Vertex links with Janssen and GlaxoSmithKline for combo trials with its VX-135 for hepatitis C

US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen Pharmaceuticals unit has entered into a non-exclusive collaboration with Vertex Pharmaceuticals (Nasdaq: VRTX) to evaluate in a Phase II study the safety and efficacy of an all-oral regimen for the treatment of hepatitis C (HCV).

The regimen will include Janssen's investigational protease inhibitor simeprevir (TMC435) and Vertex' investigational nucleotide analogue HCV polymerase inhibitor VX-135. As a first step, Janssen will conduct a drug-drug interaction (DDI) study with simeprevir and VX-135. The DDI study will support the initiation of the Phase 2 study in early 2013 pending discussions with regulatory authorities.

The treatment of hepatitis C is a market sector projected to grow to some $20 billion with the anticipated arrival of oral treatments. After around 20 years of no new products, two new hepatitis C drugs were approved last year: Victrelis (boceprevir) from Merck & Co and Incivek (telaprevir) from Vertex and Johnson & Johnson. However, there have also been some notable developmental failures, including Bristol-Myers Squibb’s BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor that was in Phase II development for the treatment of hepatitis C (The Pharma Letter August 24).