Vertex Pharmaceuticals Incorporated have signed an agreement with Mitsubishi Pharmaceutical Corporation to develop and commercialize VX-950, Vertex's investigational oral protease inhibitor in Japan and certain Far East countries.
As part of the agreement, Mitsubishi will make pre-commercial payments to Vertex to support clinical development of VX-950, which is used for the treatment of hepatitis C virus (HCV) infection. Additionally, Mitsubishi will pay royalties to Vertex on commercial sales of VX-950 in Mitsubishi's territories. Vertex will retain exclusive development and marketing rights to VX-950 in the rest of the world, including North America and Europe.
Mitsubishi will make pre-commercialization payments to Vertex of up to $33 million under the agreement, consisting of license fees, a significant contribution to drug development costs through phase II clinical development, and clinical milestone payments. Vertex anticipates that it could recognize the majority of these pre-commercial payments by the end of 2006. Further cost sharing beyond phase II clinical development will be determined by the parties based on the design of registration studies for VX-950.
"Vertex has selected hepatitis C as an important and rapidly growing therapeutic area in which to pursue independent development of its drug candidates in North America," stated Joshua Boger, chairman and CEO of Vertex. "This regional partnership provides financial support for the global development of this important product, recognizes the breakthrough potential of VX-950 as a direct antiviral therapy and provides important downstream opportunities for Vertex in one of the largest hepatitis C populations in the world," he added.
"Current treatment alternatives for chronic hepatitis C infection provide limited benefit to patients," said Akihiro Tobe, executive managing officer, division manager of Strategic Planning at Mitsubishi Pharma Corporation. "Through this partnership with Vertex, a leader in the discovery and development of HCV protease inhibitors, we hope to accelerate the advancement of novel therapeutics for hepatitis C infection and we are pleased to add VX-950 to our pipeline of innovative drugs in development," he said.
VX-950 is Vertex's lead oral HCV protease inhibitor and one of the advanced of a new class of antivirals in development for HCV. Preclinical data have shown that VX-950 significantly reduces levels of HCV-RNA in both the replicon system and infectious virus assays within days. Preclinical pharmacokinetic studies completed to date have indicated that VX-950 is orally bioavailable and achieves excellent exposure in the liver, the target organ for HCV treatment.