Long-term Commitment

Otsuka began its drug discovery programme in Tokushima, Japan, in 1971 with only 14 scientists. Tuberculosis (TB) was selected as one of the company’s first research priorities. Seeing the real suffering TB continued to cause in Asia, and driven by the personal commitment of Mr. Akihiko Otsuka to find new tools against this persisting epidemic, Otsuka continued to search for innovative solutions at a time when most pharmaceutical companies were closing their TB research and development (R&D) programmes.

Expanding the TB Portfolio

We’ve come a long way in the last 45 years. In 2014, a compound discovered and developed by in-house scientists received its first stringent regulatory approval for the treatment of adults with pulmonary multidrug-resistant TB (MDR-TB). Today, Otsuka’s Global TB Programme is involved in initiatives around the world and has an active R&D portfolio of new medicines, child-friendly formulations, mHealth projects, TB diagnostics, and treatment monitoring tools.

Otsuka’s Strategy: FighTBack Initiative

Otsuka’s strategy for fighting TB is reflected in its FighTBack initiative, which encompasses 4 pillars:

1. Innovative R&D
2. Responsible access to medicines
3. Optimised patient management
4. Collaborative capacity building.

We invite you to learn more about each of the pillars by clicking on the boxes below:

TB elimination necessitates mutually reinforcing strategies that put the patient at the centre of its efforts, providing them with optimised and shortened treatment, support necessary to complete it, and ensuring that these treatment options remain viable through a commitment to antimicrobial stewardship. Partnerships and collaborations are essential to ensure antimicrobial stewardship of TB medications and to continue R&D into more effective ways to fight the disease.

A brief history of Otsuka’s Global TB Programme.

  • 1964 Otsuka Pharmaceutical established.
  • 1971 TB selected as one of the company’s earliest research priorities.
  • 1982 Driven by the vision of Akihiko Otsuka, researchers focus on finding a new TB drug.
  • 2002 Otsuka researchers find a new anti-TB drug candidate compound.
  • 2004 Phase I clinical trial starts.
  • 2008 Phase II clinical trial for MDR-TB patients starts at 17 centres in 9 countries on 5 continents, with extensive on-site capacity-building.
  • 2010 Phase II completed.
  • 2011 Phase III clinical trial in MDR-TB patients (including HIV patients) begins in 7 countries.
  • 2011 Application filed in Europe for approval of a new compound indicated for adult pulmonary MDR-TB.
  • 2013 Application filed for approval in Japan.
  • 2013 Clinical trials in paediatric patients with MDR-TB begin.
  • 2014 Approval granted in Europe, Japan, and Republic of Korea for treatment of pulmonary MDR-TB in adult patients.
  • 2016 Phase I of a second new anti-TB compound starts.
  • 2016 Approval granted in Hong Kong for treatment of pulmonary MDR-TB in adult patients.
  • 2017 Approval granted in Turkey for treatment of pulmonary MDR-TB in adult patients.

Information current as of 26-06-2017