Generic manufacturer of a key antiretroviral treatment has been made possible by a new licensing arrangement brokered by the Medicines Patent Pool (MPP).
The agreement with AbbVie, a global biopharmaceutical company, that should ensure low cost supplies of Lopinavir/Ritonavir (LPV/r) across Africa. It is the most widely used second-line HIV treatment in use across Africa.
Under the agreement, generic ARV manufacturers, upon obtaining a sublicense from MPP, will now be able to manufacture and sell generic versions of LPV/r throughout Africa, as well as combinations of ritonavir with other ARVs, such as atazanavir and darunavir, as alternative second-line treatments.
‘This agreement, which the South African government actively encouraged, will significantly help the Ministry of Health to care for its communities living with HIV,’ said South African Minister of Health, Aaron Motsoaledi. ‘LPV/r is critical for second-line treatment in our country and we need to secure supply of the product, especially as treatment needs increase. We welcome the agreement between MPP and AbbVie which will increase the number of manufacturers that can supply the treatment to our people.’
‘This is a significant step forward that will further improve access to second-line antiretroviral treatment,’ said UNITAID Executive Director Lelio Marmora. ‘It is through catalytic partnerships that we are helping to change the reality on the ground for people living with HIV.’
The MPP will work to swiftly grant licences to generic manufacturers with stringent regulatory approval. Those that have already received regulatory approval for these medicines in South Africa will be able to distribute in the country. The South African government will consider applications from other manufacturers that wish to seek approval under its fast track process. The agreement will also allow global manufacturers to supply LPV/ r and other ritonavir-based combinations to the whole African continent.
‘Africa accounts for approximately 90% of the total usage of LPV/r in donor-funded developing countries,’ said Greg Perry, Executive Director of the Medicines Patent Pool. ‘While many African countries are currently able to purchase generic versions of these medicines from India, this licence will now enable manufacturers in other countries where there are patents, such as China and South Africa, to manufacture LPV/r and other ritonavir-based treatments for Africa, thus broadening the supplier base for the entire continent.’
The licence is royalty free and, as is the case for all MPP licences, is non-exclusive and published on the MPP website. The agreement represents the second licence established between MPP and AbbVie. The first agreement was for paediatric formulations of LPV/r signed December last year.
Mike Severino, Executive Vice President, Research and Development and Chief Scientific Officer of AbbVie, commenting on the agreement stated that, ‘As a major provider of HIV medicines in Africa for 15 years, it is of the utmost importance to AbbVie that patients have continuous access to these critical therapies. We believe that this agreement with the MPP will help to address long-term and sustainable access to ARV treatments to help meet the increasing demand for treatment in Africa.’