Tinnitus - Pipeline Review, H2 2016

Tinnitus - Pipeline Review, H2 2016


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Executive Summary

Tinnitus - Pipeline Review, H2 2016

Summary

Global Markets Direct's, 'Tinnitus - Pipeline Review, H2 2016', provides an overview of the Tinnitus pipeline landscape.

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

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

- The report assesses Tinnitus 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 Tinnitus

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 Tinnitus

- 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 Tinnitus 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 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Tinnitus Overview 7

Therapeutics Development 8

Pipeline Products for Tinnitus - Overview 8

Pipeline Products for Tinnitus - Comparative Analysis 9

Tinnitus - Therapeutics under Development by Companies 10

Tinnitus - Therapeutics under Investigation by Universities/Institutes 11

Tinnitus - Pipeline Products Glance 12

Late Stage Products 12

Clinical Stage Products 13

Early Stage Products 14

Tinnitus - Products under Development by Companies 15

Tinnitus - Products under Investigation by Universities/Institutes 16

Tinnitus - Companies Involved in Therapeutics Development 17

AudioCure Pharma GmbH 17

Auris Medical Holding AG 18

Knopp Biosciences LLC 19

Merz Pharma GmbH & Co. KgaA 20

Otonomy, Inc. 21

SciFluor Life Sciences, LLC 22

Sound Pharmaceuticals, Inc. 23

Tinnitus - Therapeutics Assessment 24

Assessment by Monotherapy Products 24

Assessment by Target 25

Assessment by Mechanism of Action 27

Assessment by Route of Administration 29

Assessment by Molecule Type 31

Drug Profiles 32

AM-102 - Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

AUT-3 - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

Drug to Activate KCNQ for Tinnitus - Drug Profile 34

Product Description 34

Mechanism Of Action 34

R&D Progress 34

esketamine hydrochloride - Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

gacyclidine SR - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

neramexane mesylate - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

SF-0034 - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

Small Molecules for Tinnitus - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

Small Molecules to Activate Kv7 for Neuropathic Pain, Epilepsy and Tinnitus - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

Small Molecules to Inhibit TNF-Alpha for Tinnitus - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

SPI-1005 - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

SPI-3005 - Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

Tinnitus - Dormant Projects 52

Tinnitus - Product Development Milestones 53

Featured News & Press Releases 53

Aug 18, 2016: Auris Medical Reports Top-Line Results from TACTT2 Trial with Keyzilen in Acute Inner Ear Tinnitus 53

Jul 19, 2016: Auris Medical Secures Loan Facility of Up To $20 Million 53

Jul 18, 2016: FDA Grants Auris Medical Fast Track Designation for Keyzilen in Acute Peripheral Tinnitus 54

Jun 28, 2016: Auris Medical Completes Enrollment of Phase 3 TACTT3 Trial with Keyzilen in Acute and Post-Acute Inner Ear Tinnitus 54

Jun 14, 2016: Auris Medical Hosts Key Opinion Leader Event Focused on Phase 3 Program for Acute Inner Ear Tinnitus 55

Jun 07, 2016: Auris Medical to Host Key Opinion Leader Event Focused on Acute Inner Ear Tinnitus and AM-101 Phase 3 Program on June 14 in New York City 55

Mar 30, 2016: Auris Medical Completes Enrollment of TACTT2 Phase 3 Trial of AM-101 in Acute Inner Ear Tinnitus 56

Nov 16, 2015: Otonomy Initiates Phase 1 Clinical Trial for Tinnitus Product Candidate, OTO-311 56

Oct 05, 2015: Otonomy Receives FDA Clearance of Investigational New Drug Application for Tinnitus Product Candidate, OTO-311 56

Jul 02, 2015: Auris Medical Holding Provides Update on U.S. Intellectual Property Portfolio 57

Jun 19, 2015: SciFluor Life Sciences Patented Compound SF0034 Highlighted in Research Published in The Journal of Neuroscience 57

Apr 20, 2015: Auris Medical Announces Publications Related to AM-101 in Peer-Reviewed Scientific and Medical Journals 58

Mar 13, 2015: Auris Medical Announces Recently Granted Patent in India for the Treatment of Tinnitus 59

Mar 11, 2015: Auris Medical to Host Key Opinion Leader Meeting on Tinnitus Treatments on March 13 in New York City 59

Mar 10, 2015: Auris Medical Announces Completion of Interim Analysis in Post-Acute Tinnitus Stratum of TACTT3 Trial with AM-101 59

Appendix 61

Methodology 61

Coverage 61

Secondary Research 61

Primary Research 61

Expert Panel Validation 61

Contact Us 61

Disclaimer 62

List of Figures

Number of Products under Development for Tinnitus, H2 2016 8

Number of Products under Development for Tinnitus - Comparative Analysis, H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Comparative Analysis by Clinical Stage Development, H2 2016 13

Comparative Analysis by Early Stage Products, H2 2016 14

Assessment by Monotherapy Products, H2 2016 24

Number of Products by Targets, H2 2016 25

Number of Products by Stage and Targets, H2 2016 25

Number of Products by Mechanism of Actions, H2 2016 27

Number of Products by Stage and Mechanism of Actions, H2 2016 27

Number of Products by Routes of Administration, H2 2016 29

Number of Products by Stage and Routes of Administration, H2 2016 29

Number of Products by Stage and Top 10 Molecule Types, H2 2016 31

List of Tables

Number of Products under Development for Tinnitus, H2 2016 8

Number of Products under Development for Tinnitus - Comparative Analysis, H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Number of Products under Investigation by Universities/Institutes, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 12

Comparative Analysis by Clinical Stage Development, H2 2016 13

Comparative Analysis by Early Stage Development, H2 2016 14

Products under Development by Companies, H2 2016 15

Products under Investigation by Universities/Institutes, H2 2016 16

Tinnitus - Pipeline by AudioCure Pharma GmbH, H2 2016 17

Tinnitus - Pipeline by Auris Medical Holding AG, H2 2016 18

Tinnitus - Pipeline by Knopp Biosciences LLC, H2 2016 19

Tinnitus - Pipeline by Merz Pharma GmbH & Co. KgaA, H2 2016 20

Tinnitus - Pipeline by Otonomy, Inc., H2 2016 21

Tinnitus - Pipeline by SciFluor Life Sciences, LLC, H2 2016 22

Tinnitus - Pipeline by Sound Pharmaceuticals, Inc., H2 2016 23

Assessment by Monotherapy Products, H2 2016 24

Number of Products by Stage and Target, H2 2016 26

Number of Products by Stage and Mechanism of Action, H2 2016 28

Number of Products by Stage and Route of Administration, H2 2016 30

Number of Products by Stage and Molecule Type, H2 2016 31

Tinnitus - Dormant Projects, H2 2016 52

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AudioCure Pharma GmbH

Auris Medical Holding AG

Knopp Biosciences LLC

Merz Pharma GmbH & Co. KgaA

Otonomy, Inc.

SciFluor Life Sciences, LLC

Sound Pharmaceuticals, Inc.

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

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