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July 31, 2001

Product Release:Hornel Tablets Active Vitamin D3 Derivative

Taisho Pharmaceutical Co. Ltd. (President: Akira Uehara) began sales on August 1 of Hornel tablets, an active vitamin D3 derivative that is generically known as falecalcitriol. Taisho received manufacturing approval on April 4, 2001, and finalized the retail price on June 1.

Hornel tablets can relieve such adverse events as hypocalcemia, rickets,osteomalacia,and secondary hyperparathyroidism. For the first time, the tablets can be administered orally to effectively control the parathyroid hormone in dialysis patients and maintain an optimal range of serum calcium concentration.

Falecalcitriol was developed in the 1980s through the joint research activities of the Tokyo Institute of Technology and the Tokyo University of Pharmacy and Life Science. Active vitamin D3 enables a highly potent and long-lasting product in a small dosage because it converts all the H26 and H27 molecules to fluoride, and limits the effects of nonactive bodies (Hydroxide 24) through metabolism. It also fosters the main metabolites (Hydroxide 23)

Taisho and Sumitomo Pharmaceuticals, Co., Ltd. jointly licensed Falecalcitriol from the Wisconsin Alumni Research Foundation (WARF) in 1984 and began developing it for the Japanese market. Sumitomo has commissioned Kissei Pharmaceutical to market its product, which will be released August 1, as Fulstan tablets.

Product Overview
Product Name Hornel tablets 0.15, Hornel tablets 0.3
Generic name Falecalcitriol
Classification dangerous drugs (toxic), designated drug
1. Treatment of secondary hyperparathyroidism during dialysis treatment.
2. Treatment of hypocalcemia and relief of ailments accompanying hypoparathyroidism (excluding chronic renal failure), including tetany, convulsions, numbness, dizziness.
3. Treatment of rickets, osteomalacia (excluding chronic renal failure) and relief of accompanying ailments, including osteodystrophy, bone aches and hypodynamia.
Dosage For secondary hyperparathyroidism during dialysis treatment:
For adults, 0.3 microgram per day; this amount should be reduced depending on age and the extent of the condition.

For hypoparathyroidism, rickets and osteomalacia:
For adults, 0.3 to 0.9 microgram per day; this amount should be adjusted depending on age and on the extent and type of the condition.
Date of manufacturing approval April 4, 2001
Date of price finalization June 1, 2001
National Health Insurance Price Hornel 0.15 tablet, 436.60 yen (per tablet)
Hornel 0.3 tablet, 636.80 yen (per tablet)
Packaging PTP (push-through packaging): 100-tablet, 500-tablet packages (for both dosage strengths)
Manufacturer and distributor Taisho Pharmaceutical Co. Ltd.