Therapeutic Class Report Overview : Hepatitis C Virus Infection

The launch of Protease inhibitors (PIs) created a wave in 2011-12 and accelerated the pace of innovation and impressive Sustained Virologic Response (SVR) rates by oral IFN free drug combinations have raised the bar and the expectations of pts, physicians and investors. Freedom from IFN, treating all genotypes and betting on vaccines could bring a sea of change in the HCV therapy class area in the future.

Roche set the trend with the acquisition of Anadys for total of $230m followed by GILD buying VRUS for $11b, Bristol-Myers Squibb (BMY) acquired Inhibitex for $2.5b, VRTX acquired Virochem in 2009 for $375m + in-licensed Alios VX-135 in 2012 for total of $775m, and Abbott in-licensed Enantas ABT-450 for total of $310m. In the next spurt of M&A in this sector, we expect companies which offer differentiated MOA to be in the limelight, are (i) Alleviate the need for Ribavarin, (ii) Address resistance, non-responders, Liver cirrhosis, HIV-HCV -co infection etc, (iii) Target other genotypes, and (iv) Vaccines or Boosters of immune system (toll like receptors). In this report, we have analyzed the novel pipeline candidates, which target unmet needs, offer promise of an all oral IFN-free treatment with at par or better efficacy / compliance, and novel vaccine candidates.

Table of Contents.

1. Executive Summary
2. Progress in the Clinical Development of HCV drugs
• Noteworthy progress in the Oral IFN -Free combinations for Treatment of HCV
• Options for the most Challenging Patient Subtypes in HCV
• IFN intolerant and other Genotypes
• Hepatitis C Virus Prevalence in ROW
3. Competitive Landscape – IFN-Free drugs
• Gilead: Sofosbuvir/GS-5885
• Abbott: ABT-450r/ABT-472/ABT-333
• Boehringer Ingelheim: Faldaprevir/BI 207127
• Medevir: Simeprevir
• Vertexs VX-135
• Bristol-Myers: Daclatasvir/Asunaprevir
• Merck: MK-5172/MK-8742
4. Market Dynamics- Present and Future
• Present- Launch of Protease Inhibitors: Sunset Sooner Than Expected.
• Future- the Best-in-Class IFN-Free Oral Pill for HCV
5. HCV Vaccines
• GlobeImmune
• Okairos
• ChronTech Pharma/ Inovio
• Transgenes TG4040
• Profectus Biosciences HCV vaccine
• Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden
6. HCV-HIV Co-infection
• Effects of co-infection
• Companies targeti ng HIV-HCV Co-infection
• Figures – Designs of ongoing IFN-free PhIII trials
• Table – Data from IFN-free combinations
• Table – Viral response in genotype-1 patients – IFN-combinations
• Key Abstract presented at AASLD 12

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