We are collaborating with Tibotec, a subsidiary of Johnson and Johnson, to develop and commercialize INCIVEK^TM (telaprevir). Vertex has rights to commercialize INCIVEK in North America. Tibotec has rights to commercialize INCIVEK in Europe, South America, Australia, the Middle East and certain other countries. The agreement also includes a royalty on product sales in Europe and other territories outside of North America and the Far East.

Vertex initiated its CF research program in 1998 as a part of a collaboration with CFFT, the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation. From 2000 through 2006, Vertex and CFFT amended and expanded the collaboration four times to support the accelerated discovery and development of VX-770 (ivacaftor), known as a CFTR potentiator, and VX-809, known as a CFTR corrector. Correctors and potentiators are medicines in development that aim to treat the underlying cause of CF by improving the function of the defective protein known to cause the disease. VX-809 is designed to help the protein reach the cell surface, while VX-770 aims to help the protein function more normally once it reaches the cell surface. In April 2011, Vertex and CFFT further expanded the collaboration to support development activities for VX-661, Vertex's second corrector to enter clinical development, and the discovery and development of next-generation correctors.

A Phase 3 clinical development program for VX-770 is complete, and Vertex submitted a New Drug Application for VX-770 to the U.S. Food and Drug Administration (FDA) in October 2011. Vertex is seeking approval of VX-770 for use in people six years of age and older who have at least one copy of the G551D mutation in the CFTR gene. Vertex also plans to start the registration process for VX-770 with the European Medicines Agency (EMA) by the end of October 2011.

Vertex is also conducting an exploratory Phase 2 clinical trial to evaluate combination regimens of VX-770 and VX-809 in people with the most common mutation in CF, known as F508del.

Click to learn more about VX-770.

Click to learn more about VX-809.

Click to learn more about VX-661.

In June 2004, Vertex signed an agreement with Osaka-based Mitsubishi Tanabe Pharma Corporation to develop and commercialize telaprevir (VX-950), Vertex’s investigational oral protease inhibitor for the treatment of hepatitis C virus (HCV) infection, in Japan and certain Far East countries. The companies amended the agreement in July 2009. Under the amended agreement, Mitsubishi Tanabe received rights in its territory for telaprevir-based combination therapy with interferon and ribavirin, as well as rights to manufacture telaprevir for sale in its territory. Vertex expects to receive a $105 million payment upon signing and has the potential to receive additional bonus milestone payments in lieu of royalties, that if realized would range between $15 million and $65 million. Mitsubishi Tanabe is currently conducting Phase 3 registration studies with telaprevir in combination with pegylated interferon and ribavirin in Japan in approximately 300 treatment-naïve and treatment-failure genotype 1 hepatitis C patients.

Janssen Pharmaceutica, a Johnson & Johnson Company, has exclusive rights to develop and commercialize telaprevir in Europe, South America, the Middle East, Africa and Australia. Vertex retains exclusive commercial rights to telaprevir in North America and continues to lead the global development for telaprevir.