November
14

Request for Proposal (RfP) for Selection of Generic Manufacturer for Development of Pediatric Dolutegravir (DTG)

Published November 14th, 2017

Under the Unitaid-funded project titled ‘Accelerating Patient Access to Optimal Antiretrovirals’ (Optimal ARV Project), CHAI is working to increase the affordability of and accelerate access to optimal antiretroviral (ARV) therapies in low- and middle-income countries (LMICs). This project is developing interventions that will:

  • Accelerate time to market for innovative ARV products
  • Generate early demand and rapid uptake through working with country HIV programs in a set of focal countries, including Cambodia, Kenya, Malawi, Nigeria, South Africa, Uganda, Zimbabwe and Francophone West Africa.

This project includes an incentive program for products that may require commercialization support, including priority pediatric ARVs and niche adult second-line ARV products. An expert Product Commercialization Review Panel was formed in October 2017 to support the program. The first product to avail of this program is a pediatric formulation for dolutegravir (DTG). DTG, a once-daily dosed ARV, has significant benefits including high barrier to resistance, and favorable safety and efficacy. These attributes make DTG an optimal ARV that can significantly improve treatment for a large number of children in resource-limited settings. ViiV Healthcare, the originator company for DTG, is collaborating in the project to expedite the development of DTG for pediatric populations in LMICs. Children living with HIV in LMICs currently have very limited optimal treatment options, and the highly efficacious DTG – with fewer side effects and a higher barrier to resistance than the current standard of care – can offer a significant improvement for children over current options.

To initiate the pediatric DTG development program, CHAI will undergo a competitive selection process to identify generic manufacturer partner(s). The RfP is open to those companies who have either a direct license from ViiV Healthcare or have a license for pediatric DTG from MPP. The manufacturer(s) will be chosen via a multi-tiered selection process, involving a written proposal and a potential face-to-face meeting. 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 November 30, 2017 at 5 pm EST.  As listed in the RfP document, CHAI will hold an informational webinar to answer all process-related questions.

Please contact Carolyn Amole (camole@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 CHAI-Unitaid collaboration here.

For Download

RfP for Manufacture of Generic Pediatric DTG (PDF)

RfP for Manufacture of Generic Pediatric DTG (Excel)

Informational slides (PDF)

Responses to manufacturers’ questions