Aspergillosis – Pipeline Review, H2 2016

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

The report provides comprehensive information on the therapeutics under development for Aspergillosis, 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 Aspergillosis 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 Aspergillosis

The report reviews pipeline therapeutics for Aspergillosis 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 Aspergillosis therapeutics and enlists all their major and minor projects

The report assesses Aspergillosis 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 Aspergillosis

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 Aspergillosis

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 Aspergillosis 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

Amplyx Pharmaceuticals, Inc.

Astellas Pharma Inc.

Biomar Microbial Technologies

Biosergen AS

Cidara Therapeutics, Inc.

F2G Ltd

Hsiri Therapeutics LLC

iCo Therapeutics Inc.

Matinas BioPharma Holdings, Inc.

Merck & Co., Inc.

Nanomerics Ltd

Novabiotics Limited

Pulmatrix, Inc.

Pulmocide Ltd

Scynexis, Inc.

Sealife PHARMA GMBH

Sigma-Tau S.p.A.

TGV-Laboratories

Vical Incorporated

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 7

List of Figures 8

Introduction 9

Global Markets Direct Report Coverage 9

Aspergillosis Overview 10

Therapeutics Development 11

Pipeline Products for Aspergillosis - Overview 11

Pipeline Products for Aspergillosis - Comparative Analysis 12

Aspergillosis - Therapeutics under Development by Companies 13

Aspergillosis - Therapeutics under Investigation by Universities/Institutes 15

Aspergillosis - Pipeline Products Glance 16

Late Stage Products 16

Clinical Stage Products 17

Early Stage Products 18

Unknown Stage Products 19

Aspergillosis - Products under Development by Companies 20

Aspergillosis - Products under Investigation by Universities/Institutes 21

Aspergillosis - Companies Involved in Therapeutics Development 22

Amplyx Pharmaceuticals, Inc. 22

Astellas Pharma Inc. 23

Biomar Microbial Technologies 24

Biosergen AS 25

Cidara Therapeutics, Inc. 26

F2G Ltd 27

Hsiri Therapeutics LLC 28

iCo Therapeutics Inc. 29

Matinas BioPharma Holdings, Inc. 30

Merck & Co., Inc. 31

Nanomerics Ltd 32

Novabiotics Limited 33

Pulmatrix, Inc. 34

Pulmocide Ltd 35

Scynexis, Inc. 36

Sealife PHARMA GMBH 37

Sigma-Tau S.p.A. 38

TGV-Laboratories 39

Vical Incorporated 40

Aspergillosis - Therapeutics Assessment 41

Assessment by Monotherapy Products 41

Assessment by Target 42

Assessment by Mechanism of Action 44

Assessment by Route of Administration 46

Assessment by Molecule Type 48

Drug Profiles 50

amphotericin B - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

amphotericin B - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

amphotericin B - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

amphotericin B - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

Amphotericin B sodium - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

APX-001 - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

ASP-9726 - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

Aspergillus fumigatus vaccine - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

BSG-005 - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

C-001 - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

C-016 - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

celastrol - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

Cellullar Immunotherapy for Viral Infections and Fungal Infections - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

F-901318 - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

itraconazole - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

KB-425796C - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

MDN-0018 - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

Myc-102 - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

NP-339 - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

NP-525 - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

PC-945 - Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

posaconazole - Drug Profile 78

Product Description 78

Mechanism Of Action 78

R&D Progress 78

PTX-3 - Drug Profile 80

Product Description 80

Mechanism Of Action 80

R&D Progress 80

SCY-078 - Drug Profile 81

Product Description 81

Mechanism Of Action 81

R&D Progress 81

SLP-0901 - Drug Profile 85

Product Description 85

Mechanism Of Action 85

R&D Progress 85

SLP-0904 - Drug Profile 86

Product Description 86

Mechanism Of Action 86

R&D Progress 86

Small Molecule for Aspergillosis - Drug Profile 87

Product Description 87

Mechanism Of Action 87

R&D Progress 87

Small Molecules for Aspergillosis and Candidiasis - Drug Profile 88

Product Description 88

Mechanism Of Action 88

R&D Progress 88

Small Molecules for Fungal Infections - Drug Profile 89

Product Description 89

Mechanism Of Action 89

R&D Progress 89

Small Molecules for Fungal Infections - Drug Profile 90

Product Description 90

Mechanism Of Action 90

R&D Progress 90

Small Molecules for Invasive Aspergillosis - Drug Profile 91

Product Description 91

Mechanism Of Action 91

R&D Progress 91

Vaccine for Fungal Infections - Drug Profile 92

Product Description 92

Mechanism Of Action 92

R&D Progress 92

VL-2397 - Drug Profile 93

Product Description 93

Mechanism Of Action 93

R&D Progress 93

Aspergillosis - Dormant Projects 94

Aspergillosis - Discontinued Products 95

Aspergillosis - Product Development Milestones 96

Featured News & Press Releases 96

Oct 26, 2016: F2G Announces Publication of Initial F901318 Data in Scientific Journal PNAS 96

Sep 12, 2016: Amplyx Pharmaceuticals Initiates Dosing in Phase 1 Clinical Trial of APX001, a Novel Antifungal Product Candidate for Treatment of Life-Threatening Infections 96

Aug 24, 2016: SCYNEXIS Receives Orphan Drug Designation for SCY-078 for the Treatment of Invasive Aspergillus Infections 97

Jun 16, 2016: Antifungal work lands SBU professor $6 million from NIH 97

Jun 14, 2016: Amplyx Pharmaceuticals Announces Qualified Infectious Disease Product Designation for APX001 in Three Life-threatening Fungal Infections 99

May 24, 2016: Amplyx Pharmaceuticals Appoints Paul C. Grint, M.D., to Board of Directors 100

Mar 30, 2016: FDA Grants Vical Fast Track Designation for VL-2397 for the Treatment of Invasive Aspergillosis 100

Mar 07, 2016: Vical Initiates Phase 1 Trial of Novel Antifungal Compound VL-2397 101

Jan 28, 2016: SCYNEXIS Receives FDA Fast Track and QIDP Designations for Intravenous Formulation of SCY-078 for the Treatment of Patients with Invasive Fungal Infections 101

Jan 06, 2016: FDA Grants Vical Orphan Drug Designation for VL-2397 for the Treatment of Invasive Aspergillosis 102

Dec 17, 2015: Matinas BioPharma’s Lead Antifungal Product Candidate MAT2203 Granted QIDP and Fast Track Designations for Treatment of Aspergillus by U.S. FDA 103

Nov 30, 2015: F2G to Participate in the Adaptive Pathways Pilot Programme 103

Sep 21, 2015: SCYNEXIS Presents Data Supporting the Potential Clinical Utility of Antifungal Drug Candidate at ICAAC/ICC 2015 104

Sep 15, 2015: Vical to Present Preclinical Data at ICAAC 2015 Meeting for Its Novel Antifungal Drug Candidate VL-2397 105

Aug 19, 2015: FDA Grants Qualified Infectious Disease Product Designation to VL-2397, Vical's Antifungal Product Candidate 105

Appendix 107

Methodology 107

Coverage 107

Secondary Research 107

Primary Research 107

Expert Panel Validation 107

Contact Us 107

Disclaimer 108

List of Tables

List of Tables

Number of Products under Development for Aspergillosis, H2 2016 11

Number of Products under Development for Aspergillosis – Comparative Analysis, H2 2016 12

Number of Products under Development by Companies, H2 2016 14

Number of Products under Investigation by Universities/Institutes, H2 2016 15

Comparative Analysis by Late Stage Development, H2 2016 16

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Development, H2 2016 18

Comparative Analysis by Unknown Stage Development, H2 2016 19

Products under Development by Companies, H2 2016 20

Products under Investigation by Universities/Institutes, H2 2016 21

Aspergillosis – Pipeline by Amplyx Pharmaceuticals, Inc., H2 2016 22

Aspergillosis – Pipeline by Astellas Pharma Inc., H2 2016 23

Aspergillosis – Pipeline by Biomar Microbial Technologies, H2 2016 24

Aspergillosis – Pipeline by Biosergen AS, H2 2016 25

Aspergillosis – Pipeline by Cidara Therapeutics, Inc., H2 2016 26

Aspergillosis – Pipeline by F2G Ltd, H2 2016 27

Aspergillosis – Pipeline by Hsiri Therapeutics LLC, H2 2016 28

Aspergillosis – Pipeline by iCo Therapeutics Inc., H2 2016 29

Aspergillosis – Pipeline by Matinas BioPharma Holdings, Inc. , H2 2016 30

Aspergillosis – Pipeline by Merck & Co., Inc., H2 2016 31

Aspergillosis – Pipeline by Nanomerics Ltd, H2 2016 32

Aspergillosis – Pipeline by Novabiotics Limited, H2 2016 33

spergillosis – Pipeline by Pulmatrix, Inc., H2 2016 34

Aspergillosis – Pipeline by Pulmocide Ltd, H2 2016 35

Aspergillosis – Pipeline by Scynexis, Inc., H2 2016 36

Aspergillosis – Pipeline by Sealife PHARMA GMBH, H2 2016 37

Aspergillosis – Pipeline by Sigma-Tau S.p.A., H2 2016 38

Aspergillosis – Pipeline by TGV-Laboratories, H2 2016 39

Aspergillosis – Pipeline by Vical Incorporated, H2 2016 40

Assessment by Monotherapy Products, H2 2016 41

Number of Products by Stage and Target, H2 2016 43

Number of Products by Stage and Mechanism of Action, H2 2016 45

Number of Products by Stage and Route of Administration, H2 2016 47

Number of Products by Stage and Molecule Type, H2 2016 49

Aspergillosis – Dormant Projects, H2 2016 94

Aspergillosis – Discontinued Products, H2 2016 95

List of Figures

List of Figures

Number of Products under Development for Aspergillosis, H2 2016 11

Number of Products under Development for Aspergillosis – Comparative Analysis, H2 2016 12

Number of Products under Development by Companies, H2 2016 13

Number of Products under Investigation by Universities/Institutes, H2 2016 15

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Products, H2 2016 18

Assessment by Monotherapy Products, H2 2016 41

Number of Products by Targets, H2 2016 42

Number of Products by Stage and Targets, H2 2016 42

Number of Products by Mechanism of Actions, H2 2016 44

Number of Products by Stage and Mechanism of Actions, H2 2016 44

Number of Products by Routes of Administration, H2 2016 46

Number of Products by Stage and Routes of Administration, H2 2016 46

Number of Products by Molecule Types, H2 2016 48

Number of Products by Stage and Top 10 Molecule Types, H2 2016 48

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