Gastrointestinal Diseases Drug Development Pipeline Review, 2018

This report provides an overview of the pipeline landscape for gastrointestinal diseases. It provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for gastroenteritis, enterocolitis, gastritis and peritonitis, and features dormant and discontinued products.

Gastroenteritis is an infection of the gut. Symptoms include stomach pain, cramping, fever, nausea, and a headache. Causes of gastroenteritis include contaminated food or water and contact with someone who has the virus. Treatment includes antibiotics, anti-emetic and anti-diarrheal medications. There are 12 products in development for this indication.

Enterocolitis is an inflammation of the large and small intestines. Symptoms include fever, abdominal swelling, nausea, diarrhea, rectal bleeding and sluggishness. Causes of enterocolitis include inflammation of the intestinal tissues, delayed gastric emptying, abdominal wall erythema, apnea, sepsis and cardiovascular collapse. Treatment includes antibiotics. There are eight products in development for this indication.

Gastritis is characterized by inflammation or swelling of the lining of the stomach. Acute gastritis lasts for a short period of time while chronic gastritis lasts for a long period of time (months to years). Gastritis can be caused by medications such as ibuprofen, aspirin, naproxen on long periods of consumption, excess intake of alcohol, Helicobacter pylori infection, certain autoimmune disorders, bile reflux, substance abuse (cocaine), consumption of corrosive or caustic substances such as poisons, extreme stress, viral infections and trauma. The symptoms of gastritis may include loss of appetite, nausea and vomiting, abdominal pain and black stools. Treatment includes use of antacids, histamine 2 (H2) antagonists and proton pump inhibitors. There are 11 products in development for this indication.

Peritonitis is inflammation of the peritoneum. There are two types of peritonitis. Spontaneous bacterial peritonitis is the result of an infection of the fluid in the peritoneal cavity. Secondary peritonitis is usually due to an infection that has spread from the digestive tract. Symptoms include abdominal bloating, nausea and vomiting, diarrhea, fatigue, fever and chills. Treatment includes antibiotics. There are seven products in development for this indication.

Molecular targets in development for gastrointestinal diseases include toll-like receptors, interleukin receptors and bacterial proteins. Companies operating in this pipeline space include Kyowa Hakko Kirin, RedHill Biopharma and GlaxoSmithKline.

Scope

– Which companies are the most active within each pipeline?

– Which pharmaceutical approaches are the most prominent at each stage of the pipeline and within each indication?

– To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies?

– What are the most important R&D milestones and data publications to have happened in this disease area?

Reasons to buy

- Understand the overall pipeline, with an at-a-glance overview of all products in therapeutic development for each indication

- Assess the products in development in granular detail, with an up-to-date overview of each individual pipeline program in each indication and a comprehensive picture of recent updates and milestones for each

- Analyze the companies, institutions and universities currently operating in the pipeline and the products being fielded by each of these

- Understand the composition of the pipeline in terms of molecule type, molecular target, mechanism of action and route of administration

Companies mentioned

Avexegen Therapeutics Inc

BCWorld Pharm Co Ltd

Daewon Pharm Co Ltd

Daewoong Pharmaceutical Co Ltd

GlaxoSmithKline Plc

Infant Bacterial Therapeutics AB

Kyowa Hakko Kirin Co Ltd

Leadiant Biosciences Inc

Medicago Inc

Nosopharm SAS

Ology Bioservices Inc

Oncodesign SA

ProMetic Life Sciences Inc

Recce Ltd

RedHill Biopharma Ltd

Regeneron Pharmaceuticals Inc

Sequella Inc

SynAct Pharma AB

Takeda Pharmaceutical Co Ltd

UMN Pharma Inc

Vaxart Inc

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 5

1.2 List of Figures 5

2 Introduction 6

2.1 Gastrointestinal Diseases Report Coverage 6

2.2 Gastroenteritis - Overview 6

2.3 Enterocolitis - Overview 6

2.4 Gastritis - Overview 6

2.5 Peritonitis - Overview 6

3 Therapeutics Development 7

3.1 Gastroenteritis 7

3.2 Enterocolitis 11

3.3 Gastritis 14

3.4 Peritonitis 17

4 Therapeutics Assessment 20

4.1 Gastroenteritis 20

4.2 Enterocolitis 26

4.3 Gastritis 31

4.4 Peritonitis 37

5 Companies Involved in Therapeutics Development 44

5.1 Gastroenteritis 44

5.2 Enterocolitis 49

5.3 Gastritis 51

5.4 Peritonitis 55

6 Dormant Projects 58

6.1 Gastroenteritis 58

6.2 Enterocolitis 58

6.3 Gastritis 59

6.4 Peritonitis 60

7 Discontinued Products 61

7.1 Gastroenteritis 61

8 Product Development Milestones 62

8.1 Gastroenteritis 62

8.2 Enterocolitis 78

8.3 Gastritis 87

8.4 Peritonitis 94

9 Appendix 96

9.1 Methodology 96

9.2 Coverage 96

9.3 Secondary Research 96

9.4 Primary Research 96

9.5 Expert Panel Validation 96

9.6 Contact Us 96

9.7 Disclaimer 97

List of Tables

1.1 List of Tables

Table 1: Number of Products under Development for Gastroenteritis 8

Table 2: Number of Products under Development by Companies, Gastroenteritis 9

Table 3: Number of Products under Development by Universities/Institutes, Gastroenteritis 10

Table 4: Products under Development by Companies, Gastroenteritis 11

Table 5: Products under Development by Universities/Institutes, Gastroenteritis 11

Table 6: Number of Products under Development for Enterocolitis 12

Table 7: Number of Products under Development by Companies, Enterocolitis 13

Table 8: Number of Products under Development by Universities/Institutes, Enterocolitis 14

Table 9: Products under Development by Companies, Enterocolitis 14

Table 10: Products under Development by Universities/Institutes, Enterocolitis 14

Table 11: Number of Products under Development for Gastritis 15

Table 12: Number of Products under Development by Companies, Gastritis 16

Table 13: Products under Development by Companies, Gastritis 17

Table 14: Number of Products under Development for Peritonitis 18

Table 15: Number of Products under Development by Companies, Peritonitis 19

Table 16: Products under Development by Companies, Peritonitis 20

Table 17: Number of Products by Stage and Target, Gastroenteritis 22

Table 18: Number of Products by Stage and Mechanism of Action, Gastroenteritis 23

Table 19: Number of Products by Stage and Route of Administration, Gastroenteritis 25

Table 20: Number of Products by Stage and Molecule Type, Gastroenteritis 26

Table 21: Number of Products by Stage and Target, Enterocolitis 28

Table 22: Number of Products by Stage and Mechanism of Action, Enterocolitis 29

Table 23: Number of Products by Stage and Route of Administration, Enterocolitis 30

Table 24: Number of Products by Stage and Molecule Type, Enterocolitis 32

Table 25: Number of Products by Stage and Target, Gastritis 33

Table 26: Number of Products by Stage and Mechanism of Action, Gastritis 35

Table 27: Number of Products by Stage and Route of Administration, Gastritis 36

Table 28: Number of Products by Stage and Molecule Type, Gastritis 38

Table 29: Number of Products by Stage and Target, Peritonitis 39

Table 30: Number of Products by Stage and Mechanism of Action, Peritonitis 41

Table 31: Number of Products by Stage and Route of Administration, Peritonitis 42

Table 32: Number of Products by Stage and Molecule Type, Peritonitis 44

Table 33: Gastroenteritis – Pipeline by Kyowa Hakko Kirin Co Ltd 45

Table 34: Gastroenteritis – Pipeline by Medicago Inc 46

Table 35: Gastroenteritis – Pipeline by Ology Bioservices Inc 46

Table 36: Gastroenteritis – Pipeline by RedHill Biopharma Ltd 47

Table 37: Gastroenteritis – Pipeline by Regeneron Pharmaceuticals Inc 47

Table 38: Gastroenteritis – Pipeline by Takeda Pharmaceutical Co Ltd 48

Table 39: Gastroenteritis – Pipeline by UMN Pharma Inc 49

Table 40: Gastroenteritis – Pipeline by Vaxart Inc 49

Table 41: Enterocolitis – Pipeline by Avexegen Therapeutics Inc 50

Table 42: Enterocolitis – Pipeline by Infant Bacterial Therapeutics AB 50

Table 43: Enterocolitis – Pipeline by Leadiant Biosciences Inc 51

Table 44: Enterocolitis – Pipeline by ProMetic Life Sciences Inc 51

Table 45: Gastritis – Pipeline by BCWorld Pharm Co Ltd 52

Table 46: Gastritis – Pipeline by Daewon Pharm Co Ltd 53

Table 47: Gastritis – Pipeline by Daewoong Pharmaceutical Co Ltd 53

Table 48: Gastritis – Pipeline by Kyowa Hakko Kirin Co Ltd 54

Table 49: Gastritis – Pipeline by Recce Ltd 55

Table 50: Gastritis – Pipeline by RedHill Biopharma Ltd 55

Table 51: Gastritis – Pipeline by Sequella Inc 56

Table 52: Peritonitis – Pipeline by GlaxoSmithKline Plc 56

Table 53: Peritonitis – Pipeline by Nosopharm SAS 57

Table 54: Peritonitis – Pipeline by Oncodesign SA 57

Table 55: Peritonitis – Pipeline by SynAct Pharma AB 58

Table 56: Gastroenteritis – Dormant Projects 59

Table 57: Enterocolitis – Dormant Projects 59

Table 58: Gastritis – Dormant Projects 60

Table 59: Peritonitis – Dormant Projects 61

Table 60: Gastroenteritis – Discontinued Products 62

List of Figures

1.2 List of Figures

Figure 1: Number of Products under Development for Gastroenteritis 8

Figure 2: Number of Products under Development by Companies, Gastroenteritis 9

Figure 3: Number of Products under Development by Universities/Institutes, Gastroenteritis 10

Figure 4: Number of Products under Development for Enterocolitis 12

Figure 5: Number of Products under Development by Companies, Enterocolitis 13

Figure 6: Number of Products under Development for Gastritis 15

Figure 7: Number of Products under Development by Companies, Gastritis 16

Figure 8: Number of Products under Development for Peritonitis 18

Figure 9: Number of Products under Development by Companies, Peritonitis 19

Figure 10: Number of Products by Targets, Gastroenteritis 21

Figure 11: Number of Products by Stage and Targets, Gastroenteritis 21

Figure 12: Number of Products by Mechanism of Actions, Gastroenteritis 22

Figure 13: Number of Products by Stage and Mechanism of Actions, Gastroenteritis 23

Figure 14: Number of Products by Routes of Administration, Gastroenteritis 24

Figure 15: Number of Products by Stage and Routes of Administration, Gastroenteritis 24

Figure 16: Number of Products by Molecule Types, Gastroenteritis 25

Figure 17: Number of Products by Stage and Molecule Types, Gastroenteritis 26

Figure 18: Number of Products by Targets, Enterocolitis 27

Figure 19: Number of Products by Stage and Targets, Enterocolitis 27

Figure 20: Number of Products by Mechanism of Actions, Enterocolitis 28

Figure 21: Number of Products by Stage and Mechanism of Actions, Enterocolitis 29

Figure 22: Number of Products by Stage and Routes of Administration, Enterocolitis 30

Figure 23: Number of Products by Molecule Types, Enterocolitis 31

Figure 24: Number of Products by Stage and Molecule Types, Enterocolitis 31

Figure 25: Number of Products by Targets, Gastritis 32

Figure 26: Number of Products by Stage and Targets, Gastritis 33

Figure 27: Number of Products by Mechanism of Actions, Gastritis 34

Figure 28: Number of Products by Stage and Mechanism of Actions, Gastritis 34

Figure 29: Number of Products by Routes of Administration, Gastritis 35

Figure 30: Number of Products by Stage and Routes of Administration, Gastritis 36

Figure 31: Number of Products by Molecule Types, Gastritis 37

Figure 32: Number of Products by Stage and Molecule Types, Gastritis 37

Figure 33: Number of Products by Targets, Peritonitis 38

Figure 34: Number of Products by Stage and Targets, Peritonitis 39

Figure 35: Number of Products by Mechanism of Actions, Peritonitis 40

Figure 36: Number of Products by Stage and Mechanism of Actions, Peritonitis 40

Figure 37: Number of Products by Routes of Administration, Peritonitis 41

Figure 38: Number of Products by Stage and Routes of Administration, Peritonitis 42

Figure 39: Number of Products by Molecule Types, Peritonitis 43

Figure 40: Number of Products by Stage and Molecule Types, Peritonitis 43

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