Kyowa Kirin Announces Approval of New Transdermal Patch HARUROPI TAPE (HP-3000) for Parkinson's Disease in Japan

TOKYO, September 20, 2019 --- Kyowa Kirin Co., Ltd. (Tokyo Japan; President & CEO: Masashi Miyamoto, "Kyowa Kirin") today announced that Hisamitsu Pharmaceutical Co., Inc. (Tosu city, Saga, Japan; Chairman and CEO: Hirotaka Nakatomi, "Hisamitsu Pharmaceutical") has received an approval for manufacturing and marketing HARUROPI® TAPE for the treatment of Parkinson's disease from Japan's Ministry of Health, Labour and Welfare (MHLW).

HARUROPI® TAPE 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.

Under the terms of the agreement signed with Hisamitsu Pharmaceutical in February 2019, Kyowa Kirin is responsible for commercializing HARUROPI® TAPE in Japan. Hisamitsu Pharmaceutical and Kyowa Kirin will contribute to a higher quality of life of patients with Parkinson's disease by providing proper medical information of the product. In addition, Kyowa Kirin will make milestone payments to Hisamitsu Pharmaceutical based on this approval.

The Kyowa 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.

Summary of the HARUROPI® TAPE
Product Name HARUROPI® TAPE 8mg
HARUROPI® TAPE 16mg
HARUROPI® TAPE 24mg
HARUROPI® TAPE 32mg
HARUROPI® TAPE 40mg
Generic Name Ropinirole hydrochloride
Indication Parkinson's disease
Dosage and Administration Usually, for adults initially apply 8mg formulation as Ropinirole hydrochloride once daily, observing the progress, increased as needed the daily dose by 8 mg at intervals of 1 week or more. For any dose, apply once daily to the skin of the chest, abdomen, flank, thigh or upper arm and replace every 24 hours. Further, the dosage can be adjusted according to the age and the symptoms, the daily dosage should not exceed 64mg as Ropinirole hydrochloride.
Size of the Formulation 5.33cm² (HARUROPI® TAPE 8mg)
10.67cm² (HARUROPI® TAPE 16mg)
16.00cm² (HARUROPI® TAPE 24mg)
21.33cm² (HARUROPI® TAPE 32mg)
26.67cm² (HARUROPI® TAPE 40mg)

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