Business Wire

BIAL Takes the Lead in Europe for the Commercialisation of Epilepsy Treatment, Zebinix ® (eslicarbazepine acetate), Expanding Neurology Footprint

Share

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 20184, 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

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Susana Vasconcelos
BIAL
susana.vasconcelos@bial.com

Chrissie Hartgill
Makara Health
Chrissie@makarahealth.com
+44 (0)7799 380 503

About Business Wire

Business Wire
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

EAG Expands Medical Device Testing Services with New Laboratory7.5.2021 17:22:00 CEST | Press release

EAG Laboratories is expanding its medical device testing capabilities with a new 20,000 square-foot laboratory located in St. Louis, Mo. The new laboratory is a bespoke design to support the requirements of the medical device industry. It increases EAG’s analytical capabilities, allows for improved turnaround times and helps meet evolving requirements from the FDA as well as the European Union Medical Device Regulations (MDR). Specialty features of the laboratory include: A cleanroom designed for particle isolation and identification A dedicated medical device polymer analysis laboratory State-of the-art instrumentation to support biocompatitility testing of ISO 10993-18 programs for medical devices and combination products EAG scientists have been investigating and resolving product failures for more than half a century and have a deep understanding of materials and testing procedures. The medical device laboratory expansion allows EAG to leverage that knowledge and apply it toward su

SoftServe Wins Learning and Development Honor at 2021 ATD Excellence in Practice Awards7.5.2021 13:00:00 CEST | Press release

SoftServe, a leading digital authority and consulting company, won the Excellence in Practice Award in the ‘Learning and Development’ category in the 2021 Association for Talent Development (ATD) Excellence in Practice Awards. SoftServe was recognized for its corporate learning hub, SoftServe University, which focuses on learning and development opportunities for associates, including the design and delivery of training. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210507005003/en/ Association for Talent Development logo. (Photo: Business Wire) “SoftServe is dedicated to creating a people-centric organization that allows associates to grow and develop professionally,” said Galyna Datsiv, AVP of Learning and Development at SoftServe. “Our corporate learning ecosystem within the integrated talent management framework enables us to reach SoftServe’s strategic business goals by ensuring associates are qualified and have the ex

Monument Assurance Belgium and Intégrale Reach Agreement for the Transfer of Intégrale's Entire Portfolio and Staff to MAB7.5.2021 12:26:00 CEST | Press release

Monument Assurance Belgium (“MAB”) and Intégrale have reached an agreement under which MAB will acquire the entire portfolio and all the staff of the insurance company Intégrale. This agreement follows a firm offer from MAB, which was considered by the provisional administrators appointed by the National Bank of Belgium (“NBB”) to be that which best meets the interests of Intégrale policyholders and staff. The transaction remains subject to the final approval of the NBB. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210507005270/en/ During the transition period, MAB and Intégrale will take all steps necessary to prepare for a seamless transfer for policyholders, brokers and staff. In the meantime, Intégrale's staff will continue to service policyholders and brokers as usual. In addition to the transfer of assets at the time of closing, MAB will offer an 18-month employment guarantee to all employees and, in addition, a 3-mo

The Metals Company Joins European Industry Alliances to Bolster Battery Supply Chain for the Clean Energy Transition7.5.2021 10:00:00 CEST | Press release

Today, The Metals Company (formerly DeepGreen), a developer of the world’s largest and highest-grade estimated source of battery metals, announced it has joined two of the European Union’s foremost industrial alliances—the European Raw Materials Alliance (ERMA) and the European Battery Alliance (EBA)—as the bloc advances its plans to become a global leader in the sustainable production of the batteries necessary to store clean energy and power electric vehicles (EVs). As a member of these industrial alliances, The Metals Company—which announced in March its plans to go public via a merger with the Sustainable Opportunities Acquisition Corporation (NYSE: SOAC)—brings a new, scalable source of battery metals to the table in the form of polymetallic nodules found unattached on the deep seafloor in the Pacific Ocean, which can help deliver upon their mandate for a diverse, reliable and responsible supply of critical minerals needed for low-carbon technologies. Under its Green Deal, the Eur

Morocco and UN Celebrate First-Ever International Argan Tree Day7.5.2021 08:30:00 CEST | Press release

Morocco and the United Nations will be marking the first-ever International Argan Tree Day on May 10th, 2021. The Argan tree, a tree specific to the Kingdom of Morocco, will thus be celebrated every year on May 10, as an intangible cultural heritage of humanity and ancestral source of sustainable development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210506005652/en/ February 22, 2021: The United Nations’ General Assembly adopted by consensus a resolution proclaiming May 10 of each year as the “International Argan Tree Day” (Photo: AETOSWire) The proclamation of the International Argan Tree Day was announced on March 3, 2021, when the UN General Assembly adopted by consensus a draft resolution initiated by Morocco and hailed by all United Nations’ member states. This milestone is a culmination of Morocco’s quest to mobilize the international community to protect and further develop the country’s Argan industry. It is al

Tigo Energy Demonstrates Optimization to Installers in Brazil with Stark Renováveis Installation7.5.2021 02:14:00 CEST | Press release

Tigo Energy, Inc., the solar industry’s leading Flex MLPE (Module Level Power Electronics) supplier, announced today that Stark Renováveis has used the Tigo TS4-A-O to mitigate energy lost due to shade on their corporate headquarters in São José do Rio Preto, Brazil. Their confidence in Tigo’s solution drove the selection of the products for their own use. The Tigo solution gives installers and commercial system owners the freedom to choose their preferred inverters and panels along with the right features for optimized, monitored and PV safe systems. The Stark Renováveis team chose a rooftop PV system with 405 Wp modules organized in multiple strings and using GoodWeTM grid-tied inverters. The optimum placement of the modules was on a roof bordering a large construction wall which would ordinarily lead to shade and a degradation of the output. To mitigate the problem of energy lost due to shade, Tigo TS4-A-O optimizers were deployed to ensure the best possible system performance. "As

93 rd Vifor Pharma Group Annual General Meeting6.5.2021 18:00:00 CEST | Press release

Regulatory News: At today’s 93rd Annual General Meeting of Vifor Pharma Ltd., shareholders approved all proposed resolutions put forward by the Board of Directors. In view of the ongoing COVID-19 pandemic and in accordance with Ordinance 3 on measures to combat the coronavirus issued by the Swiss Federal Council, on the basis of Art. 8 of the new COVID-19 Act, shareholders were not permitted to attend the event in person. Shareholders exercised their rights exclusively through the independent proxy and 61.6% of the share capital was represented. Shareholder approvals Shareholders approved the Annual Report and the Annual Financial Statements of Vifor Pharma Ltd., as well as the consolidated Financial Statements of Vifor Pharma Group for 2020 by a large majority. The maximum possible 2022 remuneration for the Board of Directors and Executive Committee was also approved, as well as the 2020 Remuneration Report in a consultative vote. In addition, shareholders discharged the members of th

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