• DNDi logo
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • COVID-19
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • HAT Platform
      • HELP Helminth Elimination Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Global Headquarters
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia/India
      • DNDi South-East Asia
      • DNDi Southern Africa
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
DNDi logo
  • DNDi logo
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • COVID-19
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • HAT Platform
      • HELP Helminth Elimination Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Global Headquarters
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia/India
      • DNDi South-East Asia
      • DNDi Southern Africa
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
Home > Viewpoints

The FACT project: a successful approach to solving public health needs

26 Jun 2015
Share on twitter
Share on facebook
Share on linkedin
Share on email
Share on print

Jean-Rene Kiechel

Viewpoint by

Jean-René Kiechel, Senior Pharma Advisor & Product Manager, DNDi

The beginning of the current millennium saw a radical change in the way malaria was treated. In 2001, in response to rising chloroquine resistance, the WHO recommended replacing this monotherapy with artemisinin-based combination therapies, known as ACTs. The Drugs for Neglected Diseases Working Group of the MSF Access Campaign and WHO-TDR came together with other experts and stakeholders from both non-endemic and endemic countries to form the Fixed-Dose Combination Therapies (FACT) consortium in 2002, with projects subsequently transferred to DNDi when it was established in 2003.

The consortium aimed to develop fixed-dose combinations (FDCs) of two of the WHO-recommended ACTs, combining artesunate (AS) – the artemisinin-based component – with amodiaquine (AQ) or mefloquine (MQ). These malaria treatments were destined for use by patients in Africa, Asia, or Latin America, and were specifically developed with them in mind. They were to be affordable, with clear, self-explanatory packaging and formulations useful for all ages, including infants, and able to withstand tropical environments.

Led by DNDi, the FACT project team was composed of members who participated initially largely on a voluntary basis, from industry, universities, and research institutes worldwide, notably including experts from endemic countries. Advisors were brought in on an ad hoc basis to help address specific problems. Patients’ needs, particularly those of children, were kept at the centre throughout: African children under the age of five account for the majority of deaths from the disease. The characteristics of the treatments to be developed were discussed in consultation with experts and defined at the outset through Target Product Profiles, with progress regularly monitored throughout in twice yearly review meetings and specific local team meetings.

Despite cultural, expertise, and organizational differences, we overcame the challenge of building a team from members spread across different continents, having a common vision. The early pharmaceutical development steps were more time-consuming than may normally occur in an industrial setting, and working with limited resources, both in terms of personnel and finance, meant that the team needed to be flexible, but this led to innovative problem-solving. Clinical data was previously available on the individual drug components from their use in loose-combinations or blister-packs, but data was needed on the safety and effectiveness of these new fixed-dose combinations in a variety of patient populations, which was used to provide evidence for registration in endemic countries.

In Brazil, ASMQ FDC was developed with the public pharmaceutical company Farmanguinhos of Fiocruz. A large study carried in collaboration with the Ministry of Health in the Amazonian state of Acre, a hot-spot for falciparum malaria, attracted immense local interest, including at the highest political level in the State. Not only did it demonstrate the usefulness of ASMQ in tackling malaria, but it was found to strengthen the local malaria management system and showed that early diagnosis and treatment of patients living in remote communities was possible.

For ASAQ FDC, DNDi and Sanofi developed an extensive programme monitoring the treatment’s safety and efficacy, and providing data to support registration in endemic countries. Studies were carried out in adults and children, and ranged from small-scale (investigating repeated and long-term use of ASAQ in areas of high endemicity where patients have multiple malaria infections in a short period of time) to large-scale trials monitoring use in real-life situations. This Risk Management Plan was the first of its kind submitted to the WHO. Results of the largest of these trials, undertaken in the Côte d’Ivoire by Sanofi with MMV and involving 15,000 patients, are expected later this year.

But clinical development is not the end of the story, and enormous and ongoing efforts have been needed to ensure that patients are able to access these treatments, ranging from obtaining WHO prequalification and registration in endemic countries, to advocating for policy change and securing sufficient supplies. The non-exclusivity agreement with Sanofi to produce the ASAQ FDC allowed its production by other generic manufacturing companies, enlarging the market and increasing its distribution: it also facilitated the transfer of technology to Zenufa which will manufacture the treatment in Tanzania. Furthermore, Sanofi’s commitment to producing ASAQ FDC at cost-plus a small margin has led to a decrease in the price of other ACTs.

The successful development of ASAQ and ASMQ, two fixed-dose ACTs given as a single daily dose of 1 or 2 tablets over 3 days, has demonstrated that development model DNDi put into place works, with the two treatments registered for use in endemic countries across the globe. To date, more than 400 million treatments of ASAQ FDC have been distributed worldwide, including products developed by generic companies, and over 800,000 treatments of ASMQ FDC. These projects were officially handed over to the Access and Product Management team of the Medicines for Malaria Venture (MMV) in May of this year. MMV is a long-term partner of DNDi and has built the largest ever portfolio for malaria, and ensures the future availability of these treatments to patients in the years to come.

Jean-René Kiechel
Senior Pharma Advisor & Product Manager, DNDi

Read, watch, share

Loading...
Lab activities
Press releases
29 Jun 2022

DNDi welcomes new PAHO recommendations for the treatment of leishmaniasis in the Americas

Publications
16 Jun 2022

DNDi‘s Commitment to the Kigali Declaration

Caregiver prepares 4-in-1 HIV treatment for child
Press releases
14 Jun 2022

Cipla and DNDi launch child-friendly 4-in-1 antiretroviral treatment for young children living with HIV in South Africa

Nurse with HIV-VL patient
Publications
8 Jun 2022

The Science Explained: Evaluating new treatment regimens for visceral leishmaniasis in people living with HIV in India and Ethiopia

Doctor with a patient
Press releases
8 Jun 2022

New WHO treatment guidelines offer hope for people co-infected with visceral leishmaniasis and HIV

Doctor talking with patient during a consultation
Press releases
1 Jun 2022

Thai partners unite with DNDi to improve access to treatments and diagnostics for people with hepatitis C in Thailand

Statements
24 May 2022

DNDi interventions at the 75th World Health Assembly

Hand holding pill
Publications
23 May 2022

DNDi briefing document: Best science for all

VIEW ALL

Help neglected patients

To date, we have delivered twelve new treatments, saving millions of lives.

Our goal is to deliver 25 new treatments in our first 25 years. You can help us get there. 

GIVE NOW
DNDi logo
Facebook-f
Twitter
Instagram
Linkedin-in
Youtube
International non-profit developing safe, effective, and affordable treatments for the most neglected patients.

Learn more

  • Diseases
  • R&D portfolio
  • Policy advocacy

Get in touch

  • Our offices
  • Contact us
  • Integrity Line

Support us

  • Donate
  • Subscribe to eNews

Work with us

  • Join research networks
  • Jobs
  • RFPs
  • Terms of Use   
  •   Acceptable Use Policy   
  •   Privacy Policy   
  •   Cookie Policy   
  •   Our policies   

  • Except for images, films and trademarks which are subject to DNDi’s Terms of Use, content on this site is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 3.0 Switzerland License   
We use cookies to track our audience and improve our content. By clicking 'Accept All', you are agreeing to our use of cookies. Click on 'Customize' to accept only some cookies.
Customize
ACCEPT ALL
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-advertisement1 yearSet by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category .
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
CookieLawInfoConsent1 yearRecords the default button state of the corresponding category & the status of CCPA. It works only in coordination with the primary cookie.
elementorneverThis cookie is used by the website's WordPress theme. It allows the website owner to implement or change the website's content in real-time.
PHPSESSIDsessionThis cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
CookieDurationDescription
_ga2 yearsThe _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors.
_ga_16Q5RH3XRG2 yearsThis cookie is installed by Google Analytics.
_gat_UA-10302561-11 minuteA variation of the _gat cookie set by Google Analytics and Google Tag Manager to allow website owners to track visitor behaviour and measure site performance. The pattern element in the name contains the unique identity number of the account or website it relates to.
_gid1 dayInstalled by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously.
_hjAbsoluteSessionInProgress30 minutesHotjar sets this cookie to detect the first pageview session of a user. This is a True/False flag set by the cookie.
_hjFirstSeen30 minutesHotjar sets this cookie to identify a new user’s first session. It stores a true/false value, indicating whether it was the first time Hotjar saw this user.
_hjIncludedInPageviewSample2 minutesHotjar sets this cookie to know whether a user is included in the data sampling defined by the site's pageview limit.
_hjIncludedInSessionSample2 minutesHotjar sets this cookie to know whether a user is included in the data sampling defined by the site's daily session limit.
_hjSession_112884430 minutesNo description
CONSENT2 yearsYouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data.
Targeting
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
CookieDurationDescription
_hjSessionUser_11288441 yearNo description
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
SAVE & ACCEPT
Powered by CookieYes Logo