OnDosis AB ("OnDosis"), a Swedish life science company developing drug device combinations for precision dosing of oral solid medicines based on the Dosage Manager device platform, and Adare Pharma Solutions ("Adare"), a technology-driven, integrated contract development and manufacturing organization (CDMO), today announced a strategic collaboration. Under the agreement, Adare will provide CDMO services to support the progression of OnDosis' lead program for the US: an extended-release oral pellet product containing mixed amphetamine salts, developed for the treatment of ADHD and delivered through OnDosis' Dosage Manager platform to enable individualized dosing.
The collaboration brings together OnDosis' precision-dosing device technology with Adare's end-to-end oral solid dosage form manufacturing capabilities, including experience with controlled-substance formulations, to support the program's development for the US market.
In addition to supporting the OnDosis program, Adare plans make this innovative offering available to additional clients working with different indications, enabling a new and better precision dosing technology to serve more patients across multiple markets.
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, The Adare team have showed 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."
Martin Olovsson, CEO and Co-Founder, OnDosis
"This program is a very innovative delivery solution that's very much needed to serve diverse patient dosing requirements," commented Tom Sellig, CEO, Adare Pharma Solutions. "Adare is dedicated to helping develop better treatments with expert application of advanced client-centric drug delivery technologies and we are honored to apply these skills to help OnDosis advance this program to patients as well as to bring this technology to other clients whose programs need better precision and flexibility for their patients."