Amendments to 2004 deal allow the firm to market the drug as a combination therapy and replace royalties due with up to $65 million in milestones.

Mitsubishi Tanabe Pharma will pay $105 million to obtain rights from Vertex Pharmaceuticals to develop telaprevir, which is already in Phase III trials as an HCV treatment, in the Far East as a combination therapy. This revision to their 2004 agreement, which only included licenses to telaprevir as a monotherapy, also calls for potential milestones instead of royalties, ranging between $15 million and $65 million.

Under the terms of the amended deal, Mitsubishi will have a fully paid license to commercialize telaprevir as part of a combination regimen with interferon and ribavirin in Japan and other countries in the Far East. The firm also gains rights to manufacture the compound for sale in its territory, which includes Japan.

Late-stage studies assessing these combinations have began. Enrollment of approximately 300 treatment-naïve and treatment-failure genotype 1 hepatitis C patients is expected to be completed during the third quarter. Sustained viral response data is anticipated in 2010.

Vertex retains exclusive development and commercial rights to telaprevir in North America. Janssen Pharmaceutica, an affiliate of Johnson & Johnson, holds development and commercial rights in Europe, South America, Australia, and the Middle East.

Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication. The drug is being evaluated as part of a global Phase III program in more than 2,200 patients, according to Vertex.

“Following this amendment, the cash received strengthens our corporate financial position during an important period of investment and growth as we advance two Phase III programs in hepatitis C and cystic fibrosis,” notes Kurt Graves, Vertex executive vp, chief commercial officer, and head of corporate development.

The cystic fibrosis therapuetic candidate, VX-770, is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, intended to increase chloride ion transport through the defective CFTR protein. Vertex has initiated Phase III trials in patients with the G551D mutation, which is reportedly present in approximately 4% of cystic fibrosis patients.

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