Microsoft Word - PressRelease：Amgen Submits Application of ETELCALCETIDE (AMG 416／ONO-5163) for the treatment of secondary hy


August 26, 2015
ONO PHARMACEUTICAL CO., LTD. Corporate Communications
Public_relations@ono.co.jp
AMGEN SUBMITS APPLICATION IN THE US FOR ETELCALCETIDE (AMG 416) FOR THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM
Amgen (NASDAQ:AMGN) announced on August 25 (PT) the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etelcalcetide (formerly AMG 416) (ONO-5163) to seek approval for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease receiving hemodialysis.
For your further information, visit the link below to the website for press release distributed by Amgen.
http://www.amgen.com/media/media_pr_detail.jsp?releaseID=2081807
In Japan, ONO PHARMACEUTICAL CO.,LTD.("ONO") is currently conducting a clinical study of secondary hyperparathyroidism in patients with chronic kidney disease receiving hemodialysis in accordance with the license agreement* concluded with Amgen, formerly KAI Pharmaceuticals in September 2011.
* In Japan, ONO has exclusive rights to develop and commercialize the agonist of calcium sensing receptor etelcalcetide (formerly AMG 416) (ONO-5163), which Amgen is currently developing.

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