Release date- 05102017 - Geneva - The Medicines Patent Pool (MPP) today announced a licence with Gilead Sciences for bictegravir (BIC), now under review in the United States and the European Union as part of a once daily, single tablet HIV regimen.
The licence allows manufacturers to develop and sell generic medicines containing BIC, if approved in the United States, in 116 low- and middle-income countries where more than 30 million people live with HIV.
'Bictegravir-containing combinations could offer improved, simplified treatment options, crucial for people living in resource-limited settings,' said Greg Perry, Executive Director of the Medicines Patent Pool. 'With this new licence, we look forward to our long-running collaboration with Gilead Sciences continuing to deliver significant results.'
Bictegravir is an integrase inhibitor in the same class as dolutegravir (DTG) and elvitegravir (EVG), also licensed to the MPP. A once-daily, single-tablet regimen containing BIC along with emtricitabine (FTC) and tenofovir alafenamide (TAF), BIC/FTC/TAF is currently under investigation in adults as well as children. In Phase 3 studies, BIC/FTC/TAF demonstrated high rates of viral suppression with no treatment-emergent resistance through 48 weeks among treatment-naive adults and among adults with undetectable viral loads who switched regimens.
'The once-daily, single-tablet BIC/FTC/TAF regimen has the potential to simplify the management of HIV, and we are committed to promoting its access globally,' said Gregg Alton, Executive Vice President at Gilead Sciences. 'MPP licensees with the rights to manufacture certain of Gilead's agents, including TAF and now BIC, will be able to produce the single tablet for low- and middle-income countries shortly after its approval in the United States.'
The MPP and Gilead are also expanding the geographical scope of licences on other HIV products, enabling generic medicines to be supplied to additional countries. Belarus, the Philippines, Malaysia and Ukraine are now added to the MPP-Gilead HIV collaboration for the first time through the expansion of the licences on TAF, cobicistat (COBI) and tenofovir disoproxil fumarate (TDF).
'We're tremendously pleased with the MPP and Gilead's collaborative efforts over the many years to improve health outcomes in low- and middle-income countries,' said Lelio Marmora, Executive Director of Unitaid, MPP's funder. 'Through their joint HIV licensing programme, millions stand to benefit from quality-assured generics of new optimised treatment regimens.'
The two parties signed their first voluntary licence in 2011, which was amended in 2014 and 2015, and covers five Gilead compounds: TDF, EVG, COBI, FTC and TAF. The new amendment permits manufacturers located in India, China and South Africa to manufacture bictegravir in such countries and sell products containing the compound in 116 countries, including 74 middle-income nations. It expands the number of countries in which a licensee may sell products containing TDF or TAF (from 112 to 116), EVG (from 100 to 109) and COBI (103 to 116).
The Medicines Patent Pool has now signed sublicences with 13 generic companies to manufacture and sell products containing TDF, EVG, COBI, FTC and TAF. To date, MPP sublicensees have distributed more than four billion doses of products containing TDF to 124 low- and middle-income countries.
Gilead Sciences submitted a new drug application for the single-tablet regimen containing BIC/FTC/TAF to the U.S. Food and Drug Administration on 12 June. The European Medicines Agency validated a marketing application on 13 July.
Access the licence agreement
Access Gilead's press release
Supportive statements on expansion of geographical scope:
'Successful cooperation of the Ministry of Health of Belarus with the Medicines Patent Pool is crucial in light of our current work to achieve the '90-90-90' goals and put an end to the epidemic in the country which is only possible when access to affordable and quality assured medicines is increased,' stated Valery Malashko, Minister of Health of Belarus. 'Generic Bictegravir as well as other medicines for treating HIV, which Belarus will be able to procure due to the MPP's agreement, are very much needed for the country.'
'The Ministry of Health of Ukraine welcomes the inclusion of Ukraine into the Medicines Patent Pool and Gilead licence for HIV medicines as it will permit competition between generic manufacturers-sublicensees on the Ukrainian market and will bring prices down for these life-saving medicines,' said Acting Minister of Health of Ukraine Dr. Ulana Suprun.
'We are pleased that the Medicines Patent Pool and Gilead have included Ukraine in the licence agreement for antiretroviral medicines as it is a step toward providing affordable treatment while expanding higher quality treatment options,' said Sergey Dmitriev, Director of Policy and Advocacy of the All-Ukrainian Network of People Living with HIV/AIDS.
'ECUO PLWH, a regional network of communities living with HIV across 15 Eastern Europe and Central Asia countries, welcomes the extension of the MPP's licence for bictegravir, tenofovir and other HIV medicines to include Ukraine and Belarus, countries that face numerous barriers to the access of inexpensive generic forms of HIV medicines. ECUO supports the strategy of the Medicines Patent Pool to scale up access to HIV, hepatitis C and tuberculosis medicines for our countries,' said Vladimir Zhovtyak, President of ECUO PLWH (East Europe and Central Asia Union of People Living with HIV).
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 thirteen HIV antiretrovirals, one HIV technology platform, two hepatitis C direct-acting antivirals and a tuberculosis treatment. The MPP was founded and is funded by Unitaid.
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