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Otsuka FighTBack Initiative

Active Since: 2015

Contributing to SDGs…

This is an initiative to scale-up access to delamanid in all low, middle-income and high-burden MDR-TB countries as well as continue TB innovation and R&D for shorter, safer, all oral and pan-TB regimens.

MEMBER COMPANIES

PARTNER ORGANISATIONS

  • Bilateral Organisations

    US Agency for International Development (USAID)

  • Global NGOs

    endTB Consortium

    Stop TB Partnership's Global Drug Facility

  • Intergovernmental Organizations and Multilaterals

    Global Drug Facility

  • Local NGOs

    Right to Care (South Africa)

  • Private foundation or development organization

    Bill and Melinda Gates Foundation

Objectives

The priorities of the FighTBack initiative are to expand access to and ensure responsible use of delamanid and continue R&D efforts into novel treatment options and pan-TB regimens as well as diagnostics, treatment monitoring tools and novel compounds. The overall objective is that by 2020, at least 20% of diagnosed and treated MDR-TB patients should have delamanid as part of their treatment regimen through high quality programs.

What are the health needs and challenges?

Considering the dramatic rise in bacterial resistance worldwide, rational use of the MDR-TB compound delamanid is critical to ensuring that the greatest number of patients have access to this medicine over the longest period of time.

Partnership activities and how they address needs and challenges

Otsuka launched a FighTBack initiative which has 4 parts:

1. Innovative Research and Development;
2. Responsible Access to Patients;
3. Optimized Patient Management;
4. Collaborative Capacity Building.

As part of the FighTBack initiative, Otsuka is participating in a number of collaborative studies. One of them is the endTB project led by Médecins Sans Frontières (MSF), Partners in Health (PIH), and Interactive Research & Development (IRD).
The endTB project will evaluate new regimens for the treatment of MDR-TB and reduce existing country-level barriers to the uptake of new TB drugs. Another study is called “MDR-END” led by the Seoul National University Hospital, looking at regimens that could shorten MDR-TB treatment. In December 2015 Otsuka provided a one-time donation of 400 treatment courses of delamanid to MSF for the endTB project in order to provide rapid access to patients in urgent need. In 2016 and 2018, 400 treatment courses were also donated to the National TB Programmes of South Africa and India, respectively, to kick-start access in those countries.

A key component of the initiative is also Otsuka’s partnership with Stop TB Partnership’s Global Drug Facility announced in February 2016, which enables about 100 eligible low- and middle-income countries to procure delamanid.  The Global Drug Facility is the largest procurer of quality-assured tuberculosis medicines and provides TB drug management technical assistance in an effort to promote equitable access to TB medicines and diagnostics.

Corresponding principle in the declaration

“As part of the WHO Global Action Plan’s proposal for a comprehensive program of sanitation, hygiene, vaccination, infection control, education, and stewardship, we support mechanisms to ensure affordable access to new and existing antibiotics to the patients who need them, in all parts of the world and at all levels of income. “

Read full Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance (AMR)

SDGs THE PARTNERSHIP CONTRIBUTES TO

SDG 3: Good Health and Wellbeing

  1. 3.3: Communicable Diseases & NTDs

SDG 9: Industry Innovation and Infrastructure

SDG 17: Partnerships for the Goals 

RESULTS & MILESTONES

Through 2019, more than 14,000 treatment courses have been distributed to over 88 countries including 29  out of 30 WHO high burden MDR-TB countries. In addition, nearly half a dozen collaborative studies with delamanid are in progress and a MAD/EBA study for a novel compound, OPC-167832, has been launched in South Africa as part of a collaboration with the Bill & Melinda Gates Foundation to develop a Pan-TB regimen in line with WHO’s Target Regimen Profiles.

  • More than 14,000 treatment courses distributed to over 88 countries.
  • 29 out of 30 WHO high MDR-TB burden countries have gained access to delamanid.
  • Launch of MAD/EBA study for novel compound, OPC-1678932.