Zug, Switzerland, 17 August 2020 – Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, is pleased to announce a collaboration with Durbin Group (Durbin), a specialist pharmaceutical supplier, for the distribution of cenobamate through a Managed Access Program (MAP). Through the MAP patients with drug-resistant focal onset seizures, with a physician-assessed clinical need, may be eligible to receive treatment with cenobamate prior to its commercial availability.
Commenting on the partnership, Ilise Lombardo MD, Co-Founder and Chief Medical Officer at Arvelle Therapeutics, said: “Over the past months we have received requests by European epileptologists with requests for access to cenobamate, indicating a high unmet need. As a result of increasing requests, we have selected a partner with extensive pan-European experience and regulatory expertise to support us with the MAP distribution. We are very pleased to partner with Durbin on this program.”
More information on the MAP can be found on Arvelle’s website at www.arvelletx.com
For more information please contact:
Head of Marketing and Corporate Communications
Consilum Strategic Communications (international strategic communications)
Mary-Jane Elliott/Susan Stuart/Alex Harrison/Lindsey Neville
Telephone: +44 (0)20 3709 5700
About Arvelle Therapeutics
Arvelle Therapeutics is an emerging biopharmaceutical company focused on bringing innovative solutions to patients suffering from CNS disorders. Arvelle is responsible for the development and commercialization of cenobamate, an investigational antiepileptic drug, in the European market. Arvelle is headquartered in Switzerland and received start-up financing of $207.8 million, one of the largest initial financing commitments for a European-focused biopharmaceutical company, with investments from a global syndicate including NovaQuest Capital Management, BRV Capital Management, LSP, H.I.G. BioHealth Partners, Andera Partners, F-Prime Capital and KB Investments. More information is available at www.arvelletx.com.
Durbin is one of the world’s leading specialist medical suppliers and an integral part of Uniphar Group’s Product Access division. Durbin works in partnership with global Pharmaceutical and Biotech companies providing Expanded Access Programs, including Named Patient Supply and Clinical Trial Supply goods in over 160 countries. More information is available at: http://www.durbinglobal.com/
Cenobamate was discovered by SK Biopharmaceuticals and SK life science and is a new FDA-approved antiseizure medication (ASM) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures). Cenobamate has been approved in the U.S. where it is commercially available under the trademark XCOPRI®. In early 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics to develop and commercialize cenobamate in Europe.
Cenobamate is believed to work through a unique, dual, complementary mechanism of action: Enhancing inhibitory currents through positive modulation of GABAA receptors at a non-benzodiazepine binding site, and decreasing excitatory currents by both inhibiting the persistent sodium current and enhancing the inactivated state of voltage-gated sodium channels.
Long term data of cenobamate is being further studied in the open-label extensions of the double-blind placebo control trials as well as the open-label safety study in adults with focal-onset seizures. Additionally, cenobamate is being assessed in an ongoing randomized, double-blind, placebo-controlled trial evaluating its safety and efficacy as adjunctive therapy in patients with primary generalized tonic-clonic seizures (NCT03678753).