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Retinal Degeneration-Pipeline Review, H1 2015

Retinal Degeneration-Pipeline Review, H1 2015


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Executive Summary

Retinal Degeneration-Pipeline Review, H1 2015

Summary

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

This report provides comprehensive information on the therapeutic development for Retinal Degeneration, 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 Retinal Degeneration 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 Retinal Degeneration

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 Retinal Degeneration and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Retinal Degeneration 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 Retinal Degeneration 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 Retinal Degeneration

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

Devise corrective measures for pipeline projects by understanding Retinal Degeneration 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

Retinal Degeneration Overview 8

Therapeutics Development 9

Pipeline Products for Retinal Degeneration-Overview 9

Pipeline Products for Retinal Degeneration-Comparative Analysis 10

Retinal Degeneration-Therapeutics under Development by Companies 11

Retinal Degeneration-Therapeutics under Investigation by Universities/Institutes 12

Retinal Degeneration-Pipeline Products Glance 13

Late Stage Products 13

Clinical Stage Products 14

Early Stage Products 15

Unknown Stage Products 16

Retinal Degeneration-Products under Development by Companies 17

Retinal Degeneration-Products under Investigation by Universities/Institutes 18

Retinal Degeneration-Companies Involved in Therapeutics Development 19

Alkeus Pharmaceuticals, Inc. 19

Applied Genetic Technologies Corporation 20

Aprogen, Inc. 21

BBB Therapeutics B.V. 22

Bionature E.A. Ltd. 23

Biovista Inc. 24

GenSight Biologics SA 25

SanBio, Inc. 26

Santhera Pharmaceuticals Holding AG 27

Senju Pharmaceutical Co., Ltd. 28

Spark Therapeutics, Inc. 29

Retinal Degeneration-Therapeutics Assessment 30

Assessment by Monotherapy Products 30

Assessment by Target 31

Assessment by Mechanism of Action 33

Assessment by Route of Administration 35

Assessment by Molecule Type 37

Drug Profiles 39

AP-202-Drug Profile 39

Product Description 39

Mechanism of Action 39

R&D Progress 39

BVA-202-Drug Profile 40

Product Description 40

Mechanism of Action 40

R&D Progress 40

BVA-203-Drug Profile 41

Product Description 41

Mechanism of Action 41

R&D Progress 41

CB-11-Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

Drug for Lebers Hereditary Optic Neuropathy-Drug Profile 43

Product Description 43

Mechanism of Action 43

R&D Progress 43

Gene Therapy for Choroideremia-Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

Gene Therapy for Retinal Degenerative Disease-Drug Profile 45

Product Description 45

Mechanism of Action 45

R&D Progress 45

Gene Therapy to Activate Retinoschisin for X-Linked Retinoschisis-Drug Profile 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

GS-010-Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

idebenone-Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

MTP-131-Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

rAAV2tYFCB-hRS1-Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

SB-623-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

Small Molecule 8 for Retinitis Pigmentosa-Drug Profile 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

Small Molecule to Activate NF-E2 Related Factor 2 for Central Nervous System, Metabolic Disorders, Cardiovascular and Ophthalmology-Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

Small Molecules for Inherited Retinal Diseases-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

Small Molecules to Agonize Neurotrophin Receptor for CNS and Ophthalmological Disorders-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

SNC-121-Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

SNJ-1945-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

Stem Cell Therapy for Cancer, Pain, Retinal Degeneration and Niemann-Pick Disease-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

Retinal Degeneration-Recent Pipeline Updates 62

Retinal Degeneration-Dormant Projects 72

Retinal Degeneration-Dormant Projects 72

Retinal Degeneration-Product Development Milestones 73

Featured News & Press Releases 73

Jun 05, 2014: European Medicines Agency Validates Santhera's Marketing Authorization Application for Raxone in Leber's Hereditary Optic Neuropathy 73

May 07, 2014: Santhera Files Marketing Authorization Application in European Union for Raxone in the Treatment of LHON 74

Mar 04, 2014: Santhera Presents New Efficacy Data from an Expanded Access Program with Raxone for the Treatment of Leber's Hereditary Optic Neuropathy 74

Jan 21, 2014: Temporary Authorization for Use Granted for Santhera's Raxone for the Treatment of Leber's Hereditary Optic Neuropathy in France 75

Mar 22, 2013: Santhera Pharma Withdraws Marketing Authorization Application For Raxone In LHON 76

Jan 18, 2013: Santhera Pharma Receives Negative Opinion From EMA's CHMP On Marketing Authorization Application For Raxone 77

Nov 16, 2012: Santhera Pharma Expects CHMP Opinion On MAA For Raxone In Early 2013 77

Jul 26, 2011: Catena Improves Sight For Patients With Inherited Blindness, Newcastle University Study Finds 78

Jul 22, 2011: EMA Accepts Santhera's Marketing Authorization Application Of Idebenone For Review In LHON 79

Jun 06, 2011: Santhera Pharma Presents Nonclinical Data In LHON At Joint Congress Of SOE/AAO 2011 79

Appendix 81

Methodology 81

Coverage 81

Secondary Research 81

Primary Research 81

Expert Panel Validation 81

Contact Us 81

Disclaimer 82

List of Tables

Number of Products under Development for Retinal Degeneration, H1 2015 9

Number of Products under Development for Retinal Degeneration-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 11

Number of Products under Investigation by Universities/Institutes, H1 2015 12

Comparative Analysis by Late Stage Development, H1 2015 13

Comparative Analysis by Clinical Stage Development, H1 2015 14

Comparative Analysis by Early Stage Development, H1 2015 15

Comparative Analysis by Unknown Stage Development, H1 2015 16

Products under Development by Companies, H1 2015 17

Products under Investigation by Universities/Institutes, H1 2015 18

Retinal Degeneration-Pipeline by Alkeus Pharmaceuticals, Inc., H1 2015 19

Retinal Degeneration-Pipeline by Applied Genetic Technologies Corporation, H1 2015 20

Retinal Degeneration-Pipeline by Aprogen, Inc., H1 2015 21

Retinal Degeneration-Pipeline by BBB Therapeutics B.V., H1 2015 22

Retinal Degeneration-Pipeline by Bionature E.A. Ltd., H1 2015 23

Retinal Degeneration-Pipeline by Biovista Inc., H1 2015 24

Retinal Degeneration-Pipeline by GenSight Biologics SA, H1 2015 25

Retinal Degeneration-Pipeline by SanBio, Inc., H1 2015 26

Retinal Degeneration-Pipeline by Santhera Pharmaceuticals Holding AG, H1 2015 27

Retinal Degeneration-Pipeline by Senju Pharmaceutical Co., Ltd., H1 2015 28

Retinal Degeneration-Pipeline by Spark Therapeutics, Inc., H1 2015 29

Assessment by Monotherapy Products, H1 2015 30

Number of Products by Stage and Target, H1 2015 32

Number of Products by Stage and Mechanism of Action, H1 2015 34

Number of Products by Stage and Route of Administration, H1 2015 36

Number of Products by Stage and Molecule Type, H1 2015 38

Retinal Degeneration Therapeutics-Recent Pipeline Updates, H1 2015 62

Retinal Degeneration-Dormant Projects, H1 2015 72

List of Figures

Number of Products under Development for Retinal Degeneration, H1 2015 9

Number of Products under Development for Retinal Degeneration-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 11

Number of Products under Investigation by Universities/Institutes, H1 2015 12

Comparative Analysis by Clinical Stage Development, H1 2015 14

Comparative Analysis by Early Stage Products, H1 2015 15

Assessment by Monotherapy Products, H1 2015 30

Number of Products by Top 10 Targets, H1 2015 31

Number of Products by Stage and Top 10 Targets, H1 2015 32

Number of Products by Top 10 Mechanism of Actions, H1 2015 33

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 34

Number of Products by Top 10 Routes of Administration, H1 2015 35

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 36

Number of Products by Top 10 Molecule Types, H1 2015 37

Number of Products by Stage and Top 10 Molecule Types, H1 2015 38

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Alkeus Pharmaceuticals, Inc.

Applied Genetic Technologies Corporation

Aprogen, Inc.

BBB Therapeutics B.V.

Bionature E.A. Ltd.

Biovista Inc.

GenSight Biologics SA

SanBio, Inc.

Santhera Pharmaceuticals Holding AG

Senju Pharmaceutical Co., Ltd.

Spark Therapeutics, Inc.

Retinal Degeneration Therapeutic Products under Development, Key Players in Retinal Degeneration Therapeutics, Retinal Degeneration Pipeline Overview, Retinal Degeneration Pipeline, Retinal Degeneration Pipeline Assessment


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