MedImmune Strengthens Inflammatory Disease Pipeline Through Collaboration With BioWa

2006-12-19 12:52 1078

- 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


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 .

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 .

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


POTELLIGENT(TM) is the trademark of Kyowa Hakko Kogyo Co., Ltd. All

rights are reserved.

Source: BioWa, Inc.