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Otsuka MDR-Tuberculosis R&D

Active Since: 2004

Contributing to SDGs…

Since 2004 Otuska has invested over a half a billion US dollars in TB research and development leading to the successful approval and launch of delamanid for the treatment of multidrug-resistant tuberculosis and continuing with the development of a second new compound, OPC-167832 for development as part of a Pan-TB regimen.

MEMBER COMPANIES

PARTNER ORGANISATIONS

  • Academia or research institute

    Seoul National University Hospital

  • Global NGOs

    FIND Diagnostics

  • Intergovernmental Organizations and Multilaterals

    Critical Path to TB Drug Regimens (CPTR)

  • Private foundation or development organization

    Bill and Melinda Gates Foundation

Objectives

The objective is to deliver safer, shorter, more effective treatment regimens towards achieving the endTB goal of Tuberculosis elimination.

What are the health needs and challenges?

TB bacteria are so resilient that patients must take a regimen of several different medicines for anywhere from six months to a year. In the case of drug-resistant strains such as multidrug-resistant TB (MDR-TB), treatment can often last twice as long.

Partnership activities and how they address needs and challenges

As a recognized leader in TB R&D, Otsuka is committed to helping eliminate this devastating disease. For more than 30 years Otsuka has made TB research a priority, including strengthening clinical trial capacity and infrastructure in selected countries affected by TB. These investments have made Otsuka the current top private funder of TB drug development in the world.

In 2002, Otsuka experienced a breakthrough in its TB research with the discovery of delamanid, a nitroimidazole, which has subsequently received its first regulatory approval from the European Medicines Agency in 2014 as an oral treatment against adult pulmonary MDR-TB. Delamanid is the first from a new class of compounds that inhibit mycolic acid biosynthesis with specificity to mycobacterium TB. Since 2015, it has been included in the World Health Organization’s Essential Medicines List.

The safety and efficacy of delamanid was further evaluated in a double-blind, placebo-controlled Phase III trial which has now completed. The trial included six months of treatment with delamanid as part of a full course of treatment with an optimized background regimen (OBR) and included HIV co-infected MDR-TB patients.

Additionally, the company has initiated a paediatric investigation plan consisting of open-label, multi-center PK and safety trials of delamanid in children with MDR-TB in four groups of descending age from less than 18 years to birth. For the youngest groups, a novel child-friendly dispersible formulation of delamanid is being used. The studies are taking place in the Philippines and South Africa.

In 2018 Otsuka launched a MAD/EBA study for a second novel compound, OPC-167832, in South Africa. OPC-167832 is being developed in combination with delamanid for potential inclusion in a future Pan-TB regimen in line with WHO’s target product profiles.

Corresponding principle in the declaration

“We are investing in a range of innovative antibiotics, vaccines, alternative technologies, and diagnostics for resistant infections. We are advancing our pipelines, but more work and investment into multiple approaches is needed to overcome the significant scientific difficulties of antibiotic discovery”

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

SDG 9: Industry Innovation and Infrastructure

SDG 10: Reduced Inequalities

SDG 17: Partnerships for the Goals 

RESULTS & MILESTONES

More than half a dozen collaborative research studies are planned or underway to optimize the role of delamanid in MDR-TB therapy. Additionally, the MAD/EBA trial for a novel compound, OPC-167832, has been launched in South Africa in partnership with the Bill & Melinda Gates Foundation to develop a Pan-TB regimen in line with the WHO’s Target Regimen Profiles.

  • MAD/EBA trial for OPC-167832 successfully launched in South Africa.