Commercial Insight: Epilepsy - Companies committed to the cause will reap the benefits

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the CNS pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Objective of the analysis
  • Datamonitor insight into the epilepsy market
  • Market forecast summary
  • Contributing experts
  • Related reports
• CHAPTER 2 MARKET DEFINITION AND OVERVIEW
  • Market definition for this report
  • Current market situation
    • Growth of the seven major epilepsy market is slowing
      • The US dominates sales revenue of the total seven major epilepsy market
      • Germany is the largest epilepsy market in the 5EU
      • Second-generation anticonvulsants outperform traditional anticonvulsants in terms of value sales
      • Keppra retains a strong foothold in the epilepsy market
      • Growth of Topamax outstrips Lamictal due to broader spectrum of approval
      • Zonegran suffers the steepest decline in sales
  • Strategic scoping and focus
• CHAPTER 3 COUNTRY MARKET ASSESSMENTS
  • Summary of environmental issues affecting epilepsy market size
  • Global market opportunities and threats
    • Opportunities
      • Treatments for refractory patients remains a significant unmet need
      • Greater treatment options are required for the growing elderly epilepsy population
      • Pediatric niche indications represent opportunities to increase market revenue
      • The under-treatment of epilepsy in developing countries cannot be ignored
      • High prevalence of co-morbid depression represents a large patient potential for companies marketing antidepressants
    • Threats
      • Ethical concerns and regulatory issues make epilepsy monotherapy licenses difficult to obtain
      • Non-adherence to treatment limits the revenue potential of the epilepsy market
      • Drive towards generic prescribing
  • US: opportunities and threats
    • Opportunities
      • Advocacy groups drive patient awareness of therapeutic options
      • Online DTC advertising facilitates patients' understanding of their condition
      • Lobbying efforts aim to make generic substitution of anticonvulsants more difficult
    • Threats
      • Higher price prices increases the impact of genericization
      • Proposed cut to Medicare will reduce reimbursement of epilepsy products for elderly patients
  • Japan: opportunities and threats
    • Opportunities
      • Underdeveloped epilepsy market in Japan has scope for growth
      • Rapidly rising elderly population will boost prevalence of epilepsy in Japan
      • Governmental funding for clinical trials could benefit research into epilepsy
    • Threats
      • Government' s pro-generics strategy aims to double the use of generics by the end of 2012
  • France: opportunities and threats
    • Opportunities
      • Price premiums and high-level reimbursement encourage innovation
      • Keppra' s non-dominant status reduces competition for potential market entrants
    • Threats
      • Take-off of generic sector
      • Formulary access
  • Germany: opportunities and threats
    • Opportunities
      • Companies can command a higher than average price-point in Germany
    • Threats
      • High level of generic incursion set to be exacerbated by introduction of generic incentivization scheme for doctors
  • Italy: opportunities and threats
    • Opportunities
      • Lack of recommendation for generic substitution will ensure generic incursion remains low
      • A record number of clinical trials were approved in Italy in 2006
    • Threats
      • Stringent reference pricing system
  • Spain: opportunities and threats
    • Opportunities
      • Reduced pharmaceutical tax set to save companies selling branded epilepsy treatments over $1.6m per annum
      • Health ministry introduces ' Spanish national formulary'
    • Threats
      • R&D activity expected to decline
  • UK: opportunities and threats
    • Opportunities
      • Reduced clinical trial times will hasten pipeline epilepsy products to the market
      • NICE guidelines advocate the use of newer drugs for epilepsy and recommend early specialist consultations
      • Increased recruitment and training of neurologists will accelerate access to treatments
    • Threats
      • Pharmaceutical Price Regulation Scheme (PPRS) implements periodic price cuts
• CHAPTER 4 FORECAST ANALYSIS
  • Key events
    • New product launches in the US and EU
      • Rufinamide
      • Lamictal XR
      • Vimpat (lacosamide)
      • Brivaracetam
      • Retigabine
      • DP-VPA
    • New product launches in Japan
      • Neurontin (gabapentin)
      • Lamictal (lamotrigine)
      • Keppra (levetiracetam)
    • Patent expiries
      • Cerebyx (fosphenytoin sodium injectable)
      • Trileptal (oxcarbazepine)
      • Depakote (valproate semisodium)
      • Keppra (levetiracetam)
      • Lamictal (lamotrigine)
      • Topamax (topiramate)
      • Felbatol (felbamate)
      • Carbatrol (carbamazepine sustained release)
  • Data definitions, limitations and assumptions
    • Standard units
    • Japanese market data
    • Derivation of sales forecasts and pricing trends
    • Drug pricing and genericization assumptions
  • Forecast methodology
• CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
  • Introduction
  • Commitment to epilepsy provides long-term growth
    • Drug innovation provides a firm grounding for growth
    • Epilepsy-focused brand strategies improve credibility
    • Post launch clinical studies and indication expansions strengthen brand loyalty
      • Keppra' s indication expansions have focused on the pediatric population
      • Seeking regulatory approval in the pediatric population remains a commercially attractive route
    • Offering a variety of drug delivery formulations provides prescribers with more options
      • Keppra injectable formulation offers utility in a small proportion of patients
    • Focus promotional spend on maintaining relationships with prescribers
    • Continued development of new treatments demonstrates long- term commitment
• BIBLIOGRAPHY
  • Journal papers
  • Websites
  • Datamonitor reports
• APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS
  • Summary epilepsy market data
  • Anticonvulsant market data
• APPENDIX B - MARKET FORECAST DATA
  • Seven major markets
  • M5EU
  • US
  • Japan
  • France
  • Germany
  • Italy
  • Spain
  • UK
• APPENDIX C
  • Contributing experts
  • Report methodology
  • About Datamonitor
    • About Datamonitor Healthcare
    • About the CNS analysis team
    • Disclaimer
  • List of Tables
    • Table 1: Key players in the epilepsy market, 2007
    • Table 2: Summary of global environmental issues affecting the epilepsy market, 2007
    • Table 3: Summary of environmental issues in the individual seven major epilepsy markets, 2007
    • Table 4: Estimated launch dates for new epilepsy drugs in the 5EU and US, 2007-2016
    • Table 5: Japan launch dates for epilepsy products, 2007-2016
    • Table 6: Patent expiry dates for the key approved epilepsy brands in the seven major markets, 2007-2016
    • Table 7: Approved additional therapeutic indications of marketed anticonvulsants, 2007
    • Table 8: Approved pediatric indications for Topamax, Lamictal and Trileptal
    • Table 9: UCB/Schwarz' s epilepsy pipeline, 2007
    • Table 10: Epilepsy summary market data ($m), 2006
    • Table 11: Keppra: key facts
    • Table 12: Lamictal: key facts
    • Table 13: Topamax: key facts
    • Table 14: Trileptal: key facts
    • Table 15: Depakine: key facts
    • Table 16: Tegretol: key facts
    • Table 17: Dilantin: key facts
    • Table 18: Carbatrol: key facts
    • Table 19: Zonegran: key facts
    • Table 20: Seven major market epilepsy drug sales forecasts ($m), 2007-2016
    • Table 21: 5EU epilepsy drug sales forecasts ($m), 2007-2016
    • Table 22: US epilepsy drug sales forecasts ($m), 2007-2016 (New)
    • Table 23: Japan epilepsy drug sales forecasts ($m), 2007-2016
    • Table 24: France epilepsy drug sales forecasts ($m), 2007-2016
    • Table 25: Germany epilepsy drug sales forecasts ($m), 2007-2016
    • Table 26: Italy epilepsy drug sales forecasts ($m), 2007-2016
    • Table 27: Spain epilepsy drug sales forecasts ($m), 2007-2016
    • Table 28: UK epilepsy drug sales forecasts ($m), 2007-2016
    • Table 29: ICD-10 codes used to size the epilepsy market
  • List of Figures
    • Figure 1: Datamonitor' s epilepsy forecast market across the seven major markets, 2007-2016
    • Figure 2: Epilepsy-specific sales revenue across the seven major markets ($m), 2003-06
    • Figure 3: Epilepsy-specific sales volume across the seven major markets ($m), 2003-06
    • Figure 4: Performance of the 5EU epilepsy markets ($m), 2005-06
    • Figure 5: Key events impacting the epilepsy market, 1995-2007
    • Figure 6: Sales volume (SU millions) and value ($m) of first- versus second-generation anticonvulsants, 2003-06
    • Figure 7: Performance of the nine key epilepsy therapies ($m), 2005-06
    • Figure 8: Population aged over 65 years in the seven major markets, 2007 and 2017
    • Figure 9: Performance of the key anticonvulsants in the US 2005-06
    • Figure 10: Average anticonvulsant standard unit price in the US and the other six major markets, 2003-06
    • Figure 11: Performance of the key anticonvulsants in Japan 2005-06
    • Figure 12: Population of Japan over the age of 65 (million), 1950-2020
    • Figure 13: Performance of the key anticonvulsants in France 2005-06
    • Figure 14: Market share of key epilepsy drugs in France(%), 2006
    • Figure 15: Generic incursion of epilepsy-specific volume sales of anticonvulsants in the 5EU, 2003-06
    • Figure 16: Performance of the key anticonvulsants in Germany 2005-06
    • Figure 17: Average anticonvulsant standard unit price in Germany and the other four EU countries ($), 2003-06
    • Figure 18: Generic incursion of the 5EU epilepsy markets, 2003-06
    • Figure 19: Performance of the key anticonvulsants in Italy 2005-06
    • Figure 20: Performance of the key anticonvulsants in Spain 2005-06
    • Figure 21: Performance of the key anticonvulsants in the UK 2005-06
    • Figure 22: Impact of key events on the 7MM epilepsy market
    • Figure 23: Forecasted UCB epilepsy franchise ($m), 2007-2016
    • Figure 24: Quarterly value sales of Keppra across the seven major markets ($m), 2003-06
    • Figure 25: Keppra' s epilepsy indication expansions, 2000-06
    • Figure 26: Sales of Keppra' s four formulations ($m), 2003-06
    • Figure 27: Promotional spend on physician detailing for Keppra in the US and 5EU, 2004-06
    • Figure 28: Promotional spend on journal advertising for Keppra in the US and 5EU, 2004-06