LONG-ACTING INJECTABLE HIV DRUG COMBINATION TECHNOLOGY
In December 2021, MPP and the University of Washington (UW) signed a licence agreement on a long-acting injectable (LAI) drug combination candidate that is being developed for use in HIV treatment, with support from Unitaid. The LAI formulation is enabled by UW’s drug combinations nanotechnology. Currently at a pre-clinical stage, the LAI developed by the Targeted, Long-acting and Combination Anti-Retroviral Therapy (TLC-ART) program based at UW, has the potential to transform the WHO-recommended daily oral dosage of TLD (tenofovir/lamivudine/dolutegravir) into a simple subcutaneous monthly injection. This LAI candidate, if proven safe, effective, and acceptable, could contribute to reducing pill burden, improving adherence for certain people, and reducing stigma associated with the necessity of taking daily pills.
The licence agreement covers all low- and middle-income countries and is royalty free in both public and private markets.
|Field||Prevention and/or treatment of HIV|
|Eligibility for sublicences||Sublicences can be issued to any qualified entity in any country of the world (for development and/or commercialisation)|
|Manufacturing||Allows manufacturing worldwide|
|Geographical scope for sale||Allows for sale in all LMICs. The licence contains a requirement of Affordable Price|
|Sales outside the licensed territory||Allowed if country issues compulsory license, or where the activity does not infringe a licensed patent granted and in force or rely upon licensed know-how|
|Royalties||Sublicences are royalty-free for all supplies to LMICs, in both public and private markets|
|Quality assurance||Products will comply with the following standards: WHO Prequalification Programme (PQ), Global Fund/ Unitaid Expert Review Panel (ERP), US FDA and/or another WHO Listed Regulatory Authority as agreed between MPP & sublicensee|
|Data exclusivity||MPP sublicensee will not seek and will waive, regulatory exclusivity in LMICs in relation to any data relating to licensed products.|
|Patent disclosure||Obligation for licensor to list licensed patents, also for improvements of LA.
A right to maintain and enforce them remains with licensor.
|Term||Until last licensed patent has expired, lapsed or has been invalidated|
|Grant back||Royalty-free, non-exclusive and sub-licensable licence over any Improvement|