Wednesday, Nov 9, 1988

New Drug Application For t-PA Filed in Japan

South San Francisco, Calif. -- November 9, 1988 --

Genentech, Inc. announced today that its Japanese licensees, Mitsubishi Kasei Corp. and Kyowa Hakko Kogyo Co. Ltd. have filed with Koseisho, the Japanese equivalent of the U.S. Food and Drug Administration (FDA), their application for approval of recombinant tissue plasminogen activator (t-PA) for the treatment of heart attack patients.

"The filing of the Japanese New Drug Applicatlon (NDA) for t-PA by our partners is a particularly significant event in that applications for marketing approval have now been filed in every major market around the world,." Robert A. Swanson, Genentech's Chief Executive Officer, said.

T-PR, which is marketed by Genentech under the tradename Activase® In North America, has already been approved for marketing in approximately twenty-five countries, with over 70,000 heart attack patients treated to date.

This month marks the one year anniversary since the introduction of Activase In the United States, where it is the most successful product launch in the history of the U.S. pharmaceutical Industry.

Genentech is a leading biotechnology company focusing on the development, manufacture and marketing of pharmaceuticals produced by recombinant DNA technology.

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