WIPO Global Challenges SeminarInnovation and Access: A Case Study for HIV/AIDS and Hepatitis C

Gregg Alton, Executive Vice President, Corporate and Medical Affairs

December 5, 2014

Gilead Sciences’ Commitment to Innovation and Access

Mission: Discover, develop and deliver innovative medicines in areas of unmet medical need

• The active ingredient in Gilead’s HIV medicines is the most widely prescribed molecule (TDF) for HIV therapy worldwide. Gilead improves HIV care by developing single tablet regimens.

• New hepatitis C (HCV) regimens provide a simple, safe and highly effective cure. An all-oral regimen to treat all HCV patients (pangenotypic) is in development.

Focus on patient needs

• All people should have access to our medicines, regardless of where they live or their economic status.

• As part of a comprehensive access approach, Gilead has entered into licensing agreements with generic pharmaceutical manufacturers to create a sustainable, market-based model for broadening access to HIV, hepatitis B (HBV) and HCV medicines in the developing world.

• Our partnership model for HIV now reaches more than 6.7 million patients in developing countries.

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The HIV Partnership Model: Creating Demand, Reducing Prices and Increasing Access

$5.6B

Donor support of the Gilead partnership model created demand for generic competition, resulting in prices falling 80% since 2006. We are now reaching

6.7 million people, 52 percent of those receiving HIV treatment globally.

$20.7B

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Benefits from the Licensing Model

• Technology transfer of the pharmaceutical manufacturing process

• Shortens regulatory approval process

• Ensures safety, quality and efficacy standards

• Reduces the length of time to scale up production and reach patients

• Partners have received a combined 34 U.S. FDA tentative approvals and WHO pre-qualifications

• Allows licensees to compete for high-volume business through national tenders and multilateral treatment programs

• Indian manufacturers are responsible for more than 80 percent of sales of TDF-containing medicines to developing countries through this partnership

• Economic growth in India: high-wage jobs for scientists, engineers, doctors and global managers

• Long-term capital investment in manufacturing for high-value medical products

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Epidemiology of Hepatitis C

Viral hepatitis is far more common than HIV; it is estimated that 185 million people are infected with HCV

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From Innovation to Access

• Research and development

• Develop HCV treatments with high cure rates and shortened duration of therapy, including single tablet, pangenotypic regimens

• Clinical development

• Support high-quality medical research conducted in countries where HCV is most prevalent

• Regulatory approvals

• Submit country dossiers for regulatory approvals

• Manufacturing and distribution

• Develop tiered-pricing structure, negotiate generic licenses and build regional partnerships to enable access

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Evolution of HCV Treatment

0

20

40

60

80

10091

1986 1998 20022001 2011 2013

Du

rati

on

of

Th

erap

y (m

on

ths)

3

IFN IFN IFN/RBV IFN/RBV Peg-IFN

69-75

54-56

394234

16

6

SV

R R

ate

(%)

Peg-IFN/RBV

PI/Peg-IFN/RBV

SOF/Peg-IFN/RBV

6 12 6 12 12 12 6-12

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LDV/SOF

201494-100

2-3

Gilead's Waves of HCV Drug Development

SOF, sofosbuvir, HCV NS5B nucleotide inhibitor; LDV, ledipasvir HCV NS5A inhibitor; STR, single tablet regimen.

2013

All-oral therapy for GT 2/3: SOF+RBVSimple, short duration for GT-1: SOF+Peg-IFNα+RBV

2014-2015

STR: SOF/LDVFDA approval October 2014 (GT-1); EMA approval (GT 1/4) November 2014

Pangenotypic STR: SOF/GS-5816•Key in the developing world where epidemiological data and access to genotyping diagnostics limited

Pangenotypic STR: Shortened treatment duration

Wave 12013

Wave 2 2014

Wave 3 2016

Wave 4 2016+

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Japan Korea Taiwan China Vietnam India Russia Egypt

HCVGenotypes

HCV Prevalence Estimate*

1-1.9% 1.29% 4.4% 1-1.9% 2-2.9% 1-1.9% 1-2.5% 14.9%

Wave 1(SOF)

Complete Complete CompleteMoH IND Review

MoH INDReview

Enrolling Complete Complete

Wave 2(LDV/SOF)

Complete Complete CompleteMoH IND Review

NA PlannedMoH IND Review

IND Filing Oct 2014

Wave 3(5816/SOF)

NA NA NA Planned Planned Planned Planned NA

Combined HCV Pool Estimate

45 – 72 M

1a 1b 2a 2b 2a/c 3a/b 4 6

Many Countries Require Local Clinical TrialsStudies Planned, Ongoing and Completed

*Cornberg M, et al. Liver Int. 2011 Jul; 31 Suppl 2: 30-60. Sievert W, et al Liver Int. 2011 Jul; 31 Suppl 2 : 61-809

Regulatory Submissions

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Generic Licensing: New HCV Agreements

• Biocon Limited

• Cadila Healthcare Ltd

• Cipla Ltd

• Hetero Labs Ltd

• Mylan Laboratories Ltd

• Ranbaxy Laboratories Ltd

• Sequent Scientific Ltd

• Strides Arcolab Ltd

Potential to supply therapy to more than 100 million people living with hepatitis C

•Gilead first company to announce generic licensing for HCV treatments

•91 countries included

• 54 middle-income countries

•54% of the estimated HCV-infected global population, including:

• Low income (70 million patients)• Lower middle-income (29 million patients)• Upper middle-income (1 million patients)

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• Tiered pricing

• Gilead considers gross national income (GNI) per capita and hepatitis C prevalence

• 50 countries in tiers lower than their World Bank classifications

• Three pricing bands are starting points for negotiations

• Generic licensing

• Direct and through the Medicines Patent Pool

• Countries outside the licensing territory, including poor populations in middle-income countries

• Gilead works with governments and NGOs to ensure access to HIV and viral hepatitis treatment

The Comprehensive Approach to Access

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Expanding Hepatitis C Treatment Access in Egypt

Increasing access in Egypt is a high priority, given the enormous national burden of HCV

− 12 million Egyptians infected; 15% of total pop.

Gilead and Egypt’s Ministry of Health signed an agreement in July 2014

− Sovaldi® priced at $300/bottle – our lowest available pricing, given national HCV burden

− Distributed through Government-run treatment centers

− Gilead to provide medical education and training initiatives

Egyptian Government strongly committed to scaling up HCV treatment in the country

− Goal of treating 1 million patients in 4 years

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• Country-level clinical and policy leadership• National guidelines

• Country strategic plans (i.e., awareness, screening, care and treatment)

• Healthcare system capacity

• Country-level funding

• International donor funding • Increases demand and enables global forecasting, which increases

competition and lowers prices

• Regulatory harmonization • Accelerates distribution and patient access

• Licensing and technology transfer partnerships• Ensures licensing partner program quality control through technology

transfer

• Protects partner investments in scale and manufacturing

The Foundation for Access to Medicines

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Thank you

BACK-UP SLIDES

HCV Tiered Pricing Structure

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HCV Tiered Pricing Structure

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Because Gilead’s tiered pricing structure takes disease burden into account, some countries fall into a lower income tier than their World Bank classification

(upper-middlelower-middle, lower-middlelow)

HCV Demonstration Projects

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Indonesia: Gilead partners with PKNI and the Ministry of Health to expand HCV testing and treatment among injection drug users

Mongolia: With Gilead support, the Onom Foundation works to eradicate HCV through prevention, early diagnosis and treatment