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July 23, 2015

Kyowa Hakko Kirin Announces Results of the Phase 3 Studies of KHK4827 in Subjects with Psoriasis in Japan

Tokyo, July 23rd, 2015 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced today that KHK4827 (Generic name: brodalumab* ) achieved the primary long-term efficacy and safety endpoint in phase 3 studies to treat subjects with psoriasis* in Japan. Plaque psoriasis and psoriatic arthritis patients were involved in the long-term extension phase 3 study, and pustular psoriasis and psoriatic erythroderma patients were involved in separately conducted phase 3 study.

KHK4827 is a fully human anti-interleukin-17* receptor antibody. IL-17 is assumed to be involved in autoimmune disease such as psoriasis. Blocking the functions of interleukin-17 may lead to slow the progression of symptoms or to be a therapeutic intervention for such diseases.

Overviews and results of the studies are following.
1. Long-term extension phase 3 study in patients with plaque psoriasis and psoriatic arthritis

Design of the study Open label, Long-term, Multicenter study
Number of the patients 145 patients
Efficacy results At week 52, Psoriasis Area and Severity Index* (PASI) had improved in 91.1% of patients treated with 140mg and 94.0% of patients treated with 210mg, confirming that long-term effects were maintained.
Safety results No clinically significant events were observed

2. Phase 3 study in patients with pustular psoriasis (generalized) and psoriatic erythroderma

Design of the study Open label, Long-term Multicenter study
Number of the patients 30 patients
Efficacy results Symptoms improved rapidly and the primary endpoint of Clinical Global Impression* was assessed at the last evaluation time point as remission in 63.3% of patients (19 of 30 patients), improved in 33.3% of patients (10 of 30 patients), and worsened in 3.3% of patients (1 of 30 patients), confirming that highly and long-term effects.
Safety results No clinically significant events were observed

These results were reported at 73rd Annual Meeting of American Academy of Dermatology (AAD) in March, 2015.

"These finding in the phase3 studies show important insights on efficacy and safety of brodalumab in psoriasis treatment." said Yoichi Sato, Managing Executive Officer, Vice President, Head of Research and Development Division of Kyowa Hakko Kirin. "We are keeping on striving to develop this IL-17 receptor inhibitor in Japan"

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 Brodalumab
In October, 2010, Kyowa Hakko Kirin licensed from Kirin-Amgen, Inc. exclusive rights to develop and commercialize brodalumab in Japan and certain other Asian countries.

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 skin. Itching, inflammatory arthritis and abnormality in nail morphology may also manifest.

About PASI
PASI is a tool to assess the severity of symptoms resulting from psoriasis by scores. The body is divided into 4 sections comprising the head, trunk, upper limbs, and lower limbs. For each section, severity of clinical signs (erythema, induration, desquamation plaque) and percentage of area of skin affected are scored.

About Interleukin-17
Interleukin-17 is a protein produced in the body, mostly in the activated T lymphocytes. Overexpression of interleukin-17 turns on the immune system to attack itself, though the system is originally supposed to work for host-defense by removing foreign pathogens.

About Clinical Global Impression
Four-point scale by Investigators (remission, improved, no change and worsened) based on the changes in PASI score and psoriatic findings.



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