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.