Expanding Access to Long-acting Therapeutics in LMICs

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 achieve optimal dosing targets with less frequent administrations of treatment, thus offering support for smoother condition management.

Long-acting therapeutics are already blooming in the fields of contraception, harm reduction, diabetes and mental health, and the first products targeting infectious diseases prevention and treatment are already available in some markets. The technologies include an array of delivery systems for new drug formulations, such as transdermal patches, implants, depots, intra-uterine devices, some of which have versatile characteristics and could accommodate a range of medicines and more than one medicine at a time.

The LA therapeutics landscape is particularly dynamic as several stakeholders are joining efforts to accelerate the development of LA products in many health areas. It includes funders, product development partnerships, industry, academia, civil society and patient groups, policy makers, as well as specialist consortia and working groups.

A concerted access plan is essential to make sure these new products are available at the same time to all who need them globally, 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 to access to new health solutions, and the Medicines Patent Pool is putting efforts to reduce that lag as much as possible, in collaboration with key stakeholders.

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’s work in the long-acting therapeutics space includes:

• Voluntary licensing among other types of public-health oriented agreements with innovators and other stakeholders in the long-acting space to ensure accelerated access to LA technologies and their applications in LMICs

• Piloting of a free online database for long-acting technologies patents and licences with the objective of enabling information exchange and collaboration

• Synergising efforts in the LA space by advocating for the need of accessible products and technologies, facilitation of collaborations and support for active pharmaceutical ingredients sourcing through partners network where possible

The First Access-Oriented Licences for Long-Acting Technologies

As a proof of concept of the feasibility and relevance of early licensing in the long-acting space, MPP is working closely with three Unitaid grantees for long-acting projects that aim to accelerate the development of existing medicines into LA versions to prevent malaria and TB and treating HIV and hepatitis C.

Intellectual property within these projects will be protected by patents that are being licensed to MPP. MPP’s work in LA therapeutics will facilitate development, secure commercial partners and ensure that products become accessible and affordable where they are needed, in a timely manner.

The three Unitaid investments where MPP will play a key role are:

• LONGEVITY project led by University of Liverpool, which is developing long-acting injectable formulations of drugs for malaria and TB prevention, and a cure for hepatitis C. A licence for the outcome of this project was signed with Tandem Nano Ltd. in September 2021.

• GLAD project led by the University of Washington, that aims to transform HIV treatment oral combination regimens based on dolutegravir into an injectable that has a lasting effect of one to three months. A licence for the outcome of this project was signed with the University of Washington in December 2021.

• IMPACT project led by MedinCell, which will develop a malaria prevention vector control tool that could be delivered sub-cutaneously for three months to adults in high-risk areas.

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