antibodies. Currently, BioWa is developing ADCC enhanced monoclonal
antibody-based therapeutics to fight cancer and other life-threatening and
debilitating diseases and both BioWa and Kyowa have POTELLIGENT(TM) antibody
products in various clinical stages. BioWa creates and develops enhanced ADCC
antibodies for itself and others, offering a full range of antibody discovery
and development capabilities. For more information about BioWa, visit its web
site at http://www.biowa.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 infectious diseases,
cancer and inflammatory diseases. With more than 2,500 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" regarding the development of product candidates
by MedImmune, Inc. and BioWa, Inc. Such forward-looking statements are based
on current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change current expectations and
could cause actual outcomes and results to differ materially from current
expectations. In addition to risks and uncertainties disclosed in MedImmune's
filings with the U.S. Securities and Exchange Commission, MedImmune can
provide no assurance that these products will be commercially successful. In
addition, no assurance exists that development efforts for these products will
succeed, that these products will receive required regulatory approval or
that, even if regulatory approval is received, they will be commercially
successful. MedImmune undertakes no obligation to update any forward-looking
statement, whether as a result of new information, future events or otherwise
except as may be required by applicable law or regulation.
POTELLIGENT(TM) is the trademark of Kyowa Hakko Kogyo Co., Ltd. All rights
are reserved.
SOURCE MedImmune, Inc.
CONTACT: Kate Barrett, +1-301-398-4320, or Investors: Beatrice Pierre,
+1-301-398-4905, both of MedImmune, Inc.; or Nobuo Hanai, Ph.D.,
+1-609-580-7500, x 7501, or Investors: Martina Molsbergen,
+1-609-580-7500, x 7506, both of BioWa, Inc.