BIAL

Press Release for European Medical and Trade Media Only

BIAL announces the end of the licence agreement established in 2009. BIAL takes the lead for the marketing and distribution of Zebinix^® (eslicarbazepine acetate) in Europe. Eslicarbazepine acetate is a once-daily anti-epileptic used to treat epilepsy patients with focal seizures (partial-onset seizures)

For over a decade, BIAL and Eisai have had an agreement in place for Eisai to market, promote, and distribute eslicarbazepine acetate in Europe. Following the end of this partnership, BIAL will take the lead for the ongoing marketing, promotion and distribution in Europe. This move reinforces its continued commitment to and ongoing investment in neurological conditions.

BIAL has over 10 years of experience of delivering life-improving medicines for neurological conditions such as epilepsy and Parkinson’s disease. Eslicarbazepine acetate was the first medicine discovered and developed by BIAL. Epilepsy has a high prevalence with 6 million people affected in Europe and 15 million Europeans estimated to experience a seizure at some time in their life¹ . Each month over 90,000 people with epilepsy around the world benefit from eslicarbazepine acetate to meet their treatment needs.

BIAL has worked closely with the relevant organisations from around Europe to put in place all the supply, quality and pharmacovigilance processes that are needed to ensure a seamless transition for both healthcare professionals and patients. All required drug safety and medicine continuity measures have been secured to ensure an uninterrupted treatment supply for all those who need it.

“Following a constructive partnership with Eisai, we are excited to be taking the lead on the commercialisation of eslicarbazepine acetate in Europe”, stated José Almeida Bastos, Chief Commercial Officer of BIAL. “It was the first medicine to be developed through BIAL’s own research and is a valuable part of our portfolio as we continue to expand into new territories, building on our established heritage and making life better for all those affected by epilepsy .”

Neil West, Vice President EMEA, Global Neurology Business Unit from Eisai, also commented, “We have enjoyed working alongside BIAL, providing our extensive commercialisation experience for the marketing and distribution of this important treatment. We believe eslicarbazepine acetate has made a real difference to patients’ lives during this period and are proud of our contribution. ”

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About Zebinix^® (eslicarbazepine acetate)

Eslicarbazepine acetate is a voltage-gated sodium channel blocker. It selectively targets the slow inactivated state of the sodium ion channel (which have been implicated in the pathogenesis of epilepsy), preventing its return to the active state, and thereby reduces repetitive neuronal firing.^2,3

Zebinix^® is indicated as monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and also as adjunctive therapy in patients aged above 6 years, with partial-onset seizures with or without secondary generalisation.⁴

The efficacy and safety of Zebinix^® when used as adjunctive therapy have been shown in clinical data from four Phase III multi-centre, randomized, double-blind, placebo-controlled trials (BIA -2093- 301, 302, 303 and 304), that included more than 1,300 patients with refractory partial-onset seizures.^5-8 On the other hand, the efficacy and safety of Zebinix^® as monotherapy have been demonstrated in a phase III, randomized, double-blind, noninferiority, active controlled (carbamazepine-CR) study (BIA-2093-311), involving 815 randomized adult patients with newly diagnosed partial-onset seizures.⁹

About Epilepsy

Around 50 million people in the world have epilepsy. It is the most common serious neurological condition.¹ It affects people of all ages, sexes, races and geographical locations.¹⁰ Access to antiseizure medications offers the potential for approximately 70% of people with epilepsy to live seizure free, with an opportunity to impact their quality of life.¹⁰

Epilepsy is a neurological disorder that is characterized by an enduring predisposition to generate epileptic seizures and the associated cognitive, psychological and social consequences. An epileptic seizure is a transient behavioural change that might be objective signs or subjective symptoms caused by abnormal excessive or synchronous neuronal activity in the brain.¹¹

The majority of people with epilepsy have a good prognosis. The prognosis is strongly influenced by the underlying cause. In many people, particularly children, the condition will remit, although a substantial proportion will have epilepsy all their lives. Overall, 60-70% of patients become seizure free after treatment with antiepileptic drugs, and some patients can remain in remission after subsequent drug withdrawal.¹² The other 30-40% continue to have seizures with varying degrees of frequency and severity (refractory epilepsy).¹²

About BIAL

Founded in 1924, BIAL's mission is to research, develop and provide therapeutic solutions within the area of health. In the last few decades, BIAL has focused strategically on quality, innovation and internationalisation.

BIAL is strongly committed to therapeutic innovation, investing more than 20% of its annual turnover into research and development within neurosciences and the cardiovascular system. The company expects to introduce new drugs on the market in the coming years, strengthening its international presence based on proprietary drugs and achieving its goal of supplying innovative products to patients worldwide.

For more information on BIAL: www.bial.com

For more information on Zebinix^® : https://www.ema.europa.eu/en/medicines/human/EPAR/zebinix#product-information-section

References

1- Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. WHO report. Available at https://www.who.int/mental_health/neurology/epilepsy/euro_report.pdf. Last Accessed January 2021

2- Hebeisen S, et al. Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: a comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology 2015; 89:122-35

3- Vilin YY; Ruben PC, Slow inactivation in voltage-gated sodium channels: molecular substrates and contributions to channelopathies. Cell Biochem Biophys 2001; 35:171–90

4- SmPC Zebinix^® 2020, last accessed in January 2021

5- Elger C, et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial onset seizures: A randomised, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia. 2009; 50:454-63

6- Ben-Menachem E, et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010;89(2-3):278-85

7- Gil-Nagel A, et al. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurol Scand. 2009; 120:281-87

8- Sperling MR et al. Eslicarbazepine acetate as adjunctive therapy in patients with uncontrolled partial-onset seizures: Results of a phase III, double-blind, randomized, placebo-controlled trial. Epilepsy. 2015 56(2): 244-253

9- Trinka et al. Efficacy and safety of eslicarbazepine acetate versus controlled release carbamazepine monotherapy in newly diagnosed epilepsy: A phase III double-blind, randomized, parallel-group, multicenter study, Epilepsia. 2018;59:479–491

10- Epilepsy: a public health imperative, World Health Organization Report 2019. Available at https://www.who.int/news-room/fact-sheets/detail/epilepsy. Last accessed January 2021

11- Devinsky, O., Vezzani, A., O'Brien, T. et al. Epilepsy. Nat Rev Dis Primers 2018 4, 18024. https://doi.org/10.1038/nrdp.2018.24

12- Brodie MJ, Kwan P, Schachter SC. Fast Facts: Epilepsy. 3rd edition. Oxford (UK): Health Press Limited; 2005

Job code ZB/FEB21/G/029

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