Growth Strategies for Supergenerics Organizations - Opportunities in Addressing Unmet Medical Needs and Providing Cost-Effective Solutions for Product Development in Emerging Markets



Summary



GBI Research, a leading business intelligence provider, has released its latest research “Growth Strategies for Supergenerics Organizations - Opportunities in Addressing Unmet Medical Needs and Providing Cost-Effective Solutions for Product Development in Emerging Markets” which assesses the strategies that companies have used to improve the efficacy, safety, ease of use and manufacture of products. It discusses the key advantages and market drivers to develop and differentiate supergenerics. It analyzes the regulatory and legislative implications on the development of supergenerics, and gives an introduction to the CRO industry. It provides an overview of leading supergeneric organizations, their technologies, product development strategies, and partnering activities and analyzes market trends and the future outlook for the growth of supergeneric organizations.

Today more than 550 new chemical entities have been approved for use, however many of these products are still only available in their original dosage form and indication. As our scientific understanding into the mechanism of action, targets, effects, and delivery technologies grows supergeneric organizations have gained significant expertise to develop novel platform technologies that can enhance the delivery of one or more agents and improve tissue targeting thereby reducing off-target side effects, potentially enhancing therapeutic effects and the ease of administration. GBI Research analysis has identified more than 60 novel supergeneric formulations of approved oncology, CNS and pain, and respiratory products that are under development which address specific unmet medical need and which may provide a cost-effective solution to develop novel products to meet the growing demands within the emerging markets.



Scope


- Market analysis identifying the key advantages for developing supergenerics and the market drivers for product development.
- Data and analysis regarding novel technologies and delivery platforms that have been developed to enhance the safety and efficacy and/or ease the administration of single molecules and combination therapies.
- Assess how supergenerics can improve manufacturing efficiencies through the adoption of continuous manufacturing processes.
- Key challenges faced by supergeneric organization with respect to the regulatory hurdles and IP protection of supergeneric products
- The competitive landscape of leading supergeneric organizations their products, technologies and partnership activities including: Access Pharmaceuticals, Adamas Pharmaceutical, Adventrx Pharmaceuticals, Azaya therapeutics, Cynapsus Therapeutics, Durect Corporation, Enzon Pharmacetuicals, Insys Therapetuics, KemPharm, Nektar Therapeutics, NuPathe, Pearl Therapeutics, PharmaEngine, Pulmatrix, Regulon, Supernus Pharmaceuticals, Talon Therapeutics and Zogenix.



Reasons to buy


- Identify the key market opportunities for supergeneric development
- Develop or license the IP for technology platforms to optimize product delivery
- Re-evaluate and reassess manufacturing processes and explore alternative ways to improve manufacturing efficiencies
- Gain a greater understanding with regards to the regulatory requirements for supergeneric development and potential IP issues
- Develop key strategic alliances with leading supergeneric organization to complement and expand product portfolios to meet the demand of developed and emerging markets

Table Of Contents

1 Table of Contents
1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6
2 Introduction 7
2.1 Generics, Supergenerics and New Chemical Entities 7
2.2 Key Advantages for Development of Supergenerics 8
2.3 Drivers for Supergeneric Organizations 9
2.3.1 High Unmet Clinical Need 10
2.3.2 Product Differentiation 11
2.3.3 Decline in RandD Productivity 12
2.3.4 Increased Generic Competition 14
2.3.5 Patent Expiration and Freedom to Operate 15
2.3.6 Rise in the Number of Paper New Drug Applications 15
2.3.7 Shift towards Orphan Drugs and Biopharmaceuticals 17
2.3.8 Aging Population 18
2.3.9 Emerging Markets 18
2.3.10 Healthcare Reform and Cost-effective Treatments 19
2.4 Report Guidance 19
3 Strategies for Developing and Differentiating Supergenerics 20
3.1 Therapeutic Strategies for Supergenerics 20
3.2 Supergenerics Improving Delivery and Clinical Profile 21
3.2.1 Oncology 21
3.2.2 Central Nervous System and Pain 27
3.2.3 Alzheimer’s Disease and Dementia 29
3.2.4 Parkinson’s Disease 29
3.2.5 Schizophrenia 30
3.2.6 Epilepsy 31
3.2.7 Depression 32
3.2.8 Migraine 32
3.2.9 Attention Deficit Hyperactivity Disorder 33
3.2.10 Pain 33
3.2.11 Respiratory 34
3.2.12 Therapeutic Conclusions 38
3.3 Supergenerics Improving Manufacturing Efficiency 39
3.3.1 Quality by Design 39
3.3.2 Regulatory Support for Continuous Manufacturing Processes 40
3.3.3 Reducing Manufacturing Costs 42
3.3.4 Pharma Investment in Continuous Manufacturing 43
3.3.5 Manufacturing Conclusions 44
3.3.6 Overall Conclusions 44
4 Regulatory and Legislative Implications 45
4.1 Introduction 45
4.2 US Regulation of Supergenerics 45
4.2.2 Paper New Drug Application 46
4.3 European Regulation of Supergenerics 47
4.3.1 Hybrid Medicinal Product 47
4.3.2 Patent Implications for Supergenerics 48
4.3.3 Conclusions 49
5 Supergeneric Organization Strategies 50
5.1.1 Access Pharmaceuticals 50
5.1.2 Adamas Pharmaceutical 51
5.1.3 Adventrx Pharmaceuticals 52
5.1.4 Azaya Therapeutics 53
5.1.5 Cynapsus Therapeutics 53
5.1.6 Durect Corporation 54
5.1.7 Enzon Pharmaceuticals 55
5.1.8 Insys Therapeutics 56
5.1.9 KemPharm Inc 56
5.1.10 Nektar Therapeutics 57
5.1.11 NuPathe Inc 58
5.1.12 Pearl Therapeutics 59
5.1.13 PharmaEngine Inc 60
5.1.14 Pulmatrix Inc. 61
5.1.15 Regulon Inc. 61
5.1.16 Supernus Pharmaceuticals 61
5.1.17 Talon Therapeutics 62
5.1.18 Zogenix Inc. 63
6 Future Outlook 65
7 Appendix 66
7.1 Abbreviations 66
7.1.1 Sources 68
7.2 Methodology 69
7.2.1 Primary Research 69
7.2.2 Secondary Research 69
7.3 Contacts Us 70
7.4 Disclaimer 70

1.1 List of Tables


Table 1: Growth Strategies for Supergenerics Organizations, Leading Branded Drugs Losing Market Exclusivity in, 2012-2016 20
Table 2: Growth Strategies for Supergenerics Organizations, Advanced Drug Delivery Technologies Utilized in Supergeneric Anticancer Drugs, 2012 22
Table 3: Growth Strategies for Supergenerics Organizations, Advanced Drug Delivery Technologies Utilized in Central Nervous System Branded Drugs, 2012 27
Table 4: Growth Strategies for Supergenerics Organizations, Relday Drug Attributes vs. Competitors, 2012 31
Table 5: Growth Strategies for Supergenerics Organizations, Branded Drugs Losing Market Exclusivity in, 2012 36
Table 6: Growth Strategies for Supergenerics Organizations, Summary of US Regulatory Pathway, 2012 45

1.2 List of Figures


Figure 1: Growth Strategies for Supergenerics Organizations, Overview of Generics, Supergenerics and New Chemical Entities, 2012 7
Figure 2: Growth Strategies for Supergenerics Organizations, Overview of Biosimilars, Biopharmaceuticals and Biobetters, 2012 8
Figure 3: Growth Strategies for Supergenerics Organizations, Characteristics of Supergeneric Drug Development vs. Generics and New Chemical Entities 9
Figure 4: Growth Strategies for Supergenerics Organizations, Market Drivers for Growth of Supergeneric Organizations, 2012 9
Figure 5: Growth Strategies for Supergenerics Organizations, Product Differentiation Strategies for Supergenerics, 2012 11
Figure 6: Growth Strategies for Supergenerics Organizations, Food and Drug Administration New Drug Application Approvals and RandD Expenditure, 2004-2010 12
Figure 7: Growth Strategies for Supergenerics Organizations, New Molecular Entity Applications to the Food and Drug Administration Centre for Drug Evaluation and Research, 1996-2010 13
Figure 8: Growth Strategies for Supergenerics Organizations, Food and Drug Administration Abbreviated New Drug Application Approvals, 2001-2011 14
Figure 9: Growth Strategies for Supergenerics Organizations, Branded Drugs Sales Facing Patent Expiry, 2001-2020 15
Figure 10: Growth Strategies for Supergenerics Organizations, Paper New Drug Application Approvals, 2004-2011 16
Figure 11: Growth Strategies for Supergenerics Organizations, Rise in Orphan Drug Designations and Approvals in the US,1995-2010 17
Figure 12: Growth Strategies for Supergenerics Organizations, Proportion of the Population Over 60, 2010 and 2050 18
Figure 13: Growth Strategies for Supergenerics Organizations, Therapeutic Split of Generic Products Losing Market Exclusivity, 2012-2016 21
Figure 14: Growth Strategies for Supergenerics Organizations, NKTR-102 Demonstrates Improved Pharmacokinetics vs. irinotecan, 2012 23
Figure 15: Growth Strategies for Supergenerics Organizations, Access Pharma’s ProLindac (prodrug) Structure, 2012 25
Figure 16: Growth Strategies for Supergenerics Organizations, Drug Release Profiles, 2012 28
Figure 17: Growth Strategies for Supergenerics Organizations, Global Respiratory Product Sales ($bn), 2010 and 2016 34
Figure 18: Growth Strategies for Supergenerics Organizations, Criteria for an Ideal Dry Powder Inhaler, 2012 35
Figure 19: Growth Strategies for Supergenerics Organizations, Pharmaceutical Manufacturing Costs (%), 2006 42
Figure 20: Growth Strategies for Supergenerics Organizations, Reducing Manufacturing Steps Me-too and New Formulations, 2012 43
Figure 21: Growth Strategies for Supergenerics Organizations, Properties Eligible for Patenting, 2012 48
Figure 22: Growth Strategies for Supergenerics Organizations, PharmaEngine Business Model, 2012 60
Figure 23: Growth Strategies for Supergenerics Organizations, Zogenix Needle Free DosePro Delivery Device and Application, 2012 64

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