samatasvir (IDX719) / Merck (MSD) - LARVOL DELTA

JNJ Pharmaceuticals: Business Review (Johnson and Johnson Ltd) - Anticipated first data from P2 (simeprevir+IDX719+TMC647055) trial for genotype 1b and genotype 4 treatment naïves hep C patients with fibrosis (stage F0-F3) in H1 2014; Anticipated first data from P2 (simeprevir+IDX719+TMC647055) trial for genotype 1 treatment naïves hep C patients with fibrosis (stage F0-F3) in H1 2014

Anticipated P2 data • Hepatitis C Virus

To evaluate the pharmacokinetics of IDX719 in subjects with normal and impaired hepatic function (clinicaltrials.gov) - P1, N=36; Sponsor: Idenix; Not yet recruiting -> Completed.

Trial completion • Hepatitis C Virus

Idenix: Cowen & Company Healthcare Conference (Idenix) - Anticipated initiation of P2 samatasvir + IDX21437 combo trial for hep C infection in H2 2014; Anticipated SVR4 data from P2 samatasvir + IDX21437 combo trial for hep C infection in H2 2014

Anticipated new P2 trial • Anticipated P2 data • Hepatitis C Virus

The preclinical profile of the pan-genotypic HCV NS5A inhibitor IDX719 demonstrates its potential for combination therapy (7th International Workshop on Hepatitis C - Resistance & New Compounds) - IDX719 showed a lack of cross-resistance with other classes of DAAs and low potential for DDIs;

Clinical data • Hepatitis C Virus

Pharmacokinetics and pharmacodynamics of IDX719, a pan-genotypic HCV NS5A inhibitor, in genotype 1, 2, 3 or 4 HCV-infected subjects (APASL 2013) - Presentation time: 07.06.2013, 08:30-17:30; P=NA, N=82; Sponsor: Idenix; "IDX719 was well-tolerated with no safety-related discontinuations or serious adverse events. In HCV-infected subjects, IDX719 exhibited dose-related plasma exposure and a long half-life (~20 h).Trough plasma concentrations (mean C24h=16 ng/mL at 100 mg on day 3) largely exceeded the protein-binding adjusted EC90 (~2.3 ng/mL) associated with the least susceptible HCV genotype."

PK/PD data • Hepatitis C Virus

Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001) (clinicaltrials.gov) - P1/2; N=130; Completed; Sponsor: Merck Sharp & Dohme Corp.; Trial primary completion date: Apr 2012 ->Jul 2012

Trial primary completion date • Biosimilar • Hepatitis C Virus • Immunology • Inflammation

After several FDA setbacks, Idenix to begin clinical study of new HCV nuc outside the U.S. (Health News Daily) - “...it will begin Phase I/II study of…IDX21437 in Canada and Belgium, bypassing FDA oversight in the early stages....moving forward in studying its NS5A inhibitor, samatasvir (IDX719), in tandem with...simeprevir...”

Anticipated new P2/3 trial • Hepatitis C Virus

Idenix Pharmaceuticals: Q3 2013 Results (Idenix) - Anticipated initiation of P2 HELIX-2 (IDX719 + simeprevir + TMC647055) trial for genotype 1 or 4 treatment-naïve hep C infected patients in 2014; Anticipated 12-week data from P2 HELIX-1 (IDX719 + simeprevir + ribavirin) trial for genotype 1b or 4 treatment-naïve, non-cirrhotic hep C infected first cohort patients in late Q4 2013

Anticipated new P2 trial • Anticipated P2 data • Hepatitis C Virus

Idenix Pharmaceuticals reports sustained virologic response rate (SVR4) for phase II all-oral combination study of samatasvir (IDX719), a potent, pan-genotypic HCV NS5A inhibitor, and simeprevir (Idenix Press Release) - P2, N=90; HELIX-1 (NCT01852604); Sponsor: Idenix; "In the treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients receiving 50 mg of samatasvir and 150 mg of simeprevir plus ribavirin, 85 percent (n=17/20) remained undetectable for HCV RNA four weeks after completing therapy (SVR4)....The HELIX-1 study results are expected to be presented at a scientific meeting in 2014....we are on track to initiate an Idenix-sponsored combination study of samatasvir and IDX21437 by mid-2014."

Anticipated new trial • Anticipated P2 data • P2 data • Hepatitis C Virus

Idenix: Bank of America Merrill Lynch Health Care Conference (Idenix) - Anticipated launch of IDX719 + simeprevir + TMC647055/ritonavir triple combo for genotype 1 and 4 hep C infected patients in 2016

Anticipated launch • Hepatitis C Virus

Idenix Pharmaceuticals announces initiation of phase II all-oral combination study of samatasvir (IDX719) and simeprevir (TMC435) for the treatment of hepatitis C virus (HCV) infection (Idenix) - P2, N=90; HELIX-1 (NCT01852604); Sponsor: Idenix; "Idenix ...announced the initiation of the phase II HELIX-1 clinical trial evaluating ...samatasvir (IDX719), ...and simeprevir (TMC435) ...HELIX-1 trial is a 12-week, randomized, double-blind, parallel group study evaluating the safety and tolerability of samatasvir and simeprevir ...90 treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients ...A second trial (HELIX-2) of samatasvir, simeprevir and TMC647055 ...is expected to initiate in the second half of 2013."

Anticipated new trial • Enrollment status • New P2 trial • Hepatitis C Virus

IDX719 in combination with simeprevir and ribavirin for 12 weeks in subjects with chronic hepatitis C infection (clinicaltrials.gov) - P2, N=90; Sponsor: Idenix; Recruiting; New P2 trial.

New P2 trial • Hepatitis C Virus

Idenix: Bank of America Merrill Lynch Health Care Conference (Idenix) - Anticipated launch of samatasvir + IDX21437 combo for hep C infection in 2017

Anticipated launch • Hepatitis C Virus

Idenix announces positive clinical data for HCV drug candidates IDX184 and IDX719 (Idenix) - P2b, N=31; NCT01371604; Of 9 of 31 pts who completed 12-week PegIFN/RBV extended treatment phase, 100% of pts (4/4) in the 100 mg arm and 80% of pts (4/5) in the 50 mg arm achieved SVR 4 weeks after the completion of treatment; Idenix announced positive data from a three-day POC study evaluating IDX719, treatment-naïve, genotype 1, 2, 3 or 4 HCV-infected pts; Detailed findings on IDX719 expected to be presented at a scientific meeting in H2 2012

P2b data • Hepatitis C Virus

Pharmacokinetic (PK) drug-drug interaction between samatasvir (IDX719), a pan-genotypic NS5A inhibitor, and simeprevir in healthy volunteers and HCV-infected subjects (EASL 2014) - Presentation time: 12.04.2014, 09:00-18:00; Abstract #P1221; P2, N=92; HELIX-1 (NCT01852604); Sponsor: Idenix; “In healthy subjects, steady-state plasma exposures of samatasvir approximately doubled (mean ratios 1.87 and 2.22 for Cmax and AUC) in the presence of simeprevir. Plasma exposures of simeprevir were increased by 40-50% (mean ratios 1.47 and 1.49 for Cmax and AUC) in the presence of samatasvir. Elimination half-lives of both drugs remained unaffected.”

PK/PD data • Hepatitis C Virus

Idenix reports favorable resistance profile for IDX719, a potent, pan-genotypic HCV NS5A inhibitor, at EASL meeting (EASL 2013, Idenix) - P1/2, N=64; NCT01508156; Sponsor: Idenix; "Data from the three-day proof-of-concept study demonstrated that IDX719 was well-tolerated at daily doses up to 100 mg and showed potent antiviral activity across HCV genotypes 1-4, with mean maximal viral load reductions up to approximately 4.0 log10 IU/mL ...evaluating IDX719 as part of all-oral combination therapies through our collaboration with Janssen ...initiation of a phase II clinical trial of IDX719 and simeprevir in the first half of this year."

Anticipated new P2 trial • P1/2 data • Hepatitis C Virus

Idenix reports favorable resistance profile for IDX719, a potent, pan-genotypic HCV NS5A inhibitor, at EASL meeting (EASL 2013, Idenix) - P1/2, N=64; NCT01508156; Sponsor: Idenix; "Data from the three-day proof-of-concept study demonstrated that IDX719 was well-tolerated at daily doses up to 100 mg and showed potent antiviral activity across HCV genotypes 1-4, with mean maximal viral load reductions up to approximately 4.0 log10 IU/mL ...evaluating IDX719 as part of all-oral combination therapies through our collaboration with Janssen ...initiation of a phase II clinical trial of IDX719 and simeprevir in the first half of this year."

Anticipated new P2 trial • P1/2 data • Hepatitis C Virus

A phase II study of samatasvir (IDX719) in combination with simeprevir and ribavirin in treatment-naïve HCV-infected subjects with genotypes 1b and 4 (HELIX-1 study) (EASL 2014) - Presentation time: 12.04.2014, 09:00-18:00; Abstract #P1222; P2, N=63; Study ID; HELIX -1; NCT01852604; Sponsor: Idenix; “Mean baseline HCV RNA was 6.4 log10 IU/mL…The most frequently reported adverse events were fatigue (21%), pruritus (16%), anemia (11%) and nausea (11%). The trial is ongoing; complete end-of-treatment (EOT) response and SVR data for these subjects will be presented.”

Anticipated P2 data • P2 data • Hepatitis C Virus

Idenix: Cowen & Company Healthcare Conference (Idenix) - "HELIX-1 Phase II Clinical Trial"; "Objectives: safety and tolerability, efficacy (primary SVR4 with supportive SVR12 and SVR 24), pharmacokinetics and pharmacodynamics, emergence of resistance"; "Well-tolerated with no treatment-related serious adverse events in the clinical trial to date"

P2 data • Hepatitis C Virus

Idenix: Barclays Healthcare Conference (Idenix) - Anticipated initiation of oral P2 combo (IDX 719+TMC435+RBV) trial for HCV in Q2 2013; Anticipated initiation of P2 combo (IDX719+TMC435+TMC055/r+/-RBV) trial for HCV in Q3 2013; Anticipated completion of P2 combo (IDX719+TMC435+TMC055/r+/-RBV) trial for HCV in Q1 2014; Anticipated IND filing for combo trial (IDX "U" Nuc+IDX719+/-RBV) for HCV in H1 2013; Anticipated initiation of POC study for HCV in H2 2013; Anticipated initiation of P2 study for HCV in Q4 2013

Anticipated IND • Anticipated new P2 trial • Anticipated new trial • Anticipated trial initiation date • Hepatitis C Virus

Idenix: J.P. Morgan Healthcare Conference (Idenix) - Anticipated initiation of 12-week P2 (DAA combo) trial for HCV in H1 2013; Anticipated initiation of P3 (DAA combo) trial for HCV in 2014; Anticipated initiation of P2 (nuc combo) trial for HCV in 2014; Anticipated initiation of P3 (nuc combo) trial for HCV in 2015; Anticipated completion of 12-week P2 (DAA combo) trial for HCV in H1 2014; Anticipated completion of P3 (DAA combo) trial for HCV in 2016; Anticipated completion of P2 (nuc combo) trial for HCV in 2014/2015; Anticipated completion of P3 (nuc combo) trial for HCV in 2016

Anticipated new P2 trial • Anticipated new P3 trial • Anticipated trial completion date • Hepatitis C Virus

Idenix Pharmaceuticals reports fourth quarter and year ended 2013 financial results (Idenix Press Release) - "In January 2014, Idenix initiated the seven-day proof-of-concept portion of a phase I/II clinical trial for IDX21437....Data are expected in the first half of 2014....Data from the HELIX-2 trial are expected in the second half of 2014....'With the advancement of our two HCV clinical programs, we remain on track to initiate an Idenix-sponsored combination clinical trial of samatasvir and IDX21437 by mid-2014.' 

Anticipated new trial • Anticipated P1/2 data • Anticipated P2 data • Hepatitis C Virus