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No. 361, October 1999

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American Companies in Japan


One of the first companies to take advantage of Japan's decision to allow the sale of oral contraceptives (see Japan-U.S. Business Report No. 358, July 1999, p. 14) was the Wyeth- Ayerst Laboratories division of AMERICAN HOME PRODUCTS CORP. Its WYETH (JAPAN) LTD. subsidiary is marketing Tridiol 21 (levonorgestrel and ethinyl estradiol tablets), which contains the world's most prescribed low-dose oral contraceptive regimen. It is sold in the United States as Triphasil.

The number of people in Japan who have HIV is relatively limited. By one count, however, 14 treatments have been approved for sale by the Health and Welfare Ministry. Two of the latest were cleared under MHW's recently introduced fast-track evaluation process for innovative HIV therapies. One is Prozei (amprenavir), a twice-daily HIV protease inhibitor that is indicated in combination with other antiretroviral agents. Known outside Japan by the trade name Agenerase, Prozei was discovered by VERTEX PHARMACEUTICAL INC. It is available through the Cambridge, Massachusetts firm's local development and commercialization partner KISSEI PHARMACEUTICAL CO., LTD. (see Japan-U.S. Business Report No. 359, August 1999, p. 14). The other new HIV treatment is a once-daily nonnucleoside reverse transcriptase inhibitor that was discovered by MERCK & CO., INC. but is sold in the United States by the pharmaceuticals subsidiary of E.I. DUPONT DE NEMOURS & CO., INC. as Sustiva (efavirenz). In Japan, it is on the market as Stocin through Merck affiliate BANYU PHARMACEUTICAL CO., LTD. It, too, is recommended in combination with other antiretroviral agents. Banyu expects sales of Stocin to be around $2.8 million a year, or about the amount of business it does with Crixivan (indinavir sulfate), another Merck drug that was the first HIV protease inhibitor approved for sale in Japan.

For reasons that were not detailed, the subsidiary of BRISTOL-MYERS SQUIBB CO. and YOSHITOMI PHARMACEUTICAL INDUSTRIES, LTD. ended their comarketing arrangement on two drugs. One is BMS's ZERIT (stavudine, d4T), a thymidine nucleoside analog for the treatment of HIV. Yoshitomi Pharmaceutical had ZERIT sales of $5.6 million in FY 1998. That equaled BMS's revenues from the sale of Serotone, a drug for controlling nausea and vomiting that was discovered and commercialized by Yoshitomi Pharmaceutical and JAPAN TOBACCO INC.

One of the world's biggest clinical contract research organizations, COVANCE INC. of Princeton, New Jersey, has teamed up with INA RESEARCH INC., a Nagano prefecture preclinical CRO, to offer pharmaceutical companies a comprehensive array of third-party testing services. The collaborative effort could significantly shorten time to market for viable therapies. Ina Research will be responsible for animal testing, while Covance will handle Phase I clinical trials as well as the first part of Phase II testing. The partners, which plan to open consulting and marketing offices in Tokyo and Osaka, predict that first-year revenues could reach as much as $23.1 million.

An exchange rate of ¥108=$1.00 was used in this report.

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