HCV new regimen on trial: simeprevir+ VX-135

Janssen Announces Collaboration With Vertex On Phase 2 Study

06/11/2012 06:05 (01:12 minutes ago) The FINANCIAL -- Janssen Pharmaceuticals announced that it has entered into a non-exclusive collaboration with Vertex Pharmaceuticals Incorporated to evaluate in a Phase 2 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's 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 goal of the Phase 2 study will be to evaluate the safety, tolerability and viral cure rates of a 12-week regimen of simeprevir and VX-135, administered with and without ribavirin, in treatment naïve patients who have chronic non-cirrhotic genotype 1 HCV.  As Johnson & Johnson Services reported, the companies will jointly fund development costs associated with the collaboration. There are no up-front or milestone payments associated with the agreement.Simeprevir is an investigational NS3/4A protease inhibitor currently in Phase 3 trials, developed in collaboration with and licensed from Medivir AB. VX-135 is an investigational uridine nucleotide analogue pro-drug designed to inhibit the replication of HCV by acting on the NS5B polymerase."There is a significant unmet need for all-oral treatment regimens for people living with hepatitis C," said Wim Parys, Global Head of Infectious Diseases at Janssen. "Janssen's collaboration with Vertex underscores our commitment to better understand the potential utility of simeprevir in a number of different IFN-free treatment combinations and HCV patient populations."

福泰制药与GSK及杨森合作开发C型肝炎药物 发布时间：2012-11-5 来源：药品资讯网信息中心 福泰制药(Vertex)2日宣布，已与葛兰素史克(GSK)和强生(JNJ)旗下杨森制药(Janssen)达成合作，开发各种潜在药物用于C型肝炎的治疗。 目前，Vertex已有一种C型肝炎药物Incivek上市，该药是当前C型肝炎治疗方案的一种组分，另一种组分为注射药物干扰素。同时，Vertex正在开发另一种C型肝炎药物VX-135，Vertex希望开发VX135作为C型肝炎治疗方案的一部分，替代注射类药物(如干扰素)。 Vertex将分别与GSK和杨森开展研究，将VX-135与后2家公司各自的药物进行组合。这些研究预计将在2013年年初开始。 Vertex目前有2种药物上市，Incivek和Kalydeco，后者为囊性纤维化药物。 Vertex在全球拥有约2100名员工，其中包括剑桥市的近1500名员工，该公司计划在2014年初将总部搬至南波士顿滨水区。