Twenty-five product developers now working with the MPP to manufacture low-cost, quality-assured treatments for developing countries
Geneva, 02 May 2018 — The Medicines Patent Pool (MPP) today announced five new generic manufacturing partners including the first companies from South Africa and South Korea to sign sublicensing agreements with the organisation. Adcock Ingram (Johannesburg) and Celltrion, Inc. (Incheon), along with Langhua Pharma from China, and Mangalam Drugs & Organics Limited and Arene Lifesciences Ltd. from India, join 20 other product developers working with the MPP to manufacture low-cost medicines for developing countries.
“We are pleased to expand our generic manufacturing network to 25 product developers from across the globe,” said Marie-Paule Kieny, Chair of MPP’s Governance Board. “Our increasing list of suppliers is contributing to the MPP’s overall mission to rapidly improve access to innovative treatments in low- and middle-income countries.”
The five new sublicensees signed agreements to produce dolutegravir, a best-in-class HIV treatment that the MPP licensed from ViiV Healthcare in 2014. DTG, considered a significant advancement in therapy, is recommended by the World Health Organization as an alternative first-line regimen. The treatment does not require boosting and has a good barrier to resistance, as well as high efficacy and tolerability at a relatively low dose. The ViiV Healthcare licence allows generic manufacturers to develop and sell the treatment in more than 100 developing countries.
“Adcock Ingram, a local pharmaceutical manufacturer in South Africa and one of the suppliers to the public sector, is proud to be partnering with the MPP to bring this essential antiretroviral to people living with HIV in our country,” said Chief Executive Officer Andy Hall. “DTG is widely used in the treatment of HIV and its introduction in countries hardest hit by HIV could greatly improve treatment quality and standard of care.”
Generic versions of DTG manufactured under MPP sublicences will soon reach people with HIV living in low- and middle-income countries. Several MPP sublicensing partners have received approval from regulatory agencies and expect to rollout DTG and DTG-combinations over the coming months. MPP’s partners Cipla received Tentative Approval from the US Food and Drug Administration for single tablet DTG, while partner Mylan received US FDA approval for a novel combination of DTG with lamivudine and tenofovir disoproxil, (TLD), as well as a combination of DTG with tenofovir alafenamide and emtricitabine. TLD could be the first affordable, generic single pill regimen containing DTG available to public sector purchasers for resource-limited settings.
“Dolutegravir combinations are the future of HIV treatment and Langhua Pharma recognises the crucial importance of increasing the volume of low-cost versions to help meet treatment scale-up targets globally,” said Zhang Weidong, General Manager of Langhua Pharma.
“Arene Lifesciences is happy to work with the MPP and play a critical role in improving health outcomes through affordability of and access to this important HIV treatment,” said S. Gopi Krishnan, company director.
In total, the MPP’s generic manufacturing network is managing 130 development projects to manufacture, register and deliver 13 antiretrovirals, as well as hepatitis C and tuberculosis treatments. The MPP expects to announce additional sublicences for other licensed products over the coming months.
“We are pleased to support active pharmaceutical ingredient (API) development of this key HIV medicine and look forward to working with the MPP to bring new DTG formulations to market soon,” said Govardhan M Dhoot, Chairman and Managing Director of Mangalam Drugs.
The MPP was founded and is funded by Unitaid.
About the Medicines Patent Pool
The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for 13 HIV antiretrovirals, two hepatitis C direct-acting antivirals and a tuberculosis treatment.