Expanding Access to Long-acting therapeutics
The field of long-acting (LA) therapeutics is emerging as the next frontier for healthcare management. By offering sustained and controlled release of medicines, LA technologies make it easier to administer the right dose of treatment, thus reducing the risk of taking medicine incorrectly and the associated increase in drug resistance. The LA therapeutics landscape is particularly dynamic as several stakeholders are joining efforts to accelerate the development of LA products. It includes funders, product development partnerships, industry, academia, civil society and patient groups, policy makers, as well as specialist consortia and working groups. Long-acting therapeutics are already blooming in the fields of contraception, harm reduction, diabetes and mental health, among others. The technologies include novel delivery systems, such as transdermal patches, implants, depots and intra-uterine devices.
In the coming years, biomedical innovations will see these new products developed for infectious diseases. An access plan is essential to make sure these new products are available at the same time to all who need them, including affordable and adapted options for those living in low- and middle-income countries (LMICs). To date, LMICs tend to lag behind when it comes access to new medicines. Long-acting therapeutics combine one or more active pharmaceutical ingredients formulated into a technology to deliver treatment or prophylaxis. This generally results in a complex multi-layered IP protection that complicates access to these LA options. The Medicines Patents Pool (MPP), with its proven model in voluntary licensing and IP-related facilitation is a natural player in this landscape. MPP is beginning to use its expertise in in- and out-licensing, identification of development and commercialisation partners, technological transfer facilitation, and advocacy within most active LA working groups to adopt global access guidelines, thus contributing to making these technologies available and affordable to everyone, everywhere.
MPP’s work in long-acting therapeutics includes:
- Comprehensive mapping of the long-acting space
- Reaching out to IP holders to ensure accelerated access to LA technologies in LMICs
- Building a user-friendly online repository of information on LA technologies with potential impact in LMICs, enabling information exchange and collaboration
- Developing a decision tree that shows the pathways and triggers that will allow us to start engaging in negotiations with patent holders
The long-acting exploratory phase
MPP’s LA exploratory phase started in July 2019. It aims to explore how the MPP model can be applied to LA technologies. The exploratory phase has been intricately connected to three Unitaid grants for long-acting projects that aim to accelerate the development of existing medicines into LA versions for preventing malaria and TB and treating HIV and hepatitis C. Intellectual property within these projects will be protected by patents that will be licensed to MPP. MPPs work in LA therapeutics will facilitate development, secure commercial partners and ensure that products become accessible where they are needed.
The three Unitaid investments where MPP will play a key role are:
- LONGEVITY project led by University of Liverpool, which will develop long-acting formulations of drugs for malaria and TB prevention, and a cure for hepatitis C.
- GLAD project led by the University of Washington, that will transform combination HIV pill regimens that contain the drug dolutegravir into an injectable that has a lasting effect of one to three months.
- IMPACT project led by MedinCell, which will develop a malaria prevention vector control tool that could be delivered sub-cutaneously for three months.