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September 13, 2013

Approval of Additional Indication of Long-Acting Erythropoiesis-Stimulating Agent NESP® for Pediatric Patients with renal anemia in Japan

Tokyo, Japan, September 13, 2013 -- Kyowa Hakko Kirin Co., Ltd. (President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that NESP® has been approved in Japan for an additional indication of renal anemia in pediatric patients.

NESP®, a long-acting erythropoiesis stimulating agent, was initially approved in July 2007. NESP® is highly recognized for its safety and efficacy for treating anemia of adult chronic kidney disease patients on / not on dialysis and is widely used in various medical institutions.
For the treatment of anemia in pediatric patients with chronic kidney disease not on dialysis or on peritoneal dialysis, ESPO® and other erythropoietin agents have been used. However, these agents are not indicated for pediatric patients on hemodialysis and require weekly or biweekly subcutaneous administration.
The approvals we received today for pediatric use make NESP® available not only for adults but also various pediatric patients suffering from renal anemia of chronic kidney disease. We expect NESP® to lessen the burden on pediatric patients with chronic kidney disease not on dialysis or on peritoneal dialysis, their families and healthcare staff through minimum number of hospital visits and injections. We also hope that pain caused by injection will be reduced now that the frequency of injection decreases by NESP® compared with erythropoietin.

Kyowa Hakko Kirin is focusing on kidney area, along with three other focused areas as our category-based strategy*. With variety kinds of products, Kyowa Hakko Kirin will contribute for kidney diseases.

* Category-based strategy: Each category (Nephrology; Oncology; Immunology and allergy; and Central Nervous System) will have its own portfolio management from R&D through to sales. We will achieve sustained growth while striving to improve productivity.


Kyowa Hakko Kirin
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