Technology

This report investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via fixed dose combinations. The key success factors in each of these pursuits have been clearly identified, emerging trends have been presented and the underlying concepts have been explained to provide a clear understanding of current industry dynamics. Case studies on popular products have been used to illustrate these concepts in the real world. An in-depth analysis of drug approval data provides context for the issues discussed. This information is juxtaposed with historic sales data to explore the correlation between the strategies employed and revenue potential.
This report explains the basics of drug lifecycle and investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via FDCs.
The key success factors in each of these pursuits have been clearly identified, emerging trends have been presented and the underlying concepts have been explained to give the reader a clear understanding of current industry dynamics. Case studies on popular products have been used to illustrate these concepts in the real world.
An in-depth analysis of drug approval data provides context for the issues discussed. This information is juxtaposed with historic sales data to explore the correlation between the strategies employed and revenue potential.
Key findings
Drug manufacturers must make the best strategic use of the patent-protected lifespan of a drug, or else risk losing the profit incentives they perceived at the start of the project. (Ch. 1)
In light of the increasing complexity of biopharmaceutical patenting, the ‘freedom to operate’, i.e. to commercialize the invention, is coming under increasing scrutiny. (Ch. 2)
The US Congress’ emerging stance on data exclusivity provisions for biologics will define the length of time a biotechnology company can keep out generic competition in new indications. The biotech industry’s stance is that the current provisions do not provide for enough time to profit from their post-approval R&D investments. (Ch. 2)
The potential for post-approval label expansion is much greater for biologics in comparison to small molecule pharmaceutical drugs. Most biologics on the market today can expect to add significant revenue streams via new indications, and potentially extend their commercial lifespan. (Ch 3)
Over 45% of all new indication approvals granted by the FDA since 1998 belong to drugs that fall in the Genito-urinary system and Nervous system.
If an FDC is launched close to the loss of exclusivity date of the constituent brand, it may be interpreted as a marketing tactic to limit post-LoE revenue losses. If launched early, it may show intent to cater to a genuine unmet need, or to legitimately maximize the potential of the parent molecule(s). (Ch. 4)
Scope of the report
In-depth case studies explore the real-world execution of the issues and challenges discussed in the report.
Analysis of historic drug approval data provides the reader with contextual reference points.
Case studies on Vytorin, Advair and BiDil illustrate the strategies employed by three leading FDC brands.
Brand histories of Yaz, Remicade and Seroquel show how label expansion is fundamental to successful lifecycle management.
Where applicable, these strategies are discussed with reference to specific therapeutic areas or geographies.
Issues related to biologics are highlighted to indicate where they differ from small molecule drugs.
Use this report to
Gain an understanding of legal provision for patent protection and data exclusivity. Understand their role in the context of product lifecycle management
Utilize the historical data on NDA approvals to identify trends and build assumptions into competitive landscape forecasts.
Understand the stance of key stakeholders and implications of off-label drug usage.
Understand the role of FDCs in optimizing the commercial potential of a product asset, and the main challenges in their commercialization
Juxtapose historic sales performance with the timing of indication expansion and FDC based strategies to assess the success or failure
     Table of Contents :   
Optimizing Lifecycle ManagementExecutive summary 8Product lifecycle and management challenges 8Influencing the commercial lifespan of the drug 9Accessing broader patient populations 10Fixed dose combinations 11Chapter 1 Product lifecycle and management challenges 14Summary 14Introduction 15The lifecycle of biopharmaceutical drugs 15Development lifecycle 17Commercial lifecycle 22Managing the lifecycle 22Longer development time 23Slower product uptake via reimbursement hurdles 24Peak sales potential is reduced by higher competition 25Earlier lifecycle decline due to therapeutic substitution 26Chapter 2 Influencing the commercial lifespan of a drug 30Summary 30Bargaining power of biopharmaceutical brands 31Brand equity 31Patent protection and “freedom to operate” 32Strategic patenting 33Patent prosecution superhighway 35Patent protection for biologics 35Data exclusivity 36Difference between data exclusivity and patent protection 408+2+1 system in the EU 40Data exclusivity in the US 42Data exclusivity in Japan 43Data exclusivity in the context of biologics 44Chapter 3 Accessing broader patient populations 46Summary 46Drug labeling and market access 47Off-label drug usage 47Commercial incentives and disincentives 48Payors stance on off-label reimbursement 49Case study: Avastin and Lucentis 51Expanding the label 53Role in product lifecycle management 53New indications 53Pediatric extensions and special populations 54Modified indications and expanded usage 54Case study: Yaz 55Case study: Remicade 58Indication expansion 59Choosing the primary indication 61Related versus unrelated indications 63Sequence of indication expansion 64Timing of indication expansion 65Launching early in commercial lifecycle 68Launching late in commercial lifecycle 69Seroquel: Using indication expansion and drug reformulation synergistically 70Recent trends in indication expansion 72Indication expansion for NDAs 72Indication expansion for biologics 75Chapter 4 Fixed dose combinations 80Summary 80Introduction 81Clinical challenges in FDC development 81FDC patents 82Data exclusivity for FDCs 83Role in product lifecycle maximization 83Case study: Advair’s role in GSK’s asthma franchise 85Case study: How Vytorin influenced Zocor’s patent expiry 88Case study: BiDil’s value proposition reinvented 90FDC uptake by geography 91Case study: FDCs for hypertension 91Clinical rationale 93Synergistic efficacy or safety 94Easier Rx management 95Correlation between FDC usage and drug compliance 95Correlation between drug compliance & improved clinical outcomes 96FDC usage by therapy area 96Key success factors and competitive hurdles 98Endorsement by treatment guidelines 98Perceived synergy effects over free combination 99Compliance advantage over the free combination 99Usage of mono compounds prior to FDC launch 99Discount compared to cheapest free combination 100Time-to-LOE of parent brand 101Chapter 5 Appendix 103Primary research methodology 103Glossary 107Index 111List of FiguresFigure 1.1: Summary of lifecycle of medicinal drugs 17Figure 1.2: Transition probabilities for clinical phases 18Figure 1.3: Out-of-pocket and capitalized costs of developing a drug ($m) 19Figure 1.4: Time taken for development of new pharma & biotech drugs 20Figure 1.5: Approval timelines at CDER for priority NDAs, 1999-08 21Figure 1.6: Approval timelines at CDER for standard NDAs, 1999-08 21Figure 1.7: Imperatives of efficient lifecycle management 23Figure 1.8: Increasing importance of payors as stakeholders 24Figure 1.9: Tougher payor environments are slowing product uptake 25Figure 1.10: Therapeutic substitution and formulary access 27Figure 2.11: 8+2+1 data exclusivity system in Europe 41Figure 2.12: Data exclusivity and patent protection in the US 43Figure 3.13: On and off-label decision making by payors 50Figure 3.14: Off-label usage of Avastin: a pharmacoeconomic model for wet AMD 52Figure 3.15: Yaz: Label expansion & sales growth – US ($m), 2006-08 57Figure 3.16: Remicade: Label expansion & sales growth – US ($m), 2001-08 59Figure 3.17: Time between launch of original and new indications in the US (by ATC), 1999-08 66Figure 3.18: Time between launch of original and new indications in the US (by ATC), 1999-08 (contd) 67Figure 3.19: Considerations in launching new indications early in the lifecycle 69Figure 3.20: Considerations in launching new indications late in the lifecycle 70Figure 3.21: Lifecycle management: Seroquel and Seroquel XR 71Figure 3.22: New indication approvals for NDAs, 1999-2008 73Figure 3.23: New indication approvals for Orphan drugs, 1999-08 73Figure 3.24: New indication approvals with priority reviews, 1999-08 74Figure 3.25: Increasing clinical and commercial potential for Remicade 77Figure 4.26: FDC approvals in the US, 1999-08 84Figure 4.27: Advair: FDA approvals and patent protection 86Figure 4.28: Advair-Serevent sales in the US: maintaining revenues post patent expiry of Flovent 87Figure 4.29: Zocor-Vytorin-Zetia brand timeline 88Figure 4.30: Cushioning the patent cliff: Zocor-Vytorin-Zetia sales in US ($m), 2001-08 89Figure 4.31: FDC usage for hypertension across major markets 93Figure 4.32: Drug classes with maximum FDC approvals in the US, 1999-08 97List of TablesTable 2.1: Data exclusivity periods by country 39Table 3.2: Success drivers and barriers in indication expansion 61Table 3.3: Unmet needs prevalent within an indication 62Table 3.4: Commercial considerations in prioritizing new indications 62Table 3.5: Disease areas and related sub-populations for hypertension and heart failure 63Table 3.6: New indication approvals by drug class, 1999-08 75Table 4.7: FDC case studies 81
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Report Description The Global Biomarker Market report analyzes the biomarker tools and services market over the period 2009-2014. The report studies the major market drivers, restraints, and opportunities for the global biomarker market; and also evaluates the major trends in the macro- and micro-markets with respect to different geographic regions. The global biomarker market is estimated to be $20.5 billion by 2014, growing at a CAGR of 19.7 % from 2009 to 2014, driven by the high demand for the biomarkers in the field of drug discovery. The markets for biomarker tools and services are expected to grow at a CAGR of 18.5% and 22.2% respectively. The increasing use of biomarkers in clinical services is boosting the overall biomarker service market.

The high growth of biomarker market is boosted by the demand from the baby boomer generation in the U.S., and from Asia’s emerging IT industry. Biomarker applications are increasing in cancer diagnosis as novel tools are being developed to increase the discovery speed of cancer biomarkers. The use of proteomics in biomarker testing and identification has in turn boosted the services for the biomarkers. Market players are now focusing on new product and service development to enhance their commercial portfolios. Strategic collaborations among companies are also increasing biomarker applications in the field of diagnosis and drug discovery.

SCOPE AND FORMAT The report analyzes the global biomarker market into the following segments: • Tools Market (pregenomic biomarkers and technologies, postgenomic biomarkers and technologies, imaging biomarkers, and others) • Services Market (pre- and post-clinical biomarker services, sample preparation, mirna analysis, and others) • Application Market (diagnosis, and drug development and discovery) The market data consists of aggregate sales figures of all biomarker submarkets. It analyzes the market aspects of new biomarker technologies and product launches; sourcing key market developments from the top companies that it profiles. The report also analyzes the documented claims and the biomarker technology patents approved over the last five years to provide an in-depth understanding of biomarker tools and services.

For more information please contact : http://www.aarkstore.com/reports/Biomarkers-Advanced-Technologies-and-Global-Market-2009-2014–27515.html http://blogs.aarkstore.com/ From: Aarkstore Enterprise Contact: Neel Email: press@aarkstore.com URL: www.aarkstore.com

Aarkstore announce a new report  “Leading Drug Delivery Companies and Technologies: Competitive landscape, company profiles and technological developments” through its vast collection of market research report.Leading Drug Delivery Companies and Technologies Competitive landscape, company profiles and technological developments Business Intelligence for the Pharmaceutical Industry Portfolio of healthcare management reports is designed to help you make well informed and timely business decisions. We understand the problems facing today’s pharmaceutical and healthcare executives when trying to drive your business forward, and appreciate the importance of accurate, up-to-date, incisive product, market and company analysis. We help you to crystallize your business decisions.

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Our healthcare portfolio of reports can be used across a wide range of business functions to assess market conditions and devise future strategy. Our reports cover key areas including strategy, industry analysis, market outlook, new business opportunities and strategic insight.

Some key findings from this report… • The oral delivery system continues to dominate the drug delivery market due to convenient usage, cost-effectiveness and low frequency of administration. Needleless injectables, PEGylation technologies and micro-electromechanical devices are among the novel technologies with the greatest growth potential. • The market for parenteral drugs and solutions sold in prefilled syringes and premixed IV systems will grow, due to the ease of administration and resistance to infections associated with these methods. The needle-free delivery sector will rise to $3bn by 2010. • Pulmonary delivery technologies are increasingly prevalent in pain management, cystic fibrosis and diabetes. Pulmonary-based delivery vehicles are currently the focus of a number of major companies including Nektar, Aradigm, 3M, and Alkermes. • Dry powder inhalers will secure the largest share of sales within the asthma market, as demand for treatments in this therapy area continues to expand. However, MDI products will experience a relatively higher rate of growth due to consistent improvements in particle size and safe propellant delivery.

Leading Drug Delivery Companies and Technologies Over the last decade, the drug delivery industry has evolved to become a key area in the development of value-added pharmaceutical products. The global market grew from $15bn to $40bn during 2000–2006 as companies increasingly turned to drug delivery technologies as a means of expanding product lifecycles, enhancing drug efficacy and maximizing revenues. Although the market is still dominated by the oral drug delivery system, a number of novel technologies are emerging across all systems of delivery. However, the pure drug delivery company model is rapidly becoming extinct as leading players attempt to consolidate their strategic opportunities by expanding their focus towards manufacturing, a trend that is expected to accelerate over the next five years.

‘Leading Drug Delivery Companies and Technologies’ is a new report examines the current and future trends that are shaping the drug delivery market and reviews the key emerging technologies across major systems of drug delivery. This report identifies the product portfolios and targeted therapeutic areas of leading drug delivery companies in addition to assessing their technology platforms to provide guidance over their applicability, regulatory implications and developmental progress. This report also evaluates the opportunities and threats facing each of the companies profiled and provides a comparative analysis of the growth strategies used to facilitate successful deals and collaborations.

Identify key trends and developments in the global drug delivery market, assess the performances and portfolios of leading drug delivery companies and benchmark their strategies with this new report…

Top reasons to order your copy today • Discover the key issues and trends in the global drug delivery market with this report’s analysis of market size and growth, the commercial value of drug delivery systems and the extended strategic focus of growing numbers of drug delivery companies. • Identify the dynamics of major drug delivery systems by evaluating the latest market developments and technological innovations in oral, pulmonary, injectable and transdermal delivery platforms. • Assess the leading players in the drug delivery market with this report’s review of the opportunities and threats, financial performances and R&D expenditures of Biovail, Elan, SkyePharma, Alkermes, Bioject, QLT, Nektar, Aradigm, Antares, Noven, Alza and 3M. • Benchmark the strategies of leading drug delivery companies by evaluating their product portfolios and pipelines, deals and alliances, targeted therapeutic areas and technology platforms

Key issues examined in this report… • Technology driving growth. Drug delivery technologies are being used to boost revenues and enhance product efficacy by developing future commercial opportunities and expanding product lifecycles. • Expanding strategic focus. A growing number of drug delivery companies are evolving into specialty pharma companies. Widening the core business to incorporate manufacturing is a strategy increasingly used to enhance revenues. • Stagnant R&D investment. The companies featured in this report recorded an average growth in R&D expenditure of just 6% during 2003–2007. This low growth in R&D spend is likely to inhibit the discovery and development of new products in the short term. • Inhaled insulin setback. The development of inhaled insulin has been the focus of many companies operating in the pulmonary drug delivery field. However, a high number late-stage terminations have raised doubts over the commercial potential of this delivery vehicle.

Your questions answered… • What are the major issues surrounding drug delivery within the global pharma industry? • What are the latest innovations and developments in different drug delivery vehicles? • What are the market dynamics for oral, injectable, pulmonary and transdermal drug delivery systems? • What are the key technologies and growth strategies of leading drug delivery companies? • What are the product portfolios, pipeline candidates, financial performances and R&D expenditures of these leading companies? • What opportunities and threats will drug delivery companies face in the future? For more information, please visit :http://www.aarkstore.com/reports/Leading-Drug-Delivery-Companies-and-Technologies-Competitive-landscape-company-profiles-and-technological-developments-14403.htmlOr email us at press@aarkstore.com or call +919272852585 Special offer till 31th Dec 2009

Aarkstore announce a new report  “Innovation in Food and Drinks Packaging: Opportunities in added value and emerging technologies” through its vast collection of market research report. Report Overview…Food and drinks packaging is in a period of rapid change. Growth in the food and drinks packaging markets of developing economies is expected to increase in conjunction with their rising GDP’s, the changing nature of consumer lifestyles and the increased amount of packaged food and drink. Emerging issues such as sustainability and recent increases in raw material prices are also having a significant impact. Understanding trends and issues within the food and drinks packaging market is important due to their significant effect up on manufacturers, retailers, and distributor costs and logistics. ‘Innovation in Food and Drinks Packaging: Opportunities in added value and emerging technologies’ is a report published by Business Insights that provides added value by exploring innovations in food and drinks packaging from both packaging and food and drinks manufacturer perspectives. This report also delivers an overview of competitor activity and an assessment of the strength of trends and market forces moving forward. Key Findings…Glass is the most common material used for new products launched with food safety packaging and this has been relatively stable over the period 2005 to 2008. The next most common material in this category is plastic. Soft drinks (23.5%), took the highest share of food and drinks launched in innovative packaging between 2005 and 2008, closely followed by alcoholic drinks (23.0%). Nanotechnology, interactive packaging, intelligent and active packaging, multi-sensory packaging, and edible packaging are developing innovations that are likely to have an impact on the future of food and drinks packaging. The most commonly used packaging materials in new food and drinks product launches in 2008 in were Plastic (33.2%), glass (11.7%) and cardboard (11.5%). Use this report to…• Understand how regulations are influencing NPD in food and drinks packaging and discover how competitors are responding to new challenges set by these regulations with this new report.• Gain insight into the most up to date packaging technologies including nanotechnology, natural polymers and edible coatings, and evaluate the pros and cons of these new packaging technologies to decide whether these may be appropriate for your organization.• Identify the key trends in food and drinks packaging and the impact that they are expected to have on the food and drinks market in the future.• Enhance your product development strategies with this report’s analysis of green, convenient and supply chain efficient packaged food and drinks product launches by region, category and material. Key issues…Changes to labelling regulations. Recent debate and regulation on food and drinks labeling means detailed information is becoming a requirement in some regions. This is having an impact on the size and design of food and drinks labels and packs in general. The Economic climate. More difficult economic times are one of the factors encouraging consumers to shop in discounters and/or switch from branded items to private labels. In a related effect, the downturn is promoting changes in format and size of packs. The effect of rising prices. The increase in raw material prices has led to some packaging manufacturers passing on price increases to their customers, making cuts within their operating expenses, and in some cases changing the design/format of the packaging material or package itself. Your questions answered…• What major trends are impacting food and drinks packaging development?• How are companies using green packaging materials to lend credibility to their ethical policies?• Who are the top food and drinks packaging manufacturers?• What innovative materials are being used within food and drinks packaging?• Which new technologies, materials and design principles are driving innovation within food and drinks packaging?• What are the key opportunities and challenges within food and drinks packaging? For more information, please visit :http://www.aarkstore.com/reports/Innovation-in-Food-and-Drinks-Packaging-Opportunities-in-added-value-and-emerging-technologies-22034.htmlOr email us at press@aarkstore.com or call +919272852585 Special offer till 31th Dec 2009