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No. 353, February 1999

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American Companies in Japan


In what surely is a record for action by the Ministry of Health and Welfare, Viagra (sildenafil citrate), PFIZER INC.'s oral therapy for erectile dysfunction, was cleared for marketing in just six months (see Japan-U.S. Business Report No. 347, August 1998, p. 9). Pfizer attributed the quick approval in part to MHW's willingness to review clinical information from the United States and other countries where Viagra is in use in addition to conducting clinical trials in Japan. To be available in late March in both 25- milligram and 50-milligram tablets, Viagra will be manufactured locally by PFIZER PHARMACEUTICALS INC. The drug will not be covered by Japan's national health insurance system so patients will have to cover the complete cost themselves. Pfizer Pharmaceuticals has suggested that dispensers charge about $9.75 for the 25mg tablet and and $11.50 for the 50mg version. Given the expected popularity of Viagra and other drugs that the company plans to introduce, Pfizer Pharmaceuticals hopes to add 560 medical representatives between 1999 and 2001 to its current staff of 1,280 salespeople. Over the same time frame, the company projects that its annual sales will expand to nearly $2.4 billion from about $1.3 billion in 1998.

BRISTOL-MYERS SQUIBB CO.'s subsidiary is marketing what in the United States is called Betapace (sotalol hydrochloride). This drug, a beta- blocker, is designed for the treatment of life-threatening ventricular arrhythmia. It was cleared for Japanese sale under the provision for treatments for rare conditions. Betapace was the first such drug approved for arrhythmia.

Genotropin, a genetic recombinant natural human growth hormone product that is the world's leading treatment for growth hormone deficiency, is being sold directly by the subsidiary of developer PHARMACIA & UPJOHN, INC. From 1988 until mid-1998, SUMITOMO PHARMACEUTICALS CO., LTD. had Japan sales and marketing rights to Pharmacia & Upjohn's top- selling product (see Japan-U.S. Business Report No. 341, February 1998, p. 11). With the start of direct sales, P&U's Tokyo operation detailed 130 medical representatives to work exclusively with Genotropin.

An oral medication for the management of the manifestations of psychotic disorders, including schizophrenia, discovered and developed by the Wilmington, Delaware-based Zeneca Pharmaceuticals unit of ZENECA INC., will be marketed exclusively in Japan by FUJISAWA PHARMACEUTICAL CO., LTD. SEROQUEL (quetiapine fumarate) belongs to a new class of atypical antipsychotics known as dibenzothiazepine derivatives. It has been available in the United States since the fall of 1997. The Osaka subsidiary of London's ZENECA GROUP PLC filed a new drug application for SEROQUEL with MHW in December. Fujisawa Pharmaceutical hopes to have the drug on the market around 2001.

In exchange for an up-front fee of $2 million and future milestone payments, TRANSKARYOTIC THERAPIES, INC. of Cambridge, Massachusetts gave SUMITOMO PHARMACEUTICALS CO., LTD. the right to develop and commercialize in Japan and elsewhere in Asia an enzyme replacement therapy for Fabry disease. This rare genetic disorder is caused by deficient activity of the lysosomal enzyme alpha-galactosidase A, which leads to the buildup of a toxic lipid in various organs and tissues of the body. These deposits can result in pain in the extremities, renal and cardiovascular disease, and stroke. In the United States, where Phase II clinical trials of TKT's alpha-gal A treatment recently started, the enzyme replacement therapy is on FDA's fast approval track. It also has received orphan drug status from the regulatory agency.

An exchange rate of ¥117=$1.00 was used in this report.aaaaaa

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