Durbin, part of Uniphar Group, has been appointed to design and implement a global Early Access Program (EAP) on behalf of Jazz Pharmaceuticals plc for a new medicine containing the active substance, solriamfetol, and known commercially as Sunosi®.
The therapy is approved in the European Union (EU) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).
A world-leading provider of EAPs, Durbin delivers innovative programs that allow patients with unmet medical needs to access therapies before they are approved or become commercially available.
Under the program, Jazz will partner with Durbin to make Sunosi available to patients meeting defined criteria. Access will be provided in response to unsolicited requests from clinical specialists on a named-patient basis, in accordance with local regulations.
Jazz made Sunosi commercially available in Germany on 15 May 2020 and will pursue rolling commercial launches across the EU. Partnering with Jazz, Durbin will use its specialist experience in the provision of EAPs to make Sunosi available in non-commercialised territories.
“At Jazz, we are committed to making our medicines available for those who need them,” said Samantha Pearce, Head of Europe & International, Jazz Pharmaceuticals. “Jazz and Durbin have a long-standing relationship and we’re looking forward to working with them to help enable people living with excessive daytime sleepiness as a result of OSA or narcolepsy have access to Sunosi through this program.”
Dan Piggott, managing director of Durbin, commented on the program, saying “We are pleased to be working in partnership once more with Jazz on a program that seeks to help people living with the effects of EDS related to OSA or narcolepsy. We have partnered with Jazz for over 10 years and this program is further confirmation of the value we have been able to deliver through such programs in that time.
“Following Durbin’s acquisition by Uniphar Group, we have invested significantly in digital platforms that support real-world data collection and global supply chain management, and that also enhance connectivity for multiple stakeholders.
“That, in turn, enables Durbin to design and implement programs that put patients’ needs first. It is clear Jazz shares our dedication to improving patients’ lives.”
Durbin is a specialist medical supplier distributing hard-to-find pharmaceuticals to 160 different countries. Durbin works in partnership with global pharmaceutical and biotech companies to provide Early Access Programs, including Named Patient Supply and Cohort Programs. The company has 25 years’ experience designing and implementing EAPs from concept and 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 and Payor negotiations to informing future study design.