Hepatitis D – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Hepatitis D – Pipeline Review, H2 2016’, provides an overview of the Hepatitis D pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Hepatitis D, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Hepatitis D and features dormant and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data.

Scope

The report provides a snapshot of the global therapeutic landscape of Hepatitis D

The report reviews pipeline therapeutics for Hepatitis D by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved Hepatitis D therapeutics and enlists all their major and minor projects

The report assesses Hepatitis D therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news related to pipeline therapeutics for Hepatitis D

Reasons to buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of therapeutics under development for Hepatitis D

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Hepatitis D pipeline depth and focus of Indication therapeutics

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Companies mentioned

Alnylam Pharmaceuticals, Inc.

Arrowhead Pharmaceuticals, Inc.

Eiger BioPharmaceuticals, Inc.

F. Hoffmann-La Roche Ltd.

Globeimmune, Inc.

REPLICor Inc.

Rodos BioTarget GmbH

SomaGenics, Inc.

Spring Bank Pharmaceuticals, Inc.

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Hepatitis D Overview 7

Therapeutics Development 8

Pipeline Products for Hepatitis D - Overview 8

Pipeline Products for Hepatitis D - Comparative Analysis 9

Hepatitis D - Therapeutics under Development by Companies 10

Hepatitis D - Therapeutics under Investigation by Universities/Institutes 11

Hepatitis D - Pipeline Products Glance 12

Late Stage Products 12

Clinical Stage Products 13

Early Stage Products 14

Hepatitis D - Products under Development by Companies 15

Hepatitis D - Products under Investigation by Universities/Institutes 16

Hepatitis D - Companies Involved in Therapeutics Development 17

Alnylam Pharmaceuticals, Inc. 17

Arrowhead Pharmaceuticals, Inc. 18

Eiger BioPharmaceuticals, Inc. 19

F. Hoffmann-La Roche Ltd. 20

Globeimmune, Inc. 21

REPLICor Inc. 22

Rodos BioTarget GmbH 23

SomaGenics, Inc. 24

Spring Bank Pharmaceuticals, Inc. 25

Hepatitis D - Therapeutics Assessment 26

Assessment by Monotherapy Products 26

Assessment by Target 27

Assessment by Mechanism of Action 29

Assessment by Route of Administration 31

Assessment by Molecule Type 33

Drug Profiles 35

ALN-HDV - Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

ARC-520 - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

GI-18000 - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

lonafarnib - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

Myrcludex-B - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

peginterferon alfa-2a - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

peginterferon lambda-1a - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

RBT-05 - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

REP-2139 - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

REP-2165 - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

RNAi Oligonucleotide for Hepatitis D - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

SB-9200 - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

vanitaracin A - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

Hepatitis D - Dormant Projects 67

Hepatitis D - Product Development Milestones 68

Featured News & Press Releases 68

Sep 07, 2016: Eiger Announces Completion of Dosing in Phase 2 LOWR HDV - 4 Study at Hannover Medical School 68

Jul 20, 2016: Eiger BioPharmaceuticals Announces Completion of Dosing in Phase 2 LOWR HDV - 3 Study at National Institutes of Health 68

Jun 01, 2016: Maxwell Biotech Venture Fund's Portfolio Company Hepatera Announces Publication of Myrcludex B Clinical Results in Journal of Hepatology 69

May 25, 2016: Maxwell Biotech Venture Fund's Portfolio Company Hepatera Announces Start Of Second Phase 2 Clinical Trial Of Myrcludex B In Chronic Hepatitis B/D Infection 69

Apr 29, 2016: Interim Results Of A Phase Ib/IIa Study Of The Entry Inhibitor Myrcludex B 69

Apr 04, 2016: Replicor to Make Three Presentations at EASL 2016 70

Mar 30, 2016: Eiger BioPharmaceuticals Announces Abstracts and Presentations of Lonafarnib Data in Hepatitis Delta at the European Association for the Study of the Liver Meeting 70

Mar 23, 2016: Maxwell Biotech Venture Fund’s Portfolio Company Hepatera Announces Start of Phase 2b clinical trial of Myrcludex B, a Novel Entry Inhibitor for Treatment of Chronic HBV and HDV Infection 71

Mar 14, 2016: Eiger BioPharmaceuticals Announces Completion of Enrollment of Phase 2 LOWR HDV - 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus - 4) Study at Hannover Medical School 72

Jan 19, 2016: Eiger BioPharmaceuticals Announces Completion of Enrollment of Phase 2 LOWR HDV - 3 (LOnafarnib With Ritonavir in Hepatitis Delta Virus - 3) Study at National Institutes of Health 72

Jan 06, 2016: Eiger BioPharmaceuticals Announces First Patient Dosed in Phase 2 LOWR HDV - 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus - 4) Study at Hannover Medical School in Hannover, Germany 73

Jul 20, 2015: The Lancet Infectious Diseases Journal Publishes Results of Phase 2 Study of Lonafarnib in Hepatitis Delta Virus Infected Patients 73

Jun 30, 2015: Replicor Discloses Updated Clinical Trial Data to the Global Virus Hepatitis Summit in Berlin 73

Jun 10, 2015: Replicor to Present at the Israel Association for the Study of Liver Conference and the Global Virus Hepatitis Summit in Berlin in June 74

Apr 29, 2015: Significant Reduction of HBsAg and HDV RNA by REP 2139-Ca in Caucasian Patients with HBV / HDV Co-Infection 74

Appendix 76

Methodology 76

Coverage 76

Secondary Research 76

Primary Research 76

Expert Panel Validation 76

Contact Us 76

Disclaimer 77

List of Tables

List of Tables

Number of Products under Development for Hepatitis D, H2 2016 8

Number of Products under Development for Hepatitis D – Comparative Analysis, H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Number of Products under Investigation by Universities/Institutes, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 12

Comparative Analysis by Clinical Stage Development, H2 2016 13

Comparative Analysis by Early Stage Development, H2 2016 14

Products under Development by Companies, H2 2016 15

Products under Investigation by Universities/Institutes, H2 2016 16

Hepatitis D – Pipeline by Alnylam Pharmaceuticals, Inc., H2 2016 17

Hepatitis D – Pipeline by Arrowhead Pharmaceuticals, Inc., H2 2016 18

Hepatitis D – Pipeline by Eiger BioPharmaceuticals, Inc., H2 2016 19

Hepatitis D – Pipeline by F. Hoffmann-La Roche Ltd., H2 2016 20

Hepatitis D – Pipeline by Globeimmune, Inc., H2 2016 21

Hepatitis D – Pipeline by REPLICor Inc., H2 2016 22

Hepatitis D – Pipeline by Rodos BioTarget GmbH, H2 2016 23

Hepatitis D – Pipeline by SomaGenics, Inc., H2 2016 24

Hepatitis D – Pipeline by Spring Bank Pharmaceuticals, Inc., H2 2016 25

Assessment by Monotherapy Products, H2 2016 26

Number of Products by Stage and Target, H2 2016 28

Number of Products by Stage and Mechanism of Action, H2 2016 30

Number of Products by Stage and Route of Administration, H2 2016 32

Number of Products by Stage and Molecule Type, H2 2016 34

Hepatitis D – Dormant Projects, H2 2016 67

List of Figures

List of Figures

Number of Products under Development for Hepatitis D, H2 2016 8

Number of Products under Development for Hepatitis D – Comparative Analysis, H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Comparative Analysis by Early Stage Products, H2 2016 14

Assessment by Monotherapy Products, H2 2016 26

Number of Products by Targets, H2 2016 27

Number of Products by Stage and Targets, H2 2016 27

Number of Products by Mechanism of Actions, H2 2016 29

Number of Products by Stage and Mechanism of Actions, H2 2016 29

Number of Products by Routes of Administration, H2 2016 31

Number of Products by Stage and Routes of Administration, H2 2016 31

Number of Products by Molecule Types, H2 2016 33

Number of Products by Stage and Molecule Types, H2 2016 33

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