BIAL AND MEDIS ENTERED INTO A PARTNERSHIP FOR INNOVATIVE MEDICINES FOR THE CENTRAL NERVOUS SYSTEM

PORTO AND LJUBLJANA, 19 July 2021 – BIAL and Medis, d.o.o. announce that they have entered into an exclusive partnership on two BIAL's proprietary drugs: Zebinix^® (eslicarbazepine acetate) and Ongentys^® (opicapone).

The established partnership comprises an exclusive distribution agreement for Zebinix^® (eslicarbazepine acetate) in the Czech Republic and Slovakia and an exclusive distribution agreement for Ongentys^® (opicapone) in 12 CEE countries (Bosnia and Herzegovina, Bulgaria, Croatia, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, North Macedonia, Serbia, Slovakia, and Slovenia.)

“We are pleased to have Medis as our new partner. We believe this partnership is another important step for the extensive commercialisation of our innovative medicines. Medis shares our long-term vision and we look forward to bringing these important treatment options to patients in the CEE region,” said António Portela, Chief Executive Officer of BIAL.

“In Medis we are excited and proud to partner with BIAL and thus being able to provide two medicines which we firmly believe represent a much-needed relief to thousands of people in the region who suffer from Parkinson’s disease and epilepsy.” claimed Martina Perharic, Medis’ Chief Executive Officer.

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 life.¹

Parkinson's disease is a chronic, progressive neurodegenerative disorder characterized by a strong reduction of the neurotransmitter dopamine, caused by the degeneration of certain neurons in the brain. The European Parkinson's Disease Association (EPDA) estimates that approximately 1.2 million people in Europe suffer from this disease.

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About Ongentys^® (opicapone)

Opicapone is a once-daily, peripherally-acting, third-generation, highly-selective COMT inhibitor.²

Opicapone works by decreasing peripheral levodopa’s conversion rate into 3-O- methyldopa, thereby prolonging the duration of levodopa’s effect in reducing the OFF-time period of Parkinson’s disease and extending the ON-time period.^2-5

In June 2016, the European Commission authorized Ongentys^® (opicapone) as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations.²

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 has been implicated in the pathogenesis of epilepsy), preventing its return to the active state, and thereby reduces repetitive neuronal firing.^{6, 7}

Zebinix^® is a once-daily antiepileptic drug that is indicated as monotherapy in the treatment of partial-onset seizures, with or without secondary generalization, 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.⁸

About BIAL

Founded in 1924, BIAL's mission is to research, develop and provide therapeutic solutions within the area of health. Over the last decades, BIAL has focused strategically on quality, innovation and internationalization. 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 visit www.bial.com.

About Medis

Medis Pharmaceutical Company is the leading independent medical marketing company focused on commercialization of innovative pharmaceutical products, with emphasis on specialty drugs, medical equipment and self-care brands. Medis aims at making the most advanced and effective medical treatments accessible to every patient in the Central and Eastern Europe (CEE). Its fully owned subsidiaries across the CEE region are leveraging its marketing know-how, scientific expertise and product knowledge. It is headquartered in Ljubljana, Slovenia, founded in 1989, and employs more than 350 people. For more information about Medis visit www.medis.com

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 in June 2021

2- SmPC EU Ongentys^®. Available at: https://www.ema.europa.eu/en/documents/product-information/ongentys-epar-product-information_en.pdf. Last accessed in May 2021

3- Ferreira J., et al. Lancet Neurol. 2016 Feb;15(2):154-165

4- Ferreira J., et al. Neurology. 2018 May 22;90(21):e1849-e185

5- Lees A., et al. JAMA Neurol. 2017 Feb 1;74(2):197-206

6- 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

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

8- SmPC Zebinix^®, April 2020, available at https://www.ema.europa.eu/en/medicines/human/EPAR/zebinix#product-information-section. Last accessed in June 2021

For more information please contact:

BIAL

Susana Vasconcelos

E-mail: susana.vasconcelos@bial.com

Medis

Ziva Janez Visnar

E-mail: ziva.janez@medis.com