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

GBI Research, April 2012, Pages: 70

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

1.1 List of Tables
1.2 List of Figures

2 Introduction
2.1 Generics, Supergenerics and New Chemical Entities
2.2 Key Advantages for Development of Supergenerics
2.3 Drivers for Supergeneric Organizations
2.3.1 High Unmet Clinical Need
2.3.2 Product Differentiation
2.3.3 Decline in R&D Productivity
2.3.4 Increased Generic Competition
2.3.5 Patent Expiration and Freedom to Operate
2.3.6 Rise in the Number of Paper New Drug Applications
2.3.7 Shift towards Orphan Drugs and Biopharmaceuticals
2.3.8 Aging Population
2.3.9 Emerging Markets
2.3.10 Healthcare Reform and Cost-effective Treatments
2.4 Report Guidance

3 Strategies for Developing and Differentiating Supergenerics
3.1 Therapeutic Strategies for Supergenerics
3.2 Supergenerics Improving Delivery and Clinical Profile
3.2.1 Oncology
3.2.2 Central Nervous System and Pain
3.2.3 Alzheimer’s Disease and Dementia
3.2.4 Parkinson’s Disease
3.2.5 Schizophrenia
3.2.6 Epilepsy
3.2.7 Depression
3.2.8 Migraine
3.2.9 Attention Deficit Hyperactivity Disorder
3.2.10 Pain
3.2.11 Respiratory
3.2.12 Therapeutic Conclusions
3.3 Supergenerics Improving Manufacturing Efficiency
3.3.1 Quality by Design
3.3.2 Regulatory Support for Continuous Manufacturing Processes
3.3.3 Reducing Manufacturing Costs
3.3.4 Pharma Investment in Continuous Manufacturing
3.3.5 Manufacturing Conclusions
3.3.6 Overall Conclusions

4 Regulatory and Legislative Implications
4.1 Introduction
4.2 US Regulation of Supergenerics
4.2.2 Paper New Drug Application
4.3 European Regulation of Supergenerics
4.3.1 Hybrid Medicinal Product
4.3.2 Patent Implications for Supergenerics
4.3.3 Conclusions

5 Supergeneric Organization Strategies
5.1.1 Access Pharmaceuticals
5.1.2 Adamas Pharmaceutical
5.1.3 Adventrx Pharmaceuticals
5.1.4 Azaya Therapeutics
5.1.5 Cynapsus Therapeutics
5.1.6 Durect Corporation
5.1.7 Enzon Pharmaceuticals
5.1.8 Insys Therapeutics
5.1.9 KemPharm Inc
5.1.10 Nektar Therapeutics
5.1.11 NuPathe Inc
5.1.12 Pearl Therapeutics
5.1.13 PharmaEngine Inc
5.1.14 Pulmatrix Inc.
5.1.15 Regulon Inc.
5.1.16 Supernus Pharmaceuticals
5.1.17 Talon Therapeutics
5.1.18 Zogenix Inc.

6 Future Outlook

7 Appendix
7.1 Abbreviations
7.1.1 Sources
7.2 Methodology
7.2.1 Primary Research
7.2.2 Secondary Research
7.3 Contacts Us
7.4 Disclaimer

1.1 List of Tables
Table 1: Growth Strategies for Supergenerics Organizations, Leading Branded Drugs Losing Market Exclusivity in, 2012–2016
Table 2: Growth Strategies for Supergenerics Organizations, Advanced Drug Delivery Technologies Utilized in Supergeneric Anticancer Drugs, 2012
Table 3: Growth Strategies for Supergenerics Organizations, Advanced Drug Delivery Technologies Utilized in Central Nervous System Branded Drugs, 2012
Table 4: Growth Strategies for Supergenerics Organizations, Relday Drug Attributes vs. Competitors, 2012
Table 5: Growth Strategies for Supergenerics Organizations, Branded Drugs Losing Market Exclusivity in, 2012
Table 6: Growth Strategies for Supergenerics Organizations, Summary of US Regulatory Pathway, 2012

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

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