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Opportunities & Challenges:Expanding Access to Hepatitis C

Treatment

Gregg Alton Executive Vice President, Corporate & Medical Affairs

Gilead Sciences

24th July, 2014

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Gilead Sciences

Discover, develop and deliver innovative medicines in areas of unmet medical need• 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• 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• 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)• Sofosbuvir/GS-5816 FDC pan-genotypic treatment in development

HBV• 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• 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

• Evolving HIV eradication program focused on two compounds – the HDAC inhibitor romidepsin and a toll-like receptor TLR-7 agonist

All treatments described above are investigational only and have not received regulatory approval

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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

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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

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Gilead HIV Treatment Expansion

5.4 million people on Gilead based ARVs today

• Viread: $17 per month (low-income)

• 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

• Generic TDF: $4 per month

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HCV Treatment Expansion

With opportunities come challenges……..what is Gilead doing?

• Appropriate drugs and diagnostics• Registration• Affordability• Education and awareness• Distribution and infrastructure

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Simple drug regimens

• Gilead’s ultimate goal is to create a simple, short-course oral cure for all HCV patients (pan genotypic, IFN, RBV free)

1st Wave(Sovaldi)

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

LDV/SOF and SOF/GS-5816 are investigational combinations only and have not received regulatory approval

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Optimal data sets for registration

• 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

– Gilead country clinical trials underway where necessary (China, India, Taiwan, Korea, Egypt, Japan, Vietnam, Russia)

• Broad data sets needed for infected population– Gilead studies in co-infection, Decompensated liver disease, Hemophilia, Sickle cell anemia,

Acute infection

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Affordability

• Need to reach low-income patients in middle-income countries

– 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

• Exploring innovative partnerships with other multinationals– Insurance companies– Islamic development Bank

• Working with global donors to encourage initial funding– PEPFAR– Global Fund

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Education & Awareness

• Health system strengthening activity– Ongoing medical and education training needs– Strengthening local health systems and local knowledge– Prevention messages

• Working with Health Ministries on medical education and knowledge exchange programs

• Working with Community Groups on awareness programs and policy change

• Working with public health providers, policy makers, and NGOs on awareness / education programs

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Distribution & Infrastructure

• On the ground distribution and logistics so the medicines get to the right patients at the right time

• Appropriate anti-diversion measures – Medicines need to go those patients for which its intended

• In-country pharmaco-vigilance– Supporting ongoing data gathering– Feedback mechanisms

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Thank you