• Arvelle Therapeutics International GmbH entered into a partnership with Arvato Systems for the serialization of “Cenobamate”, a potential anti-seizure investigational drug in Europe
• Arvelle set to implement the serialization solution "Arvato CSDB" in accordance to the pharmaceutical EU Falsified Medicines Directive (EU 2016/161)

(Arvato Systems) Gütersloh – Arvelle Therapeutics implements the proven and flexible serialization solution "Arvato CSDB" as a service to prepare for the distribution of "Cenobamate" in a counterfeit-proof manner in accordance with the EU Falsified Medicines Directive. Since February 9, 2019, the EU directive stipulates that, as of this cut-off date, prescription drugs may only be put into circulation if the packaging bears an individual serial number. The serial number can be used to verify the identity and authenticity of medicine and thus prevent counterfeit medicines from entering the legal supply chain.

Arvelle Therapeutics is going to use the IT solution from Arvato Systems to effectively supply the relevant business partners (contract manufacturers) with the necessary product-relevant serialization data and while feeding the data into the European central system (EU hub). This meets the requirements of the currently applicable EU Directive and makes the data available to all relevant stakeholders in the pharmaceutical distribution and supply chain, such as wholesalers, hospitals, and pharmacies. The drug packages from Arvelle Therapeutics can thus be checked for authenticity and integrity.

Arvelle Therapeutics is an emerging biopharmaceutical company focused on bringing innovative solutions to patients suffering from central nervous system (CNS) disorders. Arvelle is responsible for the development and commercialization of “Cenobamate”, an investigational antiepileptic drug, in the European market.

In order to reliably implement the comprehensive serialization project, Arvelle has chosen Arvato Systems as an expert in the field of anti-counterfeiting. Paolo Ragusa, Head of Supply Chain, Arvelle Therapeutics commented: “We are convinced that with Arvato Systems we can implement a robust solution to enable a secure and protected access to medicine for patients suffering from CNS disorders”.

Pascal Leppich, Manager Sales & Business Development at Arvato Systems, is also looking forward to the project: "I am very pleased that with Arvelle Therapeutics, we have been able to convince another international customer – and one of the most promising pharmaceutical start-ups in Europe – to use the Arvato CSDB. With our wealth of experience in global serialization, we will support Arvelle Therapeutics in meeting the complex requirements in Europe so that the company can concentrate on the successful market launch of Cenobamate and thus continue to focus on the patient".

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 about Arvelle Therapeutics and Cenobamate is available at http://arvelletx.com.