Oral Mucositis-Pipeline Review, H2 2015

Oral Mucositis-Pipeline Review, H2 2015


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Executive Summary

Oral Mucositis-Pipeline Review, H2 2015

Summary

Global Markets Direct's, 'Oral Mucositis-Pipeline Review, H2 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



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Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Oral Mucositis Overview 9

Therapeutics Development 10

Pipeline Products for Oral Mucositis-Overview 10

Pipeline Products for Oral Mucositis-Comparative Analysis 11

Oral Mucositis-Therapeutics under Development by Companies 12

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

Unknown Stage Products 17

Oral Mucositis-Products under Development by Companies 18

Oral Mucositis-Products under Investigation by Universities/Institutes 19

Oral Mucositis-Companies Involved in Therapeutics Development 20

Aldeyra Therapeutics, Inc. 20

Cellceutix Corporation 21

Clevexel Pharma SAS 22

Colby Pharmaceutical Company 23

Daewoong Pharmaceutical Co., Ltd. 24

Intrexon Corporation 25

Laila Pharmaceuticals Pvt. Ltd. 26

Onxeo SA 27

Otsuka Holdings Co., Ltd. 28

ProCertus BioPharm Inc. 29

Soligenix, Inc. 30

Spectrum Pharmaceuticals, Inc. 31

Sucampo Pharmaceuticals, Inc. 32

Oral Mucositis-Therapeutics Assessment 33

Assessment by Monotherapy Products 33

Assessment by Target 34

Assessment by Mechanism of Action 36

Assessment by Route of Administration 38

Assessment by Molecule Type 40

Drug Profiles 42

AG-013-Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

AP-001-Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

AP-002-Drug Profile 45

Product Description 45

Mechanism of Action 45

R&D Progress 45

brilacidin tetrahydrochloride-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

CVXL-0095-Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

dusquetide-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

GC-4403-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

GC-4419-Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

Gene Therapy for Oral Mucositis-Drug Profile 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

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

NS-2-Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

OralX-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

pralatrexate-Drug Profile 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

rebamipide-Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

Regenasyn-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

Oral Mucositis-Recent Pipeline Updates 68

Oral Mucositis-Dormant Projects 86

Oral Mucositis-Discontinued Products 88

Oral Mucositis-Product Development Milestones 89

Featured News & Press Releases 89

Aug 03, 2015: Cellceutix Announces Ongoing Enrollment of Phase 2 Trial of Brilacidin for Oral Mucositis 89

Jun 18, 2015: Onxeo Consolidates Its Industrial Property with a US Patent Protecting Validive until 2029 89

Jun 01, 2015: Enrollment in Cellceutix Phase 2 Clinical Trial of Brilacidin-OM For Oral Mucositis Expanding to Additional Centers 90

May 26, 2015: Onxeo Announces Final Data from Completed Phase II Trial of Validive for the Prevention of Severe Oral Mucositis in Head and Neck Cancer Patients 90

May 07, 2015: FDA Grants Fast Track Designation to Sucampo's Cobiprostone for Oral Mucositis 91

May 06, 2015: Oral Presentation of Phase II Trial Results of Validive at the MASCC/ISOO International Symposium 92

Apr 23, 2015: Aldeyra Therapeutics Abstract Accepted for Presentation at the 2015 Multinational Association of Supportive Care in Cancer-International Society of Oral Oncology Annual Meeting 92

Apr 02, 2015: Phase II trial results of Validive presented at the ASCO Conference 93

Mar 03, 2015: Soligenix Announces Positive Recommendation by Data Review Committee on its Phase 2 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients 93

Jan 05, 2015: Soligenix Announces Positive Preliminary Nonclinical Results in Macrophage Activation Syndrome 94

Appendix 96

Methodology 96

Coverage 96

Secondary Research 96

Primary Research 96

Expert Panel Validation 96

Contact Us 96

Disclaimer 97

List of Tables

Number of Products under Development for Oral Mucositis, H2 2015 10

Number of Products under Development for Oral Mucositis-Comparative Analysis, H2 2015 11

Number of Products under Development by Companies, H2 2015 12

Number of Products under Investigation by Universities/Institutes, H2 2015 13

Comparative Analysis by Late Stage Development, H2 2015 14

Comparative Analysis by Clinical Stage Development, H2 2015 15

Comparative Analysis by Early Stage Development, H2 2015 16

Comparative Analysis by Unknown Stage Development, H2 2015 17

Products under Development by Companies, H2 2015 18

Products under Investigation by Universities/Institutes, H2 2015 19

Oral Mucositis-Pipeline by Aldeyra Therapeutics, Inc., H2 2015 20

Oral Mucositis-Pipeline by Cellceutix Corporation, H2 2015 21

Oral Mucositis-Pipeline by Clevexel Pharma SAS, H2 2015 22

Oral Mucositis-Pipeline by Colby Pharmaceutical Company, H2 2015 23

Oral Mucositis-Pipeline by Daewoong Pharmaceutical Co., Ltd., H2 2015 24

Oral Mucositis-Pipeline by Intrexon Corporation, H2 2015 25

Oral Mucositis-Pipeline by Laila Pharmaceuticals Pvt. Ltd., H2 2015 26

Oral Mucositis-Pipeline by Onxeo SA, H2 2015 27

Oral Mucositis-Pipeline by Otsuka Holdings Co., Ltd., H2 2015 28

Oral Mucositis-Pipeline by ProCertus BioPharm Inc., H2 2015 29

Oral Mucositis-Pipeline by Soligenix, Inc., H2 2015 30

Oral Mucositis-Pipeline by Spectrum Pharmaceuticals, Inc., H2 2015 31

Oral Mucositis-Pipeline by Sucampo Pharmaceuticals, Inc., H2 2015 32

Assessment by Monotherapy Products, H2 2015 33

Number of Products by Stage and Target, H2 2015 35

Number of Products by Stage and Mechanism of Action, H2 2015 37

Number of Products by Stage and Route of Administration, H2 2015 39

Number of Products by Stage and Molecule Type, H2 2015 41

Oral Mucositis Therapeutics-Recent Pipeline Updates, H2 2015 68

Oral Mucositis-Dormant Projects, H2 2015 86

Oral Mucositis-Dormant Projects (Contd..1), H2 2015 87

Oral Mucositis-Discontinued Products, H2 2015 88

List of Figures

Number of Products under Development for Oral Mucositis, H2 2015 10

Number of Products under Development for Oral Mucositis-Comparative Analysis, H2 2015 11

Number of Products under Development by Companies, H2 2015 12

Comparative Analysis by Clinical Stage Development, H2 2015 15

Comparative Analysis by Early Stage Products, H2 2015 16

Assessment by Monotherapy Products, H2 2015 33

Number of Products by Top 10 Targets, H2 2015 34

Number of Products by Stage and Top 10 Targets, H2 2015 34

Number of Products by Top 10 Mechanism of Actions, H2 2015 36

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2015 36

Number of Products by Top 10 Routes of Administration, H2 2015 38

Number of Products by Stage and Top 10 Routes of Administration, H2 2015 38

Number of Products by Top 10 Molecule Types, H2 2015 40

Number of Products by Stage and Top 10 Molecule Types, H2 2015 40

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Aldeyra Therapeutics, Inc.

Cellceutix Corporation

Clevexel Pharma SAS

Colby Pharmaceutical Company

Daewoong Pharmaceutical Co., Ltd.

Intrexon Corporation

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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