Update on progress of MPP sublicensees Medicines Patent Pool SEPTEMBER 2018
SUMMARY This presentation showcases the progress made by MPP licensees (generic pharmaceutical companies) To date, MPP has signed agreements with nine patent holders for 13 HIV antiretrovirals, two hepatitis C direct-acting antivirals, one tuberculosis treatment and one HIV technology platform Licensed products are developed by multiple MPP licensees, with an aim of encouraging competition, reducing market prices and providing faster access to medicines for people living with HIV, hepatitis C (HCV) and tuberculosis (TB) in lowand middle-income countries (LMICs) Generic medicines are developed and filed with stringent regulatory authorities such as the U.S. Food and Drug Administration (USFDA) and the World Health Organization prequalification (WHO-PQ), ensuring availability of quality assured products in LMICs This presentation gives a snapshot of the development of each licensed product and when the product may be filed with regulators. It also shows which countries the local filing is taking place in and when thereby providing a clearer picture of availability of new formulations in each country
MPP s partnership with patent holders lopinavir ritonavir atazanavir nevirapine bictegravir cobicistat elvitegravir (separate paediatrics and adults licences) daclatasvir (HCV) (non-assert) emtricitabine tenofovir Alafenamide tenofovir Disoproxil darunavir (paed) (non-assert) sutezolid (TB) raltegravir (paed) darunavir related ravidasvir (HCV) valganciclovir (pricing agreement) solid drug nanoparticles technology for HIV abacavir (paed) dolutegravir (paed) dolutegravir (adults)
Snapshot of MPP sublicences AbacavirPaed Paed Abacavir 1 Atazanavir Atazanavir 6 Bictegravir Bictegravir 10 Cobicistat Cobicistat 8 Daclatasvir Daclatasvir 10 Dolutegravir Dolutegravir 19 * Elvitegravir Elvitegravir Lopinavir/ Ritonavir Paed Lopinavir/ Ritonavir Adult 5 1 10 Raltegravir Paed 2 Tenofovir Alafanamide Tenofovir Disoproxil Total 13 3 7 6 7 9 1 1 3 6 4 7 6 2 4 6 5 1 2 4 2 88 sublicences with 23 manufacturers; 160 active projects *MOU executed 1 1 2 1
Triangle Charts: A Snapshot Triangle charts represent a comparative analysis of each MPP licensee on filings with USFDA and WHO-PQ for each product See following slides for explanation
Filing of generics with WHO-PQ and/or USFDA Triangle charts explained (1/5)
Triangle charts explained (2/5) No. of companies that received approval out of total companies filed with WHO/stringent regulatory authorities (SRA)
Triangle charts explained (3/5) Outlined triangles (s) represent licensees planning to file Each coloured triangle corresponds to a different licensee
Triangle charts explained (4/5) Triangle charts represent a comparative analysis of each MPP licensee on filings with USFDA and WHO-PQ for each product Filled triangles (q) represent licensees who have filed
Triangle charts explained (5/5) Triangle charts represent a comparative analysis of each MPP licensee on filings with USFDA and WHO-PQ for each product A circled triangle represents a licensee who has received approval
Dolutegravir
DTG 50mg The above chart shows nine MPP licensees are developing DTG 50mg, of which: Ø Six companies have filed with WHO-PQ; of which Cipla and Hetero have received approval Ø Seven companies have filed with USFDA; of which Aurobindo, Cipla and Mylan have received approvals Emcure and Hetero have received Expert Review Panel (ERP) approvals In total, five companies are ready to supply DTG 50mg
DTG 50mg: Country-wise Filing Status Botswana Côte d'ivoire India Kenya Nicaragua Myanmar Tanzania Ukraine Uzbekistan Approved (9) 22.1% PLHIV Filed (24) 66.4% PLHIV in LMICs Burundi Kyrgyztan Senegal Congo Malawi Sierra Leone DR Congo Mauritius South Africa El Salvador Mozambique Sudan Ethiopia Namibia Uganda Gabon Nigeria Vietnam Ghana Pakistan Zambia Guyana Rwanda Zimbabwe Generic DTG has been filed in 33 countries, of which approval is received from nine. Another 30 filings are planned for 2018 (covering an additional 11.5% of people living with HIV (PLHIVs) in LMICs)
DTG 50mg Dispersible Tablets Four MPP licensees are developing DTG dispersible formulation, of which: Ø Two plan to file with WHO-PQ in Q3-19 Ø One plans to file with USFDA in early 2019 and another three by second half of 2019
TDF/3TC/DTG (TENOFOVIR DISOPROXIL/LAMIVUDINE/DOLUTEGRAVIR) 14 MPP licensees are currently developing TDF/3TC/DTG, of which: Ø Seven have filed with WHO-PQ Ø Seven have filed with USFDA; of which Aurobindo, Hetero and Mylan have received approvals Cipla, Hetero, Macleods, and Sun have received ERP approval In all, three generic versions of TLD are already in the market and an additional three are expected to be launched soon
TDF/3TC/DTG: country-wise filing status Approved (6) (19.4% PLHIV in LMICs) Botswana Côte d'ivoire India Kenya Malawi Uzbekistan Filed (25) (69.2% PLHIV in LMICs) Benin Ghana South Africa Burkina Faso Madagascar Tanzania Burundi Mali Uganda Cameroon Mozambique Ukraine Congo Namibia Vietnam DR Congo Niger Zambia El Salvador Nigeria Zimbabwe Ethiopia Rwanda Gabon Senegal Generic TLD has been filed in 31 countries, of which approval is received from six Another 25 filings are planned for 2018 (covering an additional 7.7% PLHIVs in LMICs)
TAF/FTC/DTG (TENOFOVIR ALAFENAMIDE/EMTRICITABINE/DOLUTEGRAVIR) Due to lack of clinical data, TAF is not on the WHO Guidelines as of now. However, generics have already started developing TAF combinations 10 MPP licensees are developing TAF/FTC/DTG, of which: Ø Mylan has filed with USFDA and received approval Ø Two additional filings are planned by end of 2018 We anticipate development by additional licensees to accelerate once there is an update on WHO s position about use of TAF-containing formulations
Other formulations
TAF/FTC (TENOFOVIR ALAFENAMIDE/EMTRICITABINE) Five MPP licensees are developing TAF/FTC, of which: Ø One company has filed with USFDA Ø One company is planning to file with USFDA in Q4-18 Ø An additional three companies are expected to file in 2019 We anticipate additional licensees to start development once greater clarity is obtained through WHO on the use of TAF and its combinations Note: Gilead has direct licences with additional manufacturers, details of which are not captured here
ATV/R (ATAZANAVIR/RITONAVIR) Six MPP licensees are working on ATV/r formulation, of which: Ø Mylan and Emcure received SRA approvals and have already commercialised the product Ø Cipla has received WHO-PQ approval in 2017; is yet to commercialise Ø Additionally three companies are planning to file the product Currently approved in 28 countries and filed in another 15 countries Total filing coverage: 88.7% of PLHIV in LMICs
LPV/r Seven companies are working on the LPV/r formulation, of which: Two MPP licensees approved: Aurobindo and Hetero Three additional companies (non-licensees) approved: Cipla, Macleods, Mylan And additional two companies are planning to file in the next one year Currently approved in 39 countries and filed in another 39 countries Total filing coverage: 85.1% of PLHIV in LMICs
Paediatric HIV
Paediatric projects 1 LPV/r (sprinkles in sachet or minitabs in capsule) Three companies working on this product: Ø Cipla has received USFDA approval Ø Another has filed with WHO-PQ and USFDA in Q1-18 Ø The third plans to file with USFDA and WHO-PQ in Q3-19 LPV/r/ABC/3TC (sprinkles in sachet or minitabs in capsule) Three companies working on this product: Ø One plans to file with USFDA and WHO-PQ in Dec-18 Ø Another plans to file with USFDA and WHO-PQ in 2019 Ø Another developing, filing status and plans unknown ABC/3TC/EFV Three companies working on the product Ø Filing plans in 2019 ABC/3TC/DTG Multiple companies interested in development, awaiting WHO recommendation on dosage
Daclatasvir
DAC 30mg and 60mg Seven MPP licensees currently developing the two products, of which: Ø Four have filed with WHO-PQ Ø Three filings planned in 2019 Cipla, Hetero and Mylan have received ERP approvals Currently approved in 16 countries and filed in another 30 countries
DAC 30mg & 60MG: COUNTRY-WISE FILING STATUS Approved (16) Cambodia Indonesia Chad Malawi Congo Mongolia DR Congo Myanmar Ethiopia Nicaragua Gabon Pakistan Guyana Turkmenistan India Uzbekistan Filed (30) Azerbaijan Ghana Rwanda Benin Guatemala Senegal Bolivia Haiti Sri Lanka Botswana Kenya Sudan Burkina Faso Lao PDR Suriname Burundi Namibia Tanzania Cameroon Nepal Uganda Côte d'ivoire Nigeria Vietnam Dominican Republic Paraguay Zambia Generic DAC has been filed in 46 countries, of which approval is received from 16
DAC/SOF Currently four MPP licensees are developing DAC/SOF combination, of which: Ø First filing with WHO-PQ is expected in Q3-18 Ø Another three companies plan to file in the next year Currently approved in three countries and filed in another 14 countries
DAC/SOF: Country-wise filing status and plan Approved (3) Filed (14) India Libya Uganda Dominican Republic Ghana Ethiopia Kenya Namibia Guyana Nigeria Paraguay Suriname Vietnam Zambia Myanmar Nicaragua Zimbabwe DAC/SOF has been filed in 17 countries, of which approval is received from three
MPP s Impact The MPP, through licensing agreements has enabled developing countries to benefit from access to affordable, quality-assured generics. Our impact is measured by calculating savings from the purchase of medicines developed by our licensees in additional countries where such generics sale was earlier not possible. Direct savings generated by the MPP are estimated to be USD 2.3 billion (net present value) by 2028, representing an estimated cost-benefit ratio of 1:43, which means for every USD 1 spent on MPP, the global public health community saves USD 43. The saving of USD 2.3 billion is equivalent to more than 24 million PLHIV receiving first-line ART in LMICs for one year at average prices today.
Impact of MPP agreements till DEC 2017 (HIV, HCV products) 128 countries MPP licensees distributing generics $553mn Savings 17mn patient-years Serviced by MPP licensees 146 new instances of countries Benefitted from generic competition through MPP agreements 89% average drop In formulation prices after MPP agreements Review and independent assurance of impact by KPMG* USD mn 600 500 400 300 200 100 - Cumulative savings and patients serviced through MPP licensees 2012 2013 2014 2015 2016 2017 18 16 14 12 10 8 6 4 2 - Patient years (mn) Savings Patient Years * Available at: https://medicinespatentpool.org/uploads/2018/06/final-mpp-statemen.pdf
Projected Impact of MPP Agreements Till 2028 (HIV products) The economic model projects the MPP will generate $6.8 billion in direct savings by 2028 $6.8 billion Total Direct Savings for Net Impacted PLHIVs in Expanded Territories $447 million* Total Direct Savings for Net Impacted PLHIVs in Expanded Territories till Dec-2017 * Calculation of actual impact (from data received by sub-licensees) 1:130 Cost-Benefit Ratio of MPP Operating Budget to Direct Savings
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