News Release

Kyowa Hakko Kirin and BioWa File Suit in the U.S. to Defend Patent Rights on POTELLIGENT® Technology

October 19, 2016

Tokyo, Japan, October 19, and Princeton NJ, USA, October 18 2016 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") and BioWa Inc. (Princeton, NJ, USA, President and CEO: Takeshi Masuda, "BioWa"), a wholly owned subsidiary of Kyowa Hakko Kirin, announce that they have filed a patent infringement lawsuit against Aragen Bioscience, Inc. and Transposagen, Inc. in the United States District Court for the Northern District of California. In the suit, Kyowa Hakko Kirin and BioWa allege infringement of three patents—U.S. Patent Nos. 6,946,292, 7,425,446, and 8,067,232—related to their award-winning alpha-(1,6)- fucosyl transferase-knockout host cell lines and protein expression. Filed on October 17, 2016 (local time), the suit seeks an injunction, as well as reparation for damages resulting from the infringement.

"We have made a substantial investment, over the years, in our intellectual property rights, and our patents help to protect the many innovations and discoveries we had made," said Kenya Shitara, Ph.D., Executive Officer, Director of Legal and Intellectual Property Department of Kyowa Hakko Kirin. "While we support vigorous competition in the marketplace, that competition must be fair and respect intellectual property rights. Our breakthrough and patented POTELLIGENT ® Technology is of great importance to us and this industry, and, when necessary, we intend to vigorously enforce our patent rights."

"Over the years, we have shown our commitment to innovation by licensing our POTELLIGENT® Technology to partners to develop and bring superior therapeutic antibodies to market," said Takeshi Masuda, President and CEO of BioWa. "Protecting our intellectual property rights is important to us, and we look forward to the resolution of this matter by the Court."

BioWa develops partnerships with pharmaceutical companies and biotechs through the licensing of proprietary therapeutic antibody technologies POTELLIGENT® and COMPLEGENT® developed by Kyowa Hakko Kirin. BioWa is the exclusive worldwide licensor of these technologies.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

About POTELLIGENT® Technology

POTELLIGENT® Technology improves potency and efficacy of antibody therapeutics by enhancing antibody-dependent cellular cytotoxicity (ADCC), one of the major mechanisms of action for antibody therapeutics. POTELLIGENT® Technology involves the reduction of the amount of fucose in the carbohydrate structure of an antibody using a proprietary fucosyl transferase-knockout CHO cell line as a production cell. Research shows that POTELLIGENT® Technology dramatically enhances ADCC activity of an antibody in vitro, and significantly increases potency and efficacy of the antibody in vivo. A number of POTELLIGENT® antibodies are currently being investigated in human clinical trials. On May 29, 2012, Kyowa Hakko Kirin launched POTELIGEO®, (Mogamulizumab) a POTELLIGENT® Antibody for patients with relapsed or refractory CCR4-positive Adult T-cell Leukemia-Lymphoma ( window opens). This milestone event represents a critical validation point for the POTELLIGENT® Technology.

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