Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Mitsubishi Tanabe Pharma Corporation today amended their agreement for the development and commercialization of telaprevir for the treatment of hepatitis C virus (HCV) infection in Japan and other countries in the Far East. Telaprevir is an HCV protease inhibitor currently in Phase 3 clinical trials in Japan, as well as in the United States and in Europe. Under the terms of the amended agreement, Vertex will receive $105 million following signing, and will be eligible to receive further milestones upon approval and commercialization in Japan.
The previous agreement signed in 2004 between Vertex and Mitsubishi Tanabe provided certain development and commercial rights to telaprevir as a potential monotherapy for the treatment of Hepatitis C. The amended agreement announced today provides a fully-paid license to commercialize telaprevir as part of a combination regimen with interferon and ribavirin to treat hepatitis C in Japan and the Far East. Vertex retains exclusive development and commercial rights to telaprevir in North America. Janssen Pharmaceutica, an affiliate of Johnson & Johnson, holds development and commercial rights to telaprevir in Europe, South America, Australia, and the Middle East.
"This amendment recognizes the value of telaprevir-based combination therapy as a potential major advance in the treatment of hepatitis C in Japan and Asian countries, aligning the telaprevir development program on a global basis,” said Kurt Graves, Vertex Executive Vice President, Chief Commercial Officer and Head of Corporate Development. "Moreover, following this amendment, the cash received strengthens our corporate financial position during an important period of investment and growth as we advance two Phase 3 programs in hepatitis C and cystic fibrosis.”
Terms of the Agreement
Under the amended development and commercialization agreement, Mitsubishi Tanabe will receive a license in its territory for telaprevir-based combination therapy with interferon and ribavirin, as well as rights to manufacture telaprevir for sale in its territory. Mitsubishi Tanabe will pay Vertex $105 million upon signing. In addition, the parties have reached other commercial agreements in the amendment, including potential bonus milestone payments in lieu of royalties, that if realized would range between $15 million and $65 million.
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