February 25, 2016
Otsuka Pharmaceutical Co., Ltd.
Otsuka Announces Worldwide Access Plan for Delamanid with Stop TB Partnership's Global Drug Facility
- Innovative public-private partnership opens access to delamanid for the treatment of multidrug-resistant tuberculosis (MDR-TB) to more than 100 countries that may procure anti-TB medications through GDF
- Agreement includes package of services and technical assistance to help countries incorporate delamanid into their existing treatment programmes
- MDR-TB remains a major global health concern with 480,000 people infected each year and only a 50% treatment success rate*1
Recognizing the immediate need for access to new therapeutic options for multidrug-resistant TB (MDR-TB), Otsuka Pharmaceutical Co., Ltd.'s subsidiary Otsuka Novel Products GmbH today announced an ambitious new public-private partnership with the Stop TB Partnership (Stop TB) to increase access and scale-up treatment of delamanid (Deltyba™) in low- and middle-income countries.
Any country that is eligible for TB financing from the Global Fund to Fight AIDS, TB and Malaria and follows World Health Organization (WHO) guidelines for the proper management of MDR-TB in quality-assured programs may apply to Stop TB's Global Drug Facility (GDF) to incorporate delamanid into their national treatment programmes. It is estimated that more than 100 countries may now be eligible to access delamanid through the GDF.
"This agreement with the Stop TB Partnership is only the first step in assuring wider, equitable access to delamanid," said Masuhiro Yoshitake, executive operating officer of Otsuka and TB Global Project leader. "Otsuka is committed to working with all stakeholders in the TB community to scale-up delamanid use in a rational way that supports larger efforts to combat antimicrobial resistance."
"Our goal is to ensure all people with TB have access to the best possible treatment. Until now, delamanid was not available for procurement in low- and middle-income countries. We are hopeful that this partnership is going to help give countries more tools and more options to fight MDR-TB in their communities," said Dr Lucica Ditiu, executive director of the Stop TB Partnership.
By establishing a formalized partnership that goes beyond the supply of medicine, Otsuka and Stop TB will work more closely to support communities with education, training, technical assistance, and TB advocacy activities.
This partnership is only one component of Otsuka's "FighTBack Initiative" which incorporates innovative research and development, collaborative capacity building, responsible access to patients and optimised patient management. Beyond delamanid, the initiative includes the development of a first-ever paediatric formulation for MDR-TB, diagnostic solutions, mHealth tools, and potential future anti-TB drug candidates. Otsuka is also engaging in close to a dozen third-party research collaborations looking at shorter, more effective and more patient-friendly ways to fight MDR-TB. Included in this, Otsuka is proud to work with Médecins Sans Frontières, Partners in Health and Interactive Research & Development on the endTB project which will evaluate new regimens for the treatment of MDR-TB and reduce existing country-level barriers to the uptake of new TB drugs while building a broader evidence-base for WHO recommendations.
Delamanid has received regulatory approval in the European Union, Japan and the Republic of Korea and registrations are underway in China, Hong Kong, Indonesia, Philippines and Turkey; delamanid is not currently approved in the US. In 2014, the WHO published an interim policy guidance on "The Use of Delamanid in the Treatment of Multidrug-Resistant Tuberculosis*2" and in 2015 delamanid was added to the WHO's Essential Medicines List.
- 1World Health Organization. Global Tuberculosis Report 2015. Geneva, Switzerland. WHO/HTM/TB/2015.22
- 2World Health Organization. The use of delamanid in the treatment of multidrug-resistant tuberculosis - interim policy guidance. 2014, Geneva, Switzerland. WHO/HTM/TB2014.23
Information in this news release was current as of the original release date.