- Initial Focus on Monoclonal Antibody Targeting IL-5 Receptor in Phase 1
Trials with Asthma Patients -
GAITHERSBURG, Md. and PRINCETON, N.J., Dec. 19 /Xinhua-PRNewswire/ --
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-8405
IL-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.