Posts Tagged ‘Japan’

Vision Shopsters: The Future of Orphan Disease Therapeutics – Market Forecasts to 2015, Pipeline Analysis and Reimbursement

The leading business intelligence provider, has released its latest research “The Future of Orphan Diseases Therapeutics – Market Forecasts to 2015, Pipeline Analysis and Reimbursement” The report provides in-depth analysis of unmet needs, drivers and barriers that impact the global orphan diseases therapeutics market. The report analyzes the markets for orphan diseases therapeutics in the US, the top five countries in Europe (the UK, Germany, France, Italy and Spain) and Japan. Treatment usage patterns, sales, and price are forecast until 2015 for the key geographies as well as select therapeutic segments. Further, the report provides competitive benchmarking for the leading companies and also analyzes the mergers, acquisitions and licensing agreements that shape the global markets.

http://www.visionshopsters.com/product/1247/The-Future-of-Orphan-Disease-Therapeutics-Market-Forecasts-to-2015-Pipeline-Analysis-and-Reimbursement.html

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.

Scope

The scope of this report includes:
– Annualized market data for the orphan diseases therapeutics market from 2000 to 2008, forecast forward to 2015
– Analysis of the leading therapeutic segments. These include Fabry Disease, Pompe Disease and Mucopolysaccharidosis.
– Analysis of the orphan diseases therapeutics market in the leading geographies of the world, which include the US, the UK, Germany, France, Italy, Spain, and Japan
– Market characterization of the orphan diseases therapeutics market including market size, annual cost of therapy, and treatment usage patterns
– Key drivers and barriers that have a significant impact on the market
– Coverage of pipeline molecules in various phases of drug development
– Competitive benchmarking of leading companies. The key companies studied in this report are F.Hoffmann-La Roche, Genzyme Corporation, Novartis AG, Celgene Corporation, Orphan Europe, Pfizer Inc, Actelion Pharmaceuticals and Shire Plc.
– Key M&A activities, licensing agreements, that have taken place between 2008 and 2009 in the global orphan diseases therapeutics market

Reasons to buy

The report will enhance your decision making capability. It will allow you to
– Align product portfolio to the markets with high growth potential
– Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth
– Reinforce R&D pipelines by identifying new target mechanisms which can produce first in class molecules with more efficiency and better safety
– Develop key strategic initiatives by understanding key focus areas of leading companies
– Exploit in-licensing and out-licensing opportunities by identifying products that could fill portfolio gaps

Companies Mentioned

F.Hoffmann-La Roche
Genzyme Corporation
Novartis AG
Celgene Corporation
Orphan Europe
Pfizer Inc
Actelion Pharmaceuticals
Shire Plc.

Table Of Contents :

 

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Global Orphan Disease Market : Introduction
2.1 Disease Overview
2.1.1 The United States
2.1.2 Europe
2.1.3 Japan
2.2 Report Guidance
2.3 Market Overview
3 Global Orphan Disease Therapeutics Market : Market Characterization
3.1 Market Forecasts
3.2 Orphan Drugs by Disease Sectors
3.3 Usage Patterns
3.3.1 Diseased Population
3.3.2 Treatment Seeking Population
3.3.3 Diagnosis Population
3.3.4 Prescription Population
3.3.5 Therapeutic Usage Patterns
3.4 Geographical Distribution
3.4.1 Market Drivers
3.4.2 Market Restraints
3.5 Key Market Trends
3.5.1 Increase in Federal Funding
3.5.2 Product Pipeline
3.5.3 Regulatory trends – Current Pricing and Reimbursement Scenario
4 Global Fabry Disease Therapeutics Market
4.1 Market Overview
4.2 Market Forecasts
4.3 Average Cost of Therapy
4.4 Usage Patterns
4.4.1 Diseased Population
4.4.2 Treatment Seeking Population
4.4.3 Diagnosis Population
4.4.4 Prescription Population
4.4.5 Therapeutic Usage Patterns
4.5 Product Analysis
4.5.1 Fabryzyme
4.5.2 Replagal
4.6 Drug Pipeline Analysis
5 Global Pompe Disease Therapeutics Market
5.1 Market Overview
5.2 Market Forecasts
5.3 Average Cost of Therapy
5.4 Usage Patterns
5.4.1 Diseased Population
5.4.2 Treatment Seeking Population
5.4.3 Diagnosis Population
5.4.4 Prescription Population
5.4.5 Therapeutic Usage Patterns
5.5 Product Analysis
5.5.1 Myozyme
5.6 Pipeline
6 Global Mucopolysaccharidosis VI Disease Therapeutics Market
6.1 Market Overview
6.2 Market Forecasts
6.3 Average Cost of Therapy
6.4 Usage Patterns
6.4.1 Diseased Population
6.4.2 Treatment Seeking Population
6.4.3 Diagnosis Population
6.4.4 Prescription Population
6.4.5 Therapeutic Usage Patterns
6.5 Product Analysis
6.5.1 Naglazyme
7 The US Orphan Disease Therapeutics Market
7.1 Market Overview
7.2 Market Forecasts
7.3 Usage Patterns
7.3.1 Diseased Population
7.3.2 Treatment Seeking Population
7.3.3 Diagnosis Population
7.3.4 Prescription Population
7.3.5 Therapeutic Usage Patterns
8 Europe Orphan Disease Therapeutics Market
8.1 Market Overview
8.2 Market Forecasts
8.3 Usage Patterns
8.3.1 Diseased Population
8.3.2 Treatment Seeking Population
8.3.3 Diagnosis Population
8.3.4 Prescription Population
8.3.5 Therapeutic Usage Patterns
9 Japan Orpahn Disease Therapeutics Market
9.1 Market Overview
9.2 Market Forecasts
9.3 Usage Patterns
9.3.1 Diseased Population
9.3.2 Treatment Seeking Population
9.3.3 Diagnosis Population
9.3.4 Prescription Population
9.3.5 Therapeutic Usage Patterns
10 Global Orphan Disease Therapeutics Market : Competitive Landscape
10.1 Overview
10.2 Competitor Profiling
10.2.1 Genzyme Corporation
10.2.2 Celgene Corporation
10.2.3 Actelion Pharmaceuticals
10.2.4 Shire Pharmaceuticals
10.2.5 AstraZeneca
10.2.6 Boehringer Ingelheim
10.2.7 Bristol-Myers Squibb
10.2.8 GlaxoSmithKline (GSK)
10.2.9 Novartis
10.2.10 Pfizer
10.2.11 Eli Lilly
10.2.12 Sanofi Aventis
10.2.13 UCB Pharma
10.2.14 Wyeth
11 Pipeline Analysis
11.1 Autoimmune Disorders
11.1.1 Cellcept
11.1.2 Pirfenidone
11.1.3 Rituxan
11.2 Genetic Disorders
11.2.1 Denufosol tetrasodium inhalation solution(INS37217)
11.2.2 Bronchitol(Mannitol)
11.2.3 Catena (Idebenone)
11.3 Infectious Diseases
11.3.1 XP-28 (xepol)
11.4 Neurology
11.4.1 Cladribine
11.4.2 Clazosentan (Pivlaz®)
11.5 Respiratory Disorders
11.6 Transplantation
11.7 Cardiovascular Disorders
11.7.1 ISIS 301012(Mipomersen sodium)
11.8 Cancer
11.8.1 Avastin
11.8.2 Enzastaurin
11.8.3 Patupilone
11.8.4 Zactima
11.8.5 Genasense
11.8.6 Ipilimumab (MDX-010, MDX-101)
11.9 Blood Cancer
11.10 Skin Cancer
11.11 Other Disorders
12 Global Orphan Disease Therapeutics Market: Strategic Consolidations
12.1 Mergers and Acquisitions
12.1.1 Genzyme Corp. and Bioenvision, Inc.
12.1.2 ViroPharma and Lev Pharmaceuticals
12.1.3 Biovitrum and Swedish Orphan
12.1.4 Shire plc and Zymenex A/s
12.2 Licensing Agreements
12.2.1 Overview
12.2.2 Drug Discovery & Preclinical
12.2.3 Phase I
12.2.4 Phase I
12.2.5 Phase III
12.2.6 Approved
13 Appendix
13.1 Market Definitions
13.2 Key Support Data
13.3 Abbreviations
13.4 Research Methodology
13.4.1 Coverage
13.4.2 Secondary Research
13.4.3 Primary Research
13.4.4 Forecasts
13.5 Expert Panel Validation
13.6 Contact Us
13.7 Disclaimer

To know more about this report & to buy a copy please visit :
http://www.visionshopsters.com/product/1247/The-Future-of-Orphan-Disease-Therapeutics-Market-Forecasts-to-2015-Pipeline-Analysis-and-Reimbursement.html

Contact us:

Visionshopsters
Ph : 91-22-40583000
Emailid: marketing@visionshopsters.com
Website : www.visionshopsters.com

Visionshopsters specializes in providing comprehensive collection of online market research reports, events bookings, country reports, company profiles, latest books and magazines, customized research services offering informative solutions worldwide. We constantly believe in providing inventive solutions to clients all across the globe. Our clientele consists of over thousands of top most academic organizations, financial institutions, trading companies, legal service providers, accounting consultancies and other corporate business executives.

Opportunities In Orphan Drugs: Strategies For Developing Maximum Returns From Niche Indications

 A 1984 modification to the ODA defined an Orphan Disease as any condition affecting fewer than 200,000 people in the US. The US was followed by both Japan and the EU which have also introduced their own orphan drug legislation in 1993 and 2000 respectively.

Industry has responded to this call for action and the FDA has approved over 270 orphan drugs in the US whilst there are another 583 listed in the Medtrack database as being in ongoing development. This has been motivated by the special incentives provided by the FDA and the EU including enhanced market exclusivity, research grants and tax incentives.

Orphan drugs present opportunities to pharma companies looking to move into more niche indications and away from mass market indications that have very low levels of clinical unmet need. Although there are many successful orphan drugs that have made large profits for their developers (Gleevec, NovoSeven etc) the development of these products must be approached carefully. This report uses a mixture of case studies and data from secondary sources to elucidate the key issues in the development of orphan drugs and ways to navigate them.

Key features of this report

• Overview of orphan drugs legislation in the US, EU, Japan and Australia including details of key incentives for developers and history of orphan designations and approvals.

• Evaluation of clinical trial and approval strategies including data on current clinical trial designs and strategies to maximize the chances of clinical trial success through the use of adaptive clinical trials.

• Overview of orphan drug reimbursement issues in both the US and the EU including details of the importance of the UK’s NICE and the development of novel risk sharing agreements.

• Examination of the role being played in orphan drug development by leading players in the pharmaceutical and biotech industry and the motivations behind this.

Scope of this report

• Gain an understanding of key orphan drugs legislation and the incentives available to the developers of drugs which successfully gain orphan designation.

• Get a quick overview of the overall orphan drug development pipeline in the EU and US.

• Gain strategic insight into the key differences between the development of orphan drugs and non-orphan drugs including the importance of patient advocacy groups.

• Discover key strategies to maximize revenues from orphan drugs through gaining market access and broadening the product label.

Key Market Issues

• Gaining orphan designation for a product confers access to various incentives. Once a product is granted orphan designation its developers gain a variety of incentives including extended market exclusivity, tax credits and research grants. These incentives have motivated the development of hundreds of products for orphan indications in the US, EU and Japan.

• The move away from reliance on blockbuster products towards niche indications is driving heightened interest in orphan drugs from companies of all sizes Orphan drugs lie at the opposite spectrum to blockbuster drugs and present Big Pharma with opportunities to enter specialist niche markets. Although on first analysis orphan drugs should not be particularly interesting to the pharma industry on account of their limited patient potential, by 2006 there were 50 orphan products with sales in excess of $200m of which 19 were blockbuster products and it is this which sustains the pharma industry’s interest in developing orphan drugs.

• Cancer continues to have the largest number of pipeline orphan drugs. This is largely motivated by the nature of cancer which allows it to be stratified into niche sub-diseases which qualify as orphan diseases. Developing orphan drugs for cancer indications makes additional sense as it presents opportunities to gain access to further orphan indications which have a similar disease mechanism.

Key findings from this report

• The developers of orphan drugs receive several incentives from the governments of countries that grant orphan status including extended market exclusivity, fast track assessment, research grants and tax incentives.
• There are 583 orphan drugs in active development with Cancer being the leading indication for which they are being developed with over 100 products in active development in the US alone.
• The development of an orphan drug is often a strategy pursued by small biotech and pharma companies with a view to licensing the product out in the later stages of development as part of an exit strategy. One example of this is PharmaMar’s development of Yondelis which has involved a complex network of partnerships as a source of both funding and expertise.

Key questions answered

• What is the key legislation concerning orphan drugs in the US, Japan and the EU?
• What incentives are available to the developers of orphan drugs in the US, Japan and the EU?
• What is the involvement of leading pharmaceutical companies in the development of orphan drugs?
• Why are orphan drugs an attractive proposition for pharmaceutical companies looking to expand their product portfolios?
 
 
  Table of Contents : 
Table of Contents
Opportunities in orphan drugs
Executive summary 8
Orphan drug legislation 8
The orphan drug pipeline 9
Orphan drug development trends and strategies 10
Orphan drug strategies 11
Chapter 1 Orphan drug legislation 14
Summary 14
Introduction 15
Orphan drug legislation in the US 15
Orphan drugs act 1983 15
Orphan drug designation 16
Orphan grant program 18
Orphan drug legislation in the EU 19
The Committee for Orphan Medicinal Products 19
Orphan designation process 20
EU incentives for orphan medicinal product developers 20
Orphan drug legislation in Japan 21
Incentives for orphan drug developers in Japan 22
Orphan drug legislation in Australia 23
Incentives for orphan drug developers in Australia 23
Chapter 2 The orphan drug pipeline 26
Summary 26
Introduction 27
Oncology 29
Istodax – romidepsin 29
Yondelis – trabectedin 30
Omapro – omacetaxine 33
Clolar – clofarabine 34
Onrigin – laromustine 35
TM601 36
EGEN – 001 37
Central nervous system 38
Zenas – amifampridine 38
H P Acthar Gel 39
ITI111 – midazolam 42
Respiratory and pulmonary systems 43
Surfaxin 43
Anti-infectives 44
Cayston – aztreonam lysine 44
ABthrax – raxibacumab 46
Autoimmune and inflammation 48
EN 101 48
Genetic diseases and dysmorphic syndromes 49
Uplyso – taliglucerase alfa 49
Chapter 3 Orphan drug development trends and issues 54
Summary 54
Introduction 55
Clinical trial and approval strategies for orphan drugs 55
Adaptive clinical trials in orphan drug development 58
The role of patient advocacy groups 62
Patient group/industry R&D partnerships 63
Orphan drug reimbursement issues 64
Orphan drug access in the US 65
Orphan drug access in the EU 65
Pharmaceutical risk-sharing agreements 70
Chapter 4 Orphan drug strategies 74
Summary 74
Introduction 75
The move towards niche indications 75
Opportunities in orphan drugs 76
Small pharma and biotech 77
Big pharma and established biotech 78
Pfizer 78
GlaxoSmithKline 82
Novartis 83
Sanofi-Aventis 85
Roche 86
Johnson & Johnson 88
Merck & Co 89
Eli Lilly 90
Bayer 91
Orphan drug specialists 92
Genzyme 92
Actelion 94
Strategies for sales growth for orphan drugs 96
Expansion into non-orphan indications 97
Expansion into further orphan indications 98
Using biomarkers to develop orphan drugs 101
Conclusion 104
Glossary 105
Index 106

List of Figures
Figure 1.1: Number of products receiving orphan designation in the US, 1984-December 2009 16
Figure 1.2: Number of Orphan drug approvals in the US, 1990-2008 17
Figure 1.3: Average NDA approval time, (months), 1995-2008 18
Figure 2.4: Therapeutic focus of products given orphan designation in the EU, 2009 27
Figure 2.5: Therapeutic focus of products given orphan designation in the US, 2009 28
Figure 2.6: Yondelis deals and alliances structure 32
Figure 2.7: EGEN-001 mode of action 38
Figure 2.8: Licensing deals for H P Acthar Gel 41
Figure 3.9: Blinding in US orphan drug trials, 2009 57
Figure 3.10: Randomization in US orphan drug trials, 2009 57
Figure 3.11: Comparators in US orphan drug trials, 2009 58
Figure 3.12: Reasons for adopting adaptive clinical trials 60
Figure 3.13: Overview of strategic considerations when designing adaptive clinical trials 61
Figure 3.14: Overview of operational considerations when designing adaptive trials 62
Figure 3.15: Relationship between annual cost of treatment (€) per patient and prevalence 69
Figure 3.16: The relationship between cost-effectiveness and societal value 70
Figure 4.17: Blockbuster to orphan drugs 75
Figure 4.18: Required conditions for stratified medicine 102

List of Tables
Table 1.1: Comparison of orphan drug systems 24
Table 2.2: Yondelis orphan designations 30
Table 2.3: Surfaxin’s US orphan designations by date 43
Table 3.4: Recent deals involving CFF and pharma companies 64
Table 4.5: Pfizer’s orphan designations since 2003 79
Table 4.6: Pfizer’s active orphan programs 79
Table 4.7: GlaxoSmithKline’s marketed US orphan drug portfolio 82
Table 4.8: GlaxoSmithKline’s active orphan programs 82
Table 4.9: Novartis’ marketed US orphan drug portfolio 84
Table 4.10: Novartis’s active orphan programs 84
Table 4.11: Sanofi-Aventis’s active orphan programs 86
Table 4.12: Roche’s marketed US orphan drug portfolio 86
Table 4.13: Roche’s active orphan programs 87
Table 4.14: J&J’s marketed US orphan drug portfolio 88
Table 4.15: J&J’s active orphan programs 89
Table 4.16: Merck & Co’s active orphan programs 90
Table 4.17: Eli Lilly’s marketed US orphan drug portfolio 90
Table 4.18: Eli Lilly’s active orphan programs 90
Table 4.19: Bayer’s marketed US orphan drug portfolio 91
Table 4.20: Genzyme’s global marketed orphan product portfolio ($m), 2008 92
Table 4.21: Genzyme’s lysosomal storage disorder product history 94
Table 4.22: Actelion’s global marketed portfolio ($m), 2008 95
Table 4.23: Actelion’s product pipeline 96
Table 4.24: Gleevec’s US orphan indications 99
Table 4.25: Nutropin’s US orphan indications 100
Table 4.26: Orphan designated products with at least one associated clinically validated biomarker 103 
 

 

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http://www.aarkstore.com/reports/Opportunities-in-Orphan-Drugs-Strategies-for-developing-maximum-returns-from-niche-indications-38033.html

The Politics of Adoption: International Perspectives on Law, Policy & Practice

Product Description

This book updates and significantly extends the first edition published by Springer in 2004. It addresses the social and legal functions of adoption, the changes currently taking place in England & Wales and developments in other common law countries. It identifies themes of commonality and difference in the experience of adoption in a common law context as compared and contrasted with that of civil law countries, other cultures in Asia and with the experience of indigenous peoples. It uses the international Conventions and associated ECtHR case law to benchmark developments in national law, policy and practice and to facilitate a cross-cultural comparative analysis. Like the first edition, this book will fit most comfortably in undergrad & postgrad Law and Social Work courses; also it would be relevant to sociology and politics.

This book aims to provide an analysis of adoption law, policy & practice in a common law context and to compare and contrast this with the equivalent experience of other cultures. It basically –

  • traces the evolution of adoption law, policy and practice across many centuries within England and Wales and other typical common law nations giving particular attention to conceptual and definitional matters;
  • identifies and evaluates themes in the contemporary adoption processes of England and Wales and those other common law countries;
  • identifies relevant international Conventions and related judicial decisions and analyses their capacity to function as benchmarks for national adoption law, policy and practice;
  • uses those themes and benchmarks to construct a template for comparative analysis purposes;
  • employs the template to conduct a comparative evaluation of equivalent themes in other cultural contexts, including Sweden, France, Japan and in an Islamic context;
  • contrasts the highly regulated legal process of modern western society with the traditional practice of indigenous communities such as the Maori;
  • explores the politics of intercountry adoption;
  • and concludes with an analysis of the significance of differences in cultural context for adoption law, policy & practice.

The Politics of Adoption: International Perspectives on Law, Policy & Practice

The Development of the Japanese Nursing Profession: Adopting and Adapting Western Influences

Product Description
This book tells the story of ‘Florence Nightingale-ism’ in Japan, showing how Japanese nursing developed from 1868 to the present.

The Development of the Japanese Nursing Profession: Adopting and Adapting Western Influences

Global Orphan Diseases Therapeutics Market: Strategic Consolidations

The Future of Orphan Diseases Therapeutics – Market Forecasts to 2015, Pipeline Analysis and Reimbursement

Summary

“The Future of Orphan Diseases Therapeutics – Market Forecasts to 2015, Pipeline Analysis and Reimbursement” The report provides in-depth analysis of unmet needs, drivers and barriers that impact the global orphan diseases therapeutics market. The report analyzes the markets for orphan diseases therapeutics in the US, the top five countries in Europe (the UK, Germany, France, Italy and Spain) and Japan. Treatment usage patterns, sales, and price are forecast until 2015 for the key geographies as well as select therapeutic segments. Further, the report provides competitive benchmarking for the leading companies and also analyzes the mergers, acquisitions and licensing agreements that shape the global markets. ( http://www.bharatbook.com/detail.asp?id=128489&rt=The-Future-of-Orphan-Diseases-Therapeutics-Market-Forecasts-to-2015-Pipeline-Analysis-and-Reimbursement.html )

Scope

The scope of this report includes:

• Annualized market data for the orphan diseases therapeutics market from 2000 to 2008, forecast forward to 2015
• Analysis of the leading therapeutic segments. These include Fabry Disease, Pompe Disease and Mucopolysaccharidosis.
• Analysis of the orphan diseases therapeutics market in the leading geographies of the world, which include the US, the UK, Germany, France, Italy, Spain, and Japan
• Market characterization of the orphan diseases therapeutics market including market size, annual cost of therapy, and treatment usage patterns
• Key drivers and barriers that have a significant impact on the market
• Coverage of pipeline molecules in various phases of drug development
• Competitive benchmarking of leading companies. The key companies studied in this report are F.Hoffmann-La Roche, Genzyme Corporation, Novartis AG, Celgene Corporation, Orphan Europe, Pfizer Inc, Actelion Pharmaceuticals and Shire Plc.
• Key M&A activities, licensing agreements, that have taken place between 2008 and 2009 in the global orphan diseases therapeutics market

Reasons to buy

The report will enhance your decision making capability. It will allow you to

• Align product portfolio to the markets with high growth potential
• Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth
• Reinforce R&D pipelines by identifying new target mechanisms which can produce first in class molecules with more efficiency and better safety
• Develop key strategic initiatives by understanding key focus areas of leading companies
• Exploit in-licensing and out-licensing opportunities by identifying products that could fill portfolio gaps

To know more and to buy a copy of your report feel free to visit : http://www.bharatbook.com/detail.asp?id=128489&rt=The-Future-of-Orphan-Diseases-Therapeutics-Market-Forecasts-to-2015-Pipeline-Analysis-and-Reimbursement.html

Or

Contact us at :

Bharat Book Bureau    
Tel: +91 22 27578668
Fax: +91 22 27579131
Email: info@bharatbook.com
Website: www.bharatbook.com
Blog: http://bharatbookresearch.blogspot.com
Follow us on twitter: http://twitter.com/3bbharatbook

We are the leading information aggregator, facilitates and supports the business information needs. With over 115,000 reports, you can get instant access and insights on the studies in yo for market research , corporate / strategic planning by providing the latest information in the form of reports, journals, magazines and databases on varied industries like automotive, oil and gas, shipping, textiles, pharmaceuticals, energy, banking, finance, insurance, risk management, country intelligence, consumer & durable goods, chemical and more ur areas of interest. Contact us at +91 22 27578668 / 27579438 or email info@bharatbook.com or our website www.bharatbook.com

Opportunities, Strategies, And Development Of Orphan Drugs

Opportunities in Orphan Drugs: Strategies for developing maximum returns from niche indications
 
 The US government introduced the Orphan Drugs Act (ODA) in 1983 as a means to provide incentives to drug developers so that they would develop treatments for diseases for which incidence is so low that that normal market forces are unable to deliver effective medication for these conditions. A 1984 modification to the ODA defined an Orphan Disease as any condition affecting fewer than 200,000 people in the US. The US was followed by both Japan and the EU which have also introduced their own orphan drug legislation in 1993 and 2000 respectively.  ( http://www.bharatbook.com/detail.asp?id=132643&rt=Opportunities-in-Orphan-Drugs-Strategies-for-developing-maximum-returns-from-niche-indications.html )
 
 Industry has responded to this call for action and the FDA has approved over 270 orphan drugs in the US whilst there are another 583 listed in the Medtrack database as being in ongoing development. This has been motivated by the special incentives provided by the FDA and the EU including enhanced market exclusivity, research grants and tax incentives.
 
 Orphan drugs present opportunities to pharma companies looking to move into more niche indications and away from mass market indications that have very low levels of clinical unmet need. Although there are many successful orphan drugs that have made large profits for their developers (Gleevec, NovoSeven etc) the development of these products must be approached carefully. This report uses a mixture of case studies and data from secondary sources to elucidate the key issues in the development of orphan drugs and ways to navigate them.
 
 Key features of this report
 
 • Overview of orphan drugs legislation in the US, EU, Japan and Australia including details of key incentives for developers and history of orphan designations and approvals.
 • Evaluation of clinical trial and approval strategies including data on current clinical trial designs and strategies to maximize the chances of clinical trial success through the use of adaptive clinical trials.
 • Overview of orphan drug reimbursement issues in both the US and the EU including details of the importance of the UK’s NICE and the development of novel risk sharing agreements.
 • Examination of the role being played in orphan drug development by leading players in the pharmaceutical and biotech industry and the motivations behind this.
 
 Scope of this report
 
 • Gain an understanding of key orphan drugs legislation and the incentives available to the developers of drugs which successfully gain orphan designation.
 • Get a quick overview of the overall orphan drug development pipeline in the EU and US.
 • Gain strategic insight into the key differences between the development of orphan drugs and non-orphan drugs including the importance of patient advocacy groups.
 • Discover key strategies to maximize revenues from orphan drugs through gaining market access and broadening the product label.
 
 To know more and to buy a copy of your report feel free to visit : http://www.bharatbook.com/detail.asp?id=132643&rt=Opportunities-in-Orphan-Drugs-Strategies-for-developing-maximum-returns-from-niche-indications.html
 
 Or
 
 Contact us at :
 
 Bharat Book Bureau
 Tel: +91 22 27578668
 Fax: +91 22 27579131
 Email: info@bharatbook.com
 Website: www.bharatbook.com
 Blog: http://bharatbookresearch.blogspot.com
 Follow us on twitter: http://twitter.com/3bbharatbook

We are the leading information aggregator, facilitates and supports the business information needs. With over 115,000 reports, you can get instant access and insights on the studies in yo for market research , corporate / strategic planning by providing the latest information in the form of reports, journals, magazines and databases on varied industries like automotive, oil and gas, shipping, textiles, pharmaceuticals, energy, banking, finance, insurance, risk management, country intelligence, consumer & durable goods, chemical and more ur areas of interest. Contact us at +91 22 27578668 / 27579438 or email info@bharatbook.com or our website www.bharatbook.com