Hisamitsu Pharmaceutical and Kyowa Hakko Kirin sign Commercialization Agreement for HP-3000, a Potential New Transdermal Patch for Parkinson's Disease in Japan

TOKYO, February 5, 2019 - Hisamitsu Pharmaceutical Co., Inc. (Tosu city, Saga, Japan; Chairman and CEO: Hirotaka Nakatomi, hereinafter referred to as "Hisamitsu Pharmaceutical") and Kyowa Hakko Kirin Co., Ltd. (Tokyo Japan; President & COO: Masashi Miyamoto, hereinafter referred to as "Kyowa Hakko Kirin") today announced that they have entered an agreement granting Kyowa Hakko Kirin exclusive rights to commercialize HP-3000 (code name, generic name: ropinirole hydrochloride, hereinafter referred to as "the product").

Under the terms of the agreement, Kyowa Hakko Kirin will be responsible for commercializing the product after Hisamitsu Pharmaceutical receives a manufacturing and marketing approval for the product in Japan. Hisamitsu Pharmaceutical will receive an upfront payment and milestone payments based on the regulatory approval and the sales amount.

The product is a systemic transdermal Parkinson's disease treatment patch developed by Hisamitsu Pharmaceutical's TDDS (Transdermal Drug Delivery System) technologies. Hisamitsu Pharmaceutical expects its long-lasting effect by means of maintaining a stable blood concentration, and the product to be a new option for treating Parkinson's disease.

Hisamitsu Pharmaceutical presented a positive result that the product achieved a primary endpoint in a Phase III clinical study in patients with Parkinson's disease who concomitantly use L-dopa (levodopa) in February, 2018.

Hisamitsu Pharmaceutical submitted a new drug application for the product in September 2018and the product is expected to be approved by February, 2020.

Hisamitsu Pharmaceutical has a competitive edge in TDDS (Transdermal Drug Delivery Systems) technology platform and makes efforts to develop locally and systemically-acting transdermal patches for various fields for improving peoples' QOL around the world. For more information, please visit the following URL:

Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, the company is working to realize its vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and wellbeing of people around the world.

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