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Teijin Pharma's Bonalon Bag for I.V. Infusion 900 µg Approved as Japan's First I.V. Drug for Osteoporosis


1/18/2012 9:04:41 AM

Tokyo, Japan, January 18, 2012 --- Teijin Pharma Limited (www.teijin-pharma.co.jp/english/ ), the core company of the Teijin Group’s (www.teijin.co.jp/english) medical and pharmaceutical business, announced today that Japan’s Ministry of Health, Labour and Welfare on January 18 approved Bonalon Bag for I.V. Infusion 900 µg (Alendronate sodium hydrate) as Japan’s first intravenous drip-form drug for osteoporosis. Teijin Pharma plans to launch the drug, which is administered just once every four weeks, this coming spring.

The approval will enable Teijin Pharma, which holds the largest share of osteoporosis treatments in Japan, to strengthen its commitment to improving the quality of life of patients.

Bonalon Bag for I.V. Infusion 900 µg, Japan’s first intravenous drip formulation for osteoporosis, is based on the oral bisphosphonate drug Bonalon, but does not impose the administration restrictions of oral drugs. In addition, while Bonalon is administered orally once a day or once a week, Bonalon Bag for I.V. Infusion 900 µg can be administered once every four weeks, when the patient visits their clinics, making it easier for them to continue taking the medication. Also, whereas Bonalon as an oral drug is accompanied by the risk of disorders in digestive organs due to the drug coming into contact with these organs, the administration of the drug as a drip infusion avoids this risk.

Japan has an estimated 11 million osteoporosis patients, mainly elderly women. In addition to increasing the risk of proximal femoral fractures, a direct cause of elderly people becoming bedridden or increased risk of death, osteoporosis also can have various harmful effects on ambulatory ability and visceral and respiratory functions. Moreover, evidence is increasingly linking the disease to lifestyle diseases such as hyperlipidemia and diabetes. In view of the aging of Japanese society, interest in osteoporosis treatment is increasing.

Bonalon, a bisphosphonate drug with an outstanding capacity to inhibit bone resorption, has been confirmed to increase the bone density of osteoporosis patients and reduce the occurrence of proximal femoral fractures. In the “Guidelines for the Prevention and Treatment of Osteoporosis - 2011 Version,” which was presented at the Annual Meeting of Japan Osteoporosis Society in November of last year, Bonalon was highly evaluated for its potential effects to reduce the risk of fractures such as proximal femoral fractures. In addition, efficacy and safety were proven in a long-term administration study overseas, in which patients used the drug continuously for over a decade.

In the case of most orally administered bisphosphonate drugs, however, patients are advised that after rising and taking the drug with a glass of water, they should not lie down for 30 minutes after administration, nor drink or eat during that time. The inconvenience of these restrictions has led to some patients discontinuing their use of the medication.

Teijin Pharma’s Business Targeting Bone and Joint Diseases

Teijin Pharma’s business is focused on three key therapeutic areas: bone/joint, respiratory, and metabolic/cardiovascular diseases. In the field of bone and joint diseases, Teijin Pharma commands the leading share of the market for osteoporosis treatments in Japan, due mainly to Onealfa, the company’s pioneering proprietary treatment, and Bonalon, currently the first choice among osteoporosis patients.

A large-scale clinical study conducted in Japan in recent years showed that the administration of Onealfa and Bonalon in combination can help to reduce the rate of bone fractures more than the administration of Bonalon alone. Teijin Pharma is now developing Bonalon in jelly form as the world’s first such treatment for osteoporosis, continuing its efforts to provide patients with various options for improved quality of life.

By offering such drugs for osteoporosis, together with leading treatments for other bone and joint diseases, such as Synvisc, a viscosupplement for knee osteoarthritis pain that is prescribed worldwide, and SAFHS, a sonic-accelerated fracture-healing system, Teijin Pharma aims to continue contributing to improved health in Japan’s rapidly aging society.

About the Teijin Group

Teijin is a global technology-driven group operating in eight main fields: aramid fibers, carbon fibers & composites, polyester fibers, plastics, films, medical & pharmaceuticals, fiber products marketing and IT businesses. Teijin Limited, the holding company for the Teijin Group, is listed on the Tokyo and Osaka stock exchanges. The group, comprising 150 companies and 17,542 employees worldwide, had consolidated sales of JPY 815.7 billion (USD 10.6 billion) and total assets of JPY 761.5 billion (USD 9.9 billion) in the fiscal year ending March 31, 2011. http://www.teijin.co.jp/english

Rie Mashiba

Public Relations & Investor Relations Office

Teijin Limited

+81 3 3506 4055

pr@teijin.co.jp



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