Posts tagged Combination

This report 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 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 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. 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 each of these aspirations have been identified that have been emerging trends are presented 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 freedom to use the “”, 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 will keep generic competition can be defined in new indications. 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 today can expect on the market,

to add significant revenue streams through new indications and possibly extend their commercial life. (CH 3) ; Over 45% of all new indication approved by the FDA granted since 1998 to drugs, are covered in the genitourinary system and the nervous system.

include FDC, the loss of exclusivity dates of the constituent brand started, it can be as a marketing tactic to be interpreted to limit post-LoE revenue shortfalls. 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. < , P> Analysis of 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. Show

fire stories of Yaz, Remicade and Seroquel, as label expansion of fundamental importance for successful lifecycle management is. Where are these strategies related discussion on a particular therapeutic areas or regions.

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

an understanding of the legal system of patents and data exclusivity. understanding their role in the context of Product Lifecycle Management Take advantage of building the historical data on the NDA approvals to identify trends and competitive landscape assumptions in projections .

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

understanding of role of FDCs in the optimization of the commercial potential of a product and represent the Key challenges in their marketing Juxtapose historical sales trend with the date of the extension and FDC to evaluate strategies, the success or failure
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Contents:
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
Managing the life cycle of 22
longer development time for 23
product absorption through the slow reimbursement hurdles 24
peak sales potential reduced by more competition 25
; Earlier Lifecycle decrease due to the therapeutic substitution 26
Chapter 2 influence the commercial life of a drug 30 30

Summary bargaining biopharmaceutical brands brand value 31
31
patent protection and “freedom to operate” 32
33
Strategic patenting patent prosecution data highway 35
35
patent protection for biologics Data exclusivity 36
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
Chapter 3 Accessing the broader groups of patients 46

46 Summary Drug labeling and market access 47
Off-label drug usage 47
Commercial incentives and disincentives 48
cost attitude to off-label reimbursement
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
Changed indications and expanded use 54
Case Study: Yaz
55 Case Study: Remicade 58
Indication Expansion 59
The choice of the primary indication 61
Related information independent versus 63
order of 64 indicating expansion
timing of the display 65
expansion early in the life cycle of commercial Launching 68
late start in commercial life 69
Seroquel: br With regard to expansion and synergistic drug reformulation 70
Current Trends in the indication expansion 72
expansion indication for NDAS-72 indication extension for 75 biologics
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-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
95
Easier management Rx correlation between FDC and compliance with drug use in 1995
; correlation between drug compliance and improved clinical outcomes, 96
FDC use by therapy area 96
Key success factors and barriers to competitive 98
recognition of treatment guidelines in 1998
Perceived synergies through free combination of 99
compliance advantage over the free combination of 99
use of mono-compounds prior to the start 99 FDC
discount compared to the cheapest mixed free 100 < , br /> Time-to-the umbrella brand LOE 101

Chapter 5 Appendix 103 Primary research methodology 103

Glossary Index 107 111 < br /> Table 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 for the development of new pharmaceutical & biotech drugs 20
Figure 1 removed. 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 7 1
: imperatives of effective 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
10 Figure 1: Therapeutic substitution and formulary access 27
11 Figure 2: 8 +2 +1 data exclusivity in Europe 41 Figure 2
12: Data exclusivity and patent protection in the U.S. 43
13 Figure 3: On-and off-label decision-making by cost
50 14 Figure 3: 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
17 Figure 3: Time between the start of the original and new indications in the U.S. (after ATC), 1999-1908 66 Figure 3
. 18: Between Start of the original and new indications in the U.S. (according to ATC), 1999-1908 (Cont’d) 67
19 Figure 3: Considerations for the introduction of new indications early in the life cycle Figure 69
3rd 20: considerations for the introduction of new indications in the late 70-Lifecycle
21 Figure 3: Lifecycle Management: Seroquel and Seroquel XR
71 22 Figure 3: New indication for NDAS approvals, 1999-2008 73 Figure 3
. 23: New Indication Approvals for Orphan Drugs, 1999-1908 73 Figure 3
. 24: Watch New Indication Approvals by priority, from 1999 to 1908 74 Figure 3
. 25: Increasing clinical and commercial potential for Remicade
77 26 Figure 4: FDC approvals in the U.S., 1999-1908 84 Figure 4
27: Advair FDA approvals and patent protection
86 28 Figure 4: Advair Serevent’s sales in the U.S.: maintaining sales after the patent expiry of Flovent 87
Figure 4 29: Zocor Vytorin-Zetia-brand timeline
88 30 Figure 4: Attenuation 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
32 Figure 4: Classes with a maximum of FDC drug approvals in the U.S., 1999-1908 97 List of Tables Table 2

;. 1: Data exclusivity periods by country 39 Table 3
2: Success factors and barriers in Expansion indication
61 Table 3 3: Unmet needs in a statement distributed br 62 Table 3 4: Commercial considerations in the prioritization of new indications
62 5 Table 3: Disease and related fields sub-populations for hypertension and heart failure 63
Table 3 6: New Indication Approvals by drug class, 1999-1908 75 Table 4
. 7: FDC 81 case studies
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