SK Life Science, Inc. Announces US Availability of XCOPRI® (cenobamate tablets) for the Treatment of Partial (Focal) Onset Seizures in Adults with Epilepsy
-          Arvelle Therapeutics has exclusive rights to develop and commercialize cenobamate in Europe 

Zug, Switzerland, 12 May 2020 - Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, today confirms
that SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., has now made XCOPRI® (cenobamate tablets) available by prescription in the US. XCOPRI® was recently approved by the US Food and Drug Administration (FDA) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures).

Arvelle Therapeutics licensed the exclusive rights to develop and commercialize cenobamate in Europe from SK Biopharmaceuticals and on 26 March 2020 announced that the European Medicines Agency (EMA) had accepted Arvelle’s marketing authorization application (MAA). Validation of the MAA confirms that the application is complete and marks the start of the assessment process.
Commenting on the news, Mark Altmeyer, President and CEO of Arvelle Therapeutics, said: “We welcome today’s important news and congratulate the team at SK life science on making XCOPRI available in the US. Approximately 40% of adult patients with epilepsy have inadequate control of seizures after treatment with two antiseizure medication regimens^1,2, making access to XCOPRI a significant treatment option for patients. It marks another important milestone in the development of cenobamate as we await a decision from the CHMP and continue to drive the necessary preparations to bring this potential treatment option to patients in Europe.”

Recognising the current challenges faced by the US healthcare system with COVID-19, SK life science is committed to launching XCOPRI® in a responsible way and is supporting healthcare providers virtually, leveraging a suite of digital tools to ensure they have an opportunity to gain important clinical and reimbursement information about XCOPRI®.

To help US based patients commence and continue their treatment program on XCOPRI®, SK life science has developed an extensive new patient access program called SK life science navigator. For more information about how the program can assist eligible US patients, visit www.SKLSINavigator.com. More information on XCOPRI® is available at www.XCOPRI.com and full details of the announcement from SK life science can be found here https://www.sklifescienceinc.com/pdf/SK-life-science-Announces-US-Availability-of-XCOPRI-for-the-Treatment-of-Partial-Onset-Seizures-in-Adults.pdf.

The efficacy and safety of XCOPRI® has been studied in global clinical trials, including two randomized, double-blind, placebo-controlled studies (Study 013 and Study 017) and a large, multi-centre, open-label safety study (Study 021). All three studies enrolled adults with uncontrolled focal-onset seizures, who were taking between one and three other antiseizure medications (ASMs). In the randomized studies, XCOPRI® demonstrated significant reductions in seizure frequency compared to placebo, and as many as one in five patients achieved zero seizures during the maintenance phase. The results of Study 017 were published in The Lancet Neurology in November 2019.

ENDS
For more information please contact:
Arvelle Therapeutics
Email: Juan.Vergez@arvelletx.com
Head of Marketing and Corporate Communications

Consilium Strategic Communications (international strategic communications)
Mary-Jane Elliott/Susan Stuart/Alex Harrison/Lindsey Neville
Email: arvelletherapeutics@consilium-comms.com
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 antiseizure medication, in the European market. Arvelle is headquartered in Switzerland and received start-up financing of $207.5 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 http://arvelletx.com.

About Cenobamate
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 US 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).

References:

1. Kwan P and Brodie MJ.  N Engl J Med. 2000;342(5):314-319.

2. Chen Z et al. JAMA Neurol. 2018 Mar 1;75(3):279-286.