A sustainable model to deliver affordable, quality medicines for patients

HIV Treatment Scale:up in Africa

Clifford Samuel, Vice President,

Access Operations & Emerging Markets

Gilead

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• Focus on Patients

– All people should have access to the medicines they need, regardless of where they live or ability to pay

– The private sector can use IP responsibly to ensure access

• Focus on Science

– 5,000 employees, 24 countries on 4 continents

– Mission: Transform therapeutics for life-threatening diseases

– 15 marketed medicines

– 75 Phase 2/3 clinical trials underway

Geography and Therapeutic Focus

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HIV/AIDS

Liver Disease

Visceral Leishmaniasis

1. Branded DistributionViread® and Truvada® available

at steeply discounted prices in 130+ low- and lower middle-income countries

2. Generic LicensingPartnerships with 15 Indian manufacturers

and 1 in South Africa to produce high-quality, low-cost TDF

HIV/AIDS – Gilead’s Approach

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95% of people with HIV in developing countries

HIV Prevalence

< 0.1% of adults 0.1 – < 0.5% 0.5 – < 1.0% 1.0 – < 5.0% 5.0% No data

0

0.5

1

1.5

2

2.5

3

3.5

2006 2007 2008 2009 2010 2011 2012

Pat

ient

s –

Mill

ions

Gilead HIV Medicines in Developing Countries

Generic Licensees Branded Product

Growing Patient Reach

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3.5 million patients

44%of all receiving

treatment

Regional Business Partners

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• Regional business partners assist with critical support activities (product registration, medical education, supply management, research), and serve as Gilead’s in-country representatives

Stendahl Puerto Rico Pharmaceutical

Gador

Quadri Pharma

Aspen Pharmacare

Delta MedicalMedicopharmacia

OPV Pharmaceutical LF Asia

Anspec Pty Ltd

Abbott healthcare

Innovating to Reduce Prices

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• Generic licensing has reduced TDF prices 80% in 6 years

• 96% of Gilead HIV therapies in developing countries now generic versions – cost savings passed on to large-scale treatment programs

$4.00

*USD = Average Selling Price

2006 2007 2008 2009 2010 2011 20120

5

10

15

20

Lowest TDF Price

Pric

e pe

r P

atie

nt/M

onth

*

Patents and Voluntary Licensing

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• TDF for HIV and Hepatitis B

– Full technology transfer

– Partners seek WHO/FDA certification (20+ to date)

– 3% royalty supports product registration, medical education

• New HIV medicines

– Licenses granted before FDA approval to expedite scale-up

Elvitegravir*

Cobicistat*

Stribild® single tablet regimen

• Medicines Patent Pool

– UN-supported initiative to enhance access through sharing of patents

– Gilead first innovator company to join

• Partnerships

– Collaboration with most active generic licensees to improve FTC manufacturing process

– Goal is to reduce cost and increase global accessibility

*Elvitegravir and cobicistat and Stribild in the EU are investigational agents

On-going Sustainability

Regulatory harmonization

Single African regulatory agency

PartnershipLocal partners with local knowledge

InnovationHealthcare system strengthening

FlexibilityPricing for public and private markets

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Thank You