Back Pain - Pipeline Review, H2 2012

Global Markets Direct, September 2012, Pages: 93

Back Pain – Pipeline Review, H2 2012

Summary

Global Markets Direct’s, 'Back Pain - Pipeline Review, H2 2012', provides an overview of the indication’s therapeutic pipeline. This report provides information on the therapeutic development for Back Pain, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Back Pain. Back Pain - Pipeline Review, Half Year 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.

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

Scope

- A snapshot of the global therapeutic scenario for Back Pain.
- A review of the Back Pain products under development by companies and universities/research institutes based on information derived from company and industry-specific sources.
- Coverage of products based on various stages of development ranging from discovery till registration stages.
- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.
- Coverage of the Back Pain pipeline on the basis of route of administration and molecule type.
- Key discontinued pipeline projects.
- Latest news and deals relating to the products.

Reasons to buy

- Identify and understand important and diverse types of therapeutics under development for Back Pain.
- Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive advantage.
- Plan mergers and acquisitions effectively by identifying players of the most promising pipeline.
- Devise corrective measures for pipeline projects by understanding Back Pain 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.

2
List of Tables 6
List of Figures 7
Introduction 8
REPORT COVERAGE 8
Back Pain Overview 9
Therapeutics Development 10
An Overview of Pipeline Products for Back Pain 10
Back Pain Therapeutics under Development by Companies 12
Back Pain Therapeutics under Investigation by Universities/Institutes 14
Late Stage Products 15
Comparative Analysis 15
Mid Clinical Stage Products 16
Comparative Analysis 16
Early Clinical Stage Products 17
Comparative Analysis 17
Pre-Clinical Stage Products 18
Comparative Analysis 18
Back Pain Therapeutics – Products under Development by Companies 19
Back Pain Therapeutics – Products under Investigation by Universities/Institutes 20
Companies Involved in Back Pain Therapeutics Development 21
DURECT Corporation 21
Abbott Laboratories 22
BioDelivery Sciences International, Inc. 23
Zogenix, Inc. 24
Cephalon, Inc. 25
Eisai Co., Ltd. 26
Pfizer Inc. 27
Mesoblast Ltd 28
Newron Pharmaceuticals S.p.A. 29
Teikoku Pharma USA, Inc. 30
QRxPharma Limited 31
Sosei Co. Ltd. 32
Troikaa Pharmaceuticals Ltd. 33
Back Pain – Therapeutics Assessment 34
Assessment by Monotherapy Products 34
Assessment by Combination Products 35
Assessment by Route of Administration 36
Assessment by Molecule Type 38
Drug Profiles 40
hydrocodone bitartrate - Drug Profile 40
Product Description 40
Mechanism of Action 40
R&D Progress 40
Vicodin CR - Drug Profile 42
Product Description 42
Mechanism of Action 42
R&D Progress 42
bupivacaine - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
ALO-02 - Drug Profile 46
Product Description 46
Mechanism of Action 46
R&D Progress 46
buprenorphine hydrochloride - Drug Profile 48
Product Description 48
Mechanism of Action 48
R&D Progress 48
morphine sulfate+oxycodone hydrochloride CR - Drug Profile 50
Product Description 50
Mechanism of Action 50
R&D Progress 50
ralfinamide - Drug Profile 52
Product Description 52
Mechanism of Action 52
R&D Progress 52
cycloserine - Drug Profile 53
Product Description 53
Mechanism of Action 53
R&D Progress 53
hydrocodone bitartrate ER - Drug Profile 54
Product Description 54
Mechanism of Action 54
R&D Progress 54
SD-726 - Drug Profile 56
Product Description 56
Mechanism of Action 56
R&D Progress 56
pamidronate disodium - Drug Profile 57
Product Description 57
Mechanism of Action 57
R&D Progress 57
dronabinol - Drug Profile 58
Product Description 58
Mechanism of Action 58
R&D Progress 58
Sulfasalazine + Methotrexate + Hydroxychloroquine - Drug Profile 59
Product Description 59
Mechanism of Action 59
R&D Progress 59
gabapentin - Drug Profile 60
Product Description 60
Mechanism of Action 60
R&D Progress 60
Benztropine - Drug Profile 61
Product Description 61
Mechanism of Action 61
R&D Progress 61
desipramine hydrochloride - Drug Profile 62
Product Description 62
Mechanism of Action 62
R&D Progress 62
fluoxetine - Drug Profile 63
Product Description 63
Mechanism of Action 63
R&D Progress 63
TPH-023 - Drug Profile 65
Product Description 65
Mechanism of Action 65
R&D Progress 65
zoledronic acid - Drug Profile 66
Product Description 66
Mechanism of Action 66
R&D Progress 66
milnacipran - Drug Profile 67
Product Description 67
Mechanism of Action 67
R&D Progress 67
E2000 + Diclofenac Sodium - Drug Profile 68
Product Description 68
Mechanism of Action 68
R&D Progress 68
Stem Cells For Chronic Back Pain - Drug Profile 69
Product Description 69
Mechanism of Action 69
R&D Progress 69
REC-1100 - Drug Profile 71
Product Description 71
Mechanism of Action 71
R&D Progress 71
ATNC-05 - Drug Profile 72
Product Description 72
Mechanism of Action 72
R&D Progress 72
Diclofenac + Thiocolchicoside - Drug Profile 73
Product Description 73
Mechanism of Action 73
R&D Progress 73
T-109 - Drug Profile 74
Product Description 74
Mechanism of Action 74
R&D Progress 74
anakinra - Drug Profile 75
Product Description 75
Mechanism of Action 75
R&D Progress 75
AYX-2 - Drug Profile 76
Product Description 76
Mechanism of Action 76
R&D Progress 76
Back Pain Therapeutics – Drug Profile Updates 77
Back Pain Therapeutics – Discontinued Products 84
Back Pain Therapeutics - Dormant Products 85
Back Pain – Product Development Milestones 86
Featured News & Press Releases 86
Aug 29, 2012: Collegium Pharma Initiates Enrollment In Phase III Efficacy Study Of Oxycodone DETERx In Subjects With Moderate To Severe Chronic Lower Back Pain 86
Jul 06, 2012: Lilly Obtains Six Months US Pediatric Exclusivity For Cymbalta 86
Apr 17, 2012: Mesoblast Announces Intervertebral Disc Repair Phase II Trial Update 86
Sep 26, 2011: Collegium Pharmaceutical Announces Successful Type A Meeting With FDA For Tamper-Resistant, Extended Release Opioid 87
Aug 26, 2011: Janssen's NUCYNTA ER Receives FDA Approval For Management Of Moderate To Severe Chronic Pain 88
Apr 29, 2011: Lilly Receives Health Canada Approval For Cymbalta For Chronic Low Back Pain 88
Apr 11, 2011: DURECT Announces ELADUR Phase II Study Results In Chronic Low Back Pain 89
Nov 30, 2010: Zogenix Completes Enrollment In ZX002 Phase III 12-Month Safety Study 89
Aug 30, 2010: BioDelivery Sciences Reports BEMA Buprenorphine Phase II Study Results Selected For Presentation At Pain Week 2010 90
Aug 19, 2010: Lilly Reports Approval Recommendation From FDA Advisory Committee For Expanding Pain Indications For Cymbalta 91
Appendix 92
Methodology 92
Coverage 92
Secondary Research 92
Primary Research 92
Expert Panel Validation 92
Contact Us 93
Disclaimer 93

List of Tables
Number of Products Under Development for Back Pain, H2 2012 10
Products under Development for Back Pain – Comparative Analysis, H2 2012 11
Number of Products under Development by Companies, H2 2012 13
Number of Products under Investigation by Universities/Institutes, H2 2012 14
Comparative Analysis by Late Stage Development, H2 2012 15
Comparative Analysis by Mid Clinical Stage Development, H2 2012 16
Comparative Analysis by Early Clinical Stage Development, H2 2012 17
Comparative Analysis by Pre-Clinical Stage Development, H2 2012 18
Products under Development by Companies, H2 2012 19
Products under Investigation by Universities/Institutes, H2 2012 20
DURECT Corporation, H2 2012 21
Abbott Laboratories, H2 2012 22
BioDelivery Sciences International, Inc., H2 2012 23
Zogenix, Inc., H2 2012 24
Cephalon, Inc., H2 2012 25
Eisai Co., Ltd., H2 2012 26
Pfizer Inc., H2 2012 27
Mesoblast Ltd, H2 2012 28
Newron Pharmaceuticals S.p.A., H2 2012 29
Teikoku Pharma USA, Inc., H2 2012 30
QRxPharma Limited, H2 2012 31
Sosei Co. Ltd., H2 2012 32
Troikaa Pharmaceuticals Ltd., H2 2012 33
Assessment by Monotherapy Products, H2 2012 34
Assessment by Combination Products, H2 2012 35
Assessment by Stage and Route of Administration, H2 2012 37
Assessment by Stage and Molecule Type, H2 2012 39
Back Pain Therapeutics – Drug Profile Updates 77
Back Pain Therapeutics – Discontinued Products 84
Back Pain Therapeutics – Dormant Products 85

List of Figures
Number of Products under Development for Back Pain, H2 2012 10
Products under Development for Back Pain – Comparative Analysis, H2 2012 11
Products under Development by Companies, H2 2012 12
Products under Investigation by Universities/Institutes, H2 2012 14
Late Stage Products, H2 2012 15
Mid Clinical Stage Products, H2 2012 16
Early Clinical Stage Products, H2 2012 17
Pre-Clinical Stage Products, H2 2012 18
Assessment by Monotherapy Products, H2 2012 34
Assessment by Combination Products, H2 2012 35
Assessment by Route of Administration, H2 2012 36
Assessment by Stage and Route of Administration, H2 2012 37
Assessment by Molecule Type, H2 2012 38
Assessment by Stage and Molecule Type, H2 2012 39

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