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three goals in the optimization of product development potential of the drug patent protected life, access to wider groups of patients and the starting line extensions on fixed combinations. The key factors for success in each of these efforts have been clearly identified, which were presented on emerging trends and the underlying concepts have been introduced to provide a clear understanding of the current dynamics of the industry. Case studies on the most popular products were used to illustrate these concepts in the real world. A detailed analysis of the data provided by the approval of drugs under discussion for the topics. This information is compared with historical sales data to the correlation between the strategies employed and to explore revenue potential. This report describes the fundamentals of the drug life cycle and examines three goals in the optimization of product development potential of the drug patent protected life, access to wider groups of patients and the starting line extensions via FDCs.

The key factors for success in any of these efforts have been clearly identified, which were presented on emerging trends and the underlying concepts have been explained to the reader a clear understanding of the current dynamics of the industry. Case studies on the most popular products have been used to illustrate these concepts in the real world.

A detailed analysis of the data provided by the approval of drugs under discussion for the topics. This information is compared with historical sales data to the correlation between the strategies employed and to explore revenue potential.

Key findings Drug manufacturers have the best strategic use of patent-protected life of a drug, otherwise they risk the profit incentives perceived at the beginning of the project to make. (Chapter 1) Given the increasing complexity of biopharmaceutical patenting, the â?? freedom to operate “, ie the invention to market, is increasingly coming under control. (Chapter 2)

The U.S. Congress’ attitude emerging regulations on data protection for biologics, the length of time, a biotechnology company can define away the competition from generic drugs in new indications. The biotech industry is the attitude that the current provisions do not give enough time to benefit from its post-approval R & D investment. (Chapter 2)

The potential for post-approval label expansion is much greater for biologics as compared to low molecular drugs. Most biologics on the market today can expect to add substantial revenue streams through new indications and possibly extend their commercial life. (CH 3) About 45% of new indication approvals granted by the FDA since 1998 to drugs, are covered in the genitourinary system and the nervous system. close If an FDC to be the loss of exclusivity dates of the constituent brand started, it can as a marketing tactic to be interpreted to limit post-LoE revenue losses. If started early, so he can show intent, a real unmet need, or reasonably maximize the potential of the parent molecule (s fair). (Chapter 4) scope of the report In-depth case studies to explore the real execution of the questions and challenges discussed in the report.

analysis of the historical data of the drug approval provides the reader with contextual reference points.

case studies of Vytorin, Advair and BiDil illustrate the strategies employed by three leading brands FDC.

fire stories of Yaz, Remicade Seroquel and show how label expansion is essential for successful lifecycle management. Where are these strategies with respect to a particular therapeutic areas or areas discussed.

issues related to biologics are highlighted to indicate where they differ from small molecule drugs. This report can

an understanding of legal system of patents and data exclusivity. Understanding their role in the context of Product Lifecycle Management Take the build historical data about the NDA approvals to identify trends and assumptions in competitive landscape forecasts.

understand the attitude of key players and the impact of off-label drug use.

understanding of the role of FDCs in optimizing the commercial potential of a product and represent the most important challenges in their marketing Juxtapose historical sales trend with the date of the extension and FDC strategies to evaluate the success or failure  Â

a table of contents: Â Â
< / p> Optimizing Lifecycle Management Executive

Summary 8 product lifecycle management challenges, and 8
influencing the commercial life of the drug 9
; access to wider groups of patients 10
fixed-dose combinations of 11
Chapter 1 and product lifecycle management challenges

14 Summary 14 Introduction 15
The life cycle of biopharmaceutical drugs 15
17
Commercial Development Lifecycle lifecycle 22
22
Managing the life cycle of longer development time period 23
Slow product inclusion on the reimbursement hurdles 24
peak sales potential by more competition 25
Earlier Lifecycle decline reduced because of the therapeutic substitution 26
Chapter 2 influence the commercial life of a drug 30 30

Summary bargaining biopharmaceutical brands brand 31 31

patent protection and “freedom to operate” 32
; Strategic patenting 33 br
patent prosecution data highway 35
patent protection for biologics 35
36
Data exclusivity difference between data exclusivity and patent protection 40 < /> 8 +2 +1 system in the EU 40
Data exclusivity in the U.S. 42
Data Exclusivity in Japan 43
Data exclusivity under the Biologics 44 < , br /> Chapter 3 Accessing broad groups of patients 46

46 Summary 47 Drug labeling and market access
Off-label drug usage 47
Commercial positive incentives and disincentives 48
cost attitude to off-label refund 49
Case Study: Avastin and Lucentis 51
extension of the label 53
role in the Product Lifecycle Management 53 New indications
53
Pediatric enhancements and special patient groups 54
Modified indications and expanded use 54
Case Study: Yaz 55
Case study: Remicade indication expansion 58
59
The choice of the primary indication 61
relatives versus 63 independent data
order of the expansion claim 64 < , br /> timing of the display 65
expansion early in the life cycle of commercial Launching 68
late start in commercial life 69
Seroquel: synergistic with regard to expansion and drug reformulation 70
Current Trends in the indication expansion 72
expansion indication for NDAS-72
expanded indication for Biologics 75
Chapter 4 Fixed-dose combinations 80

Summary 80 Introduction 81
Clinical challenges in the development of FDC FDC 81

82 Patents Data Exclusivity for FDCs 83
role in the product lifecycle to maximize
83 Case Study: Advair role in GSK’s asthma franchise 85
Case Study: How Vytorin Zocor’s patent expiration 88
case study : BiDil’s value proposition affects newly invented in 1990
FDC uptake by geography 91
Case Study: FDCs for hypertension 91
93
Clinical reasoning Synergistic efficacy or safety 94
Easier management Rx
95 FDC correlation between drug use and compliance with 95
correlation between drug compliance and improved clinical outcomes, 96
FDC use by therapy area 96
Key success factors and competitive hurdles in 1998
recognition of treatment guidelines in 1998
Perceived synergies through free combination of 99
compliance advantage over the free combination of 99 < , br /> Using the mono-compounds prior to the start 99 FDC
discount compared to the cheapest mixed free 100
time-to-LOE
Chapter 101 of the umbrella brand 5 Appendix 103 Primary research methodology 103

Glossary 107 Index 111 List of Figures Figure

1. 1: Summary of the life cycle of drugs 17
Figure 1 2: Transition probabilities for clinical stages 18
Figure 1 3: Out-of-pocket and capitalized costs of developing a drug ($ m) 19 Figure 1
4: Time taken for the development of new pharmaceutical & biotech drugs 20
Figure 1. 5: Approval timelines in CDER for priority NDAs, 1999-1908 21 Figure 1
6: Approval with CDER timelines for Standard NDAs, 1999-1908 21 Figure 1
7: Imperative efficient Lifecycle Management 23
Figure 1 8: Increasing importance of cost over 24 interest groups
Figure 1 9: Harder payor environments are slowing product fixture 25
Figure 1 10: Therapeutic substitution and formulary access 27
Figure 2 11: 8 +2 +1 data exclusivity in Europe 41 Figure 2
12: Data exclusivity and patent protection in the U.S. 43 Figure 3
13: On-and off-label decision-making through cost 50
Figure 3 14: Off-label use of Avastin: a health economic model for wet AMD 52
Figure 3 15: Yaz: Label expansion and sales growth – U.S. ($ m), 2006-08 57 Figure 3
16: Remicade: Label expansion and sales growth – U.S. ($ m), 2001-08 59 Figure 3
17: Start time between the original and new indications in the U.S. (by ATC), 1999-1908 66 Figure 3
. 18: Start time between the original and new indications in the U.S. (after ATC), 1999-1908 (Cont’d) 67 Figure 3
19: considerations for the introduction of new indications early in the life cycle of 69
Figure 3 20: considerations for the introduction of new indications in the late 70-Lifecycle
Figure 3 21: Lifecycle Management: Seroquel and Seroquel XR 71
Figure 3 22: New indication for NDAS approvals, 1999-2008 73 Figure 3
. 23: New Indication Approvals for Orphan Drugs, 1999-1908 73 Figure 3
. 24 See: New Indication Approvals by priority, 1999-1908 74 Figure 3
. 25: Increasing clinical and commercial potential of Remicade 77
Figure 4 26: FDC approvals in the U.S., 1999-1908 84 Figure 4
27: Advair: FDA approvals and patent protection 86
Figure 4 28: Advair Serevent’s sales in the U.S.: maintaining sales after the patent expiry of Flovent 87
Figure 4 29: Vytorin-Zetia-Zocor brand timeline 88 Figure 4
30: Damping of the patent cliff: Zocor-Zetia-Vytorin sales in the U.S. ($ m), 2001-08 89 Figure 4
31: FDC use for hypertension in 93 major markets
Figure 4

. 1: Data exclusivity periods by country 39 Table 3
2: Success factors and barriers to expansion, giving 61
Table 3 3: Unmet needs within a common claim 62
Table 3 4: Commercial considerations in the prioritization of new indications 62
Table 3 5: Disease and related areas, sub-populations for hypertension and heart failure 63
Table 3 6: New Indication Approvals by drug class,
. 7: FDC 81 case studies a
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