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Lebers Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Pipeline Review, H1 2015

Lebers Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Pipeline Review, H1 2015


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Executive Summary

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Pipeline Review, H1 2015', provides an overview of the Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)'s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy), 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 Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) 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 Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)

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 Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) 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 Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) 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 Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)

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

Devise corrective measures for pipeline projects by understanding Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) 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 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) Overview 6

Therapeutics Development 7

Pipeline Products for Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Overview 7

Pipeline Products for Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Comparative Analysis 8

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Therapeutics under Development by Companies 9

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Pipeline Products Glance 10

Late Stage Products 10

Clinical Stage Products 11

Early Stage Products 12

Unknown Stage Products 13

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Products under Development by Companies 14

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Companies Involved in Therapeutics Development 15

Alkeus Pharmaceuticals, Inc. 15

Biovista Inc. 16

GenSight Biologics 17

Santhera Pharmaceuticals Holding AG 18

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Therapeutics Assessment 19

Assessment by Monotherapy Products 19

Assessment by Target 20

Assessment by Mechanism of Action 21

Assessment by Route of Administration 22

Assessment by Molecule Type 24

Drug Profiles 26

BVA-202-Drug Profile 26

Product Description 26

Mechanism of Action 26

R&D Progress 26

BVA-203-Drug Profile 27

Product Description 27

Mechanism of Action 27

R&D Progress 27

Drug for Lebers Hereditary Optic Neuropathy-Drug Profile 28

Product Description 28

Mechanism of Action 28

R&D Progress 28

GS-010-Drug Profile 29

Product Description 29

Mechanism of Action 29

R&D Progress 29

idebenone-Drug Profile 30

Product Description 30

Mechanism of Action 30

R&D Progress 30

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Recent Pipeline Updates 32

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Dormant Projects 36

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Product Development Milestones 37

Featured News & Press Releases 37

Jun 05, 2014: European Medicines Agency Validates Santhera's Marketing Authorization Application for Raxone in Leber's Hereditary Optic Neuropathy 37

May 07, 2014: Santhera Files Marketing Authorization Application in European Union for Raxone in the Treatment of LHON 38

Mar 04, 2014: Santhera Presents New Efficacy Data from an Expanded Access Program with Raxone for the Treatment of Leber's Hereditary Optic Neuropathy 38

Jan 21, 2014: Temporary Authorization for Use Granted for Santhera's Raxone for the Treatment of Leber's Hereditary Optic Neuropathy in France 40

Mar 22, 2013: Santhera Pharma Withdraws Marketing Authorization Application For Raxone In LHON 40

Jan 18, 2013: Santhera Pharma Receives Negative Opinion From EMA's CHMP On Marketing Authorization Application For Raxone 41

Nov 16, 2012: Santhera Pharma Expects CHMP Opinion On MAA For Raxone In Early 2013 42

Jul 26, 2011: Catena Improves Sight For Patients With Inherited Blindness, Newcastle University Study Finds 42

Jul 22, 2011: EMA Accepts Santhera's Marketing Authorization Application Of Idebenone For Review In LHON 43

Jun 06, 2011: Santhera Pharma Presents Nonclinical Data In LHON At Joint Congress Of SOE/AAO 2011 44

Appendix 45

Methodology 45

Coverage 45

Secondary Research 45

Primary Research 45

Expert Panel Validation 45

Contact Us 45

Disclaimer 46

List of Tables

Number of Products under Development for Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy), H1 2015 7

Number of Products under Development for Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Comparative Analysis, H1 2015 8

Number of Products under Development by Companies, H1 2015 9

Comparative Analysis by Late Stage Development, H1 2015 10

Comparative Analysis by Clinical Stage Development, H1 2015 11

Comparative Analysis by Early Stage Development, H1 2015 12

Comparative Analysis by Unknown Stage Development, H1 2015 13

Products under Development by Companies, H1 2015 14

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Pipeline by Alkeus Pharmaceuticals, Inc., H1 2015 15

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Pipeline by Biovista Inc., H1 2015 16

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Pipeline by GenSight Biologics, H1 2015 17

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Pipeline by Santhera Pharmaceuticals Holding AG, H1 2015 18

Assessment by Monotherapy Products, H1 2015 19

Number of Products by Stage and Target, H1 2015 20

Number of Products by Stage and Mechanism of Action, H1 2015 21

Number of Products by Stage and Route of Administration, H1 2015 23

Number of Products by Stage and Molecule Type, H1 2015 25

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) Therapeutics-Recent Pipeline Updates, H1 2015 32

Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Dormant Projects, H1 2015 36

List of Figures

Number of Products under Development for Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy), H1 2015 7

Number of Products under Development for Leber's Hereditary Optic Neuropathy (LHON) (Leber optic atrophy)-Comparative Analysis, H1 2015 8

Number of Products under Development by Companies, H1 2015 9

Assessment by Monotherapy Products, H1 2015 19

Number of Products by Top 10 Routes of Administration, H1 2015 22

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 23

Number of Products by Top 10 Molecule Types, H1 2015 24

Number of Products by Stage and Top 10 Molecule Types, H1 2015 25

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Alkeus Pharmaceuticals, Inc.

Biovista Inc.

GenSight Biologics

Santhera Pharmaceuticals Holding AG

Lebers Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) Therapeutic Products under Development, Key Players in Lebers Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) Therapeutics, Lebers Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) Pipeline Overview, Lebers Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) Pipeline, Lebers Hereditary Optic Neuropathy (LHON) (Leber optic atrophy) Pipeline Assessment


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