New analysis: large pharmaceutical companies are developing five HIV/AIDS medicines for children

World AIDS Day 2016

For World AIDS Day 2016, the Access to Medicine Foundation has analysed the pharmaceutical pipelines for HIV/AIDS from 20 of the world’s largest pharmaceutical companies. Out of 51 high-burden diseases and conditions, HIV/AIDS is one of the five diseases getting the most R&D attention. Today, they have five projects in the pipeline aimed at children.

The 20 pharmaceutical companies analysed in the Index are working on 32 R&D projects for HIV/AIDS, including 23 that address high-priority product gaps. These gaps are for urgently needed new products – such as preventive vaccines, or medicines intended for use in poor countries – yet also offer low commercial incentive for companies to engage in product development. These 23 projects are being developed by eight companies.

Figure 1. Combined pipeline of R&D projects for HIV/AIDS from the 20 companies in the 2016 Access to Medicine Index

Figure 2. Individual pipelines of R&D projects for HIV/AIDS that target high-priority product gaps

Five paediatric HIV/AIDS medicines

  • ViiV Healthcare (Joint Venture between GSK and Pfizer) is developing child-sized versions of three HIV/AIDS products: maraviroc, dolutegravir (with the IMPAACT Network) and a fixed-dose combination of dolutegravir/abacavir/lamivudine. These three projects are all in phase III.
  • Johnson & Johnson is currently working on a formulation of rilpivirine for use in children, and has already gained approval for use of rilpivirine in adolescents.
  • AbbVie has received approval from the EMA for a paediatric powder formulation of ritonavir to be used in the EU. It has yet to be launched.

HIV/AIDS vaccines being developed in partnership

  • GSK and Sanofi are collaborating with others via the P5 platform (Pox-Protein Public-Private Partnership) to develop an HIV vaccine. A phase III trial in South Africa has begun.
  • Johnson & Johnson is collaborating with the Beth Israel Deaconess Medical Center and others to develop an HIV vaccine, currently in phase II trials.

The HVTN 702 HIV vaccine, developed in a partnership that includes GSK and Sanofi, is now being trialled in South Africa (image: Times Live).

New diagnostics gain approval

  • Roche’s COBAS® HIV-1 viral load test was approved by the US FDA in late 2015. Roche has committed to making its COBAS 6800/8800 diagnostic systems available at reduced prices in developing countries.
  • Merck KGaA completed development of the MUSE® kit for monitoring CD4 cell counts, including in children, in 2015. The kit is designed to be easy to use, to withstand harsh weather conditions and be compatible with variable power systems. The kit costs EUR 14,000, with each test costing EUR 4. Merck KGaA has plans to sell the kit at a lower price via the United Nations.
  • Johnson & Johnson is working with biotech firm Cue Inc. to develop a point-of-care viral-load test for HIV infections. This diagnostic is in early stages of development. It will be designed to be simple, fast and affordable in order to improve access in resource-poor settings.

Data: from the 2016 Access to Medicine Index

This analysis is based on data collected and analysed for the 2016 Access to Medicine Index, which was published on 14 November, 2016. Projects that are being developed by multiple companies are counted more than once: namely, the P5 HIV vaccine project involving GSK and Sanofi. The six HIV/AIDS medicines being developed by ViiV Healthcare (JV: GSK, Pfizer) have each been counted once.

About the Access to Medicine Index

The Access to Medicine Index analyses 20 of the world’s largest research-based pharmaceutical companies with products for high-burden diseases in low- and middle-income countries. The Index ranks these companies according to their efforts to improve access to medicine in seven areas of corporate behaviour, including pricing, patents, ethical behaviour and donations. It covers 107 low- and middle-income countries and 50 high-burden diseases, and examines eight types of products, from medicines to vaccines to diagnostics. The Index identifies best practices, highlights where progress is being made, and uncovers where critical action is still required. In this way, the Index provides both an incentive and a guide for pharmaceutical companies to do more to improve access to medicine. It is published every two years by the Access to Medicine Foundation, an independent non-profit organisation.

About the Access to Medicine Foundation

The Access to Medicine Foundation is a non-profit organisation based in the Netherlands. It aims to advance access to medicine in low- and middle-income countries by stimulating and guiding the pharmaceutical industry to play a greater role in improving access to medicine. The Foundation is funded by the Bill & Melinda Gates Foundation, the Dutch Ministry of Foreign Affairs and the UK Department for International Development. For ten years, the Foundation has been building consensus on the role for the pharmaceutical industry in improving access to medicine and vaccines. It published its first benchmark of industry activity in this area in 2008, in the first Access to Medicine Index. The fifth Access to Medicine Index has been published in 2016.