The Swedish company develops drug-device combinations for precision dosing of oral solid medicines. Its platform is built around the Dosage Manager, a handheld device that allows the dose to be tailored to each patient’s needs.

Under the agreement, Adare will provide CDMO services for OnDosis’s lead US program, Imfocy. This extended-release oral pellet product contains mixed amphetamine salts for the treatment of ADHD and is delivered through the Dosage Manager to enable individualized dosing. The collaboration combines OnDosis’s precision-dosing technology with Adare’s end-to-end manufacturing capabilities for oral solid dosage forms, including experience with controlled-substance formulations. Adare also plans to offer the technology to other clients working in different indications.

“We are truly excited to take this important step and establish a commercial-scale manufacturing capability on US soil through this strategic partnership with Adare,” says Martin Olovsson, CEO and co-founder, OnDosis. “The Adare team has shown great spirit, capabilities, and drive to support OnDosis in the final steps to pivotal bioequivalence (BE) studies and subsequent 505(b)(2) submission for our lead product Imfocy, aimed at improving outcomes for patients treated for ADHD.”

“This program is a very innovative delivery solution that’s very much needed to serve diverse patient dosing requirements,” says Tom Sellig, CEO, Adare Pharma Solutions.

An AstraZeneca spin-off

OnDosis was founded in 2017 as a spin-off from AstraZeneca by AstraZeneca, GU Ventures, and entrepreneur Martin Olovsson. At an early stage, the idea was also supported by students in the Entrepreneurship in Life Sciences program at the Sahlgrenska Academy, University of Gothenburg, and by GU Project Accelerator, a subsidiary of GU Ventures. GU Ventures remains a shareholder in the company.

“It’s very positive that the company is now establishing commercial manufacturing capacity in the US while bringing its lead ADHD program closer to the market,” says Klementina Österberg, CEO, GU Ventures.