Launch of Teribone™ osteoporosis drug in Japan

November 25, 2011
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma has launched the sale of a 56.5 µg subcutaneous injection formulation of Teribone™ (generic name: teriparatide acetate) for the indication of osteoporosis with high risk of fracture, upon listing in the NHI Drug Price Standard today.

Teribone™ is a human parathyroid hormone preparation that facilitates bone formation. A Phase III clinical trial in Japan demonstrated that, with weekly subcutaneous injections for 72 weeks, Teribone™ decreased the risk of developing new vertebral fracture1 by 78.6% compared to placebo treatment. The efficacy in preventing fracture is obtained by increasing bone strength with both improved bone quality and increased bone mass. Asahi Kasei Pharma obtained approval for the manufacture and sale of Teribone™ in Japan on September 26, 2011, having filed an application for approval on October 20, 2010.

In Japan, it is estimated that more than 11 million people suffer from osteoporosis, including those not receiving treatment,2 and the number is increasing as the population ages. Since osteoporosis carries an increased risk of vertebral and femoral fracture, with a high probability of resulting in confinement to bed, the implementation of effective measures against osteoporosis is an important social issue.

Asahi Kasei Pharma believes that, with its efficacy in preventing fracture, Teribone™ will make a significant contribution to the treatment of osteoporosis.

Product outline

Product name:   Teribone™ 56.5 µg for subcutaneous injection
Generic name:   Teriparatide acetate
Indication:   Osteoporosis with high risk of fracture
Dosage and administration:   For adults, ordinarily administered in a single 56.5 µg injection once a week for up to 72 weeks.
Manufacture and sale:   Asahi Kasei Pharma Corp.
Approval:   September 26, 2011
NHI price listing:   November 25, 2011
Launch of sale:   November 25, 2011
NHI price:   ¥12,971 per 56.5 µg vial

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