Thursday, Jun 6, 1991
South San Francisco, Calif. -- June 6, 1991 --Genentech, Inc. (NYSE: GNE) today announced its heart attack drug t-PA has been approved for marketing by the Japanese Ministry of Health and Welfare for acute myocardial infarction. Product shipments from Genentech to its licensees in Japan already have begun.
Under the Japanese health care system, before a product can be marketed, its price must be established by the National Health Insurance System. The NHI has set the price for t-PA at approximately $2,250 U.S. (Y315,000) for a 40 mg dose, a price which reflects the value of t-PA as determined by that government agency. The drug had been approved March 29 by Koseishio, the Japanese equivalent of the U.S. Food and Drug Administration. Both the NHI and Koseishio are part of the Ministry of Health and Welfare.
Known as Activase® in the United States, t-PA will be marketed by Mitsubishi Kasei Corp. as GRTPATM and by Kyowa Hakko Co. Ltd. as Activacin?. Both Mitsubishi and Kyowa Hakko are large companies with long-established pharmaceutical divisions. Mitsubishi will co-market GRTPA with Tanabe Seiyaku, an Osaka-based pharmaceutical company which will provide Mitsubishi with additional sales and marketing resources.
Acute myocardial infarction strikes approximately 140,000 people each year in Japan, although the market size for t-PA in Japan is not known. t-PA dissolves the clots of patients who are having heart attacks; it has been used to treat more than 250,000 patients since it was approved in the United States in 1987. There are three other approved thrombolytic agents in Japan: a recombinant t-PA product marketed by Toyobo, urokinase, and a non-recombinant t-PA for intracoronary use. Two U.S.-approved thrombolytics, streptokinase and APSAC, have not been approved in Japan.
Kyowa Hakko and Mitsubishi will perform final manufacturing and packaging of t-PA in addition to marketing. Both companies have been responsible for the development of t-PA in Japan as Genentech co-licensees since 1982.
Genentech has filed a number of patent applications in Japan for t-PA. To protect its licensees, Genentech filed suit alleging patent infringement against Toyobo, which is a licensee of U.S.-based Genzyme Corp., and against Sumitomo, licensee of the Wellcome Foundation. Genentech believes the courts will uphold its patents.
t-PA joins Genentech products previously approved and now marketed through licensees in Japan, including human insulin, human growth hormone, and alpha interferon. Genentech, Inc. is a biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant medical needs.
# # #