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news.NPS Pharmaceuticals has received approval for cinacalcet hydrochloride from the Japanese Pharmaceuticals and Medical Devices Agency for the treatment of secondary hyperparathyroidism.
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As a result, NPS will receive a milestone payment plus royalties from Kirin Pharma, a wholly-owned subsidiary of Kirin Holdings, which will market the drug in Japan. Kirin has licensed cinacalcet from NPS for the development and commercial sale in Japan, China, North and South Korea and Taiwan.
Cinacalcet is an oral medication for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. It regulates the over-secretion of parathyroid hormone (PTH) in patients with chronic kidney insufficiency by acting directly on the parathyroid gland calcium-sensing receptor.
Elevated levels of PTH, the hallmark of secondary hyperparathyroidism, are associated with altered metabolism of calcium and phosphorus, bone pain, fractures, and an increased risk for cardiovascular death. The drug is currently marketed in the US and Europe by Amgen as a treatment for this condition and for the treatment of elevated levels of calcium in patients with parathyroid carcinoma.