Kyowa Hakko and Amgen Enter Licensing Agreement for Anti-CCR4 Humanized Monoclonal Antibody
KW-0761 Studies Underway in Inflammation and Oncology
THOUSAND OAKS, Calif. & TOKYO -- March 5, 2008 -- Kyowa Hakko Kogyo Co., Ltd (Kyowa Hakko) (TSE: 4151) and Amgen (NASDAQ: AMGN) today announced an agreement under which Amgen will receive an exclusive license to develop and commercialize Kyowa Hakko's humanized monoclonal antibody KW-0761 worldwide, except in Japan, Korea, China and Taiwan. Kyowa Hakko will retain the development and commercialization rights in these countries.
Under the terms of the deal, Amgen will make an upfront payment to Kyowa Hakko of $100 million. Kyowa Hakko could receive up to $420 million in additional payments, including development, approval and sales milestones. Kyowa Hakko will also be entitled to receive double digit royalties on sales.
KW-0761 is currently being studied in inflammation and oncology settings. Kyowa Hakko has completed Phase 1 studies of KW-0761 in healthy volunteers and allergic rhinitis patients, and is currently conducting Phase 1 studies of KW-0761 in lymphoma patients.
Amgen will initially acquire rights in all non-oncology indications, and Kyowa Hakko will continue its development activities in oncology until the completion of Phase 2a. At that time, Amgen may elect to reimburse Kyowa Hakko for its oncology-related development costs, expand its license to include oncology and assume the development and commercialization of KW-0761 in oncology settings.
The agreement is subject to approval from the Federal Trade Commission and will be effective immediately upon such approval.
Financial guidance previously provided on Jan. 24, 2008 by Amgen for 2008 adjusted earnings per share will remain unchanged by this transaction.
About CCR4 and KW-0761
CCR4 is a chemokine receptor that binds specifically to its ligands TARC and MDC, and participates in the control of T cell migration. CCR4 is expressed mainly on Th2-type helper T cells and regulatory T cells in normal conditions. CCR4+ T cells are implicated in the pathology of asthma and other inflammatory diseases and T-cell malignancies.
KW-0761 is a humanized monoclonal antibody targeting CCR4 utilizing the POTELLIGENT(R) technology platform for the development of antibody-dependent cell-mediated cytotoxicity- (ADCC) enhanced antibodies.
About POTELLIGENT(R) Technology
ADCC activity is an important immune mechanism that permits immune cells to kill targets, e.g. cancer cells. Enhancement of this activity is one promising approach in the next generation of antibody technologies.
The POTELLIGENT(R) technology involves the reduction of the amount of fucose in the carbohydrate structure of an antibody. Research shows that POTELLIGENT(R) technology significantly enhances the ADCC activity of antibodies in vitro, thereby increasing the potential for improved activity in vivo.
About Kyowa Hakko
Kyowa Hakko is a biotechnology-based company focused on two businesses: pharmaceutical operations engaged in the research and development, manufacturing, and marketing of prescription drugs; and bio-chemical operations that handle a variety of products such as amino acids, nucleic acids, and nutritional supplements/healthcare products. Its pharmaceutical business places emphasis on research and development in the fields of oncology, allergy, and the central nervous system. In Japan, Kyowa Hakko is marketing medications for a wide range of diseases, including allergy, hypertension, angina pectoris, and cancer. With the aim of penetrating the global market, Kyowa Hakko has overseas development bases in the U.S. (Kyowa Pharmaceutical, Inc. and BioWa, Inc) and in the U.K. (Kyowa Hakko U.K. Ltd.). In the U.S., the U.K., and China, they are pushing ahead with the clinical development of new drug candidates as well as the therapeutic antibody business based on Kyowa Hakko's proprietary technology (POTELLIGENT(R)) that enhances the activity of antibodies.
Last autumn, Kyowa Hakko announced that the Kyowa Hakko group and the Kirin group entered into an agreement to merge. Through this merger, the two groups will endeavor to build a global leader in the research and development-driven life sciences business based in Japan, which is centered on pharmaceutical operations with strengths in biotechnology. The new company "Kyowa Hakko Kirin Co., Ltd." will start operating on Oct. 1, 2008.
For more information on Kyowa Hakko, KW-0761 and POTELLIGENT(R) technology, visit http://www.kyowa.co.jp/eng/.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
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