Marktanalyse - Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline Review, H2 2016

Global Markets Direct
12.2016
87 Seiten

 
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Marktanalyse
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  • Europa
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Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline Review, H2 2016


Summary


Global Markets Direct's latest Pharmaceutical and Healthcare disease pipeline guide Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) — Pipeline Review, H2 2016, provides an overview of the Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) (Immunology) pipeline landscape.

Hereditary angioedema (HAE) is a rare inherited disease that causes considerable swelling in various body tissues, such as the abdomen or face. Symptoms include severe abdominal pain and cramping, dehydration, diarrhea and shock, hoarse voice, difficulty swallowing and difficulty breathing. Treatment includes medications, such as epinephrine, antihistamines, and corticosteroids.

Report Highlights

Global Markets Direct's Pharmaceutical and Healthcare latest pipeline guide Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) — Pipeline Review, H2 2016, provides comprehensive information on the therapeutics under development for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) (Immunology), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases.

The Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) (Immunology) pipeline guide also reviews of key players involved in therapeutic development for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Phase III, Phase II, Phase I, Preclinical and Discovery stages are 1, 3, 2, 4, 9 and 1 respectively.

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) (Immunology) pipeline guide 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. The guide 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. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data.


Scope

- The pipeline guide provides a snapshot of the global therapeutic landscape of Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) (Immunology).
- The pipeline guide reviews pipeline therapeutics for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) (Immunology) by companies and universities/research institutes based on information derived from company and industry-specific sources.
- The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages.
- The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities.
- The pipeline guide reviews key companies involved in Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) (Immunology) therapeutics and enlists all their major and minor projects.
- The pipeline guide evaluates Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) (Immunology) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type.
- The pipeline guide encapsulates all the dormant and discontinued pipeline projects.
- The pipeline guide reviews latest news related to pipeline therapeutics for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) (Immunology)


Reasons to buy

- Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies.
- Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage.
- Find and recognize significant and varied types of therapeutics under development for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) (Immunology).
- Classify potential new clients or partners in the target demographic.
- Develop tactical initiatives by understanding the focus areas of leading companies.
- Plan mergers and acquisitions meritoriously by identifying key players and it’s most promising pipeline therapeutics.
- Formulate corrective measures for pipeline projects by understanding Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) (Immunology) 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.
- Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline.
Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) Overview 8

Therapeutics Development 9

Pipeline Products for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Overview 9

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Therapeutics under Development by Companies 10

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline Products Glance 11

Late Stage Products 11

Clinical Stage Products 12

Early Stage Products 13

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Products under Development by Companies 14

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Companies Involved in Therapeutics Development 16

ActiveSite Pharmaceuticals Inc 16

Adverum Biotechnologies Inc 17

Arrowhead Pharmaceuticals Inc 18

BioCryst Pharmaceuticals Inc 19

Cevec Pharmaceuticals GmbH 20

CSL Ltd 21

Global Blood Therapeutics Inc 22

iBio Inc 23

Ionis Pharmaceuticals Inc 24

Kalvista Pharmaceuticals Ltd 25

Pharming Group NV 26

ProMetic Life Sciences Inc 27

Shire Plc 28

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Therapeutics Assessment 29

Assessment by Monotherapy Products 29

Assessment by Target 30

Assessment by Mechanism of Action 32

Assessment by Route of Administration 34

Assessment by Molecule Type 36

Drug Profiles 38

ADVM-053 - Drug Profile 38

Product Description 38

Mechanism Of Action 38

R&D Progress 38

ARCF-12 - Drug Profile 39

Product Description 39

Mechanism Of Action 39

R&D Progress 39

BCX-7353 - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

BEL-0215 - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

C1 esterase inhibitor (human) - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

C1 esterase inhibitor (human) - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

C1 esterase inhibitor (human) - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

C1 esterase inhibitor (recombinant) - Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

C1 esterase inhibitor (recombinant) - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

CSL-312 - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

GBT-18713 - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

icatibant acetate - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

IONIS-PKKRx - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

KVD-818 - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

lanadelumab - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

Recombinant Protein to Inhibit C1-esterase for Hereditary Angioedema - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

SHP-623 - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

Small Molecules to Inhibit Plasma Kallikrein for Hereditary Angioedema - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

Small Molecules to Inhibit Plasma Kallikrein for Hereditary Angioedema - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

Small Molecules to Inhibit Plasma Kallikrein for Hereditary Angioedema - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Dormant Projects 75

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Discontinued Products 76

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Product Development Milestones 77

Featured News & Press Releases 77

Dec 01, 2016: CSL Commits to New Phase I Clinical Trials of CSL312 in Australia 77

Nov 14, 2016: Pharming Announces the Presentation of the Results of the RUCONEST Phase II study for Prophylaxis of Hereditary Angioedema Attacks 78

Nov 10, 2016: Pharming Group Receives CHMP Positive Opinion recommending change to the terms of the marketing authorisation for Ruconest 78

Aug 30, 2016: FDA Accepts CSL Behring’s BLA for First Subcutaneous Prophylactic Therapy to Prevent Hereditary Angioedema Attacks 78

Aug 11, 2016: BioCryst Announces Initiation of the APeX-1 Clinical Trial of BCX7353 for Hereditary Angioedema 79

Jul 18, 2016: U.S. FDA Approves CSL Behrings Berinert as the First and Only Pediatric Treatment for Hereditary Angioedema (HAE) 79

Jul 18, 2016: Pharming Announces Positive Results from Randomized Controlled Trial with RUCONEST for HAE Prophylaxis 79

May 19, 2016: KalVista Pharmaceuticals to Support Global Conference Focused on Hereditary Angioedema 81

Apr 07, 2016: Pharming Announces Adoption By The European Commission Of The CHMP Recommendation To Change The Terms Of The Marketing Authorisation For Ruconest 81

Mar 23, 2016: CINRYZE (C1 inhibitor [human]) now available in Canada 82

Feb 26, 2016: Pharming Announces Positive CHMP Opinion To Change The Terms Of The Marketing Authorisation For Ruconest 82

Feb 09, 2016: Pharming And Cytobioteck Announce Extension Of Distribution Agreement For Ruconest 83

Jan 06, 2016: Pharming Announces Completion Of Patient Enrolment In Clinical Study Of Ruconest For Prophylaxis Of Hereditary Angioedema 84

Dec 21, 2015: Pharming And Hyupjin Announce Receipt Of The South Korean Marketing Authorisation For Ruconest 84

Dec 07, 2015: European Medicines Agency Reaffirms Important Health Benefits and Safety of RUCONEST for Patients With Hereditary Angio-edema 85

Appendix 86

Methodology 86

Coverage 86

Secondary Research 86

Primary Research 86

Expert Panel Validation 86

Contact Us 86

Disclaimer 87





List of Tables

Number of Products under Development for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency), H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Comparative Analysis by Late Stage Development, H2 2016 11

Comparative Analysis by Clinical Stage Development, H2 2016 12

Comparative Analysis by Early Stage Development, H2 2016 13

Products under Development by Companies, H2 2016 14

Products under Development by Companies, H2 2016 (Contd..1) 15

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by ActiveSite Pharmaceuticals Inc, H2 2016 16

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by Adverum Biotechnologies Inc, H2 2016 17

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by Arrowhead Pharmaceuticals Inc, H2 2016 18

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by BioCryst Pharmaceuticals Inc, H2 2016 19

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by Cevec Pharmaceuticals GmbH, H2 2016 20

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by CSL Ltd, H2 2016 21

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by Global Blood Therapeutics Inc, H2 2016 22

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by iBio Inc, H2 2016 23

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by Ionis Pharmaceuticals Inc, H2 2016 24

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by Kalvista Pharmaceuticals Ltd, H2 2016 25

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by Pharming Group NV, H2 2016 26

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by ProMetic Life Sciences Inc, H2 2016 27

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Pipeline by Shire Plc, H2 2016 28

Assessment by Monotherapy Products, H2 2016 29

Number of Products by Stage and Target, H2 2016 31

Number of Products by Stage and Mechanism of Action, H2 2016 33

Number of Products by Stage and Route of Administration, H2 2016 35

Number of Products by Stage and Molecule Type, H2 2016 37

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Dormant Projects, H2 2016 75

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) - Discontinued Products, H2 2016 76





List of Figures

Number of Products under Development for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency), H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Comparative Analysis by Late Stage Development, H2 2016 11

Comparative Analysis by Clinical Stage Development, H2 2016 12

Comparative Analysis by Early Stage Products, H2 2016 13

Assessment by Monotherapy Products, H2 2016 29

Number of Products by Targets, H2 2016 30

Number of Products by Stage and Targets, H2 2016 30

Number of Products by Mechanism of Actions, H2 2016 32

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

Number of Products by Routes of Administration, H2 2016 34

Number of Products by Stage and Routes of Administration, H2 2016 34

Number of Products by Molecule Types, H2 2016 36

Number of Products by Stage and Molecule Types, H2 2016 36

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