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Treatment Expansion in Access & Emerging Markets
Cristin Lis
Vice President, Government Affairs
October 22, 2014
Gilead Sciences
Mission: Discover, develop and deliver innovative medicines in areas of unmet medical need
•7,000 employees in 28 countries on 5 continents
•17 marketed medicines (US) and more than 250 ongoing and planned clinical studies
Focus on patient needs
•All people should have access to our medicines, regardless of where they live or their economic status
•Gilead also supports medical education and local health system improvement
2
Access Operations & Emerging Markets Geography
Gilead medicines reach patients in more than 125 countries supplied by 20 regional business partners
Access Guiding Principles
PartnershipCollaborate with public
sector and other companies
AdaptabilityHeed lessons learned;
continually innovate
SustainabilityDesign access efforts for
the long term
ResponsibilityFocus where needs
are greatest
Gilead’s Access Operations & Emerging Markets business unit works to improve treatment access in resource-limited countries
Viread® (TDF) tenofovir disoproxil fumarate 300 mg
Truvada® (TDF/FTC) emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
Complera®
(RVP/TDF/FTC)emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg
Tybost® cobicistat 150mg
Vitekta® elvitegravir 150mg
Stribild®
(EVG/COBI/TDF/FTC)elvitegravir 150 mg/cobicistat 150 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg
Sovaldi® sofosbuvir 400 mg
AmBisome® 1 amphotericin b liposome for injection 50 mg/vial
Gilead Access Medicines
1 AmBisome is not available in generic form. Gilead provides AmBisome to public sector agencies at no-profit prices and donates the medicine to WHO for use in high-burden countries.
Gilead’s developing world programs enable access to eight medicines and generic versions of their chemical compounds
Gilead Approach to Treatment Expansion
Tiered PricingBased on a country’s disease burden, development status, and healthcare
infrastructure
Generic LicensingPartnering with multiple generic drug
manufacturers encouraging marketplace competition to lower prices
Partnerships & Health Systems Strengthening
Agreements with non-profit service providers and on the ground medical education and
training
Product DonationsTargeted donations enabling treatment
initiation for key underserved populations
Relevant DataBroad clinical trials across broad patient
populations; local clinical trials where appropriate; key demonstration projects
Drug RegistrationSubmission of individual regulatory dossiers
on a country by country basis
Generic Licensing
Innovative Use of Intellectual Property
Medicines Patent Pool• UN-supported initiative to enhance drug access
through sharing of patents
• Gilead first innovator company to join (2011)
• HIV, HBV and HCV
- Treatment scale:up in resource poor settings
- Indian, Chinese and African licensees
- Full technology transfer
- Small royalty to ensure sustainability of programs
Critical Support Activities
Together with our partners, we conduct a number of support activities to help ensure effective and appropriate use of Gilead medicines and
strengthen health systems in developing countries
Product Registration
Medical Education & Training
Logistics & Supply
Management
Collaborative Research
Critical Support Activities: Product Registration
Regional business partners help register medicines with national regulatory authorities, ensuring that documents conform to national
requirements and are processed efficiently
9
Gilead Medicine Truvada Complera Stribild Viread for HIV Viread for HBV Sovaldi
DevelopingWorld
Registrations109 21 7 109 65 1
Critical Support Activities: Medical Education
Medical education events and materials increase knowledge of available therapies and standards of care
Patient education aid for low-literacy populations in Chad
Gilead-supported HIV medical education event in Myanmar, 2013
Gilead works with regional business partners and local health agencies to ensure that medical education materials are culturally appropriate
Critical Support Activities: Supply Management
A reliable supply chain is essential to treatment expansion
Proprietary information tools track orders and inventory across regions and avoid supply stock-outs
Partnerships with organizations such as the Clinton Health Access Initiative help coordinate large-scale purchasing of medicines
Critical Support Activities: Collaborative Research
Gilead supports clinical research to determine optimal use of its
medicines in Africa, Asia and Latin America
Studies address:
•How to reach more patients by streamlining clinical procedures
•The potential benefits of early treatment initiation
•The safety and efficacy of treatment for children and adolescents
Recognition of Gilead’s Access Efforts
Access to Medicine Index• #1 ranking in product pricing
• #1 ranking in use of patents to expand access
Patents for Humanity• Innovative use of IP
recognized by U.S. Patent and Trademark Office's “Patents for Humanity” award
Therapeutic Area Focus
35 million people living with HIV
worldwide
Leading cause of liver failure and
liver cancer
Second deadliest parasitic disease
after malaria
HIV/AIDS Viral HepatitisVisceral
Leishmaniasis
HIV/AIDS Treatment Expansion Milestones
20062006 20112011 2014201420032003
Gilead HIV medicines are reaching 6 million patients in the developing world
Gilead launches its HIV Access Program to provide access to TDF in nearly 60 developing countries
Gilead establishes licensing agreements with 11 Indian generic manufacturers, reaching a total of 94 countries; Gilead develops a network of regional distributors
Gilead becomes the first HIV manufacturer to sign a licensing agreement with the Medicines Patent Pool
More than 50% of patients on antiretroviral therapy in the developing world are receiving Gilead medicines
Increasing Patient Reach
Generic drug manufacturers account for 99% of Gilead HIV medicines prescribed in developing countries
Increased Competition Lowers Drug Prices
17 generic partners are licensed to manufacture and sell Gilead HIV therapies; market competition has helped reduce the cost of TDF
by 80% since 2006
2006 2007 2008 2009 2010 2011 2012 2013
$25
$20
$15
$10
$5
TDF/FTC
TDF
Case Study: Zambia
1UNAIDS Country Profile. Accessed April 17, 20142UNGASS, 2011 Zambia Country Progress Report*Gilead interview with Zambian Health Ministry, October 2013
20072007 20092009 20112011 2013201320052005
More than 70K people die of AIDS in Zambia
“In 2007, we made the most dramatic change in our guidelines, when we opted for tenofovir-based regimens.”
– Dr. Albert MwangoNational ARV CoordinatorZambia Ministry of Health
“In 2007, we made the most dramatic change in our guidelines, when we opted for tenofovir-based regimens.”
– Dr. Albert MwangoNational ARV CoordinatorZambia Ministry of Health
AIDS deaths fall to 37K
Zambia introduces generic Atripla® as first-line therapy
90% of treatment-eligible adults in Zambia are receiving HIV therapy
AIDS deaths fall to 30K
Special Initiatives
Myanmar
In October 2013, signed agreement with National AIDS Program to donate generic Atripla® for 2,000 patients at
government hospitals
Ethiopia and Uganda
In early 2013, supported HiV-Link pilot, which
connects rural Ethiopian and Ugandan healthcare providers with U.S. and UK treatment experts
via text
Tanzania
In early 2014, with the Holy See’s Good
Samaritan Foundation, launched an HIV “test-
and-treat” demonstration project to screen 120,000
patients and provide ARVs to 20,000
Viral Hepatitis
Viral hepatitis is far more common than HIV; it is estimated that more than 500 million people are affected by viral hepatitis
Chronic hepatitis B (HBV) is estimated to affect nearly 350 million people worldwide
More than 185 million people around the world have been infected with the hepatitis C virus (HCV)
HBV Prevalence HCV Prevalence
≥ 8%5-7%2-4%< 2%No Data
> 4%2-4%1-1.9%< 1%No Data
Viral Hepatitis Treatment Expansion
Hepatitis B
• Viread for hepatitis B is available in same 125+ countries and at same prices as for HIV
• Viread for HBV is now registered in over 60 countries and has been filed for approval or is pending submission in more than 50 additional countries
Hepatitis C
• WHO HCV treatment guidelines recommend treatment with Sovaldi for genotypes 1-4
• Three tiered pricing bands for Gilead branded medicines
• Generic licenses to produce low cost SOF and SOF/LDV
• NGO / Gov’t partnerships
Gilead’s strategy is to invest in long-term partnerships with governments and NGOs to implement public health plans, and engage regulatory and funding agencies to support national treatment strategies
Chronic Hepatitis C
Tiered pricing of Gilead branded medicines for low-, lower-middle and upper-middle income countries
Licensed generic SOF and LDV/SOF for distribution in 91 developing countries
Over 20 regional business partnerships to manage supply chains and distribute branded Sovaldi in developing countries
Registrations focusing initially on the highest-burden countries & greatest needs
Medical education to train health care providers in hepatitis C diagnosis and care
Generic Licensing
• Companies granted rights to manufacture sofosbuvir and single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries
- The countries account for more than 100 million people living with hepatitis C globally – 54% of the total global infected population
- Companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible
- Licensees required to manufacture to local Indian DCGI quality standards
- Licensees set their own prices for the product they produce, paying a royalty on sales to Gilead to support product registrations, medical education/training, safety monitoring and other business essential activities
- Large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries.
15th September 2014: Gilead Sciences signed non-exclusive license agreements with seven generic pharmaceutical manufacturers to expand access to hepatitis C medicines in developing countries
Indian Generic Licensees
• Cadila Healthcare Ltd
• Cipla Ltd
• Hetero Labs Ltd
• Mylan Laboratories Ltd
• Ranbaxy Laboratories Ltd
• Strides Arcolab Ltd
• Sequent Scientific Ltd
More than 100 million people living with hepatitis C
•91 countries included
•54% of the estimated HCV infected global population
• 75% of countries designated low-middle Income
• 90% of people living in low-middle income countries
• Three basic tiered pricing bands that serve as the starting point for negotiations with national governments
• Countries are categorized within the bands according to gross national income (GNI) per capita (a reflection of the average income of a country’s citizens) and hepatitis C prevalence.
- The tiers follow World Bank nomenclature of (i) Low-income; (ii) Lower-middle-income; (iii) Upper-middle-income
- Gilead classifies more countries as low- and lower-middle-income than the World Bank does
- As disease prevalence is considered, some countries classified as lower-middle-income by the World Bank are included in Gilead’s lowest tier
• Final prices are determined on a country-by-country basis
Tiered Pricing
Looking Ahead
2015
• New HCV access agreements with Ministries of Health and international NGOs
• Development of pan-genotypic regimen for chronic HCV
• Further expansion of HIV partnerships
• Roll out TAF treatment expansion for HIV and HBV
• Continued collaboration with WHO, NGOs on VL
2014 (Q2) HIV Dashboard Gilead Access Operations & Emerging Markets
Growth in Patients Reached*Low and Low-Middle Income Countries
Gilead’s access efforts reach 58% of people in developing countries receiving HIV treatment
Over 130 Access Countries
Access countries are home to 95%of people with HIV in developing countries
ProductsMedicine Lowest Price Registrations
Viread 109
Truvada 109
Complera 22
Branded Generic
FDA/WHO generic approvals: 34
17.00
4.00
26.25
5.29
* TDF-containing regimens from tech transfer recipients, branded sales, direct and MPP licensees
Thank you