Forecast Insight: Epilepsy - Future market upgrade following new drug launches

Publication Date	December 2008
Publisher	Datamonitor
Product Type	Report
Pages	140
ISBN Number	not applicable
Product Code	DAT14049

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Summary

Introduction

Driven primarily by continued uptake of UCB's market leading anticonvulsant, Keppra (levetiracetam), seven major market epilepsy revenues grew strongly at a compound annual growth rate of 11.7% to reach almost $3.8 billion in 2007.

Scope

This report gives a strategic analysis of the likely impact that recent events will have on the future epilepsy market
Includes epilepsy-specific sales forecasts for the key brands, generics, and pipeline agents in the seven major markets to 2017
Provides a global market snapshot by including epilepsy-specific sales analysis for leading brands outside the seven major markets
Key conclusions are supported by key opinion leader comment

Highlights

Despite the failure of UCB's brivaracetam to meet its primary endpoint in a Phase III trial in Unverricht Lundborg disease, the drug is expected to receive strong uptake in patients with refractory partial-onset seizures. Interviewed key opinion leaders remain optimistic about brivaracetam's future prospects.

As a result of Valeant's August 2008 collaboration with GlaxoSmithKline and the release of positive Phase III clinical trial data in September 2008, Datamonitor has upgraded its epilepsy-specific sales forecast for retigabine. However, the drug's likely three-times daily dosing is not expected to be well received by patients and physicians.

D-Pharm's DP-VPA (a prodrug of valproic acid), has not made any known progress through clinical development since 2006. As a result, launch of DP-VPA is expected to take place 1 year later than what was estimated in Datamonitor's previous epilepsy market report and epilepsy-specific sales forecasts for the drug have been downgraded.

Reasons to Purchase

Understand when late-stage pipeline products will launch and what impact these will have on the market during the forecast period 2008 to 2017
Quantify the current size of the seven major markets and the trends in the rest of the world
Assess the impact of events, such as patent expiries and new product launches, on the epilepsy-specific sales of key brand name products

Content

ABOUT DATAMONITOR HEALTHCARE
About the Central Nervous System pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Strategic scoping and focus
- Datamonitor insight into the disease market
- Related reports
CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Market definition for this report
- Countries and regions included in this report
- Seven major market assessment
- Seven major market dynamics
- The seven major epilepsy market grew to almost $3.8 billion in 2007
- Epilepsy market prescription volume has plateaued between 2004-07
- The seven major epilepsy market is forecast to grow to over $5.5 billion by 2017
- The UK represents the most rapidly growing epilepsy market in the seven major markets
- Dominance of the US epilepsy market is set to continue
- Comparison with previous forecast
- Upgrade since 2007 forecast
- Rest of the world snapshot
- Rest of the world epilepsy market was almost half the size of the US market in 2007
- The rest of Europe remains the largest region in the rest of the world
- Turkey offers the greatest growth potential in the rest of world markets
- Depakene (valproic acid, Abbott) is the best selling product in the rest of the world epilepsy market with 2007 sales of $190m
CHAPTER 3 BRAND DYNAMICS
- Overview of competitive landscape
- UCB's Keppra remained the market leading anticonvulsant in 2007
- Update of key marketed anticonvulsant drugs
- FDA acknowledgement of suicidality risk will have minimal impact on epilepsy-specific drug sales
- Keppra (levetiracetam, UCB)
- Cautious generic prescribing in the epilepsy market will provide Keppra with some insulation from generic erosion
- Keppra's pediatric indication expansions look set to continue
- Uptake in international markets will partially offset generic erosion in the US and EU
- Topamax (topiramate, Johnson & Johnson)
- Topamax enters Japanese epilepsy market in September 2007
- Grant of pediatric extension will delay launch of US generics until March 2009
- Lamictal (lamotrigine, GlaxoSmithKline)
- Neurontin and Topamax will be Lamictal's key competitors upon launch in Japan
- Generic lamotrigine entered the US market in July 2008
- Depakote (valproate semisodium, Abbott Laboratories, Sanofi-Aventis)
- Depakote has faced generic competition in the US since July 2008
- Banzel (rufinamide, Eisai)
- Banzel is set to enter the US epilepsy market in January 2009
- Although well placed to penetrate the Japanese epilepsy market, Eisai is no longer expected to launch Banzel in this market
- Lyrica (pregabalin, Pfizer)
- Interviewed key opinion leaders do not expect Lyrica to receive strong uptake in the indication of epilepsy
- Lyrica is expected to gain approval as monotherapy in 2011
- Datamonitor's epilepsy-specific forecast for Lyrica has been upgraded due to greater than expected uptake during 2007
- Sabril (vigabatrin, Sanofi-Aventis/Ovation Pharmaceuticals)
- Sabril is expected to receive approval for the treatment of infantile spasms and refractory complex partial seizures in the US in Q1 2009
- Despite possessing the potential to satisfy a key unmet need, approval of Sabril in the US market remains uncertain
- Trileptal (oxcarbazepine, Novartis)
- Generic oxcarbazepine entered the US market in October 2007
- Frisium (clobazam, Ovation Pharmaceuticals)
- Clinical trial data
- Frisium will struggle to gain market share from Topamax and Banzel
- Recently launched products
- Stavzor (valproic acid delayed release, Noven Pharmaceuticals)
- Clinical trial data - adjunctive use of Stavzor leads to a 45% response rate among patients with complex partial seizures
- Stavzor will struggle to gain market share from other valproate-based medications
- Keppra XR (levetiracetam extended release, UCB)
- Clinical trial data: Keppra XR leads to a 46.1% median reduction of partial onset seizures
- Keppra XR is unlikely to provide a substantial revenue boost to the Keppra franchise
- Vimpat (lacosamide, UCB)
- Clinical trial data - Vimpat demonstrates a lower responder rate than Keppra
- Vimpat represents a new treatment option for patients who experience uncontrolled seizures
- Novel, dual mechanism of action represents a key product differentiator
- Forecasted late-stage pipeline products
- Brivaracetam (UCB)
- Clinical trial data
- Retigabine (Valeant Pharmaceuticals/GlaxoSmithKline)
- Valeant's collaboration with GlaxoSmithKline will benefit uptake of retigabine
- Phase III data announced at two conferences in 2008: retigabine leads to a responder rate of 55.5%-38.6%
- Revenue forecast for retigabine has been upgraded due to announcement of positive clinical trial data and Valeant's collaboration with GlaxoSmithKline
- Carisbamate (RWJ-333369, Johnson & Johnson)
- Carisbamate entered pre-registration in the US in October 2008
- Low efficacy and lack of optimum switching time frame will limit uptake
- Lamictal XR (lamotrigine extended release, GlaxoSmithKline)
- Lamictal XR is currently experiencing regulatory delays in the US
- An extended release version represents a small improvement to treatment options, with an unfavorable cost/benefit profile
- Lamictal XR will play a minor role in offsetting generic erosion of Lamictal
- Clinical trial data: Phase III data published in October 2007
- SEP-0002093 (eslicarbazepine acetate, BIAL Group/Sepracor)
- Future monotherapy approval and pediatric indication expansions will increase commercial potential
- Clinical trial data
- SPN-804 (oxcarbazepine extended release, Supernus Pharmaceuticals)
- Clinical trial data: none available at present
- Lack of novelty and competition from generic oxcarbazepine will limit uptake of SPN-804
- Perampanel (Eisai)
- Clinical trial data: Phase II results announced in April 2008
- DP-VPA (D-Pharm)
- Forecast downgraded due to lack of progress through development pipeline
- Unforecasted epilepsy pipeline candidates
BIBLIOGRAPHY
- Journal and conference papers
- Websites
- Datamonitor reports
APPENDIX A - MARKET ASSUMPTIONS
- New product launches
- Patent expiries
- Epilepsy diagnostic values for key branded anticonvulsants
- Standard units
- Japanese market data
- Derivation of sales forecasts and pricing trends
- Sales calculations
- Forecast methodology
APPENDIX B
- Contributing experts
- Conferences attended
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the central nervous system analysis team
- Disclaimer
- Table 1: Epilepsy market sales forecasts in the seven major markets ($m), 2007-2017
- Table 2: Comparison of leading branded drug sales ($m) for epilepsy in the seven major markets and the rest of the world (ROW), 2007
- Table 3: Leading branded drug sales ($m) for epilepsy in the seven major markets, 2007-2017
- Table 4: Sales forecast for late-stage R&D pipeline products for epilepsy, 2008-2017
- Table 5: Key facts: Phase III trial of clobazam in patients with Lennox-Gastaut Syndrome
- Table 6: Key facts: Phase III trial of brivaracetam in adults with partial onset seizures
- Table 7: Key facts: Phase III trial of brivaracetam in adolescents and adults with epilepsy
- Table 8: Key facts: Phase III, open-label study of a flexible dose of brivaracetam in patients aged 16 years and above
- Table 9: Key factors impacting sales of brivaracetam, 2008-2017
- Table 10: Clinical trial summary for retigabine IR
- Table 11: Key factors impacting sales of retigabine IR, 2008-2017
- Table 12: Phase III clinical trial summary for carisbamate
- Table 13: Key factors impacting sales of carisbamate, 2008-2017
- Table 14: Phase III clinical trial summary for Lamictal XR
- Table 15: Key facts: Phase III trial of lamotrigine extended-release in elderly patients with epilepsy
- Table 16: Key facts: Phase III trial of lamotrigine extended-release monotherapy for treatment of partial seizures
- Table 17: Key factors impacting sales of Lamictal XR, 2008-2017
- Table 18: Phase III clinical trial summary for SEP-0002093
- Table 19: Key factors impacting sales of SEP-0002093, 2008-2017
- Table 20: Key facts: Phase III trial of SPN-804
- Table 21: Key factors impacting sales of SPN-804, 2008-2017
- Table 22: Key facts: Phase III trial of perampanel
- Table 23: Key factors impacting sales of perampanel, 2008-2017
- Table 24: Key factors impacting sales of DP-VPA, 2008-2017
- Table 25: Unforecasted pipeline drugs in Phase II development for epilepsy, 2008
- Table 26: Datamonitor's estimated launch dates for epilepsy products in the seven major markets, 2008-2017
- Table 27: Patent expiry dates for the approved anticonvulsants in the seven major markets, 2008-2017
- Table 28: Percentage of sales attributed to epilepsy prescription for key branded anticonvulsants in the seven major markets, 2007
List of Figures
- Figure 1: Epilepsy-specific sales value ($m) in the US, 5EU and Japan, 2004-07
- Figure 2: Epilepsy market volume (IMS standard units sold, million) in the US, 5EU and Japan, 2004-07
- Figure 3: Key events impacting the epilepsy market, 2008
- Figure 4: Epilepsy-specific sales ($m) of total marketed and pipeline products in the seven major markets, 2004-2017
- Figure 5: Key events impacting the epilepsy market, 2008-17
- Figure 6: Epilepsy market sales value ($m) growth dynamics by country in the seven major markets, 2004-07
- Figure 7: Epilepsy-specific sales ($m) by country in the seven major markets, 2004-2017
- Figure 8: Comparison of depression-specific forecasts in the seven-major markets, 2006-2017
- Figure 9: The global epilepsy market value ($m) split in by region, 2007
- Figure 10: Epilepsy-specific annual sales of anticonvulsants in the small and emerging markets, 2004-07
- Figure 11: Performance of the seven highest value ex-seven major epilepsy markets, 2004-07
- Figure 12: Performance of the top six anticonvulsant brands across the seven major markets, 2004-07
- Figure 13: Datamonitor's epilepsy-specific sales ($m) forecast for Keppra (levetiracetam) in the seven major markets, 2008-2017
- Figure 14: Datamonitor's epilepsy-specific sales ($m) forecast for Topamax (topiramate) in the seven major markets, 2008-2017
- Figure 15: Datamonitor's epilepsy-specific sales ($m) forecast for Lamictal (lamotrigine) in the seven major markets, 2008-2017
- Figure 16: Datamonitor's 2007 and updated epilepsy-specific sales ($m) forecast for Depakote (valproate semisodium) in the seven major markets, 2008-2017
- Figure 17: Datamonitor's epilepsy-specific sales ($m) forecast for Banzel (rufinamide) in the seven major markets, 2008-2017
- Figure 18: Datamonitor's 2007 and updated epilepsy-specific sales ($m) forecast for Lyrica (pregabalin) in the seven major markets, 2008-2017
- Figure 19: Datamonitor's epilepsy-specific sales ($m) forecast for Sabril (vigabarin)in the seven major markets, 2008-2017
- Figure 20: Datamonitor's 2007 and updated epilepsy-specific sales ($m) forecast for Trileptal (oxcarbazepine) in the seven major markets, 2008-2017
- Figure 21: Datamonitor's epilepsy-specific sales ($m) forecast for Frisium (clobazam) in the seven major markets, 2008-2017
- Figure 22: Datamonitor's epilepsy-specific sales ($m) forecast for Stavzor (valproic acid delayed release) in the seven major markets, 2008-2017
- Figure 23: Datamonitor's epilepsy-specific sales ($m) forecast for Keppra XR (levetiracetam extended release) in the seven major markets, 2008-2017
- Figure 24: Datamonitor's sales ($m) forecast for Vimpat (lacosamide) in the seven major markets, 2008-2017
- Figure 25: Datamonitor's epilepsy-specific sales ($m) forecast for brivaracetam in the seven major markets, 2008-2017
- Figure 26: Datamonitor's 2006 and updated epilepsy-specific sales ($m) forecast for retigabine in the seven major markets, 2008-2017
- Figure 27: Datamonitor's sales ($m) forecast for carisbamate in the seven major markets, 2008-2017
- Figure 28: Datamonitor's sales ($m) forecast for Lamictal XR (lamotrigine extended release) in the seven major markets, 2008-2017
- Figure 29: Datamonitor's epilepsy-specific sales ($m) forecast for SEP-0002093 in the seven major markets, 2008-2017
- Figure 30: Datamonitor's epilepsy-specific sales ($m) forecast for SPN-804 in the seven major markets, 2008-2017
- Figure 31: Datamonitor's sales ($m) forecast for perampanel in the seven major markets, 2008-2017
- Figure 32: Datamonitor's 2006 and updated epilepsy-specific sales ($m) forecast for D-Pharm's DP-VPA in the US and 5EU, 2008-2017