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


September 7, 2015
ONO PHARMACEUTICAL CO., LTD. Corporate Communications
Public_relations@ono.co.jp
AMGEN SUBMITS MARKETING AUTHORIZATION APPLICATION
FOR NOVEL INTRAVENOUS CALCIMIMETIC ETELCALCETIDE (AMG 416) TO THE EUROPEAN MEDICINES AGENCY
Amgen (NASDAQ:AMGN) announced on September 2 (PT) the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized procedure 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=2084722
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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