— Vertex to receive $105 million from Mitsubishi following signing,
plus the potential for additional milestones upon commercialization —
— Phase 3 registration program for telaprevir in Japan expected to
complete enrollment in the third quarter of 2009 —
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.
