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Executive Summary

VERTEX ORAL AIDS DRUGS PROGRAM WILL RECEIVE UP TO $20 MIL. FROM KISSEI for compounds targeting the HIV protease enzyme, Cambridge, Mass.-based Vertex Pharmaceuticals announced April 13. Under the agreement, the Japanese firm Kissei Pharmaceutical Co. Ltd. will provide Vertex with technical assistance and up to $20 mil. over three years in milestone payments, funding and a small equity investment toward the development of orally active HIV protease inhibitors. In exchange, Kissei gains the right to commercialize any HIV protease inhibitors that are developed through the collaboration in Japan and China. Kissei, which markets primarily cardiovascular and allergy drugs and had estimated sales of $350 mil. in FY 1993 (ended March 31), will pay Vertex royalties on those sales. Vertex retains marketing rights to the products in the rest of the world, as well as worldwide manufacturing rights for the bulk compounds. The rational drug design firm has several non-peptidal HIV protease inhibitor candidates in preclinical trials and could file an IND for a compound as early as the beginning of 1994. Vertex Senior Scientist Manuel Navia, PhD, was the first to report the molecular structure of the HIV protease enzyme while he worked at Merck. Vertex further explored the protease structure through X-ray crystallography experiments aboard the space shuttle Columbia last June ("The Pink Sheet" June 29, 1992, T&G-6). In October 1990, Vertex signed an R&D agreement with another Japanese firm, Chugai Pharmaceuticals, to fund its "Immunophilins" program. Under that agreement, Chugai through September has provided Vertex with $10 mil. and is slated to pay the firm $19 mil. in research funding and $9 mil. in milestone payments over five years. Initially, the research targeted the development of immunosuppressive drugs with less toxicity and more efficacy than cyclosporine and Fujisawa's experimental drug FK-506. The company has shifted its strategy so that multi-drug resistance in cancer therapy will be the first area of development for the Immunophilins.

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