BIAL
18.2.2021 01:03:05 CET | Business Wire | Press release
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. ”
###
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20210217005821/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
First Plus Expands Relationship with SS&C to Support Cross-Border Operations in APAC3.8.2026 03:00:00 CEST | Press release
SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced that First Plus Asset Management (FPAM), a multi-asset investment management firm, has selected SS&C to provide cross-border operations support across Asia. SS&C will service First Plus across the full investment lifecycle, delivering a scalable, integrated solution supporting transfer agency, order management and execution and investment accounting. FPAM will utilize SS&C to service its growing cross-border operating model and support around $200 million in assets under management*. “As First Plus has expanded, managing our operations has become increasingly complex,” said Jeb Li, Co-Founder and CEO at First Plus. “SS&C’s global footprint and integrated offerings enable us to easily optimize our workflows, so we can focus on scaling quickly and securely while continuing to deliver risk-adjusted returns and best-in-class client service.” The engagement highlights the breadth and scalability of SS&C’s global service model.
Europe’s Largest Celebration of Irish Culture Arrives in Belfast2.8.2026 10:01:00 CEST | Press release
Fleadh Cheoil na hÉireann arrives in Belfast today (2 August), bringing eight days of traditional music, culture and celebration to the city, with organisers expecting up to 800,000 visitors over the course of the festival. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260729147569/en/ Belfast Fleadh - Maddens Bar accordian, guitar and fiddle player (Chris Heaney) One of Europe’s largest cultural events, Fleadh Cheoil na hÉireann is taking place in Belfast for the first time, transforming the city into a vibrant stage for Irish music, dance, language and culture. More than 200 events and 180 traditional music competitions are taking place across venues, streets and neighbourhoods throughout the week-long celebration. The landmark festival showcases the very best of Irish culture, with a packed programme of All-Ireland competitions, concerts, community events and performances from both established and emerging artists. As Ir
2PointZero Group Signals Global Scale With Revenue Surge to AED 21.9 Billion and Net Profit of AED 7.7 Billion in H1 202631.7.2026 13:42:00 CEST | Press release
Group revenue growth supported by stable gross profit margin of 29%, and adjusted EBITDA of AED 5.0 billionGlobal expansion milestones include the completed sale of TAQA stake, and the acquisition of Traverse Midstream Partners in North America, Baobab Group in Africa, and 60.8% of ISEM in ItalyTIME ranks the Group 36th on the World’s Growth Leaders list for 2026, highlighting market stability, operational scale and disciplined approach to capital 2PointZero Group (ADX: 2POINTZERO), a leading Abu Dhabi-based investment holding firm, announced its financial results for the first half of 2026, reporting revenue of AED 21.9 billion and delivering a Group Net Profit of AED 7.7 billion. This robust performance is reflected in the Group’s adjusted EBITDA, which reached AED 5.0 billion after excluding fair value changes and one-offs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260731538982/en/ Samia Bouazza, CEO of 2PointZero (P
Datroway® Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy31.7.2026 08:30:00 CEST | Press release
Approval based on TROPION-Breast02 phase 3 trial results where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival Datroway now approved for two breast cancer indications in the EU Datroway® (datopotamab deruxtecan) has been approved in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The approval by the European Commission follows the positive opinionof the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on result
Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate31.7.2026 08:30:00 CEST | Press release
Polpharma Biologics International AG today announces that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda’s reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. The BLA and MAA acceptances represent significant milestones in Polpharma Biologics' development program and underscore the company's commitment to advancing high-quality biosimilars and expanding global access to affordable biologic medicines. "FDA and EMA acceptances for review of our IV vedolizumab biosimilar candidate mark a major achievement for Polpharma Biologics and validate our deep scientific expertise in biosimilar development and manufacturing," said
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom