Durbin to run pan-European Managed Access Program for new epilepsy drug
Durbin, has been appointed to design and implement a Europe-wide Managed Access Program (MAP) for a new investigational anti-seizure medication known as cenobamate.
Durbin to run pan-European Managed Access Program for new epilepsy drug
Durbin, a specialist pharmaceutical supply and distribution business under the Uniphar Group umbrella, has been appointed to design and implement a Europe-wide Managed Access Program (MAP) for a new investigational anti-seizure medication known as cenobamate.
A world-leading provider of MAPs, Durbin delivers innovative programs that allow patients with unmet medical needs to access therapies before they are approved or become commercially available.
Durbin will collaborate on the program with Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from central nervous system disorders. In 2019, Arvelle Therapeutics entered an exclusive licensing agreement with SK Biopharmaceuticals to develop and commercialize cenobamate in Europe.
Through the MAP, patients suffering from drug-resistant focal onset seizures who have a physician-assessed clinical need will receive the product prior to its commercial availability. Access will be provided in response to unsolicited requests from clinical specialists on an individual named-patient basis, in accordance with local and international regulations.
Dan Piggott, managing director of Durbin, said of the collaboration, “This product shows real potential to improve the quality of life of people across Europe living with uncontrolled seizures, so we are privileged to partner with Arvelle Therapeutics on the project.
”We have made significant recent investments in digital platforms at both the business unit and Uniphar Group levels that allow us to add value to such programs with real-world data collection, stakeholder connectivity and a streamlined global supply chain.
“With those optimizations in place, our teams our well-equipped to design and manage programs that put the patients’ needs and wellbeing front and centre. That is a goal we know both Arvelle Therapeutics and Durbin share.”
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.”
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®.
The medicine was also designated by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) on 11 August as a Promising Innovative Medicine (PIM) for the treatment of drug-resistant focal-onset seizures in adults.
People with uncontrolled seizures have higher morbidity and mortality rates and often experience comorbid illnesses, social stigmatisation, psychological dysfunction and reduced quality of life.
Whilst reduction in seizure frequency brings benefits to patients, seizure freedom is the treatment outcome that has the unique potential to impact the disease burden associated with epilepsy significantly.
As a once-a-day tablet, cenobamate has been studied in over 2,500 subjects, including more than 1,900 patients across the two phase 2 and one phase 3 trials. Seizure freedom rates seen in the double-blind placebo controlled pivotal studies of adult patients with drug-resistant focal onset seizures who were administered cenobamate as an adjunctive therapy have exceeded existing supportive care.
More information on the MAP can be found on Arvelle’s website at www.arvelletx.com
About Cenobamate
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).
About Durbin
Durbin is a specialist pharmaceutical supplier distributing pharmaceuticals to 160 different countries. Durbin works in partnership with global Pharmaceutical and Biotech companies providing Expanded Access Programs, including Named Patient Supply and Clinical Trial Supply goods.
The company has 25 years’ experience designing and implementing MAPs from concept. The business specialises in developing robust and compliant voluntary data collection initiatives that run seamlessly alongside the programs they manage.
Those initiatives help partners capture real-world insights from outside the clinical trial environment that can then have a variety of potential uses, ranging from Regulatory/Payor negotiations to informing future study design.
For more information, please visit http://www.durbinglobal.com/.
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 http://arvelletx.com.