Transcript Powerpoint

Opportunities & Challenges:
Expanding Access to Hepatitis C
Treatment
Gregg Alton
Executive Vice President, Corporate & Medical Affairs
Gilead Sciences
24th July, 2014
www.aids2014.org
Gilead Sciences
Discover, develop and deliver innovative medicines in
areas of unmet medical need
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6,400 employees in 28 countries on 5 continents
18 marketed medicines (US) and more than 250 ongoing and planned
clinical studies
Focus on patient needs
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All people should have access to our medicines, regardless of where
they live or their economic status
Gilead also supports medical education and training, together with local
health system improvement
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Research & Development
HCV
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Recently filed for approval of Sofosbuvir/Ledipasvir FDC in the US for treatment-naïve and
treatment-experienced GT 1 patients (8 or 12 weeks of therapy)
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Sofosbuvir/GS-5816 FDC pan-genotypic treatment in development
HBV
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Conducting early-stage research to find a cure for HBV
– Collaborating with GlobeImmune to explore an investigational therapeutic vaccine (in Phase
2 studies)
– Evaluating toll-like receptor 7 (TLR7) agonist (Phase 1 studies)
HIV
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Investigational STR (single tablet regimen) containing low-dose ARV tenofovir alafenamide (TAF)
in Phase 3 studies to address medical needs in several key populations
– Also trials for treatment of hepatitis B
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Evolving HIV eradication program focused on two compounds – the HDAC inhibitor romidepsin
and a toll-like receptor TLR-7 agonist
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All treatments described above are investigational only and have not received regulatory approval
Gilead Approach to Treatment Expansion
Tiered Pricing
Generic Licensing
Based on a country’s disease burden,
development status, and healthcare
infrastructure
Partnering with multiple generic drug
manufacturers encouraging marketplace
competition to lower prices
Relevant Data
Product Donations
Broad clinical trials across broad patient
populations; local clinical trials where
appropriate; key demonstration projects
Targeted donations enabling treatment
initiation for key
underserved populations
Partnerships & Health
Systems Strengthening
Drug Registration
Agreements with non-profit service providers
and on the ground medical education and
training
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Submission of individual regulatory dossiers
on a country by country basis
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Gilead HIV Treatment Expansion
5.4 million people on Gilead based
ARVs today
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Viread: $17 per month (low-income)
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Truvada: $26 per month (low-income)
Over 240 HIV drug registrations
17 generic licensing partnerships
First company signed to MPP
80% price reduction in TDF-based
Gilead ARVs over 8 years
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Generic TDF: $4 per month
HCV Treatment Expansion
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With opportunities come challenges…
…..what is Gilead doing?
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Appropriate drugs and diagnostics
Registration
Affordability
Education and awareness
Distribution and infrastructure
Simple drug regimens
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Gilead’s ultimate goal is to create a simple, short-course oral cure for all
HCV patients (pan genotypic, IFN, RBV free)
First all oral therapy
Sovaldi+RBV
Simple, short and effective
Sovaldi+PEG+RBV
2nd Wave
(GT 1)
First single tablet regimen
FDC of LDV/SOF
3rd Wave
(Pan-GT)
Oral therapy for all HCV
genotypes
FDC of
SOF/GS-5816
1st
Wave
(Sovaldi)
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LDV/SOF and SOF/GS-5816 are investigational combinations only and have not received regulatory approval
Optimal data sets for registration
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Submitting individual regulatory dossiers on a country by country basis
takes time. Clinical trials needed in certain countries in order for drugs to be
approved
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Gilead country clinical trials underway where necessary (China, India, Taiwan, Korea, Egypt,
Japan, Vietnam, Russia)
Broad data sets needed for infected population
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Gilead studies in co-infection, Decompensated liver disease, Hemophilia, Sickle cell anemia,
Acute infection
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Affordability
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Need to reach low-income patients in middle-income countries
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Exploring innovative partnerships with other multinationals
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Tiered pricing based on burden of disease and economic means
Allowing generic manufacturing encouraging generic competition
Working with Ministries of Health to encourage treatment scale up
Working with NGOs to undertake demonstration projects
Insurance companies
Islamic development Bank
Working with global donors to encourage initial funding
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PEPFAR
Global Fund
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Education & Awareness
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Health system strengthening activity
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Ongoing medical and education training needs
Strengthening local health systems and local knowledge
Prevention messages
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Working with Health Ministries on medical education and knowledge
exchange programs
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Working with Community Groups on awareness programs and policy
change
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Working with public health providers, policy makers, and NGOs on
awareness / education programs
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Distribution & Infrastructure
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On the ground distribution and logistics so the medicines get to the right
patients at the right time
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Appropriate anti-diversion measures
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Medicines need to go those patients for which its intended
In-country pharmaco-vigilance
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Supporting ongoing data gathering
Feedback mechanisms
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Thank you
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