MMV AT A GLANCE Towards a malaria-free world
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MMV
AT A
GLANCE
Towards a malaria-free world
Medicines for Malaria Venture (MMV) and partners discover, develop and deliver new, effective and
affordable antimalarials to give populations at risk a better chance to achieve good health and wellbeing.
Since 2000, global malaria eradication efforts towards achieving the targets set by the WHO As we celebrate successes, we are also
have made significant gains, averting 1.5 billion Global Technical Strategy for Malaria 2016– prioritizing the unmet medical needs of
cases and saving 7.6 million lives.1 MMV is 2030. In 2020, we worked with partners to pregnant women and newborns. The “MiMBa”
proud to have contributed to this achievement. ensure that seasonal malaria chemoprevention strategy (Malaria In Mothers and Babies) aims
Since 1999 MMV and its partners have campaigns stayed on track, helping protect to expand treatment options and generate
brought forward 11 new antimalarials and two 30 million children. We are also bringing data on existing compounds to inform their
others have been transferred to its portfolio chemoprevention closer to home by enabling use in these underserved populations.
post-approval. To date, these medicines have Nigerian and Kenyan manufacturers to produce
saved an estimated 2.7 million lives. quality-assured sulfadoxine-pyrimethamine for Our antimalarial portfolio is the largest ever
prevention of malaria in pregnancy in their own assembled (see p. 3) and the compounds in
Despite this progress, according to the World countries. development target unmet medical needs,
Health Organization, 409,000 deaths still including medicines for children, pregnant
occur worldwide from malaria each year. In MMV continues to progress towards tackling the women and people suffering from drug-
addition, the malaria community faces the dual ongoing threat of antimalarial drug resistance resistant malaria. These antimalarials hold
challenge of defeating the disease in the face by collaborating with partners to advance next- the promise of contributing to the global
of the COVID-19 pandemic. generation antimalarial compounds. MMV's drive towards malaria eradication as well as
current portfolio contains 11 new compounds Sustainable Development Goal 3 to achieve
Given the interest in malaria medicines as in clinical development, all of which are active good health and wellbeing for all. n
potential treatments for COVID-19, we joined against resistant malaria parasites.
forces with the World Health Organization
(WHO), partners and manufacturers to advise
on linkages with industry and coordinate
efforts to safeguard access to critical malaria
commodities. We also sent our antimalarial
compound collections with potential
SARS-CoV-2 activity to testing centres
and distributed open access compound
collections to researchers. In addition, we
are supporting clinical studies to repurpose
existing antimalarials as potential COVID
treatments and launched a Phase II clinical
study in South Africa.
Despite joining the global effort to fight
COVID-19, our work continued unabated
1. WHO World Malaria Report 2020.
Defeating Malaria Together
Maximizing value every step of the way
MMV’s PDP model – The innovative route to neglected disease drug development
MMV’s Product Development Partnership
Malaria (PDP) continues to bear fruit. Combining
the technical skills of our network of
takes a child’s life every 2 minutes 1 partners from industry and academia with
our in-house expertise, MMV remains
a highly productive and cost-effective
kills an estimated 409,000 people
research and development organization.
each year – the vast majority are
children 2
Each partner brings technical know-how,
enabling technologies, research facilities and
can kill within 24 hrs of symptom funding. MMV brings a wealth of malaria and
onset1,2 R&D knowledge together with industry-style
portfolio management. Our Target Product
Profiles and Target Candidate Profiles (see
drug resistance has emerged
in Southeast Asia, where an p. 3) provide a clear framework for research
and development. With this in mind, support Donors and in-kind contributions
estimated 6.3 million annual
cases occur 2 is provided for the most promising drug Academic research and clinical trial sites
candidates, while those that do not meet the Pharmaceutical research and development
New medicines for malaria
target profile are quickly terminated.
is both a cause and
consequence of poverty This rigorous candidate selection and
management enables us to maximize value A network of over
1. WHO. Malaria, 2020.
2. WHO. World Malaria Report, 2020.
while accelerating the progress of compounds
through the pipeline. n
400
dedicated partners over 21 years
Quality medicine at an affordable price
MMV strongly believes that all malaria patients, To keep the development costs as low as
239
years of in-house malaria
rich or poor, deserve treatments that are high possible, MMV benchmarks costs and follows
experience
quality, efficacious and well tolerated. In order a robust procurement process when engaging
to ensure that is the case, all new medicines with research service providers. We also aim
supported by MMV must meet internationally to contain production costs by working with
accepted standards set by Stringent Regulatory our partners to seek the most efficient routes
Authorities (SRAs) and/ or WHO prequalification. of synthesis for our medicines—beyond
USD USD
1 = 3.50
reductions expected from economies of scale.
All development projects conducted by MMV
and partners follow ICH1, 4 guidelines every step In this way, MMV is able to maximize the value
of the way – from GLP standards for preclinical
2
of every donor dollar to our highly focused
work to GCP3 standards for clinical trials in mission and develop high-quality medicines
Direct and in-kind support from
our public and private partners
malaria-endemic countries that also adhere that are affordable for vulnerable populations. n
more than triples the value of each
to national regulations. This is underpinned by
donor dollar for R&D.
strict adherence to GMP4 requirements for both
investigational and registered products.
1. International Conference on Harmonisation of Technical
When MMV and a partner enter into a contractual Requirements for Registration of Pharmaceuticals
relationship, they commit to developing a for Human Use (ICH) Goal:
2. Good Laboratory Practice (GLP)
product together that will be accessible and
affordable for endemic populations.
3. Good Clinical Practice (GCP)
4. Good Manufacturing Practice (GMP) 50 cents
or less to treat a child
MMV at a Glance 2021 I www.mmv.org
2
MMV-supported projects
Antimalarial drug discovery and development projects scientifically and/or financially supported by MMV.
Research Translational Product development Access
Lead Candidate Preclinical Human Patient Patient Regulatory Approved/ERP
optimization profiling volunteers exploratory confirmatory review
Pyrazines Miniportfolio MMV1581373 MMV371 M5717 Ganaplacide– Dihydro– 4 Tafenoquine 11 Artemether– 1 Artesunate–
GSK Novartis Novartis Janssen Merck KGaA lumefantrine artemisinin– paediatric lumefantrine mefloquine
Novartis piperaquine GSK dispersible Cipla
dispersible Novartis
Alfasigma
Phenotypic 4-amino- MMV1793609 MMV183 ZY19489 Cipargamin Artemether– Sulfadoxine- Artesunate 2 Sulfadoxine– 7
lead quinoline Kentucky (TropIQ) Zydus Cadila Novartis lumefantrine pyrimethamine for injection pyrimethamine
Mitsubishi < 5 kg Universal Fosun Pharma + amodiaquine
Tanabe Novartis Corporation dispersible
Fosun Pharma
Intra-muscular Molecular MMV646 Atoguanil Ferroquine Sulfadoxine– Artesunate 3 Sulfadoxine– 8
Calibr target (Jacobus) Ipca (Sanofi) pyrimethamine for injection pyrimethamine
UCB Swipha/Biogaran Ipca + amodiaquine
dispersible
S Kant
Phenotypic DHODH INE963 MMV533 Sulfadoxine– Dihydro– 4 Artesunate 9
lead Broad Institute Novartis (Sanofi) pyrimethamine artemisinin– rectal capsules
BMS Emzor piperaquine Cipla
Pharmaceutical Alfasigma
GWT1 DHODH GSK701 Pyronaridine– 5 Artesunate 10
artesunate rectal capsules
Eisai Univ. of Texas GSK
Southwestern/ Shin Poong Strides Pharma
Univ. of Washington/
Monash Univ.
Molecular Phenotypic Pyronaridine– 5 Tafenoquine 11
target lead artesunate GSK
Drug Discovery Unit Merck KGaA granules
Univ. of Dundee Univ. of Cape Town Shin Poong
Azabenzi- Artesunate– 6
midazole amodiaquine
UNICAMP Sanofi
(Univ. of Campinas)
APM
Access & Product
Management
GOVERNANCE
ESAC Expert Scientific Advisory Committee APMAC
GSB Access & Product
Management
Global Safety Board APAC Authorization for Phase III/Advancement Committee Advisory Committee
MMV Board of Directors/Executive Committee/Financial Audit Committee
Target product profiles and Target Candidate Profiles
MMV has defined Target product profiles and Target Candidate Profiles for medicines to support the eradication campaign.
Macintyre F et al., «Injectable anti-malarials revisited: discovery and development of new agents to protect against malaria” Malar J. 2018 Nov 1;17(1).
Burrows JN et al., “New developments in anti-malarial target candidate and product profiles”. Malar J 16:26 (2017) - (Updates the previous profiles in Burrows J. et al., Malar J 12:187 (2013)).
Target product profiles (TPPs) Target Candidate Profiles (TCPs)
indicated by bars at the bottom of each compound box activities for each individual molecule, indicated by symbols added
to compounds in the translational or product development portfolio
Burrows et al., 2013 Burrows et al., 2017
3-day cure, artemisinin-based combination therapies (TPP1)
Asexual blood stages (TCP 1, 2) TCP 1
Uncomplicated malaria treatments for single-exposure radical cure (SERC)
Relapse prevention (TCP 3a) TCP 3
and/or resistance management (TPP1)
Causal prophylaxis (TCP 4) TCP 4
Intermittent preventive treatment (TPP1)
Transmission reduction (TCP 3b) TCP 5, 6
Severe malaria treatment/pre-referral intervention (TPP1)
Products targeting prevention of relapse for P. vivax (TPP1) Included in MMV portfolio after product approval and/or development
Prophylaxis (TPP2) Global Fund Expert Review Panel reviewed product – permitted for time-limited
procurement, while regulatory/WHO prequalification review is ongoing
Paediatric formulation
Brand names: 1. Coartem® Dispersible; 2. Artesun®; 3. Larinate® 60mg; 4. Eurartesim®;
5. Pyramax® tablets or granules; 6. ASAQ Winthrop®; 7. SPAQ-COTM; 8. Supyra®; WHO prequalified OR approved/positive opinion by regulatory bodies
9. 100 mg Artesunate Rectocaps; 10. ArtecapTM; 11. Krintafel/Kozenis (Trademarks owned who are ICH* members/observers
or licensed by GSK) Via a bioequivalence study
(-) Past partners are in brackets
* International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
MMV at a Glance 2021 I www.mmv.org
3
Working in partnership
Since its inception in 1999, MMV has
successfully worked in over 50 countries More than 400 partners
with more than 400 partners from: $
– the public and private sectors
– NGOs and non-profit organizations
– clinical trial sites
Today, around 150 active partners are working
on MMV projects in 30 countries.
...over 50 countries
The road to health impact
Discovering and developing new lifesaving antimalarials are not enough to ensure patient impact, which is why MMV is also committed to
delivering these medicines to those most in need. There are numerous barriers to creating access to medicines; here is how we work to
overcome some of them.
The graphic to the right shows key hurdles that understand how to safely and effectively to decision makers. This helps to make quality
must be addressed as laboratory-developed administer new medicines. medicines available for procurement where they
drugs are transformed into life-saving medicines are most needed.
that can have massive impact. The roles of both the public and private
sectors are central to ensuring global access Today, an estimated 409,000 people still die from
As a first step, it is critical that medicines brought to antimalarial medicines. An imperative to malaria every year. By increasing the accessibility
to market have demonstrated their efficacy and understand the market and how these actors of both new antimalarials co-developed by MMV
safety both to Stringent Regulatory Authorities interact drives our commitment to invest in both and medicines that are already available, we are
(SRAs) as well as to WHO Prequalification. quantitative and qualitative market research. In working with partners in pursuit of a future where
National regulators must also be assured that addition, linking our pharma partners with market no one will suffer or die from malaria. n
new medicines will be tracked for safety in “real- Saving lives by addressing barriers to access
demand forecasts helps ensure that there is
life” settings. This pharmacovigilance expands advanced visibility for industry to prepare for
knowledge about product safety after launch. evolving demand for their products.
Crucial to catalyzing the uptake of medicines Regulatory
after in-country registration is their inclusion Lastly, as new medicines and safety
in national treatment protocols. The Standard become more widely adopted, Global
Treatment Guidelines from WHO’s Global we carefully consider the Ensuring and national
Malaria Programme (GMP) provide global international financing of new supply guidance
guidance to countries in this regard. MMV and medicines for lower income
its partners help generate real-world evidence countries, as well as the
to support and refine policy recommendations. need to ensure that global
supplies will be adequate. Financing Acceptance
Both during product development and after Targeted funding is allowing
launch, MMV works closely with national us to support the aspirations
research partners to ensure that key aspects of leading manufacturers in
of product acceptance facilitate adoption— Kenya and Nigeria to pursue Understanding Training for
this work can include palatability testing of WHO prequalification of their the market optimal use
medicines designed for children or refinement antimalarial products. MMV supports
of product packaging and instructions for financing and procurement institutions
caregivers. Similarly, we focus closely on to ensure that all pertinent data about the
developing training materials and programmes affordability, availability, and unique attributes Saving lives by addressing
to ensure healthcare professionals will readily of new products are clearly communicated barriers to access
MMV at a Glance 2021 I www.mmv.org
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Focus on finances
Medicines for Malaria Venture receives Figure 1 Total donations received in 2020
sustained funding and support from Private Foundations
government agencies, private foundations, Bill & Melinda Gates Foundation (BMGF) 43.80%
international organizations, corporations, Governments
corporate foundations and private individuals. UK Foreign, Commonwealth & Development Office (FCDO, ex-DFID)) 27.20%
European and Developing Countries Clinical Trials Partnership (EDCTP)
These funds are used to finance MMV’s 11.20%
Ministry of Foreign Affairs of the Netherlands (DGIS) 3.80%
portfolio of R&D projects as well as specific,
German Federal Ministry of Education and Research (BMBF) 3.20%
targeted access and delivery interventions Australian Government Department of Foreign Affairs and Trade (DFAT) 3.10% 53.6%
that aim to make it easier for vulnerable Swiss Agency for Development and Cooperation (SDC) 2.60%
Ireland Department of Foreign Affairs (Irish Aid) 1.30%
populations to access MMV products.
United States Agency for International Development (USAID) 43.8%
and National Institutes of Health (NIH) 1.00%
Since its foundation in 1999, MMV’s R&D Principality of Monaco Direction de la Coopération Internationale (DCI) 0.10%
portfolio of new and innovative antimalarial Others (Other donors, partnerships, individual donations)
medicines remains the largest ever built. Global Health Innovative Technology Fund (GHIT) 1.50%
Bristol Myers Squibb Foundation 0.60% 2.6%
With partners, MMV has brought forward
Program for Appropriate Technology in Health (PATH) 0.30%
11 new antimalarials and taken over the Newcrest Mining Limited 0.20%
access stewardship of two others. Together, 100.00%
these medicines have saved an estimated
2.7 million lives. To sustain this work, MMV’s
current portfolio will require an investment of
approximately USD 85 million per annum over Figure 2 MMV expenditure 2020 Total: USD 89.2 million
the 5-year period 2021-2025.
Progress in research is dependent on funding. R&D & APM
Research & development 69%
With approximately USD 276 million available at R&D & APM
Access & product management 14% 86%
the start of 2021 (USD 41.9 million cash as of
Other portfolio expenditure 3%
1 January 2021, USD 218.2 million committed Indirect
costs
pledges over the period 2021–2025 and a Indirect costs 14%
residual USD 16.2 million receivable from Administration & finance 7%
Corporate affairs 7%
pharmaceutical partner GSK payable 50% in July
2022 and 50% in July 2023), the organization has
sufficient funds for 2021 but is currently tracking
a shortfall of approximately USD 150 million over
the 5-year period 2021–2025. To overcome this,
we are striving to expand and develop current
and new donor relationships and negotiate the
best terms with our partners. n
Board of Directors Expert Scientific Advisory Committee (ESAC) Access & Product Management Advisory
Mr Per Wold-Olsen (Chairman), Dr David Brandling- Dr Michael Witty Co-Chairman (Discovery), Committee (APMAC)
Bennett, Mr Alan Court, Dr Aileen Allsop, Ms Jennifer Dr John Pottage Co-Chairman (Development), Dr Elizabeth Juma, Dr Corine Karema, Ms Maeve
Cain Birkmose, Prof. Sir Michael Ferguson, Dr Tesfaye Biftu, Dr Nick Cammack, Sir Simon Magner, Dr Wilfred Mbacham, Dr Kamini Mendis,
Dr Winston E. Gutteridge, Ms Yuli Ismartono, Campbell, Mr Robert Clay, Dr Anne Cooper, Dr Ric Price, Dr Frank O Richards Jr and Dr Martin
Mr Gabriel Jaramillo, Dr Dominique Limet, Prof. Brian Cox, Ms Delese Mimi Darko, De Smet
Ms Elizabeth J. Linder, Dr Robert Newman, Ms Joy Dr Monica Hemben Eimunjeze, Dr Rick Fairhurst,
Phumaphi, Dr David Reddy, Dr Wendy R. Sanhai, Dr Tim Hammond, Dr Laurent Hennequin, Dr Robert Editors: Murchana Roychoudhury, Danielle Sessa
Dr Dennis Schmatz and Dr Elisabeth Svanberg T. Jacobs, Dr Marcus Lacerda, Dr Lynn Marks, Photos: Toby Madden/MMV (cover & p 6a),
Dr George Mooney, Dr Robert Riley, Dr Phil Rosenthal, Elizabeth Poll (p 6b) and Anna Wang/MMV (p 6c)
MMV North America Inc. Board Members Dr Esperança Sevene, Prof Dennis Shanks, Designer: ComStone - Pierre Chassany
Ms Sylvie Fonteilles-Drabek (Chair), Mr Andrea Dr Peter Siegl, Dr Shailja Singh, Prof Dennis Smith,
Buscaglia, Mr Alan Court, Ms Andrea Lucard, Dr Dominique Soldati Favre, Dr Jane Stewart,
Dr David Reddy and Dr Dennis Schmatz Dr John R. J. Surtees, Dr Melissa Tassinari,
Dr Pol Vandenbroucke, Prof Stephen Ward, Dr Dyann
Wirth, Dr Taiyin Yang and Dr Takeshi Yura
Medicines for Malaria Venture (MMV) | International Centre Cointrin | Route de Pré-Bois 20 | PO Box 1826 | 1215 Geneva 15 - Switzerland
T +41 22 555 03 00 | F +41 22 555 03 69 | www.mmv.org | communications@mmv.org
© July 2021 Medicines for Malaria Venture - All rights reserved
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5
Key Achievements
11+ 2
malaria
430
million
medicines treatments of
available to patients.
child-friendly
Coartem®
Dispersible
2.7
( a r t e m e t h e r- l u m e f a n t r i n e ,
An estimated
co-developed with Nova r t is
distributed in more than
50 countries since launch
in 2009, saving an
million
estimated 926,000 lives.
209 lives saved
by MMV-supported
million
medicines since 2009.
vials of
1
injectable
artesunate st single
d i s t r i b u t e d b y M M V- -dose
supported manufacturers
Fosun Pharma and Ipca, cure for
saving an estimated 1.36
million additional lives when
relapsing
malaria
536
compared with quinine.
(tafenoquine, co-developed with GSK)
approved in three malaria-
endemic countries, inclu-
ding Thailand, the first in
1.73 million
the Asia Pacific region.
courses of
million
patients treated with
SPAQ
delivered to countries
Pyramax
(pyronaridine-artesunate
® in Africa's Sahel region
b y M M V- s u p p o r t e d
developed with Shin Poong) manufacturers S Kant and
tablets approved in 29 Fosun Pharma, protecting
countries and granules over 30 million children
in 19 countries. from malaria in 2020.
MMV at a Glance 2021 I www.mmv.org
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