INNOVATIVE PUBLIC-PRIVATE PARTNERSHIP INITIATIVE TO ACCELERATE DEVELOPMENT OF OPTIMAL PAEDIATRIC FORMULATIONS OF DOLUTEGRAVIR TO IMPROVE THE LIVES OF CLHIV

We are delighted to announce the joint launch of a partnership to speed up development and introduction of optimized paediatric formulations of dolutegravir for children living with HIV in resource-limited settings.

The new initiative includes an incentive program and is a key feature of Unitaid’s US$34 million Optimal Antiretroviral (ARV) grant to CHAI. The optimal ARV grant aims to bring optimized HIV drugs to market more quickly than in the past and integrate them into treatment programs in communities that need them most. As part of this, CHAI is also working closely with health ministries, community leaders and other partners to support introduction in resource-limited settings.

Accelerating the development of paediatric ARVs and increasing access to HIV testing for children in resource-limited setting is a strategic investment priority for Unitaid. As part of this program, and with funding from Unitaid, CHAI and ViiV Healthcare will work together to improve the availability of paediatric formulations of dolutegravir. A key aspect of the initiative to-date has been the competitive selection of two generic manufacturers, Mylan Laboratories Limited and Macleods Pharmaceuticals Limited. The initiative provides Mylan and Macleods with a financial incentive award from Unitaid via CHAI, as well as the technical expertise of ViiV Healthcare, to catalyse the development, manufacture and supply of generic formulations of paediatric dolutegravir.

ViiV Healthcare, the company that researched and developed dolutegravir, continues to press ahead with the clinical development and registration of its own paediatric formulations of dolutegravir. ViiV Healthcare is also enabling generic pharmaceutical companies to manufacture and sell generic versions of the medicine in resource-limited settings through existing royalty-free licensing agreements that have been granted both directly and via the Medicines Patent Pool.

This initiative is an important step towards our commitments under the Rome Action Plan agreed in November 2017 at the Vatican, to ramp up access to paediatric HIV treatment with innovative medicines like dolutegravir.

We look forward to sharing updates as the program progresses.