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January 25, 2016

Kyowa Hakko Kirin Entered an Agreement with Sandoz for Exclusive Marketing Rights of Rituximab biosimilar in Japan

Tokyo, Japan, January 25, 2016 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo 4151; President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced that it entered into an agreement with Sandoz KK (Tokyo; President: Tomohiro Hasegawa, "Sandoz KK"), a Novartis company, for exclusive marketing rights to Sandoz' biosimilar Rituximab in Japan.

Rituximab is a chimeric monoclonal antibody against CD20 for treatment of hematological malignancies. Sandoz is developing a biosimilar Rituximab globally which is mainly targeted for the treatment of patients with CD20-positive, indolent B-cell Non-Hodgkin's Lymphoma in Japan.
Under the terms of the agreement, Kyowa Hakko Kirin will pay Sandoz an up-front fee, subsequent payments for regulatory filing, regulatory approval, and success based milestones as well as royalties. Sandoz will file for marketing authorization of the product. Kyowa Hakko Kirin will be responsible for all sales, marketing and promotion activities in Japan.

"Since Biosimilar market is expected to expand more than ever in Japan, Biosimilars are becoming important for pharmaceutical business." Said Masashi Miyamoto, Ph.D., Executive Officer, Director, Strategic Product Portfolio Department of Kyowa Hakko Kirin. "We are pleased to enter into this agreement with Sandoz who is the pioneer in the biosimilar market."

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.



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