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

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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

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Gilead Sciences Commitment to Innovation and
Access

• Mission Discover, develop and deliver innovative
  medicines in areas of unmet medical need
• The active ingredient in Gileads 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
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
5.6B
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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
2014
94-100
LDV/SOF
2-3
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Gilead's Waves of HCV Drug Development
All-oral therapy for GT 2/3 SOFRBV Simple,
short duration for GT-1 SOFPeg-IFNaRBV
2013
STR SOF/LDV FDA approval October 2014 (GT-1)
EMA approval (GT 1/4) November 2014
2014-2015

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

Pangenotypic STR Shortened treatment duration

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

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Many Countries Require Local Clinical
TrialsStudies Planned, Ongoing and Completed
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 Complete MoH IND Review MoH INDReview Enrolling Complete Complete
Wave 2(LDV/SOF) Complete Complete Complete MoH IND Review NA Planned MoH 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 45 72 M 45 72 M 45 72 M 45 72 M 45 72 M 45 72 M 45 72 M
Cornberg M, et al. Liver Int. 2011 Jul 31 Suppl
2 30-60. Sievert W, et al Liver Int. 2011 Jul
31 Suppl 2 61-80
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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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The Comprehensive Approach to Access

• 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

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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 Egypts 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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The Foundation for Access to Medicines

• 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

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• Thank you

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BACK-UP SLIDES
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HCV Tiered Pricing Structure
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HCV Tiered Pricing Structure
Because Gileads tiered pricing structure takes
disease burden into account, some countries fall
into a lower income tier than their World Bank
classification (upper-middle?lower-middle,
lower-middle?low)
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HCV Demonstration Projects
Mongolia With Gilead support, the Onom
Foundation works to eradicate HCV through
prevention, early diagnosis and treatment
Indonesia Gilead partners with PKNI and the
Ministry of Health to expand HCV testing and
treatment among injection drug users
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