Analyst Outlook
Keppra (levetiracetam; UCB/Otsuka) boasts one of the broadest ranges of approved epilepsy indications of all agents in the epilepsy market, contributing to its market-leading status. Having faced competition from cheaper, generic equivalents in the US and EU markets since 2008 and 2010, respectively, UCB has bolstered sales by launching an extended-release formulation of the drug in the US, by maintaining its strong marketing and commercialization capabilities, by acquiring more indications across the major markets, and by capitalizing on the high brand loyalty that occurs in the epilepsy market. UCB has also successfully pursued the Japanese market; in July 2010, Keppra gained regulatory approval in Japan. This was followed by a number of successful epilepsy indication expansions in Japan, resulting in a larger treatable patient base and thus minimizing the impact of the generic erosion of US and EU revenues.
Drug Overview
UCB’s Keppra binds to synaptic vesicle glycoprotein 2A (SV2A). SV2A plays a substantial role in the release of neurotransmitters that are essential for normal neuronal activity in the brain and spinal cord. Its novel mechanism of action provides a useful treatment option for patients unresponsive to other anti-epileptic medications. UCB initially launched Keppra in the US and EU in April and September 2000, respectively, for the adjunctive treatment of partial-onset seizures in adults with epilepsy. Since its initial launch, Keppra has received numerous indication expansions (see table below). In 2008, UCB and Otsuka entered into a licensing agreement for the co-development and co-promotion of Keppra in Japan (UCB, 2009) and the product launched in this region (under the
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Keppra and Keppra XR : Epilepsy
LIST OF FIGURES
19 Figure 1: Keppra and Keppra XR for epilepsy – SWOT analysis
20 Figure 2: Datamonitor Healthcare’s drug assessment summary for Keppra in epilepsy
21 Figure 3: Datamonitor Healthcare’s drug assessment summary for Keppra in epilepsy
LIST OF TABLES
4 Table 1: Keppra/Keppra XR epilepsy indication approvals
6 Table 2: Keppra and Keppra XR drug profile
9 Table 3: Keppra pivotal trial data in epilepsy
16 Table 4: Safety profile for Keppra in epilepsy
17 Table 5: Keppra XR pivotal trial data in epilepsy
18 Table 6: Safety profile for Keppra XR in epilepsy