Helicobacter pylori Infections - Pipeline Review, H2 2016

Global Markets Direct’s, ‘Helicobacter pylori Infections - Pipeline Review, H2 2016’, provides an overview of the Helicobacter pylori Infections pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Helicobacter pylori Infections, 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 Helicobacter pylori Infections 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 Helicobacter pylori Infections

The report reviews pipeline therapeutics for Helicobacter pylori Infections 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 Helicobacter pylori Infections therapeutics and enlists all their major and minor projects

The report assesses Helicobacter pylori Infections 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 Helicobacter pylori Infections

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 Helicobacter pylori Infections

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 Helicobacter pylori Infections 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

Daewoong Pharmaceutical Co., Ltd.

Debiopharm International SA

EpiVax, Inc.

Frost Biologic, Inc.

ImevaX GmbH

ImmunoBiology Limited

Recce Pty Ltd

RedHill Biopharma Ltd.

Sequella, Inc.

Sigmoid ...

Daewoong Pharmaceutical Co., Ltd.

Debiopharm International SA

EpiVax, Inc.

Frost Biologic, Inc.

ImevaX GmbH

ImmunoBiology Limited

Recce Pty Ltd

RedHill Biopharma Ltd.

Sequella, Inc.

Sigmoid Pharma Limited

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

Helicobacter pylori ...

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Helicobacter pylori Infections Overview 7

Therapeutics Development 8

Pipeline Products for Helicobacter pylori Infections - Overview 8

Pipeline Products for Helicobacter pylori Infections - Comparative Analysis 9

Helicobacter pylori Infections - Therapeutics under Development by Companies 10

Helicobacter pylori Infections - Therapeutics under Investigation by Universities/Institutes 11

Helicobacter pylori Infections - Pipeline Products Glance 12

Late Stage Products 12

Clinical Stage Products 13

Early Stage Products 14

Helicobacter pylori Infections - Products under Development by Companies 15

Helicobacter pylori Infections - Products under Investigation by Universities/Institutes 16

Helicobacter pylori Infections - Companies Involved in Therapeutics Development 17

Daewoong Pharmaceutical Co., Ltd. 17

Debiopharm International SA 18

EpiVax, Inc. 19

Frost Biologic, Inc. 20

ImevaX GmbH 21

ImmunoBiology Limited 22

Recce Pty Ltd 23

RedHill Biopharma Ltd. 24

Sequella, Inc. 25

Sigmoid Pharma Limited 26

Helicobacter pylori Infections - Therapeutics Assessment 27

Assessment by Monotherapy Products 27

Assessment by Combination Products 28

Assessment by Target 29

Assessment by Mechanism of Action 31

Assessment by Route of Administration 33

Assessment by Molecule Type 34

Drug Profiles 36

(amoxicillin sodium + omeprazole sodium + rifabutin) - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

Debio-1453 - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

DWJ-1325 - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

FROST-900 - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

Helicobacter pylori [strain Hel-305] (multivalent) vaccine - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

Helicobacter pylori vaccine - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

Helicobacter pylori vaccine - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

Helicobacter pylori vaccine - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

Helicobacter pylori vaccine - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

HPi-1 - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

IMX-101 - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

RECCE-327 - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

Small Molecules for Helicobacter Pylori Infections - Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

Small Molecules to Inhibit DNA Synthesis for Infectious Diseases - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

SQ-109 - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

Helicobacter pylori Infections - Dormant Projects 57

Helicobacter pylori Infections - Product Development Milestones 58

Featured News & Press Releases 58

Apr 18, 2016: RedHill Announces Positive FDA Meeting on RHB-105 Path to Approval and Planned Confirmatory Phase III Study for H. pylori Infection 58

Mar 08, 2016: RedHill Biopharma Reports Successful Final Results of Phase III Study with RHB-105 for H. pylori Infection 59

Mar 01, 2016: RedHill Biopharma Provides Update on RHB-105 60

Sep 08, 2015: RedHill Announces Standard-of-Care Eradication Data from the RHB-105 Phase III Study Further Supporting the Study’s Positive Results 61

Aug 26, 2015: Recipharm Signs Agreement with RedHill Biopharma for Manufacturing of RHB-105 for treatment of H. pylori infection 62

Jun 15, 2015: RedHill Biopharma Successfully Meets Primary Endpoint in Phase III Study of RHB-105 for H. pylori Infection 63

Jun 15, 2015: RedHill Biopharma to Host Conference Call to Review Positive Phase III Top-Line Results with RHB-105 for H. pylori Infection 64

Jun 08, 2015: RedHill Biopharma Completes Treatment of Last Patient with RHB-105 in Phase III Study 64

Jun 03, 2015: RedHill Biopharma Provides Update on Development Pipeline and Expected Timing for RHB-105 Phase III Top-Line Results 65

May 18, 2015: RedHill Biopharma’s Investor Webcast Forum Provides Update on the RHB-105 Phase III Program and Potential H. Pylori Eradication Market 67

May 07, 2015: RedHill Biopharma to Host Investor Webcast Forum Following Completion of RHB-105 Dosing in Phase III Study 68

Apr 27, 2015: RedHill Biopharma Announces Completion of Patient Enrollment in a Phase III Study of RHB-105 for H. pylori Infection 69

Apr 16, 2015: RedHill Biopharma Receives Notice of Allowance for Additional U.S. Patent for RHB-105 H. pylori Bacterial Infection Treatment 70

Nov 10, 2014: FDA Grants QIDP Fast-Track Designation To RedHill Biopharma's Phase 3 H. Pylori Drug RHB-105 71

Aug 27, 2014: RedHill Biopharma Provides Update on Expansion of Ongoing RHB-105 Phase III Study, Targeting Broadened H. pylori Indication Authorized by FDA 72

Appendix 74

Methodology 74

Coverage 74

Secondary Research 74

Primary Research 74

Expert Panel Validation 74

Contact Us 74

Disclaimer 75

List of Tables

List of Tables

Number of Products under Development for Helicobacter pylori Infections, H2 2016 8

Number of Products under Development for Helicobacter pylori Infections - ...

List of Tables

Number of Products under Development for Helicobacter pylori Infections, H2 2016 8

Number of Products under Development for Helicobacter pylori Infections - 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

Helicobacter pylori Infections - Pipeline by Daewoong Pharmaceutical Co., Ltd., H2 2016 17

Helicobacter pylori Infections - Pipeline by Debiopharm International SA , H2 2016 18

Helicobacter pylori Infections - Pipeline by EpiVax, Inc., H2 2016 19

Helicobacter pylori Infections - Pipeline by Frost Biologic, Inc., H2 2016 20

Helicobacter pylori Infections - Pipeline by ImevaX GmbH, H2 2016 21

Helicobacter pylori Infections - Pipeline by ImmunoBiology Limited, H2 2016 22

Helicobacter pylori Infections - Pipeline by Recce Pty Ltd, H2 2016 23

Helicobacter pylori Infections - Pipeline by RedHill Biopharma Ltd., H2 2016 24

Helicobacter pylori Infections - Pipeline by Sequella, Inc., H2 2016 25

Helicobacter pylori Infections - Pipeline by Sigmoid Pharma Limited, H2 2016 26

Assessment by Monotherapy Products, H2 2016 27

Assessment by Combination Products, H2 2016 28

Number of Products by Stage and Target, H2 2016 30

Number of Products by Stage and Mechanism of Action, H2 2016 32

Number of Products by Stage and Route of Administration, H2 2016 33

Number of Products by Stage and Molecule Type, H2 2016 35

Helicobacter pylori Infections - Dormant Projects, H2 2016 57

List of Figures

List of Figures

Number of Products under Development for Helicobacter pylori Infections, H2 2016 8

Number of Products under Development for Helicobacter pylori Infections - ...

List of Figures

Number of Products under Development for Helicobacter pylori Infections, H2 2016 8

Number of Products under Development for Helicobacter pylori Infections - 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 27

Number of Products by Targets, H2 2016 29

Number of Products by Stage and Targets, H2 2016 29

Number of Products by Mechanism of Actions, H2 2016 31

Number of Products by Stage and Mechanism of Actions, H2 2016 31

Number of Products by Stage and Routes of Administration, H2 2016 33

Number of Products by Molecule Types, H2 2016 34

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

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