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Medicines for Malaria Venture (MMV)

Active Since: 1999

Multi-Company Partnership

Contributing to SDGs…

Reducing the burden of malaria in disease-endemic countries by working with partners to discover, develop and facilitate delivery of new, effective and affordable antimalarial drugs.

PARTNER ORGANISATIONS

  • Academia or research institute

    Drugs for Neglected Diseases initiative (DNDi)

  • Global NGOs

    Wellcome Trust

    PATH

  • Intergovernmental Organizations and Multilaterals

    Global Health Innovative Technology (GHIT) Fund

  • Private foundation or development organization

    Bill and Melinda Gates Foundation

    European and Developing Countries Clinical Trials Partnership Programme (EDCTP)

  • Product development partnerships

    Medicines for Malaria Venture (MMV)

  • Financial institutions

    Singapore Economic Development Board

Objectives

The mission of Medicines for Malaria Venture (MMV) is to reduce the burden of malaria in disease-endemic countries by working with partners to discover, develop and facilitate delivery of new, effective and affordable antimalarial drugs.

MMV seeks to maximise the impact of medicines for malaria control and elimination by focusing on three strategic areas of activity:

  1. Facilitating equitable access to quality antimalarials to maximise the use and health impact of existing products (near-term).
  2. Developing better medicines for case management, including patient-adapted new combinations to overcome drug resistance, to facilitate deployment of shorter treatment courses and to protect vulnerable populations like children and pregnant women (medium-term).
  3. Bringing forward new tools for resistance and elimination to help countries reduce transmission and ultimately become malaria free (long-term).

Medicines for Malaria Venture (MMV) is a product development partnership (PDP) in antimalarial drug research, launched in November 1999 with initial seed finance of US$4 million from the Government of Switzerland, UK Department for International Development, the Government of the Netherlands, The World Bank and Rockefeller Foundation.

MMV has an extensive network of over 400 pharmaceutical, academic and endemic-country partners in more than 55 countries. MMV and partners manage a portfolio of over 65 projects, the largest portfolio of antimalarial R&D and access projects ever assembled. The portfolio includes ten compounds in clinical development addressing unmet medical needs in malaria, including medicines for children, pregnant women and relapsing malaria, and drugs that could support the elimination/eradication agenda.
MMV leverages the facilities, knowledge and expertise of the pharmaceutical and biotechnology industries, drawing on their valuable experience and resources at every stage of the drug development process. This could include gaining access to novel and proprietary compound libraries to boost the diversity of candidate drugs in discovery research or benefiting from industry experience in manufacturing and distribution in preparation for the launch of products.

MMV receives funding and support from government agencies, private foundations, international organisations, corporate foundations and private individuals. These funds are used to finance MMV’s portfolio of research and development (R&D) projects to develop new, effective and affordable medicines for the treatment and prevention of malaria. They also support specific, targeted access and product management interventions to help ensure that vulnerable populations in malaria-endemic countries can access new malaria medicines.

GSK activities:

GSK and MMV have worked together to establish a joint preclinical portfolio of antimalarial assets. As compounds move into clinical development, GSK provides clinical, regulatory and manufacturing expertise and resources via its global R&D and supply network. In 2008, GSK and MMV announced a collaboration to identify novel drugs for the treatment of malaria. In 2018, GSK and MMV announced the US FDA and later the Australian TGA approval of tafenoquine, a single-dose radical cure (prevention of relapse) of P. vivax malaria in patients aged 16 and over. This is the first new treatment for this type of relapsing malaria in over 60 years and marks a major contribution towards efforts to eliminate the disease. Together, and with our partner on diagnostic development PATH, we aim to provide the treatment at an affordable price in malaria endemic countries, with an appropriate complementary diagnostic test. Because a significant part of the global burden of P. vivax malaria is in children, we are also studying the use of tafenoquine in young patients. The tafenoquine clinical programme is part of GSK’s global health programme aimed at improving healthcare for vulnerable populations.

In 2010 GSK published research findings that could help identify potential new treatments for malaria. The research was the result of a year-long screening process in which five GSK scientists reviewed more than two million compounds in GSK’s chemical library to seek out those that could inhibit the malaria parasite. This process identified 13,533 compounds that showed greatest activity. More than 80% of these molecules are proprietary to GSK, and it is the first time they have been made available to the wider research community. GSK’s malaria compound set is part of the ‘malaria box set’ that MMV has sent to more than 160 groups around the world.

Merck activities:

In April 2013, Merck’s biopharmaceutical division, Merck Serono, signed a partnership with MMV. Together, MMV and Merck work to develop new long lasting anti-malarial compounds through current lead optimization programs, contributing to global efforts to find new therapies to fight re-emergence of drug resistance to currently available malarials. A first program has already been evaluated by the External Scientific Advisory Committee (ESAC) of MMV and has obtained full support for further development.

Novartis activities:

In 2009, Novartis and MMV introduced Coartem® Dispersible, the first artemisinin-based combination (ACT) formulation developed for children with malaria. The medicine contains the same concentration of active ingredients as the regular tablet, but in a dispersible formulation that is easier to give to babies and children, which helps to ensure that this population receives the correct dose. The sweet-tasting formulation dissolves quickly in small amounts of water which enhances its use in young children.

Novartis is working with MMV to help to prevent, treat and block the spread of malaria by developing new classes of drugs that attack both liver and blood stages. In June 2016, Novartis announced the expansion of its partnership with MMV to develop KAF156. KAF156 belongs to a novel class of antimalarial compounds that act against both the blood and liver stages of the parasite’s lifecycle and in September 2016, Novartis published proof of concept study results in the New England Journal of Medicine showing that KAF156 demonstrated activity against both vivax and falciparum malaria, including artemisinin-resistant parasites. Novartis leads the development of this compound with scientific and financial support from MMV in collaboration with the Bill & Melinda Gates Foundation. KAF156 holds the potential to be the first new chemical class of compound for the treatment of acute malaria in 20 years, which in combination with the new formulation of lumefantrine, could be administered as a single-dose treatment. The combination is currently in late-stage clinical trials across 17 centers in nine countries in Africa and Asia. The European  & Developing Countries Clinical Trials Partnership (EDCTP) will grant €10 million over five years to “WANECAM 2,” a unique collaboration between antimalarial drug researchers in Africa and Europe from ten academic institutions, Novartis and MMV. The grant will support African trials of KAF156 and lumefantrine and will also help to build and strengthen research capabilities in the four participating African countries: Burkina Faso, Gabon, Mali and Niger.

KAE609 is another novel antimalarial development program led by Novartis. It was discovered through a joint research program with the Novartis Institute for Tropical Diseases, Novartis Natural Products Research Group, the Genomics Institute of the Novartis Research Foundation, and the Swiss Tropical and Public Health Institute. Research was supported by the Wellcome Trust, the Singapore Economic Development Board, and MMV. KAE609 belongs to the spiroindolone class and has a novel mechanism of action (PfATP4 inhibitor) that has demonstrated rapid clearance of parasites pre-clinically and in patients. It is currently in a Phase 2 dose-escalation study to further characterize the safety and efficacy profile in people with malaria. The ongoing trial has so far completed the recruitment of four planned cohorts. Novartis is leading the development of KAE609 in collaboration with MMV and with financial support from the Wellcome Trust.

Sanofi activities:

In 2008, MMV signed a MoU with Sanofi for discovery work, including early-stage molecule testing, and screening, plus clinical development of ferroquine, SAR97276 and trioxaquine. Starting in 2009, MMV contributed to the DNDi and Sanofi ‘ASAQ field monitoring program’ in Côte d’Ivoire. With approximately 15,000 patients, this is the largest study ever done on an antimalarial and should help African experts and government bodies to develop innovative pharmacovigilance methods in ‘real life’ conditions. In 2011 Sanofi and MMV announced a three-year agreement to research malaria treatments titled “Orthology Malaria”.  As part of the agreement, both parties will work together to identify, characterize and optimize new candidate compounds to treat malaria and conduct early development programs to demonstrate proof of concept in men.

Takeda activities:

In June 2013, with support from the GHIT Fund, Takeda began to work with MMV, in a program to screen Takeda’s drug compound library for new candidate compounds that might have the potential to be developed into new drugs for the treatment of malaria.

SDGs THE PARTNERSHIP CONTRIBUTES TO

SDG 3: Good Health and Wellbeing

  1. 3.2: Reduce Under-5 Mortality 
  2. 3.3: Communicable Diseases & NTDs

SDG 10: Reduced Inequalities

SDG 17: Partnerships for the Goals 

RESULTS & MILESTONES

Since its foundation in 1999, MMV and partners have developed and brought forward ten new medicines; these include:

  • Krintafel/Kozenis* (tafenoquine), a single-dose anti-relapse treatment for P.vivax malaria developed with GSK
  • Pyramax® and Pyramax® Granules for children (pyronaridine-artesunate) for uncomplicated malaria, with Shin Poong
  • Eurartesim® (dihydroartemisinin-piperaquine) with Sigma-Tau
  • the first high-quality child-friendly formulation Coartem® Dispersible (artemether-lumefantrine) with Novartis.

The further five products have been brought forward by providing significant support to attain WHO prequalification. These includes two injectable artesunate products for the treatment of severe malaria, Artesun® from Guilin and Larinate 60 from Ipca Laboratories, as well as sulfadoxine–pyrimethamine + artesunate amodiaquine (SP+AQ) for seasonal malaria chemoprevention from Guilin and two rectal artesunate (RAS) products for the pre-referral management of severe malaria from Cipla and Strides Pharma.

In addition, MMV has taken over the stewardship of two other medicines for uncomplicated malaria developed by Drugs for Neglected Diseases initiative (DNDi) and partners – ASAQ Winthrop® (artesunate-amodiaquine) and ASMQ (artesunate-mefloquine).

Since 2009, over 350 million courses of Coartem Dispersible treatment have been supplied to 50 malaria-endemic countries; and since prequalification in 2010, an estimated 127 million vials of Artesun have been delivered, saving 800,000 additional lives. In total, an estimated 1.9 million lives have been saved by MMV co-developed drugs.

ADDITIONAL INFORMATION