On world AIDS day, the Medicines Patent Pool (MPP) and AbbVie announced a licensing agreement for lopinavir (LPV) and ritonavir (r), top World Health Organization-recommended medicines for children.  The license will enable other companies and organisations to re-formulate and manufacture specially designed LPV/r and r paediatric treatments for distribution in low- and middle-income countries where 99 per cent of children with HIV in the developing world live.

Greg Perry, executive director of MPP informed, “This is a crucial licence for paediatric programmes in resource-limited countries as LPV/r in its current form is not suitable for those most vulnerable, infants and toddlers living with HIV.  Now, MPP and its partners have the green light to speed the development and distribution of new formulations for young children, the vast majority of whom have no access to HIV therapy.”

LPV/r-based regimens are now the WHO-preferred option for first-line treatment in children less than three years of age and second-line for older children. The MPP-AbbVie agreement supports the work of the Paediatric HIV Treatment Initiative (PHTI), a collaboration among UNITAID, MPP, the Drugs for Neglected Diseases initiative (DNDi), and the Clinton Health Access Initiative (CHAI) to spur the development of more appropriate and affordable HIV medicines for children. The PHTI is currently working with a range of stakeholders to help develop treatment options for paediatrics in the form of fixed-dose combinations (FDCs), to share patents and technology and to encourage market uptake once new FDCs are developed.

“Of the 3.2 million children with HIV in the world, more than 90 per cent live in sub-Saharan Africa with South Africa bearing a significantly high burden. New adapted treatments of LPV/r and other medicines are urgently needed to end the HIV paediatric crisis. We are thus very pleased with the agreement signed today,” said Aaron Mostoaledi, South African minister of health.

The AbbVie-MPP collaboration, which marks the first time AbbVie has granted a licence for generic production of its HIV drugs, extends MPP’s portfolio to eleven ARVs and one medicine for an opportunistic infection. MPP holds licences for other paediatric medicines from patent holders Bristol-Myers Squibb, Gilead Sciences and ViiV Healthcare and is in negotiations with Merck/MSD to license paediatric formulations of raltegravir. The LPV/r licence thus has broad implications as it enables the development of important FDCs with other MPP licensed medicines such as atazanavir/ritonavir (ATV/r) an alternative to LPV/r for children.

The MPP-AbbVie agreement covers 102 countries of which more than 65 are classified as middle-income nations. Moreover, provisions in the agreement permit manufacture and distribution in countries where AbbVie does not hold patents, such as in India where the company has withdrawn its patent applications for both lopinavir and ritonavir.

According to Mike Severino, executive vice president, research and development and chief scientific officer of AbbVie, “As a global leader in the HIV field, AbbVie is committed to working with the PHTI and MPP to ensure that all children living with HIV have access to the best medicines available. It is imperative to improve the plight of these children and our actions today will help provide the necessary access worldwide,” said Severino.

The Medicines Patent Pool is a United Nations-backed organisation founded in 2010 by UNITAID to increase access to HIV treatment and spur innovation worldwide.  The MPP offers a public health approach to negotiating patent licences for the production of low-cost versions of new and existing medicines and works with manufacturers to encourage the development of needed new technologies such as FDCs and formulations suitable for children.  To date, MPP has signed agreements for eleven antiretrovirals (ARVs) and for one medicine for an HIV opportunistic infection. Ten generic manufacturers have now licenced from the organisation.