TOKYO, JAPAN [April 19, 2007] − Kirin Brewery Company, Limited (President and CEO: Kazuyasu Kato) was granted manufacturing and marketing approval for Long-acting Erythropoiesis Stimulating Agent, Darbepoetin alfa (brand name NESP® INJECTION SYRINGE, hereafter NESP®) on April 18, 2007.
NESP® is manufactured by partially modifying the amino acid sequence of human erythropoietin (EPO) and attaching new sugar chains. The addition of the sugar chains endows this recombinant protein with a longer serum half-life and sustained erythropoietic activity as compared with conventional recombinant human EPO (rHuEPO) preparations. As a result, NESP® has the advantage of less frequent administration as compared with conventional rHuEPO preparations, and excellent efficacy in the treatment of anemia.
NESP® was developed through a collaborative research effort by Kirin and Amgen Inc. (USA) that was initiated in 1996. The drug was first introduced under the brand name Aranesp® in the United States and Australia in May of 2001, and it is currently marketed in more than 40 countries worldwide, including Europe, Canada, Taiwan and Korea. In Japan, clinical studies of NESP® were initiated in 2000 in hemodialysis patients, and an application for approval was filed in 2005 for the treatment of renal anemia in patients receiving dialysis.
Today, more than 250,000 patients are undergoing dialysis treatment in Japan, and that number continues to rise. Renal anemia is the main complication in these patients, and about 80% are treated with rHuEPO preparations.1) Kirin began marketing a rHuEPO preparation（brand name ESPO® INJECTION） for the treatment of renal anemia in 1990, which has contributed greatly to the care of dialysis patients with renal anemia. Now, the launch of NESP® is expected not only to contribute to the treatment of dialysis patients but also to provide various additional benefits such as reducing the burden on the health care provider by virtue of its reduced frequency of administration.
Additional clinical studies are being carried out on NESP® for the treatment of anemia in patients with chronic kidney disease who are not on dialysis, and for chemotherapy induced anemia in cancer patients.
Kirin has established a diverse product pipeline in the field of chronic kidney disease through the introduction of rHuEPO preparations (ESPO® INJECTION), Rocaltrol® INJECTION, for the treatment of secondary hyperparathyroidism and PHOSBLOCK® TABLETS for the treatment of hyperphosphatemia. The approval of NESP® enables Kirin to add a new product to its renal disease pipeline, and to strengthen the activity of medical representatives.
Kirin's pharmaceutical business is focused on the three core disease fields: Chronic kidney disease, cancer (includinghematologic cancers) and immunology/infectious disease. Kirin is committed to the development of novel and innovative live-saving products for the improvement of human health worldwide.
1) Explanatory tables: An overview of regular dialysis treatment in Japan as of Dec. 31, 2005. The Japanese Society for Dialysis Therapy: 2006. http://www.jsdt.or.jp/overview/index.html
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