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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.

Since 2019, MPP is leveraging its expertise in in- and out-licensing, identification of development and commercialisation partners, technology 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 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



Access MPP’s licence agreements



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


Know more about LAPaL, MPP’s long-acting technologies patents and licences database


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



Know more about MPP’s activities to foster access to LA technologies in LMICs


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.

These licences represent a milestone as first ever access-oriented agreements for long-acting technologies, specifically tailored for expanded access to infectious diseases life-saving commodities

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.


Access the Tandem Nano-MPP licence


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.


Access the UoW-MPP licence


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.


Access the MedinCell-MPP licence

Related Events & Reports

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                            [post_date] => 2023-07-13 13:02:21
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The Journal of the International AIDS Society (JIAS) supplement,“Advancing use of long-acting and extended delivery (LAED) HIV prevention and treatment regimens” published a paper by Medicines Patent Pool co-authors on voluntary licensing of long-acting HIV prevention and treatment regimens: using a proven collaboration- and competition-based mechanism to rapidly expand at-scale, sustainable, quality-assured and affordable supplies in LMICs.
Click Here To Access The Paper

The JIAS commentary explained how emerging long-acting (LA) prevention and treatment medicines, technologies and regimens could be game-changing for the HIV response, helping reach the ambitious goal of halting the epidemic by 2030. To attain this goal, the rapid expansion of at-scale, sustainable, quality-assured, and affordable supplies of LA HIV prevention and treatment products through accelerated and stronger competition, involving both originator and generic companies, will be essential.


"To do this, global health stakeholders should take advantage of voluntary licensing of intellectual property (IP) rights, such as through the UN-backed, not-for-profit Medicines Patent Pool, as a proven mechanism to support broad access to existing HIV medicines across low- and middle-income countries (LMICs)." shared MPP co-authors, Lobna Gaayeb, Aditi Das, Ike James, Rajesh Murthy, Sandra Nobre, Esteban Burrone, Sébastien Morin

[embed]https://youtu.be/h57gXs4aQtg[/embed]


The paper discusses 10 enablers of voluntary licensing of IP rights as a model to rapidly expand at-scale, sustainable, quality-assured, and affordable supplies of LA HIV prevention and treatment regimens in LMICs:
1. Identifying promising LA technology platforms and drug formulations at an early developmental stage and engaging with patent holders
2. Consolidating a multidisciplinary network and strengthening early-stage coordination and collaboration to foster innovation
3. Embedding public health considerations in product design and delivery
4. Building innovative partnerships for product development and commercialization
5. Raising awareness of and creating demand for emerging LA products
6. Estimating the market size, ensuring sufficient competition and protecting sustainability
7. Using technology transfer and hands-on technical support to reduce product development timelines and costs
8. Exploring de-risking mechanisms and financial incentives to support generic manufacturers
9. Optimizing strategies for generic product development and regulatory filings
10. Aligning and coordinating efforts of stakeholders across the value chain.
Discover Our Long-Acting Therapeutics Patents and Licences Database(LAPaL)
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Paving the way to access to long-acting technologies
On 9 December, the Medicines Patent Pool held an online satellite symposium at ICASA entitled "Paving the way to access to long-acting technologies". With the recent signing of the first MPP long-acting technologies voluntary licence, what should we consider in order to enhance access to long-acting therapeutics for HIV prevention and treatment, and why is it critical to anticipate potential access hurdles as early as possible?

Opening remarks were made by Lobna Gayeeb from MPP. She announced a licence agreement between MPP and the University of Washington for an investigational long-acting injectable drug combination candidate for HIV. Cherise Scott from Unitaid announced the launch of a landscape report on novel technologies for the prevention of HIV, STIs, and unwanted pregnancy.

A panel discussion followed with questions to:

 	
Prof. Quarraisha Abdool Karim, CAPRISA
 	
Dr. N Kumarasamy, Clinton Health Access Initiative
 	
Yves Kugbe, Long-Acting Technologies Community Advisory Board
 	
Siobhan Crowley, The Global Fund

Sandra Nobre from MPP made concluding remarks.

Download the flyer

Download the presentation
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                            [post_content] => The Long-Acting/Extended Release (LA/ER) Antiretroviral Research Resource Program (LEAP) pre-CROI Investigator Meeting and Annual Workshop was held virtually on Friday 5 March 2021, with the objective to discuss the recent advances in the long-acting field, novel applications and related approaches for the treatment and prevention of HIV, viral hepatitis and tuberculosis.

The Medicines Patent Pool (MPP) was invited to address some of the access issues that long-acting technologies and their formulations may face in low- and middle-income countries (LMICs), and to propose possible interventions to overcome this bottleneck.

MPP is working towards fostering development and broadening access to long-acting technologies in order to facilitate access to these ground-breaking therapeutics by:

 	
Negotiating public-health driven licences with technologies patent owners, ensuring maximum access to their inventions in LMICs;
 	
Encouraging patent owners to commit to a set of access principles to facilitate collaborations in the long-acting space towards accelerated access to quality and effective products with impact for global health;
 	
Sharing information and catalysing matches through the collaborative creation of an online database for long-acting technologies called “LA PaL”, regularly updated with technology platforms, technical profiles, and an overview of their patent and licences landscape.

 
You can access a recording of MPP’s presentation on the LEAP website or by clicking below:


 



More information on LEAP programme supported by the division of AIDS, NIAID

More information on MPP's long-acting therapeutics initiative below:
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                            [post_content] => REGISTER HERE
 
                            [post_title] => AIDS 2020 SATELLITE SYMPOSIUM: Harnessing access to long-acting technologies in low- and middle-income countries. Are we on track to resolving the conundrum?
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The event that took place on the 6th and 7th of February 2020 in La Jolla-San Diego, USA, was co-organised by Drug Delivery Experts and the Controlled Release Society, and co-sponsored by the Medicines Patent Pool along with Medincell.

The conference focused on the Long-Acting Injectables and Implantables technologies, and MPP's Head of Policy and Advocacy Esteban Burrone was part of the panel discussion.






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                            [post_content] => Geneva, 12 December 2018 - The Medicines Patent Pool (MPP) and Unitaid have jointly published a study into the patent landscape for the long-acting technologies that could have major impact for preventing or treating major diseases in low- and middle-income countries. The report can be accessed here.

The report provides an overview of the intellectual property status of long-acting products for major diseases that are under development or already on the market.

Specifically, the report finds that the patent situation for long-acting products can be complex, with patent protection on the drugs themselves, on the technologies needed to manufacture them, and, in some cases, on the delivery devices. In the case of nanoformulations for example, there is high potential for multiple overlapping patents.  The delivery platforms are often applied to multiple products and are covered as well by extensive intellectual property protection. The above complexity, as well as other factors summarised in the report, may present challenges to the freedom-to-operate and eventually access to long-acting products adapted to the needs of LMICs.

The report also finds that, in terms of the geographical breadth of patent protection for different long-acting products, the situation varies significantly between products. However, in general, products appear to have patents pending or granted in key countries for generic manufacturing.

“There is huge potential for long acting technologies to make a substantial difference to treatment adherence in low- and middle-income countries, for diseases including HIV, hepatitis C and tuberculosis. But this won’t happen by itself.” said Charles Gore, Executive Director, the MPP.

“Much collaboration is still required to develop them and then ensure affordable access. This report, by mapping the patent landscape for these technologies, will help accelerate this process.”

Developing a healthy market for long-acting products in LMICs has its challenges. The report can aid in understanding the range of different actors involved in the development of long acting formulations and the opportunities for partnerships that could lead to faster development and wider access.

“To avoid the pitfalls of the past, when new medicines were introduced first in high-income countries and only much later in LMICs, we need to be thinking ahead of the curve to prepare for a healthy market and prompt access to these game-changing long-acting tools”, said Lelio Marmora, Executive Director of Unitaid.
Notes
Intellectual Property Report on Long-Acting Technologies was compiled by the MPP and Unitaid and provides a patent landscape of intellectual property protection for long-acting products marketed or under development for prevention and treatment of HIV, hepatitis C, tuberculosis, and malaria.

The information is correct as of October 2018. This report should not be interpreted as a freedom to operate analysis. It provides a snapshot based on the information that was available to the MPP and Unitaid at time of writing. Users are encouraged to seek further advice as appropriate.

For more information:

Long-acting technologies for infectious diseases in LMICs – The Lancet, October 2018



About the Medicines Patent Pool
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, the 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, the MPP has signed agreements with nine patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals and a tuberculosis treatment. The MPP was founded by Unitaid, which serves as sole funder for the MPP’s activities in HIV, hepatitis C and tuberculosis. The MPP is now expanding its activities to cover Essential Medicines, which requires engagement with many new stakeholders, including potential funders.
Contact
Jo Waters

Head of Communications
Medicines Patent Pool
jwaters@medicinespatentpool.org
About Unitaid
Unitaid brings the power of new medical discoveries to the people who most need them. Through time-limited investments, we identify the best health innovations with the potential to alleviate the burden of major diseases and set the stage for their large-scale introduction by governments and partners such as PEPFAR, the Global Fund and WHO. Our investments result in better ways to prevent, diagnose and treat diseases including HIV/AIDS, hepatitis C, tuberculosis and malaria more quickly, affordably and effectively. A growing number of our projects address more than one disease, maximizing the effectiveness of health systems as a whole, and more than half of our portfolio is linked to antimicrobial resistance.
Contact
Andrew Hurst

Head of Communications
Unitaid
hursta@unitaid.who.int
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