State of Industry Readiness for the New Demand Following the New Treatment Guidelines
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1 JOINT MEDICINES PATENT POOL & WHO SATELLITE ON BRIDGING THE NEW TREATMENT GAP: WHAT WILL IT TAKE? State of Industry Readiness f the New Demand Following the New Treatment Guidelines Louis J. Riceberg, Ph.D. and Harald Rinde, MD, MBA Copenhagen, Denmark, 24 September 2013 UN City Copenhagen, Marmvej, 51. DK-2100 Copenhagen
2 Study Objective Me Complex Questions Original Question Is there sufficient capacity f tenofovir as a result of the new guidelines? 1. Is there sufficient capacity f the increased demand f ARV s? 2. What is the overall readiness f delivering anti-retroviral therapies (ART s)? 3. What are the ptfolio considerations that companies will assess? 4. What is the risk f ARV drug shtages? 2
3 First Line Recommendations 2010 Zidovudine (AZT) Tenofovir (TDF) Lamivudine (3TC) Emtricitabine (FTC) Efavirenz (EFV) Nevirapine (NVP) 2013 Tenofovir (TDF) Lamivudine (3TC) Emtricitabine (FTC) Efavirenz (EFV) 3
4 2010 Tenofovir (TDF) Lamivudine (3TC) Emtricitabine (FTC) Second Line Recommendations Atazanavir (ATV)/ritonavir Lopinavir (LPV)/ritonavir Zidovudine (AZT) Lamivudine (3TC) Emtricitabine (FTC) Atazanavir (ATV)/ritonavir Lopinavir (LPV)/ritonavir 2013 Zidovudine (AZT) Tenofovir (TDF) Lamivudine (3TC) Emtricitabine (FTC) Lamivudine (3TC) Emtricitabine (FTC) Atazanavir (ATV)/ritonavir Lopinavir (LPV)/ritonavir Atazanavir (ATV)/ritonavir Lopinavir (LPV)/ritonavir 4
5 Utilization of NRTI s in ART Therapy 2009 The use of first line NRTI s and NNRTi s will dramatically increase as a result of the new guidelines NRTI s TDF FTC ABC ddi Lamivudine (3TC) 44.9 Stavudine (d4t) 30.8 Zidovudine (AZT) 16.2 Tenovovir (TDF) 4.3 Emtricitabine (FTC) 3.4 Didanosine (ddi) 0.2 Abacavir (ABC) 0.2 AZT d4t 3TC LPV/r IDV First Line Second Line NNRTI s and PI s Nevirapine (NVP) 72.6 EFV Efavirenz (EFV) 23.9 Lopinavir/ritonavir (LPV/r) 3.4 Indinavir (IDV) 0.1 Nelfinavir (NFV) 0 NVP Source: Filler, SJ et al., J Acquir Immune Defic Syndr 2011;57:e1 e6 5
6 Increase in Tenofovir Utilization % FDC 50% 45% 40% 35% 30% 25% 20% Increase in Tenofovir and FDC's 50.0% 45.0% 40.0% 35.0% 30.0% 25.0% 20.0% %Tenofovir In 2012 tenofovir containing ARV s represented 48% of all ARV s purchased by the Global Fund Of the tenofovir purchases, 47% of the dollars spent were fixed dose combinations 15% 15.0% 10% 10.0% 5% 5.0% 0% YEAR 0.0% %FDC Source: Global Fund Database %Tenofovir Rapid rise in tenofovir even befe the WHO change 6
7 Large Underserved Population Numbers of people eligible f antiretroviral therapy in low- and middle-income countries under WHO 2010 and WHO 2013 antiretroviral guidelines, based on the epidemic and response status at the end of Pre-2013 guidelines: 55% ART coverage (9.1 mill of 16.9 mill patients) Post-2013 guidelines: 35% ART coverage (9.1 mill of 25.9 mill patients) Source: HIV TREATMENT, GLOBAL UPDATE ON HIV TREATMENT 2013: RESULTS, IMPACT AND OPPORTUNITIES WHO rept in partnership with UNICEF and UNAIDS, JUNE
8 PEPFAR 2011 Operational Plan Program Area Total Approved Funding (millions) PMTCT MTCT PMTCT $ Sexual Prevention Biomedical Prevention Budget Code HVAB Abstinence and Fidelity $ HVOP Other Prevention $ CIRC Male Circumcision $86.90 HMIN Injection Safety $24.40 HMBL Blood Safety $50.70 IDUP Injecting and non Injecting Drug Use $27.70 Counseling and Testing HVCT Counseling and Testing $ Adult Care and Treatment Pediatric Care and Treatment HTXS PDCS Adult Treatment Pediatric Care and Suppt $ $59.50 HBHC PDTX Adult Care and Suppt Pediatric Treatment $ $ TB/HIV HVTB TB/HIV $ OVC HKID Orphans and Vulnerable Children $ ARV Drugs HTXD ARV Drugs $ Labaty Infrastructure HLAB Labaty Strengthening $ Strategic Infmation HVSI Strategic Infmation $ Health Systems Strengthening OHSS Health Systems Strengthening $ Management & Operations Subtotal: Prevention, Treatment and Care Total: All Program Areas M&O Management and Operations $ $3, $4, % Spent on ARV Drugs % OVC 10% OVC budgetary requirement 10%: (HKID) / (Subtotal, Prevention, Treatment and Care) % Care and Treatment f PLWHA 51% Care & Treatment budgetary requirement 50%: (HBHC + HTXS + PDCS + PDTX + HVTB + HTXD) / (Subtotal, Prevention, Treatment and Care) 8
9 Suppt costs of ARV s far exceed the cost of the medicines... ARV Suppt Costs Patient management includes Antiretroviral drugs (ARVs) f patient treatment Non-ARV recurrent costs such as: Clinical staff salaries and benefits Labaty and clinical supplies Non-ARV drugs f opptunistic infections Building utilities Travel Contracted services Investment (health system strengthening) costs such as: ARV buffer stock (inventy) to suppt a reliable supply chain Building renovation & construction Labaty and clinical equipment In-service training of ART providers Program management and central suppt costs 9
10 Global Fund Expenditures 23 % Spent on Medicines and Pharmaceutical Products 10
11 Regulaty and Purchasing Environment Manufacturers with experience in and approvals f FDC s could be the fastest route to addressing capacity issues Global Fund FDA PQP Aspen Pharmacare Ltd. Aurobindo Pharma Limited Aurobindo Pharma Ltd Aurobindo Pharma Ltd Cipla Limited Cipla Ltd Cipla Ltd Hetero Labs Limited Unit III Gilead Sciences, Inc. Gilead Sciences, Inc. Macleods Pharmaceuticals Limited Hetero Labs Limited Hetero Labs Limited Mylan Labaties Limited Macleods Pharmaceuticals Ltd Mylan Labaties Ltd Ranbaxy Labaties Ltd Strides Arcolab Limited =FDC Suppliers/Approved API with PQP APPROVAL 11 Ranbaxy Labaties Ltd Strides Arcolab Limited INN Applicant Lamivudine Shanghai Desano Chemical Pharmaceutical Co Ltd Laurus Labs Pvt Ltd Shijiazhuang Lonzeal Pharmaceuticals Co Ltd Nevirapine Laurus Labs Pvt Ltd Mylan Labaties Ltd Tenofovir disoproxil (fumarate) Laurus Labs Pvt Ltd Zidovudine Zhejiang Langhua Pharmaceutical Co Ltd Sequent Scientific Ltd Shanghai Desano Chemical Pharmaceutical Co Ltd
12 Learn from Histy Reasons f Drug Shtages in Europe % (n=41) Lack of profitability 37% (Parallel) Expt 20% Restrictive reference pricing 17% Tender issues 17% Dependency on a single few manufacturers 17% Manufacturer capacity issues 15% Upfront payments / delayed payments 15% Regulaty insufficiencies 15% Increased demand 12% Production / quality issues 12% Political / economic issues 12% Cheapest product substitution policy 10% Distribution inefficiencies 10% Supply chain issues 10% Lack reduction in local manufacturing 7% Procurement inefficiencies 5% Lack of API 2% Cruption 0% Potential Issue with ARV Availability Source: Harald RINDE (BioBridge Strategies), Anke-Peggy HOLTORF (BioBridge Strategies), Jie SHEN. Drug shtages, the extent and causes (publication in preparation) 12
13 The Business Challenge Manage Overall Profitability Decreasing average selling prices have enabled treating me patients Generic manufacturers mainly in India - have successfully maintained profitability through efficiencies in manufacturing Variable costing approach has maintained single digit profitability But, is that sufficient to ensure long term sustainable supply? 13
14 Is there profitability in the ARV market Nakakeeto and Elliott analysis. Three Drug Combination Tablets Two Drug Combination Tablets Single Drug Fmulations Material Cost Employee Cost Operating Expenditures R&D Interest Depreciation Amtization of Goodwill Profit Indian Manufacturers Public Manufacturers Median Price 1,488 1,488 Total Production Cost 2,041 1,634 (557) (147) Fully burdening ARVs with fixed cost may lead to a negative net profit level 14
15 Drugs Going Off Patent Between 2011 and drugs will go off patent Total Cumulative U.S. revenue (2011) of $51 billion Source: 2012 Medco Health Solutions, Inc 15
16 Cost of Expansion Building a manufacturing facility can cost $40 million. Cost of land Cost of shell Cost of manufacturing equipment Cost of Quality Control equipment Cost of communication infrastructure 16
17 Capacity Availability Availability of capacity is a relative analysis. How much capacity is being dedicated to ARV s and how much unused capacity is available both in API s and in FPP s. API Capacity FPP Capacity Excess Capacity ARV Needs Other Indications Excess Capacity ARV Needs Other Indications ARV Increased Capacity Requirements Current Capacity Utilization ARV Increased demand f non ARV s will compete f capacity in API s and FPP s. 17
18 Path Fward Despite the challenges, if we wk together and are not afraid to modify our attitudes, policies and behavis we will be able to achieve our ultimate goals. 18
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