The Future Of Virtualization: Emerging Trends And The Evolving Vendor Landscape-Aarkstore Enterprise

This report investigates three goals in optimizing				Chapter 3 Accessing broader patient populations
product potential- expanding the drug's patent				46
protected lifespan, accessing broader patient				Summary 46
populations and launching line-extensions via fixed				Drug labeling and market access 47
dose combinations. The key success factors in				Off-label drug usage 47
each of these pursuits have been clearly identified,				Commercial incentives and disincentives 48
emerging trends have been presented and the				Payors stance on off-label reimbursement 49
underlying concepts have been explained to				Case study: Avastin and Lucentis 51
provide a clear understanding of current industry				Expanding the label 53
dynamics. Case studies on popular products have				Role in product lifecycle management 53
been used to illustrate these concepts in the real				New indications 53
world. An in-depth analysis of drug approval data				Pediatric extensions and special populations 54
provides context for the issues discussed. This				Modified indications and expanded usage 54
information is juxtaposed with historic sales data				Case study: Yaz 55
to explore the correlation between the strategies				Case study: Remicade 58
employed and revenue potential.				Indication expansion 59
This report explains the basics of drug lifecycle				Choosing the primary indication 61
and investigates three goals in optimizing product				Related versus unrelated indications 63
potential- expanding the drug's patent protected				Sequence of indication expansion 64
lifespan, accessing broader patient populations and				Timing of indication expansion 65
launching line-extensions via FDCs.				Launching early in commercial lifecycle 68
The key success factors in each of these				Launching late in commercial lifecycle 69
pursuits have been clearly identified, emerging				Seroquel: Using indication expansion and drug
trends have been presented and the underlying				reformulation synergistically 70
concepts have been explained to give the reader				Recent trends in indication expansion 72
a clear understanding of current industry				Indication expansion for NDAs 72
dynamics. Case studies on popular products have				Indication expansion for biologics 75
been used to illustrate these concepts in the real				Chapter 4 Fixed dose combinations 80
world.				Summary 80
An in-depth analysis of drug approval data				Introduction 81
provides context for the issues discussed. This				Clinical challenges in FDC development 81
information is juxtaposed with historic sales data				FDC patents 82
to explore the correlation between the strategies				Data exclusivity for FDCs 83
employed and revenue potential.				Role in product lifecycle maximization 83
Key findings				Case study: Advair's role in GSK's asthma
Drug manufacturers must make the best				franchise 85
strategic use of the patent-protected lifespan of				Case study: How Vytorin influenced Zocor's
a drug, or else risk losing the profit incentives				patent expiry 88
they perceived at the start of the project. (Ch. 1)				Case study: BiDil's value proposition reinvented 90
In light of the increasing complexity of				FDC uptake by geography 91
biopharmaceutical patenting, the ‘freedom to				Case study: FDCs for hypertension 91
operate', i.e. to commercialize the invention, is				Clinical rationale 93
coming under increasing scrutiny. (Ch. 2)				Synergistic efficacy or safety 94
The US Congress' emerging stance on data				Easier Rx management 95
exclusivity provisions for biologics will define the				Correlation between FDC usage and drug
length of time a biotechnology company can keep				compliance 95
out generic competition in new indications. The				Correlation between drug compliance &
biotech industry's stance is that the current				improved clinical outcomes 96
provisions do not provide for enough time to				FDC usage by therapy area 96
profit from their post-approval R&D				Key success factors and competitive hurdles 98
investments. (Ch. 2)				Endorsement by treatment guidelines 98
The potential for post-approval label expansion is				Perceived synergy effects over free combination
much greater for biologics in comparison to small				99
molecule pharmaceutical drugs. Most biologics on				Compliance advantage over the free combination
the market today can expect to add significant				99
revenue streams via new indications, and				Usage of mono compounds prior to FDC launch
potentially extend their commercial lifespan. (Ch 3)				99
Over 45% of all new indication approvals granted				Discount compared to cheapest free combination
by the FDA since 1998 belong to drugs that fall in				100
the Genito-urinary system and Nervous system.				Time-to-LOE of parent brand 101
If an FDC is launched close to the loss of				Chapter 5 Appendix 103
exclusivity date of the constituent brand, it may				Primary research methodology 103
be interpreted as a marketing tactic to limit				Glossary 107
post-LoE revenue losses. If launched early, it may				Index 111
show intent to cater to a genuine unmet need, or				List of Figures
to legitimately maximize the potential of the				Figure 1.1: Summary of lifecycle of medicinal drugs
parent molecule(s). (Ch. 4)				17
Scope of the report				Figure 1.2: Transition probabilities for clinical phases
In-depth case studies explore the real-world				18
execution of the issues and challenges discussed in				Figure 1.3: Out-of-pocket and capitalized costs of
the report.				developing a drug ($m) 19
Analysis of historic drug approval data provides				Figure 1.4: Time taken for development of new
the reader with contextual reference points.				pharma & biotech drugs 20
Case studies on Vytorin, Advair and BiDil illustrate				Figure 1.5: Approval timelines at CDER for priority
the strategies employed by three leading FDC				NDAs, 1999-08 21
brands.				Figure 1.6: Approval timelines at CDER for
Brand histories of Yaz, Remicade and Seroquel				standard NDAs, 1999-08 21
show how label expansion is fundamental to				Figure 1.7: Imperatives of efficient lifecycle
successful lifecycle management.				management 23
Where applicable, these strategies are discussed				Figure 1.8: Increasing importance of payors as
with reference to specific therapeutic areas or				stakeholders 24
geographies.				Figure 1.9: Tougher payor environments are
Issues related to biologics are highlighted to				slowing product uptake 25
indicate where they differ from small molecule				Figure 1.10: Therapeutic substitution and formulary
drugs.				access 27
Use this report to				Figure 2.11: 8+2+1 data exclusivity system in
Gain an understanding of legal provision for patent				Europe 41
protection and data exclusivity. Understand their				Figure 2.12: Data exclusivity and patent protection
role in the context of product lifecycle				in the US 43
management				Figure 3.13: On and off-label decision making by
Utilize the historical data on NDA approvals to				payors 50
identify trends and build assumptions into				Figure 3.14: Off-label usage of Avastin: a
competitive landscape forecasts.				pharmacoeconomic model for wet AMD 52
Understand the stance of key stakeholders and				Figure 3.15: Yaz: Label expansion & sales
implications of off-label drug usage.				growth - US ($m), 2006-08 57
Understand the role of FDCs in optimizing the				Figure 3.16: Remicade: Label expansion &
commercial potential of a product asset, and the				sales growth - US ($m), 2001-08 59
main challenges in their commercialization				Figure 3.17: Time between launch of original and
Juxtapose historic sales performance with the				new indications in the US (by ATC), 1999-08 66
timing of indication expansion and FDC based				Figure 3.18: Time between launch of original and
strategies to assess the success or failure				new indications in the US (by ATC), 1999-08
				(contd) 67
				Figure 3.19: Considerations in launching new
				indications early in the lifecycle 69
Table of Contents :				Figure 3.20: Considerations in launching new
				indications late in the lifecycle 70
Optimizing Lifecycle Management				Figure 3.21: Lifecycle management: Seroquel and
Executive summary 8				Seroquel XR 71
Product lifecycle and management challenges 8				Figure 3.22: New indication approvals for NDAs,
Influencing the commercial lifespan of the drug 9				1999-2008 73
Accessing broader patient populations 10				Figure 3.23: New indication approvals for Orphan
Fixed dose combinations 11				drugs, 1999-08 73
Chapter 1 Product lifecycle and management				Figure 3.24: New indication approvals with priority
challenges 14				reviews, 1999-08 74
Summary 14				Figure 3.25: Increasing clinical and commercial
Introduction 15				potential for Remicade 77
The lifecycle of biopharmaceutical drugs 15				Figure 4.26: FDC approvals in the US, 1999-08 84
Development lifecycle 17				Figure 4.27: Advair: FDA approvals and patent
Commercial lifecycle 22				protection 86
Managing the lifecycle 22				Figure 4.28: Advair-Serevent sales in the US:
Longer development time 23				maintaining revenues post patent expiry of
Slower product uptake via reimbursement hurdles				Flovent 87
24				Figure 4.29: Zocor-Vytorin-Zetia brand timeline 88
Peak sales potential is reduced by higher				Figure 4.30: Cushioning the patent cliff:
competition 25				Zocor-Vytorin-Zetia sales in US ($m), 2001-08 89
Earlier lifecycle decline due to therapeutic				Figure 4.31: FDC usage for hypertension across
substitution 26				major markets 93
Chapter 2 Influencing the commercial lifespan of a				Figure 4.32: Drug classes with maximum FDC
drug 30				approvals in the US, 1999-08 97
Summary 30				List of Tables
Bargaining power of biopharmaceutical brands 31				Table 2.1: Data exclusivity periods by country 39
Brand equity 31				Table 3.2: Success drivers and barriers in indication
Patent protection and "freedom to operate" 32				expansion 61
Strategic patenting 33				Table 3.3: Unmet needs prevalent within an
Patent prosecution superhighway 35				indication 62
Patent protection for biologics 35				Table 3.4: Commercial considerations in prioritizing
Data exclusivity 36				new indications 62
Difference between data exclusivity and patent				Table 3.5: Disease areas and related
protection 40				sub-populations for hypertension and heart failure
8+2+1 system in the EU 40				63
Data exclusivity in the US 42				Table 3.6: New indication approvals by drug class,
Data exclusivity in Japan 43				1999-08 75
Data exclusivity in the context of biologics 44				Table 4.

Rubicon Med

The Future Of Virtualization: Emerging Trends And The Evolving Vendor Landscape-Aarkstore Enterprise