Innovative CNS medicines partnership announced

Bial and Medis have partnered on two of Bial’s proprietary drugs: Zebinix (eslicarbazepine acetate) and Ongentys (opicapone).

The established partnership comprises an exclusive distribution agreement for Zebinix in the Czech Republic and Slovakia and an exclusive distribution agreement for Ongentys in 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.” said Martina Perharic, Medis’ Chief Executive Officer.

Opicapone is a once-daily, peripherally-acting, third-generation, highly-selective COMT inhibitor.² In June 2016, the European Commission authorised Ongentys 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 stabilised on those combinations.² Zebinix is a once-daily antiepileptic drug that 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 six years, with partial-onset seizures with or without secondary generalisation.⁸

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