(October 19, 2007)
REGPARA® TABLETS, a novel medicine (calcium receptor agonist) for secondary hyperparathyroidism, receives manufacturing and marketing approval
TOKYO, JAPAN [October 19, 2007] On October 19, 2007, Kirin Pharma Company, Limited (hereinafter, "Kirin Pharma"; headquarters: Shibuya-ku, Tokyo; President and Chairman of the Board of Directors, Katsuhiko Asano) obtained manufacturing and marketing approval for REGPARA® TABLETS (generic name: cinacalcet hydrochloride), a medicine for secondary hyperparathyroidism.
REGPARA® TABLETS are a novel medicine for secondary hyperparathyroidism that are characterized by their direct action on calcium receptors. In Japan, we began a clinical trial on domestic hemodialysis patients in 2000 and applied for manufacturing and marketing approval in 2006 with "secondary hyperparathyroidism during maintenance dialysis" as the indication. Overseas, Amgen Inc. of the United States has obtained approval for this product in over 30 countries, including the United States, EU, and Australia.
Secondary hyperparathyroidism is a common complication among dialysis patients that occurs with progression of chronic renal failure, and involves excessive production and secretion of parathyroid hormone (PTH) from the parathyroid gland. PTH, which promotes calcium efflux from bone, causes symptoms including bone and joint pain when secreted in excessive amounts. In addition, it increases the risk of ectopic calcification (*),which is associated with a higher incidence of cardiovascular events.
(*)Ectopic calcification:
A condition in which calcification occurs in blood vessels and other soft tissue in addition to bones due to excess calcium and phosphorus in the blood.
By acting directly on calcium receptors in the parathyroid gland, REGPARA® TABLETS suppress PTH secretion without elevating serum calcium levels, and also exert lowering effects on serum calcium and phosphorus levels. Thus, this innovative drug is thought to contribute not only to alleviation of bone and joint pain, but also prevention of the development and progression of cardiovascular disorders caused by ectopic calcification.
We launched a rHuEPO preparation ESPO® INJECTION for the treatment of renal anemia in 1990, followed by Rocaltrol® INJECTION for the treatment of secondary hyperparathyroidism, PHOSBLOCK® TABLETS for the treatment of hyperphosphatemia, in addition to the launch in July this year of the new anemia treatment drug NESP® INJECTION. By adding REGPARA® TABLETS to this broad lineup of products for dialysis patients with renal disorders, Kirin Pharma hopes to further contribute to advancements in treatment for dialysis patients.
Kirin Pharma, which was launched on July 1st of this year as the pharmaceutical business of the Kirin Group, is focused on the three core disease fields of chronic kidney disease, cancer (including hematologic cancer), and immunology/infectious disease. Kirin Pharma will remain committed to the development of novel and innovative live-saving products for the improvement of human health worldwide.
Kirin Group will always continue to create various close "bonds" with customers and to offer the joys of "food and health".
