Transcript Gilead Presentation

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
Gilead’s Access Operations & Emerging Markets business unit works
to improve treatment access in resource-limited countries
Sustainability
Design access efforts for
the long term
Partnership
Adaptability
Collaborate with public
sector and other
companies
Heed lessons learned;
continually innovate
Responsibility
Focus where needs
are greatest
Gilead Access Medicines
Gilead’s developing world programs enable access to eight medicines
and generic versions of their chemical compounds
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
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 Approach to Treatment Expansion
Drug Registration
Submission of individual regulatory dossiers
on a country by country basis
Relevant Data
Broad clinical trials across broad patient
populations; local clinical trials where
appropriate; key demonstration projects
Tiered Pricing
Based on a country’s disease burden,
development status, and healthcare
infrastructure
Generic Licensing
Partnering with multiple generic drug
manufacturers encouraging marketplace
competition to lower prices
Product Donations
Targeted donations enabling treatment
initiation for key underserved populations
Partnerships & Health
Systems Strengthening
Agreements with non-profit service providers
and on the ground medical education and
training
Innovative Use of Intellectual Property
Generic Licensing
• 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
Medicines Patent Pool
• UN-supported initiative to enhance drug access
through sharing of patents
• Gilead first innovator company to join (2011)
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
Gilead Medicine
Truvada
Complera
Stribild
Viread for HIV
Viread for HBV
Sovaldi
Developing
World
Registrations
109
21
7
109
65
1
9
Critical Support Activities: Medical Education
Medical education events and materials increase knowledge of
available therapies and standards of care
Gilead works with regional business
partners and local health agencies to
ensure that medical education materials are
culturally appropriate
Gilead-supported HIV medical education event in Myanmar, 2013
Patient education aid for low-literacy
populations in Chad
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
Patents for Humanity
• #1 ranking in product
pricing
• #1 ranking in use of patents
to expand access
• Innovative use of IP
recognized by U.S. Patent
and Trademark Office's
“Patents for Humanity”
award
Therapeutic Area Focus
HIV/AIDS
Viral Hepatitis
Visceral
Leishmaniasis
35 million people
living with HIV
worldwide
Leading cause
of liver failure and
liver cancer
Second deadliest
parasitic disease
after malaria
HIV/AIDS Treatment Expansion Milestones
Gilead launches its HIV
Access Program to
provide access to TDF
in nearly 60 developing
countries
2003
2006
Gilead becomes the
first HIV manufacturer
to sign a licensing
agreement with the
Medicines Patent Pool
2011
Gilead establishes
licensing agreements
with 11 Indian generic
manufacturers,
reaching a total of 94
countries; Gilead
develops a network of
regional distributors
2014
Gilead HIV
medicines are
reaching
6 million
patients in the
developing
world
Increasing Patient Reach
More than 50% of patients on antiretroviral therapy in the developing
world are receiving Gilead medicines
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
$25
TDF/FTC
$20
TDF
$15
$10
$5
2006
2007
2008
2009
2010
2011
2012
2013
Case Study: Zambia
“In 2007, we made the most dramatic
change in our guidelines, when we
opted for tenofovir-based regimens.”
Zambia
introduces
generic Atripla®
as first-line
therapy
– Dr. Albert Mwango
National ARV Coordinator
Zambia Ministry of Health
2005
2007
More than
70K people
die of AIDS
in Zambia
1UNAIDS
Country Profile. Accessed April 17, 2014
2011 Zambia Country Progress Report
*Gilead interview with Zambian Health Ministry, October 2013
2UNGASS,
2009
AIDS deaths
fall to 37K
2011
2013
AIDS deaths
fall to 30K
90% of treatment-eligible
adults in Zambia are
receiving HIV therapy
Special Initiatives
Myanmar
Ethiopia and Uganda
Tanzania
In October 2013,
signed agreement
with National AIDS
Program to donate
generic Atripla® for
2,000 patients at
government hospitals
In early 2013, supported
HiV-Link pilot, which
connects rural Ethiopian
and Ugandan healthcare
providers with U.S. and
UK treatment experts
via text
In early 2014, with the
Holy See’s Good
Samaritan Foundation,
launched an HIV “testand-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
HBV Prevalence
Chronic hepatitis B (HBV) is
estimated to affect nearly
350 million people worldwide
≥ 8%
5-7%
2-4%
< 2%
No Data
HCV Prevalence
More than 185 million people
around the world have been
infected with the hepatitis C
virus (HCV)
> 4%
2-4%
1-1.9%
< 1%
No Data
Viral Hepatitis Treatment Expansion
Hepatitis B
Hepatitis C
• Viread for hepatitis B is available
in same 125+ countries and at
same prices as for HIV
• WHO HCV treatment guidelines
recommend treatment with
Sovaldi for genotypes 1-4
• 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
• Three tiered pricing bands for
Gilead branded medicines
• Generic licenses to produce low
cost SOF and SOF/LDV
• NGO / Gov’t partnerships
Chronic Hepatitis C
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
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
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
• Companies granted rights to manufacture sofosbuvir and single tablet regimen of
ledipasvir/sofosbuvir for distribution in 91 developing countries
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The countries account for more than 100 million people living with hepatitis C globally
– 54% of the total global infected population
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Companies receive a complete technology transfer of the Gilead manufacturing
process to enable them to scale up production as quickly as possible
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Licensees required to manufacture to local Indian DCGI quality standards
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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
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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.
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
Tiered Pricing
• 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
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Gilead classifies more countries as low- and lower-middleincome than the World Bank does
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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
Looking Ahead
• New HCV access agreements with
Ministries of Health and international
NGOs
• Development of pan-genotypic regimen
for chronic HCV
2015
• 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
Growth in Patients Reached*
Gilead Access Operations & Emerging Markets
Over 130 Access Countries
Low and Low-Middle Income Countries
95%
Access countries are home to
of people with HIV in developing countries
Products
Medicine
Lowest Price
Registrations
n Branded n Generic
17.00
Viread
26.25
Truvada
58%
Gilead’s access efforts reach
of people
in developing countries receiving HIV treatment
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4.00
5.29
Complera
FDA/WHO generic approvals: 34
* TDF-containing regimens from tech transfer recipients, branded sales, direct and MPP licensees
109
22
Thank you