BIAL, moksha8 partner to commercialize Eslicarbazepine Acetate in Brazil and Mexico

Epilepsy is one of the most common neurological diseases, affecting 70 million worldwide and up to 5 million people in Latin America – and the successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge. Up to 40% of patients with partial seizures do not achieve sustained seizure control with current treatments (1).There are many patients with epilepsy whose condition is difficult to treat with existing anti-epileptic drugs. Eslicarbazepine acetate is an add-on (adjunctive) therapy for adults with partial-onset seizures, with or without secondary generalization (where the seizure spreads to both sides of the brain).

"moksha8 is committed to providing the highest quality products to physicians and patients to improve the treatment of critical CNS indications," said Simba Gill, CEO of moksha8. "Epilepsy is a serious condition that not only affects the people who suffer from seizures, but also their family, caregivers and friends. We look forward to bringing eslicarbazepine acetate to Brazil and Mexico."

"Eslicarbazepine acetate developed by BIAL is the outcome of BIAL’s longstanding scientific commitment to CNS research and development and the desire to improve the quality of life in those patients with poor seizure control," commented Antonio Portela, CEO of BIAL. "We are pleased to be working with moksha8 in Brazil and Mexico as a high quality partner in two of the largest markets in Latin America."

The Latin America retail pharmaceutical market is estimated by IMS at USD $68 billion in 2013, growing at 12% CAGR to over USD $110 billion by 2017. Brazil is expected to be the fourth largest pharmaceutical market in the world by 2017.

Eslicarbazepine acetate was approved by the European Commission in 2009 based on data showing that it reduces seizure frequency and improves health-related quality of life and is commercialized in the European Union under the trade name Zebinix. Eslicarbazepine acetate was approved by the U.S., Food and Drug Administration (FDA), in November 2013 and is sold in the U.S. under the trade name APTIOM. Eslicarbazepine acetate does not yet have a marketing authorization in Brazil or Mexico.

Eslicarbazepine acetate is a once-daily, voltage-gated sodium channel blocker. It preferentially targets the inactivated state of the ion channel, preventing its return to the active state, and thereby reduces repetitive neuronal firing (2-4).

The EU approved file is based on efficacy and safety data from an initial proof-of concept phase II study (5) and four subsequent phase III randomized, placebo controlled studies in more than 1700 patients with refractory partial-onset seizures (6-11). These patients had a history of at least four partial-onset seizures per month despite treatment with up to three concomitant anti-epileptic drugs (6-11).

Over the 12-week maintenance period, eslicarbazepine acetate 800mg and 1200mg once-daily significantly reduced seizure frequency, and was significantly more effective than placebo (6-11). Long-term safety and maintenance of therapeutic effect was demonstrated in one-year open-label extensions of these studies (12, 13).

In the Phase III clinical trials adverse events mainly occurred during the first 6 weeks of treatment and the majority of patients experienced adverse events of mild to moderate intensity (6-11). After 6 weeks of treatment, there were no observed differences in the incidence of side effects between patients treated with eslicarbazepine acetate and the placebo group. Treatment-emergent adverse events affecting >10% of patients in the pivotal studies were dizziness and somnolence (2, 6-11).