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Vertex, Janssen Reach Deal To Begin Phase 2 All-Oral Study Of VX-135, Simeprevir

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11/1/2012 7:49 AM ET

Vertex Pharmaceuticals Inc. (VRTX: Quote) announced Thursday 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 or HCV polymerase inhibitor VX-135 and Janssen's protease inhibitor simeprevir or TMC435.

Janssen R&D Ireland and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ: Quote).

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 noted that they 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.

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).

The company noted that 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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by RTT Staff Writer

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