TLC-ART Program

December 9, 2021

TLC-ART and MPP sign a licence agreement for a long-acting injectable candidate for HIV

9 December 2021

Geneva and Washington – Thanks to a licence agreement announced today between the Medicines Patent Pool (MPP) and the University of Washington (UW) through CoMotion, people living with HIV in low- and middle-income countries (LMICs) might, one day, be able to get a monthly injection that will offer an alternative method of delivery to existing oral therapies.

The licence covers the patents and expertise relating to 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 combination 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 fixed-dose combination of tenofovir, lamivudine and dolutegravir (known as TLD), in its oral form, is the preferred WHO-recommended first-line regimen for HIV treatment.  Thanks to our licensing agreements with ViiV Healthcare and the work of our partners, around 10 billion doses of dolutegravir-based products had been distributed at affordable prices in LMICs by the end of 2020,” said Charles Gore, Executive Director of MPP. “The LAI being developed by UW offers an exciting new avenue for HIV treatment which could complement our current efforts. We are very proud to be partnering with UW and Unitaid through the GLAD project to ensure these innovations, if proven safe and effective, are available in LMICs as soon as possible.”

28.2 million people worldwide are currently on antiretroviral therapy.  Streamlining antiretroviral treatment could simplify treatment for people living with HIV and help them stay on antiretroviral therapy, which keeps the virus suppressed and prevents the risk of transmission and further infections.

“Long-acting technologies are the next frontier for sustained suppression of HIV worldwide, and we are delighted to sign this licence agreement to ensure our innovation, if proven effective and safe, will be made available in LMICs,” said Prof. Rodney Ho, Director of the TLC-ART program and the GLAD project at UW’s Department of Pharmaceutics. “UW’s three-drug combination in one injection is based on a drug-combination nano-particle platform (DcNP) technology which allows up to four drugs to be integrated into a single injectable suspension and can be scaled up for generic manufacturing production, thus ticking all the boxes for effective, easy to administer, affordable access in LMICs.”

“A long-acting alternative to HIV treatment could free patients from daily pills, make it easier to start and stay on medicines and reduce the burden on health systems. Unitaid is proud to support efforts that we hope will provide additional options, reach more people and contribute to achieving the UN goal that 95% of all people who know their HIV status receive treatment,” said Dr Philippe Duneton, Executive Director of Unitaid.

The licence agreement covers all low- and middle-income countries and is royalty free in both public and private markets.

More information on the licence agreement

More information on MPP’s work in long-acting therapeutics

About MPP:

The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders, to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with 13 patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, two long-acting technologies, two experimental oral antiviral treatments for COVID-19 and a COVID-19 serological antibody diagnostic test. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government and SDC. More information at https://medicinespatentpool.org/ and follow us on TwitterLinkedIn and YouTube.

About UW and CoMotion:

The University of Washington was founded in 1861 and is one of the preeminent public higher education and research institutions in the world. The UW has more than 150 members of the National Academies, elite programs in many fields, and annual standing since 1974 among the top five universities in receipt of federal research funding. Learn more at uw.edu

CoMotion at the University of Washington partners with the UW community on their innovation journey, providing tools, connections, and acumen to transform ideas into economic and societal impact. Find more information at https://comotion.uw.edu

MPP media contact

Sophie Thievenaz

press@medicinespatentpool.org

UW media contact

Jake Ellison

jbe3@uw.edu