Illustrated Fdc
Tuesday, January 27th, 2009
Optimizing Lifecycle Management: Maximizing the commercial life through expansion and product mix Label
This report examines three goals in optimizing the potential output growth of the patent life of drugs safely, access large patient populations and the launch line-through Extensions of fixed-dose combinations. The key success factors in each of these activities have been clearly identified, new trends and concepts presented underlying are explained in order to provide an understanding of current industry dynamics. Case studies on popular products have been used to illustrate these concepts in the real world. A thorough analysis of the data Drug Approval puts into context the issues. This information is juxtaposed with historical sales data to explore the correlation between the strategies employed and revenue opportunities.
This report explains the basics of the life cycle of drugs and examines three goals in the optimization drug product potential expansion of the life of the patent protected access broader patient populations and the launch of line extensions through the ADF.
The key success factors in each of these activities have been clearly identified, new trends have been presented and the underlying concepts are explained to give the reader a clear understanding of the dynamics of the industry. Case studies on the products people are used to illustrate these concepts in the real world.
A thorough analysis of data for drug approval is contextualizing the problems. This information is juxtaposed with historical sales data to discover the correlation between the strategies employed and revenue opportunities.
Main conclusions
Drug manufacturers must make the best strategic use life protected by a patent of a drug, or risk losing the incentives received early in the project. (Chapter 1)
In view of the increasing complexity of biopharmaceutical patents, the "freedom to act, or to commercialize the invention, is under increasing scrutiny. (Ch. 2)
The emerging position of the U.S. Congress on data exclusivity provisions for organic products will define the length of time a biotech company may exclude generic competition in new directions. The position is that the biotechnology industry Current legislation does not provide enough time to enjoy its post-approval, investments in R & D. (Ch. 2)
The possibility of extension after the approval of the label is much greater for products organic compared to small molecule drugs. Most organic products on the market today can expect to add significant revenue streams through new indications and potentially longer life. (CH 3)
Over 45% of all approvals granted new indication by the FDA since 1998 belong to drugs within the genito-urinary system and nervous system.
If one starts the CDF, around the time of loss of exclusivity of the constituent can be interpreted as a marketing tactic to limit revenue losses LoE post. If you start early, it can show intended to fulfill a real unmet need, or legitimately maximize the potential of the compound (s). (Ch. 4)
Scope of report
in-depth case studies exploring the application in real-world issues and challenges outlined in the report.
The analysis of historical data approval drug provides the reader with contextual reference points.
Case studies on Vytorin, Advair BiDil and illustrate the strategies employed by the three major brands of the FDC.
Yaz brand stories, and Remicade Seroquel label show how the expansion is essential for managing the life cycle successfully.
The Where applicable, these strategies are discussed with reference to therapeutic areas and geographies.
Questions Organic products are highlighted for indicate where they differ from small molecule drugs.
Use this report to
Develop an understanding of the laws protection of patents and data exclusivity. Understand your role in the context of managing product life cycle
From historical data on NES authorizations to identify trends and build hypotheses about the expected competitive landscape.
Understand the position of key stakeholders and the implications the use of off-label drug.
Understanding the role the ADF to optimize the commercial potential of an active ingredient and the main challenges in marketing
The juxtaposition of historical performance when sales and indication expansion strategies DCF basis for assessing the success or failure
Table Content
Optimization life cycle management
Summary 8
Life and challenges of management 8
Influences commercial life of the drug 9
Access to broader populations of patients 10
11 fixed-dose combinations
lifecycle of the product Chapter 1 and 14 problems Management
Summary 14
Introduction 15
The life cycle of biopharmaceuticals 15
Development Life Cycle 17
business life cycle 22
Lifecycle Management 22
The long development time 23
Slower absorption barriers caused by reimbursement 24
Peak sales potential reduced by increased competition 25
At the beginning of the life cycle decrease due to therapeutic substitution 26
Chapter 2 affecting the commercial life of a 30 drug
Summary 30
Bargaining power of brand biopharmaceutical 31
31 Brand Equity
Patent protection and "freedom of action" 32
33 patents Strategic
patent prosecution highway 35
Patent protection of biological products 35
36 data exclusivity
Difference between data exclusivity and patent protection 40
8 2 1 40 EU system
Data exclusivity in the United States 42
Exclusivity data in Japan 43
Data exclusivity in the context of biological products 44
Chapter 3 Access to wider populations of patients 46
Summary 46
The labeling of drugs and access to 47 markets
47 Off-label drug use
Commercial incentives and deterrence 48
position in reimbursement from payors unbranded 49
Case study: Avastin and Lucentis 51
Expand 53 etiquette
Role in managing the product life cycle 53
Indications York 53
Extensions of the pediatric population and 54 special
Modified and expanded the indications for use 54
Case Study: 55 Yaz
Study Case: 58 Remicade
59 Indication expansion
61 Select the primary indication
Note more than 63 independent
Sequence 64, expansion
Indicative timetable 65 expansion
Released early life cycle of business 68
Launched at the end of commercial life cycle 69
Seroquel: The use of the expansion and reformulation indication of drug synergy 70
Recent trends indicate expansion in 72
Indication expansion and 72
Indication expansion for organic products 75
Chapter 4 80 combinations of fixed doses
Abstract 80
Introduction 81
challenges in clinical development FDC 81
82 FDC Patents
Exclusivity for the CDF data 83
Role in maximizing the life cycle Product 83
Case study: the role of Advair asthma free 85-GSK
Case Study: How influenced Vytorin Zocor patent expires 88
Case study: the proposal BiDil value reinvented 90
absorption by geography FDC 91
Case Study: 91 FDC hypertension
93 clinical reasons
efficacy or safety 94 synergistic
95 Facilitate Management Rx
The correlation between the use of the CDF and 95 drugs taken
Correlation between drug compliance and improve clinical outcomes 96
FDC therapy use by area 96
The key success factors and competitive barriers 98
Adoption of treatment guidelines 98
Perceived effects of synergy in the free combination of 99
compliance advantage of free association 99
Using mono before launch FDC 99
Discount of the free combination of 100 cheaper
Time-to-parent brand PG 101
Chapter 5 Appendix 103
research methodology 103 primary
Glossary 107
111 Index
LOF
Figure 1.1: Summary of the life cycle of 17 drug substances
Figure 1.2: The transition probabilities to the clinical phases 18
Figure 1.3: Out-of-pocket and capitalized costs of drug development ($ m) 19
Figure 1.4: Time development of new pharmaceuticals and biotechnology drugs 20
Figure 1.5: Approval times CDER Priority NDA, 1999-08 21
Figure 1.6: Times for the standard and approval CDER, 1999-08 21
Figure 1.7: The imperatives of managing the life cycle of 23
Figure 1.8: increasingly important to pay 24 interested
Figure 1.9: A tougher environment are paying slow absorption Products 25
Figure 1.10 that the replacement therapy and access to Form 27
Figure 2.11: System Exclusive 8 +2 +1 data in Europe 41
Figure 2.12: Data exclusivity and patent protection for U.S. 43
Figure 3.13: In the decision and off-label by paying 50
Figure 3.14: Off-label use of Avastin: A Model for Drug-52 wet AMD
Figure 3.15: Yaz: expansion and sales growth Label – USA ($ M), 2006-08 57
Figure 3.16: Remicade: label expansion and sales growth – U.S. ($ M), 2001-08 59
Figure 3.17: Time elapsed between the start of indications of origin and the new United States (ATC), 1999-08 66
Figure 3.18: The time between the release of information of origin and the new United States (ATC), 1999-08 (continued) 67
Figure 3.19: Considerations in the launch of new directions at the top lifecycle 69
Figure 3.20: Considerations in the launch of new indications in the last stages of life 70
Figure 3.21: Lifecycle Management: Seroquel and Seroquel 71 XR
Figure 3.22: New indication for DNA approvals, 1999-2008 73
Figure 3.23: New approvals indication orphan drugs, 1999-08 73
Figure 3.24: New Indication Approvals priority reviews, 1999-08 74
Figure 3.25: Increase clinical and commercial potential of Remicade 77
Figure 4.26: FDC approvals in the United States, 1999-08 84
Figure 4.27: Advair: authority to the FDA and patent protection 86
Figure 4.28: Advair, Serevent sales in the U.S.: the maintenance of the patent expiry of office income Flovent 87
Figure 4.29: Timeline of the brand Zocor, Vytorin, Zetia 88
Figure 4.30: Cushioning the patent cliff Sales of Zocor-Zetia-Vytorin in the U.S. ($ M), 2001-08 89
Figure 4.31: FDC use of hypertension in 93 major markets
Figure 4.32: Drug approvals classes with the majority of FDC United States, 1999-08 97
List of Tables
Table 2.1: exclusivity periods data for 39 countries
Extension Table 3.2: the main achievements and obstacles in the indication 61
Table 3.3: Unmet needs in a common 62 indicates
Table 3.4: priority to commercial considerations 62 new indications
Table 3.5: Areas of diseases and subpopulations of renal hypertension and 63 heart
Table 3.6: New Indication Approvals by drug class, 1999-08 75
Table 4.7: FDC 81 Case Studies
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