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December 18, 2014

Approval for Additional Indication of NESP® for Anemia with Myelodysplastic Syndromes in Japan

Tokyo, Japan, December 18, 2014 --- Kyowa Hakko Kirin Co, Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced that NESP® Injection Plastic Syringe (NESP®), a long-acting erythropoiesis stimulating agent, has been approved in Japan for an additional indication of anemia with myelodysplastic syndromes*1.

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 chronic kidney disease patients on/not on dialysis and is widely used in various medical institutions.
Overseas guidelines for the treatment of myelodysplastic syndromes recommend the administration of darbepoetin alfa as the primary therapeutic agent for the treatment of anemia mainly in patients who have low serum erythropoietin level and are in the low risk or intermediate-1 risk categories under the International Prognostic Scoring System*2. However, darbepoetin alfa was not previously approved in major industrialized nations for the indication of anemia with myelodysplastic syndromes*3.
In Japan, medical societies and patient groups had submitted petitions calling for the rapid approval of NESP® to treat anemia with myelodysplastic syndromes. The application was submitted in March 2014, based on clinical studies performed in Japan and South Korea and other clinical studies performed overseas. Approval has now been granted for the indication of anemia with myelodysplastic syndromes.
Now that NESP® can be used to treat anemia in patients with myelodysplastic syndromes, we expect various therapeutic benefits for patients, such as an improved safety profile due to reduced/no red blood cell transfusions.

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.

Myelodysplastic syndromes are a group of diseases in which abnormalities occur in pluripotent hematopoietic stem cells in the bone marrow, and which can progress to cytopenia or acute myeloid leukemia. It is reported that there are approximately 11000 patients in Japan with myelodysplastic syndromes, the main clinical symptoms of which are cytopenia related anemia, infection and bleeding.
The International Prognostic Scoring System is a classification system for predicting prognosis. It is considered that three factors are strongly related to the prognosis for myelodysplastic syndromes patients: (1) Percentage of immature blood cells (blasts) in the bone marrow; (2) Types of cytopenia in the peripheral blood; and (3) Types and degree of chromosomal abnormalities. By the scoring of these factors, patients are classified into one of four categories of low risk, intermediate-1 risk, intermediate-2 risk or high risk.
In a few countries including US and France, Treatment with darbepoetin alfa for anemia with myelodysplastic syndromes is approved under health insurance systems because of evidence obtained from some clinical studies.


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