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Presentation by Gilead made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.
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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
2
• 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
3
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
4
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
5
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
7
• 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
9
Thank You
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