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Tokyo, Japan, September 15, 2006, - Teijin Pharma Limited (head office: Chiyoda-ku, Tokyo. President: Shigeo Oyagi) announced today that its new product Bonalon® Tablet 35mg (Alendronate sodium hydrate), the Japan's first once-weekly drug for osteoporosis, was registered on the reimbursement (NHI) price list. The product was launched on the same day. Osteoporosis is a chronic disease that is associated with bone fractures. It is estimated to affect 10 million Japanese. The major factors causing elderly patients to be bedridden are fractures and falls. Ongoing treatment is seen as an important means of addressing these factors and reducing the risk of fractures. Teijin has been committed to developing a drug for osteoporosis for many years and has previously marketed two preparations with different mechanisms: Onealfa®, an active vitamin D3 preparation with a stimulatory effect on bone formation and Bonalon® Tablet 5mg, which has an inhibitory effect on bone resorption. With the launch of Bonalon® Tablet 35mg, Japan's first once-weekly drug for osteoporosis, Teijin makes a new contribution to pharmacotherapeutic advances in the treatment of osteoporosis. Details of the product are as follows: 1. About alendronate sodium hydrate (abbreviated to alendronate)
2. About Bonalon® Tablet 35mg Since the daily Bonalon® Tablet 5mg must be taken upon rising with a glass of plain water and patients cannot lie down at least for 30 minutes after intake, some patients have had difficulties adhering to the treatment regimen and have finally discontinued the drug. A phase III double-blind comparison trial conducted in Japan showed that the efficacy of treatment with the once-weekly Bonalon® Tablet 35mg was equivalent and the safety was similar to treatment those with the once-daily Bonalon® Tablet 5mg. Therefore, Bonalon® Tablet 35mg will reduce the number of drugs that need to be taken to achieve the same therapeutic effects. This should in turn attenuate the burden on patients. Features of Bonalon® Tablet 35mg
3. Sales target Teijin expects sales of more than three billion yen for the first year and peak sales of more than 20 billion yen combined with Bonalon® 5mg (more than 35 billion yen further combined with Onealfa®) in the future. These forecasts are based on the NHI price. Bonalon® is the registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA. For further information, please contact: Public Relations & Investor Relations Office Teijin Limited Tel: +81-3-3506-4055 / Fax: +81-3-3506-4150 E-mail: pr@teijin.co.jp Product Summary Product Name Bonalon® Tablet 35mg, Teijin Pharma Limited Generic Name Alendronate sodium hydrate Indications Osteoporosis (Precautions for use related to the indications)
Dosage and Administration Normally adults should take a 35 mg tablet of alendronate orally once a week upon rising with approximately 180 mL of plain water. The patient should not lie down for at least 30 minutes after intake and should not ingest food, beverages (excluding water), or other drugs during this period. Regulatory Classification Powerful, designated and ethical drug (*) (*Warning: This drug is to be used only when prescribed by and under the direction of a physician.) Packaging PTP (Blister sheet packaging): 20 tablets (2 tablets x 10 sheets) 50 tablets (2 tablets x 25 sheets) Approval Number 21800AMZ10368000 NHI Price 847.8 yen/tablet Date of Registration on the NHI Price List September 15, 2006 Manufacture/Marketing Teijin Pharma Limited |
Information in the press releases is current on the date of the announcement.
It is subject to change without prior notice.
