Asahi Kasei Pharma is announcing that Reclast® for intravenous (i.v.) infusion 5 mg (generic name: zoledronic acid, development code: AK156) for the treatment of osteoporosis has been listed on the National Health Insurance (NHI) drug price standard as of today. In addition, the launch of the product is scheduled on November 25, 2016.

Zoledronic acid (Reclast®) is a bisphosphonate developed by Novartis (Basel, Switzerland). As an osteoporosis drug capable of a year-long treatment with once a year i.v. administration, it was first approved in 2007 in the US and EU followed by approval in over 115 countries worldwide.

Asahi Kasei Pharma received rights to develop and market Reclast® in Japan through an agreement concluded in June 2010, and obtained approval for the manufacture and sale in September this year.

Reclast® will provide a new treatment option in Japan for patients with osteoporosis.

About RECLAST®

Product name

Reclast® for i.v. infusion 5 mg

Generic name

Zoledronic acid

Indication

Osteoporosis

Dosage and administration

The usual adult dosage is 5 mg administered by intravenous infusion over not less than 15 minutes, once per year.

Manufactured and distributed by

Asahi Kasei Pharma Corp.

Date of approval for manufacturing and marketing

September 28, 2016

Date of NHI drug price listing

November 18, 2016

Date of initial marketing in Japan

November 25, 2016 (scheduled)

NHI drug price

¥39,485 per 5 mg 100 mL bottle

Reclast® is a trademark of Novartis.