Application for approval to manufacture and market zoledronic acid hydrate for treatment of Osteoporosis in Japan

September 30, 2015
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma Corporation (“Asahi Kasei Pharma”) today filed an application for approval to manufacture and market zoledronic acid hydrate (development code: AK156), a bisphosphonate agent, for treatment of osteoporosis. This agent, developed by Novartis Pharma AG (“Novartis Pharma”, head office: Basel, Switzerland), is administered once a year for the osteoporosis indication. Asahi Kasei Pharma concluded an agreement with Novartis Pharma in June 2010, under which Asahi Kasei Pharma received exclusive rights to develop and market zoledronic acid hydrate in Japan. Asahi Kasei Pharma hopes that this agent will provide a new treatment option for osteoporosis.

About AK156

  1. Product name
    Reclast® for i.v. infusion 5 mg/100 mL (tentative)
  2. Generic name
    Zoledronic acid hydrate
  3. Indication
    Osteoporosis (tentative)
  4. Characteristics
    Zoledronic acid hydrate, developed by Novartis Pharma, is a bisphosphonate which inhibits elevated bone turnover. Bisphosphonates accumulate in mineralized bone matrix. They are released during bone resorption and are internalized by osteoclasts. Bisphosphonates inhibit osteoclast activity and shorten their life span by inducing apoptosis. First approved in 2007 in the US and then in the EU as the only osteoporosis drug capable of a year-long treatment with once-a-year intravenous infusion, zoledronic acid hydrate is now approved in over 110 countries worldwide. It is marketed under the trade name Reclast® in the US and Aclasta® in the rest of the world.

Aclasta® and Reclast® are trademarks of Novartis Pharma.