November
12

Request for proposals (RfP) for selection of new manufacturer(s) for development and commercialization of affordable Rifapentine-based formulations

Published November 12th, 2018

Approximately, 1.7 billion individuals were latently infected with tuberculosis in 2014, just under a quarter of the global population. Among the latently infected population, people living with HIV and children under 5 who are household contacts of bacteriologically-confirmed pulmonary TB cases, are at a higher risk of progressing from latent infection to active disease. In 2016, the World Health Organization reported that 1.3 million people living with HIV and 160,000 children under 5 were started on TB preventive therapy globally. With newly available shorter Rifapentine (RPT)-based regimens, uptake is expected to continue to increase significantly over the next 5 years.

The Unitaid-funded project titled ‘Increasing Market and Public health outcomes through scaling up Affordable Access models of short Course preventive Therapy for TB’ (IMPAACT4TB), led by Aurum Institute, is working to accelerate access to optimal RPT-based therapies for latent TB infection (LTBI) in low- and middle-income countries. This project is implementing interventions that will:

    • Accelerate availability, development and affordability of quality assured RPT-based formulations for the 3HP regimen: a short-course TB preventive therapy regimen consisting of a high-dose of isoniazid (INH) and RPT weekly for three months for latent TB treatment, in collaboration with the innovator of RPT and new, generic manufacturers of RPT; and

    • Generate early demand and rapid uptake of the 3HP regimen by working with national TB and HIV programs in a set of focal countries included in the IMPAACT4TB project (Brazil, Cambodia, Ethiopia, Ghana, India, Indonesia, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe).

This project includes an incentive program for new, generic manufacturer(s) to develop and commercialize RPT-based products at an affordable and sustainable price. RPT, given weekly with high-dose INH for the treatment of LTBI, has significant benefits including a shorter course, once-weekly dosing and fewer side effects than other therapies. These attributes make RPT an optimal drug that can significantly improve adherence and outcomes for a large number of high-risk individuals, including people living with HIV and those in close contact with TB patients.

To initiate the generic RPT development and commercialization program, CHAI will undertake a competitive selection process to identify generic manufacturing partner(s). The RfP is open to generic manufacturers who are developing or plan to develop RPT 300 mg single and/or RPT/INH 300/300 mg fixed dosed combination and can meet the regulatory filing and pricing targets. The goal of this RfP is to mitigate some of the risks to the manufacturer(s) associated with the accelerated development and launch of a new RPT product, by providing support for product development and/or advance market commitments for Unitaid-funded procurement volumes. The manufacturer(s) will be chosen via a multi-tiered selection process.

The first step in this process is to submit a proposal in response to this RfP, with all required documents as outlined in the RfP document by Dec. 14, 2018 at 12pm EST. As listed in the RfP document, CHAI will hold an informational webinar on Nov. 15, 2018 to answer all process-related questions. For more information on how the incentive program will work, please refer to the RfP document. Companies are encouraged to submit any questions, which CHAI will be collecting and uploading in a Q&A document to be posted on CHAI’s website. For details on the webinar and how to submit questions, please refer to the RfP.

Please send an email to RifapentineRFP@clintonhealthaccess.org with any further questions you have on the program.

About Unitaid
Unitaid is an international organization that invests in new ways to prevent, diagnose and treat HIV/AIDS, hepatitis C, tuberculosis and malaria more quickly, more affordably and more effectively. It accelerates access to innovation so that critical health products can reach the people who most need them. Unitaid’s work facilitates large-scale introduction of health products through funding by the Global Fund, the United States President’s Emergency Plan for AIDS Relief (PEPFAR) and by governments. Learn more about the IMPAACT4TB-Unitaid collaboration here. For more information, please visit: https://unitaid.org/

About Aurum Institute
Established in 1998, the Aurum Institute is an African Public Benefit Organization whose mission is to improve the health of people and communities living in poverty through innovation in global health research, systems and delivery. The Aurum Institute has over 20 years of experience in public health programmatic management, implementation, clinical and translational research that seeks to inform national and international policy and practice in TB and HIV and other diseases. It has offices in South Africa, Ghana, Mozambique and the United States. For more information, please visit: https://www.auruminstitute.org/

About CHAI
The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to saving lives and reducing the burden of disease in low- and middle-income countries, while strengthening the capabilities of governments and the private sector in those countries to create and sustain high-quality health systems that can succeed without our assistance. For more information, please visit: https://clintonhealthaccess.org/

For download
RfP for development and commercialization of RPT-based formulations (PDF)
RfP for development and commercialization of RPT-based formulations (Excel)
RfP supplier information session (PPT)
RfP supplier information session (Recording)
Q&A: Responses to questions regarding the RfP (PDF)