Generic manufacturers sign sublicences to produce long-acting HIV medicine
Posted: 31 March 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
Sublicence agreements signed by the Medicines Patent Pool (MPP) and three generic manufacturers could enable millions to access a long-acting HIV medicine.
The Medicines Patent Pool (MPP) has signed sublicence agreements with three generics manufacturers to produce generic versions of cabotegravir long-acting (LA) injectable for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP).
First sublicence agreement signed by MPP for a long-acting medicine
Through the sublicences, the selected generic manufacturers will be able to develop, manufacture, and supply generic versions of cabotegravir LA for PrEP, in 90 countries, subject to required regulatory approvals. The pharma companies who will manufacture the generic versions are Viatris, Aurobindo and Cipla.
The sublicense agreements are the first that MPP has signed for a long-acting medicine, according to Executive Director of MPP, Charles Gore. They have “the potential to enable substantial scale-up and implementation of Cabotegravir LA for HIV prevention… in the long term,’’ according to Dr Meg Doherty, Director of World Health Organization (WHO)’s Global HIV, Hepatitis and STIs Programmes.
“This is the first time a longer acting injectable product for prevention of HIV infection will be made available in the LMIC, through this license,” Kambam Nithyananda Reddy, Vice Chairman & Managing Director of Aurobindo noted.
Only seven months after the first regulatory approval of cabotegravir LA for PrEP by the US Food and Drug Administration (FDA), ViiV Healthcare and MPP signed a voluntary licence agreement in July 2022. This was for patents relating to cabotegravir LA for PrEP, to facilitate access in all least developed, low-income, lower-middle-income and sub-Saharan African countries.
Cabotegravir long-acting injectable for HIV
Cabotegravir LA for PrEP has the potential to change the trajectory of HIV”
Cabotegravir long-acting injectable for HIV prevention is the first and only long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition.
The treatment “has the potential to change the trajectory of HIV,” stated Deborah Waterhouse, CEO at ViiV Healthcare.
Biopharmaceuticals, Distribution & Logistics, Drug Development, Drug Supply Chain, Industry Insight, Legal, Manufacturing, Patents, Production, Regulation & Legislation, Therapeutics
Aurobindo, Cipla, The Medicines Patent Pool (MPP), The World Health Organization (WHO), Viatris, ViiV Healthcare
Charles Gore, Deborah Waterhouse, Dr Meg Doherty, Kambam Nithyananda Reddy