Kyowa Hakko and Amgen Enter Licensing Agreement for Anti-CCR4 Humanized Monoclonal Antibody
- KW-0761 Studies Underway in Inflammation and Oncology
-
TOKYO, March 6, 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® technology platform for the development of antibody-dependent cell-mediated cytotoxicity- (ADCC) enhanced antibodies.
About POTELLIGENT® 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® technology involves the reduction of the
amount of fucose in the carbohydrate structure of an antibody.
Research shows that POTELLIGENT® technology significantly
enhances the ADCC activity of antibodies in vitro, thereby
increasing the potential for improved activity in vivo.
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