February 15, 2017

Launch of PARSABIV® Intravenous Injection for Dialysis (Generic Name: Etelcalcetide Hydrochloride), a Calcimimetic Agent, for Treatment of Secondary Hyperparathyroidism in Patients on Hemodialysis

Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director and CEO, Gyo Sagara; "ONO") announced today that it launched PARSABIV® Intravenous Injection for Dialysis 2.5 mg, 5 mg and 10 mg (generic name: etelcalcetide hydrochloride, "Parsabiv") for the treatment of secondary hyperparathyroidism in patients on hemodialysis on February 15, 2017.

Secondary hyperparathyroidism, one of complications of chronic renal failure, is a pathological condition where excessive parathyroid hormone (PTH) is secreted by the parathyroid gland. Excessive PTH secretion promotes phosphorus and calcium efflux from bone which may cause symptoms including bone and joint pain. Further, it is reported that vascular calcification due to accumulation of phosphorus and calcium from bone in vessels aggravates risk of cardiovascular events which adversely affects life prognosis.*

Parsabiv activates the calcium sensing receptor in the parathyroid and suppresses excessive PTH secretion, and also lowers phosphorus and serum calcium level. Parsabiv is an intravenous injection for dialysis patients to be administered through the dialysis circuit by the physician or medical staff upon completion of dialysis and such administration is expected to reduce the burden of oral medications in patients.

In Japan, ONO has exclusive rights to develop and commercialize Parsabiv, in accordance with the license agreement concluded in September 2011 with KAI Pharmaceuticals, Inc., now a wholly-owned subsidiary of Amgen. In Europe, Amgen received an approval for a Marketing Authorization Application (MAA) of Parsabiv from the European Commission (EC) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis on November 11, 2016. In the US, Amgen received an approval for a New Drug Application (NDA) of Parsabiv for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis from the Food and Drug Administration (FDA) on February 7, 2017.

* Japanese Clinical Practice Guideline for the management of chronic kidney disease-mineral and bone disorders (CKD-MBD) issued by the Japanese Society for Dialysis Therapy in 2012.

Overview of Parsabiv® Intravenous Injection for Dialysis

Product name

Parsabiv® Intravenous Injection for Dialysis 2.5 mg Parsabiv® Intravenous Injection for Dialysis 5 mg Parsabiv® Intravenous Injection for Dialysis 10 mg

Generic name

Etelcalcetide Hydrochloride

Indications

Secondary hyperparathyroidism in patients on hemodialysis

Dosage and Administration

In adults, Parsabiv is usually administered into venous line of the dialysis circuit at the end of dialysis session during rinse back at a dose of 5 mg as etelcalcetide 3 times a week as a starting dose.

Thereafter, the dose may be adjusted in a range from 2.5 mg to 15 mg as necessary and administered 3 times a week at the end of dialysis session during rinse back while parathyroid hormone (PTH) and serum calcium level

should be carefully monitored in patients.

Packaging

Parsabiv Intravenous Injection for Dialysis 2.5mg : 10 vial Parsabiv Intravenous Injection for Dialysis 5mg : 10 vial Parsabiv Intravenous Injection for Dialysis 10mg : 10 vial

Manufacturing and marketing approval date

December 19, 2016

Drug price listing date

February 15, 2017

Drug price

Parsabiv Intravenous Injection for Dialysis 2.5mg vial: ¥873 Parsabiv Intravenous Injection for Dialysis 5mg vial: ¥1,283 Parsabiv Intravenous Injection for Dialysis 10mg vial: ¥1,885

Launched date

February 15, 2017

Distributor

Ono Pharmaceutical Co., Ltd.

Conditions for approval

ONO should establish Risk Management Plan to be implemented appropriately.

Product photograph

ONO PHARMACEUTICAL CO., LTD.

Corporate Communications public_relations@ono.co.jp

ONO Pharmaceutical Co. Ltd. published this content on 15 February 2017 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 15 February 2017 01:03:07 UTC.

Original documenthttp://www.ono.co.jp/eng/news/pdf/sm_cn170215.pdf

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