Indivior PLC announced that it has gained exclusive global rights to develop, manufacture, and commercialize Alar Pharmaceuticals Inc.'s (Alar) portfolio of long-acting injectable formulations that release a prodrug1 of buprenorphine at varying durations, including its lead long-acting injectable (LAI) candidate, ALA-1000. ALA-1000 is a sustained-release LAI prodrug of buprenorphine. With dosage intervals of potentially up to four times per year, ALA-1000 could address unmet opioid use disorder (OUD) patient needs with a longer duration of treatment, which could provide an option for patients seeking a less frequent maintenance therapy regimen, for patients living in remote areas without easy access to care, and for high-risk patients, such as those transitioning from the Justice system.

Under the agreement with Alar, Indivior will pay $10 million to secure exclusive global rights (except in China, Hong Kong, Taiwan and Macau) to develop, manufacture and commercialize ALA-1000 and Alar's future buprenorphine-based LAI product candidates. The $10 million payment is in addition to an initial $5 million option payment made by Indivior to Alar in First Quarter. Alar is entitled to potential milestone payments if various development, regulatory, and commercial goals are achieved.

ALA-1000 is an investigational drug and is positioned to be the first three-month buprenorphine administered subcutaneously entering the clinical stage. Results from a single-ascending dose (SAD) study, announced by Alar in January 2022, demonstrated the safety, tolerability and sustained release profile of ALA-1000 over 12 weeks in patients with OUD. Alar has been granted composition of matter and formulation patents for ALA-1000 covering sustained-release buprenorphine formulations with expiry in 2037 and 2039.