UCB has initiated a Phase III clinical program for brivaracetam as an adjunctive treatment in partial-onset epilepsy. Should it perform well here and gain marketing approval, the launch of this drug would serve to strengthen UCB’s epilepsy franchise, as well as potentially representing an important treatment option for patients with refractory epilepsy.
Brivaracetam’s Phase III clinical program consists of three multicenter, multinational trials and will involve almost 1,300 epilepsy patients aged between 16 and 70. Two trials are designed to evaluate the efficacy of brivaracetam (5, 20 and 50mg/day or 20, 50 and 100mg/day) over 12 weeks in patients with partial onset epilepsy that remains uncontrolled despite treatment with one or two anticonvulsant drugs.
A third trial is designed to evaluate the efficacy and safety of brivaracetam in patients with uncontrolled partial onset or generalized seizures. UCB anticipates first results of this program in Q3 2009 and has proposed Rikelta as the brand name for the drug.
Brivaracetam is an analog of the company’s flagship epilepsy drug, Keppra (levetiracetam), which leads the market with epilepsy-specific sales of $807 million in 2006. UCB’s development of brivaracetam and the presence of Vimpat (lacosamide) in its epilepsy pipeline is a clear demonstration of the company’s commitment to this disorder and its intention to build a strong epilepsy franchise.
Despite the launch of several anticonvulsant drugs over the past decade, approximately 20% to 30% of patients continue to suffer from uncontrolled seizures (refractory epilepsy), which may lead to serious consequences, including diminished cognition. If brivaracetam’s ongoing trials demonstrate efficacy in treating this patient group, the drug will go some way to improving the quality of life for a substantial number of epilepsy patients, and can expect to receive strong uptake in patients unresponsive to Keppra.
International epilepsy opinion leaders interviewed by Datamonitor were positive about brivaracetam’s prospects and UCB’s established relations with neurologists will bode well for the drug’s launch. On account of UCB’s well-established presence in the epilepsy market, as well as brivaracetam’s promising Phase IIb data and long patent life, Datamonitor forecasts sales of brivaracetam to reach $502 million by 2015 and successfully offset generic erosion of Keppra from 2009 onwards. Therefore, despite the anticipated launch of five anticonvulsants before the end of 2011, brivaracetam will play a key role in maintaining UCB’s leading position in the epilepsy market in the future.
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