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No. 363, December 1999

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American Companies in Japan


In a sign that regulatory reform slowly is changing the competitive landscape for big American pharmaceutical companies, BRISTOL-MYERS SQUIBB CO. will close its research facility in Aikawa, Kanagawa prefecture by the end of 1999. The center, which employs 40 people, conducts early-phase clinical testing and compiles other information for products that BMS hopes to develop for introduction in Japan. However, now that the Ministry of Health and Welfare is more willing to accept the results of clinical trials generated overseas when companies submit new drug applications, the BMS facility has become superfluous. Should the pharmaceutical company need in-country clinical data in the future, it will outsource this work. Most of the staff at the research institute will be transferred to BMS's headquarters in Tokyo.

In another indication that the U.S. pharmaceutical industry believes that Japan's market environment is changing, ELAN PHARMACEUTICALS, INC. of South San Francisco, California has outlined plans to launch sales there. The firm, the drug division of Ireland's ELAN CORP., PLC, a big drug-delivery company, already has established a subsidiary in Tokyo and is in negotiations with prospective domestic partners. Elan has two candidates for clinical development in Japan. One is ziconotide, a novel N-type neuronal calcium channel blocker. Administered directly into the spinal cord, it has shown promise in clinical studies of significantly reducing chronic, intractable pain in patients for whom morphine-type therapies have failed. The other product is NeuroBloc, a botulinum toxin type B injectable solution for the treatment of the painful neurological condition known as cervical dystonia, which generally affects the muscles of the neck and the shoulders.

AFFYMETRIX, INC. — the developer of the GeneChip system for acquiring, analyzing and managing complex genetic information to enhance the diagnosis and the treatment of disease — has given SANKYO CO., LTD. a broad license to its technology. The subsidiary of AMERSHAM PHARMACIA BIOTECH CORP., the Santa Clara, California company's distribution partner, arranged the deal. Sankyo is the first Japanese drug firm to be able to tap on a widespread, preferential basis Affymetrix's standard and custom GeneChip arrays, instrumentation and software to monitor gene expression. Last summer, TAKEDA CHEMICAL INDUSTRIES, LTD. gained more limited access to the GeneChip platform (see Japan-U.S. Business Report No. 358, July 1999, p. 13).

Japanese and other multinational pharmaceutical and biotechnology companies interested in outsourcing their international product development work to a full-service contract research organization have a new option. FAMILY HEALTH INTERNATIONAL, a not-for-profit clinical research and technical assistance organization, and E.P.S. CO., LTD., which also is in the clinical research services business, have tied up. After establishing common operating procedures and sharing technologies to maximize service and clinical data quality, the Research Triangle Park, North Carolina FHI and its Tokyo-based partner will start comarketing their service. E.P.S. will conduct all clinical studies in Japan, while FHI will handle all trials in North America and elsewhere outside Japan. Midsize trader KASHO CO., LTD. of Tokyo will help to coordinate activities between the two companies.

Broadening its push into Japan, nutritional supplement supplier REXALL SUNDOWN, INC. has formed a development and marketing alliance with SNOW BRAND MILK PRODUCTS CO., LTD. Under it, the Sundown Vitamins Division of the Boca Raton, Florida company will work with Japan's largest maker of dairy products to come up with vitamins and other supplements for the local market. These will be sold through Snow Brand's extensive distribution system. The first product could be on the market as soon as March 2000. Rexall Sundown previously teamed up with ROHTO PHARMACEUTICAL CO., LTD. (see Japan-U.S. Business Report No. 355, April 1999, p. 13).

NUTRITION FOR LIFE INTERNATIONAL, INC., a direct seller of nutritional supplements and other consumer goods, opened a support subsidiary in preparation for launching sales of its products through a network of independent distributors. The Houston company will ship merchandise directly to its distributors, who will be linked to headquarters through a state-of-the-art computer system.

An exchange rate of ¥105=$1.00 was used in this report.aaaaaa

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