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Vertex Announces Collaboration With Janssen To Initiate Phase 2 All-Oral Study Of VX-135 And Simeprevir (TMC435) For The Treatment Of Hepatitis C

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has entered into a non-exclusive collaboration with Janssen Pharmaceuticals, Inc. to conduct a Phase 2 proof-of-concept study of an all-oral regimen for the treatment of hepatitis C containing Vertex’s nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135 and Janssen’s protease inhibitor simeprevir (TMC435). As part of the collaboration, Janssen will conduct a drug-drug interaction study with VX-135 and simeprevir to support the planned initiation of a Phase 2 proof-of-concept study in early 2013, pending discussions with regulatory authorities. The Phase 2 study is expected to evaluate safety, tolerability and viral cure rates using a 12-week combination of VX-135 and simeprevir. The companies will jointly fund development costs associated with the collaboration. There are no up-front or milestone payments associated with the agreement. VX-135 is an investigational uridine nucleotide analogue pro-drug designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase. Simeprevir is a potent, once-daily investigational hepatitis C protease inhibitor, currently in Phase 3 trials, being jointly developed by Janssen R&D Ireland and Medivir AB.

“This collaboration is an important step forward in our commitment to develop new all-oral treatment regimens for people with hepatitis C – both in collaboration with other companies like Janssen and with medicines within our own pipeline,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. “We believe that an all-oral regimen of VX-135 and simeprevir has the potential to achieve high cure rates with only 12 total weeks of treatment for people with hepatitis C, and we look forward to the start of the Phase 2 proof-of-concept study with Janssen."

Clinical Development Plans

Vertex and Janssen expect to initiate a Phase 2 proof-of-concept study of VX-135 and simeprevir in early 2013, following the completion of a drug-drug interaction (DDI) study and pending discussions with regulatory authorities. Costs associated with the studies will be shared equally between the two companies. The goals of the study will be to evaluate safety, tolerability and viral cure rates (SVR12; undetectable hepatitis C virus 12 weeks after the end treatment) of multiple 12-week combination regimens of VX-135 and simeprevir, with and without ribavirin, in people who have chronic non-cirrhotic genotype 1 hepatitis C and have not previously been treated (treatment-naïve). Further clinical development activities beyond the Phase 2 proof-of-concept study are not covered as part of this collaboration. Additional information on the Phase 2 study will be provided upon initiation of the study.

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