FIRST LAUNCH OF FUJISAWA'S PROGRAF

Fujisawa Pharmaceutical's immunosuppressant Prograf (tacrolimus, formerly FK-506) was launched on June 7 in Japan, its first market, for its first authorized indication of suppression of rejection in liver transplantation. There are only between 30 and 40 cases of liver transplantation a year in Japan, so the product's earnings potential will be somewhat limited until approvals in other countries and for other indications are achieved.

Tacrolimus is recommended for administration either orally (0.15mg/kg twice daily tapering to 0.1mg/kg twice daily), or by injection (0.05mg/kg twice daily in a 4-12 hour infusion). Intravenous administration should be switched to the oral route as soon as possible. The price of a 1mg capsule has been set at 1,756 yen ($16), while the price of a 5mg injection is 7,876 yen ($75). This price is at a premium to existing treatments, and reflects tacrolimus' designation as an innovative new drug.

Fujisawa says it plans to file marketing applications for the liver transplantation indication in the USA and Europe within the next few months. In addition to this use, the company is continuing to develop tacrolimus in other transplant areas such as kidney and bone marrow, and is also investigating the drug's potential in Phase II trials as a therapeutic in certain auto-immune diseases, notably psoriasis, multiple sclerosis and refractory uveitis associated with Behcet's disease.