News Release

LUMICEF® approved in Japan

July 4, 2016

Tokyo, Japan, July 4th, 2016 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that LUMICEF® Subcutaneous Injection 210 mg Syringe (code name: KHK4827, generic name: Brodalumab (Genetical Recombination), hereafter LUMICEF®) has been approved in Japan, the first approval of the product worldwide. LUMICEF® has received the manufacturing and marketing approval for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma from the Ministry of Health, Labour and Welfare (MHLW).

LUMICEF® is a novel fully human anti-interleukin-17 (IL-17) receptor A antibody that inhibits biological activity of IL-17A, IL-17F and other IL-17s.

"We are very pleased to announce the approval of LUMICEF® in Japan" said Yoichi Sato, Director of the Board, Managing Executive Officer, Vice President, Head of Research and Development Division of Kyowa Hakko Kirin. "We believe that LUMICEF® will provide a new therapeutic option for the treatment of psoriasis and will greatly contribute to better improvement of treatment satisfaction and improved QOL (quality of life) of patients with psoriasis".

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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Product information
Product Name LUMICEF® Subcutaneous Injection 210 mg Syringe
Generic Name Brodalumab (Genetical Recombination)
Indications The following diseases that respond inadequately to existing therapies; Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma.
Dosage and administration In adults, administer 210 mg subcutaneously as brodalumab(Genetical Recombination) at Weeks 0, 1, and 2, followed by 210 mg every 2 weeks.
Package LUMICEF® Subcutaneous Injection 210 mg / 1 Syringe
Date of approval July 4th, 2016
About Psoriasis

Psoriasis is a chronic skin disorder. Typical symptoms include systemic erythema with clearly demarcated lesions, induration and hyperplasia inducing silver white plaques on the skin. Itching, inflammatory arthritis and abnormal nail morphology may also manifest.

About IL-17 receptor A

Interleukin-17 receptor A is a component of the receptor for IL-17A, IL-17A/F, IL-17F and IL-17C. These pro-inflammatory cytokines are thought to contribute to the pathophysiology associated with psoriasis.

About IL-17

IL-17A, IL-17F and other IL-17s are pro-inflammatory cytokines thought to be involved in autoimmune diseases including psoriasis.

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