WIPO Global Challenges Seminar Innovation and Access: A Case Study for HIV/AIDS and Hepatitis C Gregg Alton, Executive Vice President, Corporate and Medical Affairs December 5, 2014 Gilead Sciences’ Commitment to Innovation and Access Mission: Discover, develop and deliver innovative medicines in areas of unmet medical need • The active ingredient in Gilead’s HIV medicines is the most widely prescribed molecule (TDF) for HIV therapy worldwide. Gilead improves HIV care by developing single tablet regimens. • New hepatitis C (HCV) regimens provide a simple, safe and highly effective cure. An all-oral regimen to treat all HCV patients (pangenotypic) is in development. Focus on patient needs • All people should have access to our medicines, regardless of where they live or their economic status. • As part of a comprehensive access approach, Gilead has entered into licensing agreements with generic pharmaceutical manufacturers to create a sustainable, market-based model for broadening access to HIV, hepatitis B (HBV) and HCV medicines in the developing world. • Our partnership model for HIV now reaches more than 6.7 million patients in developing countries. 2 The HIV Partnership Model: Creating Demand, Reducing Prices and Increasing Access Donor support of the Gilead partnership model created demand for generic competition, resulting in prices falling 80% since 2006. We are now reaching 6.7 million people, 52 percent of those receiving HIV treatment globally. Patients $17.00 TDF Price Global HIV Funding 6,700 5,400 $12.42 Patients Reached (Thousands) Lowest Price (Per Patient/Month) $20.7B $12.42 $8.25 $6.50 2,400 $5.50 1,400 $5.6B 2,900 $4.49 703 30 2006 133 2007 $4.00 $4.00 413 2008 2009 2010 Year 2011 2012 2013 2014 3 Benefits from the Licensing Model • • Technology transfer of the pharmaceutical manufacturing process • Shortens regulatory approval process • Ensures safety, quality and efficacy standards • Reduces the length of time to scale up production and reach patients Partners have received a combined 34 U.S. FDA tentative approvals and WHO prequalifications • • Allows licensees to compete for high-volume business through national tenders and multilateral treatment programs Indian manufacturers are responsible for more than 80 percent of sales of TDFcontaining medicines to developing countries through this partnership • Economic growth in India: high-wage jobs for scientists, engineers, doctors and global managers • Long-term capital investment in manufacturing for high-value medical products 4 Epidemiology of Hepatitis C Viral hepatitis is far more common than HIV; it is estimated that 185 million people are infected with HCV 5 From Innovation to Access • Research and development • Develop HCV treatments with high cure rates and shortened duration of therapy, including single tablet, pangenotypic regimens • Clinical development • Support high-quality medical research conducted in countries where HCV is most prevalent • Regulatory approvals • Submit country dossiers for regulatory approvals • Manufacturing and distribution • Develop tiered-pricing structure, negotiate generic licenses and build regional partnerships to enable access 6 Evolution of HCV Treatment 1986 1998 2001 2002 2011 2013 2014 100 91 69-75 80 SVR Rate (%) 94-100 54-56 60 42 34 40 39 16 20 6 Duration of Therapy (months) 0 IFN IFN 6 12 IFN/RBV IFN/RBV Peg-IFN 6 12 12 PegPI/Peg- SOF/Peg- LDV/SOF IFN/RBV IFN/RBV IFN/RBV 12 6-12 3 2-3 7 Gilead's Waves of HCV Drug Development Wave 1 2013 All-oral therapy for GT 2/3: SOF+RBV Simple, short duration for GT-1: SOF+Peg-IFNα+RBV 2013 Wave 2 2014 20142015 Wave 3 2016 Wave 4 2016+ STR: SOF/LDV FDA approval October 2014 (GT-1); EMA approval (GT 1/4) November 2014 Pangenotypic STR: SOF/GS-5816 • Key in the developing world where epidemiological data and access to genotyping diagnostics limited Pangenotypic STR: Shortened treatment duration SOF, sofosbuvir, HCV NS5B nucleotide inhibitor; LDV, ledipasvir HCV NS5A inhibitor; STR, single tablet regimen. 8 Many Countries Require Local Clinical Trials Studies Planned, Ongoing and Completed Japan Korea Taiwan China Vietnam India Russia Egypt 1-1.9% 1.29% 4.4% 1-1.9% 2-2.9% 1-1.9% 1-2.5% 14.9% Complete Complete Complete MoH IND Review MoH IND Review Enrolling Complete Complete Complete Complete Complete MoH IND Review NA Planned MoH IND Review IND Filing Oct 2014 NA NA NA Planned Planned Planned Planned NA HCV Genotypes HCV Prevalence Estimate* Wave 1 (SOF) Wave 2 (LDV/SOF) Wave 3 (5816/SOF) Combined HCV Pool Estimate 45 – 72 M 1a 1b 2a 2b 2a/c 3a/b 4 6 *Cornberg M, et al. Liver Int. 2011 Jul; 31 Suppl 2: 30-60. Sievert W, et al Liver Int. 2011 Jul; 31 Suppl 2 : 61-80 9 Regulatory Submissions 10 Generic Licensing: New HCV Agreements Potential to supply therapy to more than 100 million people living with hepatitis C • Biocon Limited • Cadila Healthcare Ltd • Cipla Ltd •Gilead first company to announce generic licensing for HCV treatments • Hetero Labs Ltd •91 countries included • Mylan Laboratories Ltd • Ranbaxy Laboratories Ltd • Sequent Scientific Ltd • Strides Arcolab Ltd • 54 middle-income countries •54% of the estimated HCV-infected global population, including: • • • Low income (70 million patients) Lower middle-income (29 million patients) Upper middle-income (1 million patients) 11 The Comprehensive Approach to Access • Tiered pricing • Gilead considers gross national income (GNI) per capita and hepatitis C prevalence • 50 countries in tiers lower than their World Bank classifications • Three pricing bands are starting points for negotiations • Generic licensing • Direct and through the Medicines Patent Pool • Countries outside the licensing territory, including poor populations in middle-income countries • Gilead works with governments and NGOs to ensure access to HIV and viral hepatitis treatment 12 Expanding Hepatitis C Treatment Access in Egypt Increasing access in Egypt is a high priority, given the enormous national burden of HCV − 12 million Egyptians infected; 15% of total pop. Gilead and Egypt’s Ministry of Health signed an agreement in July 2014 − Sovaldi® priced at $300/bottle – our lowest available pricing, given national HCV burden − Distributed through Government-run treatment centers − Gilead to provide medical education and training initiatives Egyptian Government strongly committed to scaling up HCV treatment in the country − Goal of treating 1 million patients in 4 years 13 The Foundation for Access to Medicines • Country-level clinical and policy leadership • • • • National guidelines Country strategic plans (i.e., awareness, screening, care and treatment) Healthcare system capacity Country-level funding • International donor funding • Increases demand and enables global forecasting, which increases competition and lowers prices • Regulatory harmonization • Accelerates distribution and patient access • Licensing and technology transfer partnerships • • Ensures licensing partner program quality control through technology transfer Protects partner investments in scale and manufacturing 14 Thank you BACK-UP SLIDES HCV Tiered Pricing Structure 8 HCV Tiered Pricing Structure Because Gilead’s tiered pricing structure takes disease burden into account, some countries fall into a lower income tier than their World Bank classification (upper-middlelower-middle, lower-middlelow) 8 HCV Demonstration Projects Mongolia: With Gilead support, the Onom Foundation works to eradicate HCV through prevention, early diagnosis and treatment Indonesia: Gilead partners with PKNI and the Ministry of Health to expand HCV testing and treatment among injection drug users 8