Diabetic Neuropathy Pipeline Review, H1 2015

Transcription

1 Reference Code: GMDHC6713IDB Publication Date: June 2015 Global Markets Direct. This report is a licensed product and is not to be photocopied Page(1)

2 Table of Contents Table of Contents... 2 List of Tables... 6 List of Figures... 7 Introduction... 8 Global Markets Direct Report Coverage... 8 Diabetic Neuropathy Overview... 9 Therapeutics Development Pipeline Products for Diabetic Neuropathy Overview Pipeline Products for Diabetic Neuropathy Comparative Analysis Diabetic Neuropathy Therapeutics under Development by Companies Diabetic Neuropathy Therapeutics under Investigation by Universities/Institutes Diabetic Neuropathy Pipeline Products Glance Late Stage Products Clinical Stage Products Early Stage Products Diabetic Neuropathy Products under Development by Companies Diabetic Neuropathy Products under Investigation by Universities/Institutes Diabetic Neuropathy Companies Involved in Therapeutics Development Acorda Therapeutics, Inc Araim Pharmaceuticals Inc Astellas Pharma Inc Cebix Incorporated Eli Lilly and Company Glucox Biotech AB Longevity Biotech, Inc Lpath, Inc Neuralstem, Inc Omeros Corporation Pfizer Inc R-Tech Ueno, Ltd Spinifex Pharmaceuticals Pty Limited Sumitomo Dainippon Pharma Co., Ltd Virobay Inc ViroMed Co., Ltd Diabetic Neuropathy Therapeutics Assessment Assessment by Monotherapy Products Assessment by Target Assessment by Mechanism of Action Assessment by Route of Administration Assessment by Molecule Type Drug Profiles Antimunocel - Drug Profile Global Markets Direct. This report is a licensed product and is not to be photocopied Page(2)

3 Product Description Mechanism of Action R&D Progress ARA Drug Profile Product Description Mechanism of Action R&D Progress ASP Drug Profile Product Description Mechanism of Action R&D Progress BBI Drug Profile Product Description Mechanism of Action R&D Progress Biologic for Diabetic Nephropathy - Drug Profile Product Description Mechanism of Action R&D Progress BNV Drug Profile Product Description Mechanism of Action R&D Progress capsaicin - Drug Profile Product Description Mechanism of Action R&D Progress CBX Drug Profile Product Description Mechanism of Action R&D Progress Cyndacel-M - Drug Profile Product Description Mechanism of Action R&D Progress Drug for Peripheral Neuropathic Pain and Diabetic Peripheral Neuropathy - Drug Profile Product Description Mechanism of Action R&D Progress EMA Drug Profile Product Description Mechanism of Action R&D Progress ketoprofen - Drug Profile Global Markets Direct. This report is a licensed product and is not to be photocopied Page(3)

4 Product Description Mechanism of Action R&D Progress Lpathomab - Drug Profile Product Description Mechanism of Action R&D Progress Monoclonal Antibodies to Inhibit MASP-2 for Rheumatoid Arthritis and Diabetic Complications - Drug Profile Product Description Mechanism of Action R&D Progress NRD-135SE1 - Drug Profile Product Description Mechanism of Action R&D Progress NSI Drug Profile Product Description Mechanism of Action R&D Progress OMS Drug Profile Product Description Mechanism of Action R&D Progress Peptide to Activate G Protein-Coupled Receptor Mas for Cardiovascular, Metabolic Disorders and Erectile Dysfunction - Drug Profile Product Description Mechanism of Action R&D Progress PF Drug Profile Product Description Mechanism of Action R&D Progress ranirestat - Drug Profile Product Description Mechanism of Action R&D Progress Recombinant Protein to Antagonize VEGFR-2 for Oncology and Metabolic Disorders - Drug Profile Product Description Mechanism of Action R&D Progress RTU Drug Profile Product Description Mechanism of Action R&D Progress Global Markets Direct. This report is a licensed product and is not to be photocopied Page(4)

5 Small Molecule to Inhibit NOX-4 for Diabetic Neuropathy - Drug Profile Product Description Mechanism of Action R&D Progress Small Molecules for Diabetic Neuropathy - Drug Profile Product Description Mechanism of Action R&D Progress Small Molecules for Peripheral Neuropathy and Amyotrophic Lateral Sclerosis - Drug Profile Product Description Mechanism of Action R&D Progress Synthetic Peptides for Central Nervous System Disorders and Diabetic Neuropathy - Drug Profile Product Description Mechanism of Action R&D Progress VBY Drug Profile Product Description Mechanism of Action R&D Progress VM Drug Profile Product Description Mechanism of Action R&D Progress Diabetic Neuropathy Recent Pipeline Updates Diabetic Neuropathy Dormant Projects Diabetic Neuropathy Discontinued Products Diabetic Neuropathy Product Development Milestones Featured News & Press Releases Mar 06, 2015: ViroMed dba VM BioPharma: A Phase II Study Done at Northwestern Hospital Shows Potential Relief for Diabetics with Painful Condition Sep 23, 2013: Lpath Awarded NIH SBIR Grant for Lpathomab Jun 09, 2012: Cebix's Ersatta Demonstrates Encouraging Results In Phase I Study Of Diabetic Peripheral Neuropathy Sep 12, 2011: Spinifex Pharmaceuticals Presents New Data On EMA401 In Model Of Diabetic Neuropathy At 21st Annual NEURODIAB Meeting Sep 07, 2011: Cebix To Chair Symposium On C-Peptide And Pathophysiology Of Diabetes At EASD Annual Meeting May 11, 2011: Dainippon Sumitomo Pharma Announces Results Of Phase II Clinical Trial For Ranirestat For Diabetic Complications Mar 18, 2011: ViroMed Enrolls Final Patient For US VM202-DPN Phase I/II Clinical Trial Mar 04, 2009: ViroMed Receives Approval from US FDA for Phase I/II Trial for Diabetic Neuropathy Sep 29, 2005: Dainippon And Eisai Signs Licensing Agreement For A Potential New Treatment For Diabetic Neuropathy 106 Appendix Methodology Coverage Secondary Research Global Markets Direct. This report is a licensed product and is not to be photocopied Page(5)

6 Primary Research Expert Panel Validation Disclaimer List of Tables Number of Products under Development for Diabetic Neuropathy, H Number of Products under Development for Diabetic Neuropathy Comparative Analysis, H Number of Products under Development by Companies, H Number of Products under Investigation by Universities/Institutes, H Comparative Analysis by Late Stage Development, H Comparative Analysis by Clinical Stage Development, H Comparative Analysis by Early Stage Development, H Products under Development by Companies, H Products under Development by Companies, H (Contd..1) Products under Investigation by Universities/Institutes, H Diabetic Neuropathy Pipeline by Acorda Therapeutics, Inc., H Diabetic Neuropathy Pipeline by Araim Pharmaceuticals Inc., H Diabetic Neuropathy Pipeline by Astellas Pharma Inc., H Diabetic Neuropathy Pipeline by Cebix Incorporated, H Diabetic Neuropathy Pipeline by Eli Lilly and Company, H Diabetic Neuropathy Pipeline by Glucox Biotech AB, H Diabetic Neuropathy Pipeline by Longevity Biotech, Inc, H Diabetic Neuropathy Pipeline by Lpath, Inc., H Diabetic Neuropathy Pipeline by Neuralstem, Inc., H Diabetic Neuropathy Pipeline by Omeros Corporation, H Diabetic Neuropathy Pipeline by Pfizer Inc., H Diabetic Neuropathy Pipeline by R-Tech Ueno, Ltd., H Diabetic Neuropathy Pipeline by Spinifex Pharmaceuticals Pty Limited, H Diabetic Neuropathy Pipeline by Sumitomo Dainippon Pharma Co., Ltd., H Diabetic Neuropathy Pipeline by Virobay Inc., H Diabetic Neuropathy Pipeline by ViroMed Co., Ltd., H Assessment by Monotherapy Products, H Number of Products by Stage and Target, H Number of Products by Stage and Mechanism of Action, H Number of Products by Stage and Route of Administration, H Number of Products by Stage and Molecule Type, H Diabetic Neuropathy Therapeutics Recent Pipeline Updates, H Diabetic Neuropathy Dormant Projects, H Diabetic Neuropathy Dormant Projects (Contd..1), H Diabetic Neuropathy Dormant Projects (Contd..2), H Diabetic Neuropathy Dormant Projects (Contd..3), H Diabetic Neuropathy Discontinued Products, H Diabetic Neuropathy Discontinued Products (Contd..1), H Global Markets Direct. This report is a licensed product and is not to be photocopied Page(6)

7 List of Figures Number of Products under Development for Diabetic Neuropathy, H Number of Products under Development for Diabetic Neuropathy Comparative Analysis, H Number of Products under Development by Companies, H Comparative Analysis by Late Stage Development, H Comparative Analysis by Clinical Stage Development, H Comparative Analysis by Early Stage Products, H Assessment by Monotherapy Products, H Number of Products by Stage and Top 10 Targets, H Number of Products by Stage and Top 10 Mechanism of Actions, H Number of Products by Top 10 Routes of Administration, H Number of Products by Stage and Top 10 Routes of Administration, H Number of Products by Top 10 Molecule Types, H Number of Products by Stage and Top 10 Molecule Types, H Global Markets Direct. This report is a licensed product and is not to be photocopied Page(7)

8 Introduction Global Markets Direct Report Coverage Global Markets Direct s, Diabetic Neuropathy - Pipeline Review, H1 2015, provides an overview of the Diabetic Neuropathy s therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Diabetic Neuropathy, 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 Diabetic Neuropathy 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 update 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. Global Markets Direct. This report is a licensed product and is not to be photocopied Page(8)

9 Diabetic Neuropathy Overview Diabetic neuropathy, a common complication of diabetes, is damage to the nerves that allow feeling things such as pain. Symptoms include tingling, numbness, burning and pain. The predisposing factors are obesity, hypertension, high lipid and sugar levels, smoking, etc. It may be managed by medication and dietary modification. Global Markets Direct. This report is a licensed product and is not to be photocopied Page(9)

10 Therapeutics Development Pipeline Products for Diabetic Neuropathy Overview Number of Products under Development for Diabetic Neuropathy, H Number of Products under Development for Diabetic Neuropathy, H Stage of Development Number of Products Under Development Global Markets Direct. This report is a licensed product and is not to be photocopied Page(10)

11 Diabetic Neuropathy Companies Involved in Therapeutics Development Acorda Therapeutics, Inc. Diabetic Neuropathy Pipeline by Acorda Therapeutics, Inc., H Product Name Indication Name Stage of Development Territory Araim Pharmaceuticals Inc. Diabetic Neuropathy Pipeline by Araim Pharmaceuticals Inc., H Product Name Indication Name Stage of Development Territory Astellas Pharma Inc. Diabetic Neuropathy Pipeline by Astellas Pharma Inc., H Product Name Indication Name Stage of Development Territory Global Markets Direct. This report is a licensed product and is not to be photocopied Page(21)

12 Cebix Incorporated Diabetic Neuropathy Pipeline by Cebix Incorporated, H Product Name Indication Name Stage of Development Territory Eli Lilly and Company Diabetic Neuropathy Pipeline by Eli Lilly and Company, H Product Name Indication Name Stage of Development Territory Glucox Biotech AB Diabetic Neuropathy Pipeline by Glucox Biotech AB, H Product Name Indication Name Stage of Development Territory Global Markets Direct. This report is a licensed product and is not to be photocopied Page(22)

13 Diabetic Neuropathy Therapeutics Assessment Assessment by Monotherapy Products Assessment by Monotherapy Products, H Assessment by Monotherapy Products, H Stage of Development Number of Monotherapy Products Global Markets Direct. This report is a licensed product and is not to be photocopied Page(33)

14 Drug Profiles Antimunocel - Drug Profile Product Description Mechanism of Action R&D Progress Global Markets Direct. This report is a licensed product and is not to be photocopied Page(42)

15 ARA Drug Profile Product Description Mechanism of Action R&D Progress Global Markets Direct. This report is a licensed product and is not to be photocopied Page(43)

16 Appendix Appendix Methodology Global Markets Direct s dedicated Research and Analysis Teams consist of experienced professionals with a pedigree in marketing, market research, consulting background in the pharmaceutical industry and advanced statistical expertise. Global Markets Direct adheres to the Codes of Practice of the Market Research Society ( and the Strategic and Competitive Intelligence Professionals ( All Global Markets Direct databases are continuously updated and revised. The following research methodology is followed for all databases and reports. Coverage The objective of updating Global Markets Direct coverage is to ensure that it represents the most up to date vision of the industry possible The report covers all the pharmaceutical/biopharmaceutical products under development across the globe. The scope of the pipeline products coverage aims at setting up the boundaries of the project. It comprises all the therapeutic products that are in the course of development, however, if a drug is solely used for research purpose, where the intention for its further development as a drug is not clear or the strategy for commercialization is not known, the drug is not included in the report. Global Markets Direct aims to cover major news events and deals in the pharmaceutical industry, updated on daily basis. The coverage is further streamlined and strengthened with additional inputs from Global Markets Direct Expert Panel (see below). Secondary Research The research process begins with exhaustive secondary research on internal and external sources being carried out to source/update the pipeline products information. The secondary research sources that are typically referred to include, but are not limited to: Company websites, annual reports, financial reports, company pipeline chart, broker reports, investor presentations and SEC filings, journals and conferences, clinical trials registries, internal proprietary databases, news articles, press releases and web-casts specific to the companies operating in the respective indication/therapy area. Primary Research Global Markets Direct conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its pipeline products data. A typical research interview provides first-hand information on the pipeline therapeutics landscape and helps in validating and strengthening the secondary research findings. Primary research involves interactions with the industry participants across geographies. The participants who typically take part in such a process include, but are not limited to: CEOs, VPs, business development managers, market intelligence managers and national sales managers. Expert Panel Validation Global Markets Direct uses a panel of experts to cross verify research methodologies, and drive its analytical content. The Global Markets Direct expert panel comprises senior research managers, marketing managers, product specialists & international sales managers. Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, Global Markets Direct. Global Markets Direct. This report is a licensed product and is not to be photocopied Page(108)