Geneva, 1 December 2019 — On World AIDS Day, the Medicines Patent Pool (MPP) announces a sublicence agreement with Indian manufacturing partner Cipla for the development, manufacture and supply of HIV treatment lopinavir (LPV) and ritonavir (RTV or r) individually or in combination, for paediatric use.
LPV boosted with RTV (LPV/r) is recommended by the World Health Organization (WHO) as a component of first- and second-line HIV treatment regimens for neonates and children.
“According to UNAIDS, only half of the 1.7 million children living with HIV receives antiretroviral therapy, largely because of the dearth of appropriate formulations adapted for children of different ages and weight bands,” says Charles Gore, Executive Director of MPP. “Cipla’s engagement with MPP is a very positive sign for all the children living with HIV in developing countries who will soon be able to access this key HIV treatment.”
The licence agreement signed by MPP with patent holder Abbvie in November 2014 permits generic manufacturers to produce high-quality low-cost versions of LPV/r for paediatric use for at least 102 low- and middle-income countries. The licence also allows sales of LPV/r for paediatric use in additional countries where there is no patent infringement. As a result, countries that together are home to 98.8% of children living with HIV in developing countries, benefit from the licence.
“At Cipla, we recognise the crucial importance of increasing the availability of HIV treatment options for children living with HIV, especially in developing countries,” says Paul Miller, Cipla South Africa CEO. “We look forward to working with MPP to bring LPV/r for paediatric use to market soon.”
Cipla received tentative approval from the U.S. Drug and Food Administration for its LPV/r 40/10mg in pellets for paediatric use in 2015. Such treatment is included in the 2018 optimal formulary list for paediatric ARVs, which provides guidance to country programmes, procurement entities and funding agencies on the minimum set of paediatric antiretroviral (ARV) dosage forms needed to deliver WHO-recommended ARV regimens to neonates, infants and children for all lines of treatment.
The MPP-Cipla sublicence agreement also covers Quadrimune, the new “4‑in‑1” paediatric treatment containing LPV/r currently under review by the US Food and Drug Administration (FDA) for use in children between 3 and 25 kg bodyweight.