What are the health needs and challenges?

Globally about half a million people get ill with drug resistant forms of tuberculosis every year. Therapy includes a cocktail of various medicines. Up to now, only about half of those who are put on treatment have a successful outcome. The gap is due to lack of availability of novel and more effective treatment regimens. Furthermore, therapeutics for children and/or those who are also affected by other diseases and conditions such as HIV infection are often more complicated. Considering the dramatic rise in bacterial resistance worldwide, rational use of antibiotics is critical to ensuring that the greatest number of patients have equitable access to them over the longest period of time.

Partnership activities and how they address needs and challenges

Otsuka’s FighTBack initiative has 4 main pillars:

• Innovative research and development
• Responsible access to medicines
• Optimized disease management and patients’ support and care
• 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 evaluates new regimens for the treatment of MDR-TB and aims to reduce existing country-level barriers to the uptake of new TB drugs. In December 2015, Otsuka provided a one-time donation of 400 treatment courses of delamanid to MSF for the endTB project to provide rapid access to patients in urgent need. In 2016 and 2018, 400 treatment courses were also donated to the National TB Programs of South Africa and India respectively, to kick-start access in those countries.

Otsuka’s second Compassionate Use (CU) delamanid ​project began in 2019. The project operates globally, in countries which haven’t yet granted respective marketing authorization or where access to delamanid is otherwise restricted.  Adults or paediatric patients with rifampicin-resistant TB receive delamanid with other anti-TB medications as a last option when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Children weighing between 10 and 30 kgs have received the child-friendly version of delamanid, a 25 mg tablet which dissolves in water.

A key component of the initiative is also Otsuka’s collaboration with Stop TB Partnership’s Global Drug Facility (GDF) since 2016, which enables more than 100 eligible low- and middle-income countries to procure delamanid.  The GDF 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.  As of June 2022, Otsuka, in cooperation with the GDF, has been facilitating supply of its child-friendly medicine for treatment of drug resistant TB to more than 34 countries including those with high burden of TB, drug resistant TB and TB/HIV coinfection.

Corresponding principle in the declaration by the AMR Industry Alliance

“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)