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No. 356, May 1999

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Japanese Companies in the US


The Food and Drug Administration has approved for marketing LIDODERM (Lidocaine patch 5%), a patch dermal delivery system codeveloped by TEIKOKU SEIYAKU CO., LTD. and HIND HEALTHCARE INC. of Fresno, California. LIDODERM is the first product the FDA has sanctioned specifically for the treatment of pain associated with postherpetic neuralgia. PHN results from nerve injury or damage during an outbreak of shingles, a reactivation of the herpes zoster virus that causes chicken pox. Kagawa prefecture-based Teikoku Seiyaku expects LIDODERM to be launched in the third quarter of this year. It will be imported by wholly owned TEIKOKU PHARMA USA, INC. and distributed by ENDO PHARMACEUTICALS INC. of Chadds Ford, Pennsylvania, another wholly owned subsidiary that Teikoku Seiyaku formed in 1997. As the first drug for hard-to-treat PHN-caused pain, LIDODERM sales could total $100 million, the Japanese maker of anti-inflammatory and analgesic patches estimates.

About 750 people will be ready to promote TAKEDA CHEMICAL INDUSTRIES, LTD.'s treatment for Type II diabetes once the FDA approves ACTOS (pioglitazone hydrochloride). The marketing go-ahead now is expected this summer, earlier than initially anticipated (see Japan-U.S. Business Report No. 352, January 1999, p. 3). ACTOS appears to have less effect on patients' livers than Rezulin, the first of a new class of drugs to target insulin resistance that was developed by SANKYO CO., LTD. and is marketed by WARNER-LAMBERT CO. Under a May 1998 pact, TAKEDA PHARMACEUTICALS AMERICA, INC. of New York City, which has a sales force of about 250 people, will market ACTOS along with roughly 500 representatives from ELI LILLY AND CO.

PLETAL (cilostazol), a treatment for relief from the leg pain caused by hardening of the arteries that was commercialized by OTSUKA AMERICA PHARMACEUTICAL, INC. (see Japan-U.S. Business Report No. 353, February 1999, p. 3), will be copromoted by the Rockville, Maryland company and PHARMACIA & UPJOHN, INC. The prescription drug was to be available in early May. P&U has exclusive rights to market PLETAL in Canada. It also could handle distribution in other countries.

MEIJI SEIKA KAISHA, LTD. already has licensed cefditoren pivoxil (cefditoren), a potent, broad-spectrum cephalosporin antibiotic, to TAP PHARMACEUTICALS INC., an equally owned joint venture between TAKEDA CHEMICAL INDUSTRIES, LTD. and ABBOTT LABORATORIES, for U.S. sale. Now, the discoverer and developer of the advanced-generation oral cephalosporin has awarded Abbott comarketing rights in Europe and exclusive manufacturing and marketing rights in Latin America. The Abbott Park, Illinois company, which is strong in anti-infectives, also will be able to market cefditoren pivoxil in Asia outside of Japan and South Korea. The drug, available in Japan since 1994, currently is in Phase III clinical trials in the United States and Europe, where it is being developed as a first-line agent for respiratory tract infections, including pneumonia.

Japanese pharmaceutical companies continue to tap the drug discovery expertise of American companies to expedite the commercialization of new products. One such arrangement is the tie-up between FUJISAWA PHARMACEUTICAL CO., LTD. and NEXSTAR PHARMACEUTICALS, INC. Under it, the Boulder, Colorado firm will use its proprietary SELEX compound-identification process to develop what it calls an aptamer against an immunology target of interest to Fujisawa Pharmaceutical. If the big Japanese drug company decides to develop and commercialize the aptamer, it will provide licensing fees, milestone payments and royalties to NeXstar Pharmaceuticals. The two companies have previous ties. FUJISAWA HEALTHCARE, INC. of Deerfield, Illinois has exclusive U.S. distribution rights to NeXstar Pharmaceuticals' AmBisome (liposomal amphotericin B) antifungal drug.

In an agreement valued at more than $19 million, FUJISAWA PHARMACEUTICAL CO., LTD. also has arranged for QUARK BIOTECH, INC. to use its pathology-specific genomics and bioinformatics technology to discover genes for use as targets for the development of therapeutics for strokes. As is standard, QBI will receive research funding, milestone payments and royalties on sales from Fujisawa Pharmaceutical in exchange for worldwide development, manufacturing and marketing rights to the products discovered by the San Ramon, California company. Quark Biotech recently agreed with SANKYO CO., LTD. to use its gene discovery know-how to identify drug candidates for Type II diabetes (see Japan-U.S. Business Report No. 354, March 1999, p. 2).

A fifth Japanese pharmaceutical house has contracted with TELIK, INC. in an attempt to accelerate the process of identifying new compounds for development. The South San Francisco, California biopharmaceutical company will use its proprietary TRAP chemoinformatics drug discovery technology to screen its small-molecule library for compounds that exhibit potential pharmacological activity against targets selected by SANKYO CO., LTD. Japan's number-two drug company will make up-front payments to Telik and will have the option to acquire an exclusive worldwide license to develop and commercialize any or all of the identified molecules. As many as 10 targets could be evaluated for Sankyo. SANWA KAGAKU KENKYUSHO CO., LTD., SOSEI CO., LTD., TAIHO PHARMACEUTICAL CO., LTD. and TEIJIN LTD. also have partnerships with Telik.

Broadening a May 1997 arrangement, ASAHI CHEMICAL INDUSTRY CO., LTD. and MOLECUMETICS LTD. have signed a multiyear agreement intended to develop new drugs for the treatment of central nervous system, cardiovascular, inflammatory and metabolic diseases. The earlier alliance was limited to cardiovascular disorders. Asahi Chemical and the Seattle chemistry-based drug discovery company will select multiple molecular targets in each of the four therapeutic areas. Molecumetics' libraries of compounds then will be reviewed to identify drug lead compounds. The two will share responsibility for screening and optimizing the lead compounds into drug candidates, with the Japanese company handling their preclinical and clinical development. Asahi Chemical, the first company to sign a partnership agreement with Molecumetics, will provide research funding as well as make milestone payments and pay royalties on sales of products resulting from the collaboration. TEIJIN LTD. also is working with the U.S. firm.

Although the details still are being worked out, OKAMOTO INDUSTRIES, INC. plans to begin sales this year of a substitute for polyvinyl chloride film. The Tokyo manufacturer's polypropylene-derived Ecolofin family of transparent and flexible films is available in thicknesses of 0.1 millimeter, 0.15 mm, 0.2 mm and 0.3 mm. It is said to be comparable in quality to PVC but lower priced.

An exchange rate of ¥120=$1.00 was used in this report. aaaaa

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