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Oral Mucositis-Pipeline Review, H1 2015

Oral Mucositis-Pipeline Review, H1 2015


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Executive Summary

Oral Mucositis-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Oral Mucositis-Pipeline Review, H1 2015', provides an overview of the Oral Mucositis's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Oral Mucositis, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Oral Mucositis and special features on late-stage 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, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct's team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

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

Scope

The report provides a snapshot of the global therapeutic landscape of Oral Mucositis

The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in the therapeutics development for Oral Mucositis and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Oral Mucositis products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

A detailed assessment of monotherapy and combination therapy pipeline projects

Coverage of the Oral Mucositis pipeline on the basis of target, MoA, route of administration and molecule type

Latest news and deals relating related to pipeline products

Reasons To Buy

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

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

Develop strategic initiatives by understanding the focus areas of leading companies

Identify and understand important and diverse types of therapeutics under development for Oral Mucositis

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

Devise corrective measures for pipeline projects by understanding Oral Mucositis 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

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Oral Mucositis Overview 8

Therapeutics Development 9

Pipeline Products for Oral Mucositis-Overview 9

Pipeline Products for Oral Mucositis-Comparative Analysis 10

Oral Mucositis-Therapeutics under Development by Companies 11

Oral Mucositis-Therapeutics under Investigation by Universities/Institutes 13

Oral Mucositis-Pipeline Products Glance 14

Late Stage Products 14

Clinical Stage Products 15

Early Stage Products 16

Oral Mucositis-Products under Development by Companies 17

Oral Mucositis-Products under Investigation by Universities/Institutes 18

Oral Mucositis-Companies Involved in Therapeutics Development 19

ActogeniX NV 19

Alder Biopharmaceuticals Inc. 20

Cellceutix Corporation 21

Colby Pharmaceutical Company 22

Daewoong Pharmaceutical Co., Ltd. 23

GliaMed, Inc. 24

Laila Pharmaceuticals Pvt. Ltd. 25

Onxeo SA 26

Otsuka Holdings Co., Ltd. 27

ProCertus BioPharm Inc. 28

Soligenix, Inc. 29

Spectrum Pharmaceuticals, Inc. 30

Sucampo Pharmaceuticals, Inc. 31

Oral Mucositis-Therapeutics Assessment 32

Assessment by Monotherapy Products 32

Assessment by Target 33

Assessment by Mechanism of Action 35

Assessment by Route of Administration 37

Assessment by Molecule Type 39

Drug Profiles 41

AG-013-Drug Profile 41

Product Description 41

Mechanism of Action 41

R&D Progress 41

AP-001-Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

AP-002-Drug Profile 43

Product Description 43

Mechanism of Action 43

R&D Progress 43

brilacidin-Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

clazakizumab-Drug Profile 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

clonidine hydrochloride ER-Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

cobiprostone-Drug Profile 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

GC-4403-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

GC-4419-Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

Gene Therapy for Oral Mucositis-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

GM-1485-Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

JVRSOD-Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

LP-00409-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

nepidermin-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

OralX-Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

pralatrexate-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

rebamipide-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

Regenasyn-Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

SGX-942-Drug Profile 66

Product Description 66

Mechanism of Action 66

R&D Progress 66

Oral Mucositis-Recent Pipeline Updates 68

Oral Mucositis-Dormant Projects 85

Oral Mucositis-Discontinued Products 86

Oral Mucositis-Product Development Milestones 87

Featured News & Press Releases 87

Jan 05, 2015: Soligenix Announces Positive Preliminary Nonclinical Results in Macrophage Activation Syndrome 87

Dec 08, 2014: Cellceutix Antibiotic Brilacidin Receives QIDP Designation From FDA 87

Nov 24, 2014: Cellceutix Provides Update On lead drug candidate Brilacidin 88

Nov 11, 2014: Patient Enrollment in Cellceutix Phase 2 Clinical Trial of Brilacidin-OM for Oral Mucositis Targeted to Begin in December 2014 88

Oct 13, 2014: Cellceutix Investigational New Drug Application Becomes Effective, Selects First Site for Phase 2 Clinical Trial of New Treatment for Oral Mucositis 89

Sep 09, 2014: Cellceutix Provides Initial Observations of Completed ABSSSI Phase 2b Trial; Company Submits Investigational New Drug Application to FDA for Phase 2 Trial of Brilacidin-OM for Oral Mucositis 90

Aug 11, 2014: Cellceutix Prepares for Phase 2 Clinical Trial of Brilacidin-OM for Oral Mucositis 91

May 05, 2014: BioAlliance Pharma announces major achievements on Validive: Enrollment completion in the international Phase II trial with Validive in severe oral mucositis, Presentation of preclinical data at the next ASCO annual meeting 92

Apr 07, 2014: Soligenix Announces $200,000 NIDCR SBIR Grant Award Supporting Phase 2 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer 92

Jan 23, 2014: FDA Grants Validive with a Fast Track Designation for the Prevention and Treatment of Oral Mucositis Induced by Anticancer Treatments 93

Appendix 94

Methodology 94

Coverage 94

Secondary Research 94

Primary Research 94

Expert Panel Validation 94

Contact Us 95

Disclaimer 95

List of Tables

Number of Products under Development for Oral Mucositis, H1 2015 9

Number of Products under Development for Oral Mucositis-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 12

Number of Products under Investigation by Universities/Institutes, H1 2015 13

Comparative Analysis by Late Stage Development, H1 2015 14

Comparative Analysis by Clinical Stage Development, H1 2015 15

Comparative Analysis by Early Stage Development, H1 2015 16

Products under Development by Companies, H1 2015 17

Products under Investigation by Universities/Institutes, H1 2015 18

Oral Mucositis-Pipeline by ActogeniX NV, H1 2015 19

Oral Mucositis-Pipeline by Alder Biopharmaceuticals Inc., H1 2015 20

Oral Mucositis-Pipeline by Cellceutix Corporation, H1 2015 21

Oral Mucositis-Pipeline by Colby Pharmaceutical Company, H1 2015 22

Oral Mucositis-Pipeline by Daewoong Pharmaceutical Co., Ltd., H1 2015 23

Oral Mucositis-Pipeline by GliaMed, Inc., H1 2015 24

Oral Mucositis-Pipeline by Laila Pharmaceuticals Pvt. Ltd., H1 2015 25

Oral Mucositis-Pipeline by Onxeo SA, H1 2015 26

Oral Mucositis-Pipeline by Otsuka Holdings Co., Ltd., H1 2015 27

Oral Mucositis-Pipeline by ProCertus BioPharm Inc., H1 2015 28

Oral Mucositis-Pipeline by Soligenix, Inc., H1 2015 29

Oral Mucositis-Pipeline by Spectrum Pharmaceuticals, Inc., H1 2015 30

Oral Mucositis-Pipeline by Sucampo Pharmaceuticals, Inc., H1 2015 31

Assessment by Monotherapy Products, H1 2015 32

Number of Products by Stage and Target, H1 2015 34

Number of Products by Stage and Mechanism of Action, H1 2015 36

Number of Products by Stage and Route of Administration, H1 2015 38

Number of Products by Stage and Molecule Type, H1 2015 40

Oral Mucositis Therapeutics-Recent Pipeline Updates, H1 2015 68

Oral Mucositis-Dormant Projects, H1 2015 85

Oral Mucositis-Discontinued Products, H1 2015 86

List of Figures

Number of Products under Development for Oral Mucositis, H1 2015 9

Number of Products under Development for Oral Mucositis-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 11

Comparative Analysis by Clinical Stage Development, H1 2015 15

Comparative Analysis by Early Stage Products, H1 2015 16

Assessment by Monotherapy Products, H1 2015 32

Number of Products by Top 10 Targets, H1 2015 33

Number of Products by Stage and Top 10 Targets, H1 2015 33

Number of Products by Top 10 Mechanism of Actions, H1 2015 35

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 35

Number of Products by Top 10 Routes of Administration, H1 2015 37

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 37

Number of Products by Top 10 Molecule Types, H1 2015 39

Number of Products by Stage and Top 10 Molecule Types, H1 2015 39

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ActogeniX NV

Alder Biopharmaceuticals Inc.

Cellceutix Corporation

Colby Pharmaceutical Company

Daewoong Pharmaceutical Co., Ltd.

GliaMed, Inc.

Laila Pharmaceuticals Pvt. Ltd.

Onxeo SA

Otsuka Holdings Co., Ltd.

ProCertus BioPharm Inc.

Soligenix, Inc.

Spectrum Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc.

Oral Mucositis Therapeutic Products under Development, Key Players in Oral Mucositis Therapeutics, Oral Mucositis Pipeline Overview, Oral Mucositis Pipeline, Oral Mucositis Pipeline Assessment


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