This presentation is a school work and represents student ideas and analysis ( safe harbor). Perrine Dieusaert, Malam Aboubakar and I, presented it in January 2009.

1. 1

2. Increasing antiretroviral treatment
access in developing countries
Malam Aboubakar
Perrine Dieusaert
Jean-Luc Hitimana

3. A global view of HIV infection
worldwide
16 000
40 million
2,7 million
95% 2 millionMore than 28%
3

4. Treatment coverage worldwide
6%
84% 19%
5%
2-5%
7%
4

5. AIDS, a real weapon of mass
destruction
75%
5

7. - Treatment
 1987 : 1st Nucleoside Reverse transcriptase Inhibitors (AZT)
 1989-1994 : New Reverse transcriptase Inhibitors (d4T, 3TC)
 1995 : Bitherapy
 1996 : Protease Inhibitors (Kaletra) and tritherapy
 1998-1999 : Non nucleoside Reverse transcriptase Inhibitors
( Viramune, Efavirenz, Sustiva )
 2002 : Nucleotide Reverse transcriptase Inhibitors (Viread)
 2003 : Entry Inhibitors (Fuzeon)
 2006 : Tritherapy once a day
(Atripla = Sustiva+Emtriva+Viread)
7

8. - Treatment in developed countries :
 DOT-HAART (Directly Observed Therapy of Highly-Active
AntiRetroviral Treatment)
- Example in South Africa :
 first line regimen :
d4T, 3TC and Efavirenz
 second line regimen :
AZT, ddI and Kaletra
 Old medicines
 Irrational use of treatment
 Opportunistic infections treatment 8

9. CD4 below 350 or viral loads greater than 30,000 copies/ml of plasma.
Clinical signs and symptoms : Opportunistic infections, chronic diarrhea, weight loss,
neurologic complications, lowering of red/white blood cells counts…
9

10. - According to the WHO (World Health Organization),
in developed countries, a course of 1 year’s treatment
costs the equivalence of 4 or 6 months’ salary.
- In developing countries, it would consume 30 years
income.
10

11. The WHO’s 3*5 Program :
3M people access in 2005
6 M people infected with HIV in the developing world,
of which only 400,000 had access.
RESULT: « Missing the target »
(1,3M in 2005, december) 11

12. - International Institutions
 The World Health Organization (WHO)
- Published treatment guidelines
- Prequalification process
- Essential medicines list
- National Institutions
 A drug had to be registered in each country
 A drug could be brought through an import waiver
12

13. - Funding
The main sources of funding in 2003 were :
 The Global Fund
 The President’s Emergency Plan for AIDS Relief (PEPFAR)
- Intellectual Property
 The standards of patent protection varied widely around the
world.
 The 1986-1994 of multilateral trade negociations resulted in
the Agreement on Trade-Related Aspects of Intellectual
Property Rights ( TRIPS)
13

14. The TRIPS agreement
 Harmonizes the patent rights
•Patent protection for pharmaceutical products
•20 years protection
 TRIPS provided for exceptions
•Compulsory Licence
•Parallel Importation
14

15. - Distribution
No physical presence
No local contact
No in-house expertise.
- Public Perception
Aids activist groups, health care providers
and some governments are strong critics
of pharmaceutical companies.
15

16. Let’s try to take
the Industries’ state of mind…
What are the positive and risky points?
 Positive publicity for the company
BUT…
 Reputational risk
 Loss of profit
 Parallel import, market risk
16

17. Parallel import
17

18. Let’s try to take
the Industries’ state of mind…
What are the positive and risky points?
 Positive publicity for the company
BUT…
 Reputational risk
 Loss of profit
 Parallel import, market risk
 Emergence of resistance worldwide
 Intellectual property problem
 Lots of difficulties … 18

19. K Y P Y R IN TH G O A H M R E
E LA E S E L B L IV A K T
Bb
u ble S = R
ize elative Sales
60%
50% Gilead
40%
Growth (12 months to 3Q2006)
30%
20% Abbott
B. Ingleheim BMS
10% GSK
Roche
0%
0% 5% 10% 15% 20% 25% 30% 35%
Merck
-10%
-20%
Pfizer
-30%
Source: IM H lth (M T 3Q2006)
S ea A Share of Global H Market
IV
Source course of Pr. Jean-Pierre Osselaere 19

20. GILEAD SCIENCES
 Research-based biopharmaceutical compagny.
 Area of focus :
- Antiretrovirals
 11 marketed products such as :
- Atripla (Emtricitabine+Efavirenz+Tenofovir) : 2006
- Truvada (Emtricitabine+Tenofovir) : 2004
- Viread (Tenofovir) : 2001
20

21.  VIREAD(tenofovir disoproxil fumarate). U.S approval 2001
 Immediate success.
- Once-a-day dosage
- Greater effectiveness
- A much improved side-effect profile.
 Gilead planned the drug to be global in early 2003.
 A high priority was to make it rapidly available to
millions of people in the least developed nations.
21

22. Gilead Access Program (April 2003)
OBJECTIVE :
make available the company's new drug VIREAD
at no profit to developing world.
22

23. QUALITY TIERED PRICING
GILEAD ACCESS PROGRAM
PRINCIPLES
PROTECTION
OF
INTELLECTUAL PARTNERSHIPS
PROPERTY

24. IMPLEMENTING THE GILEAD ACCESS PROGRAM
FOR HIV DRUGS
IN DEVELOPING COUNTRIES
2 KEY CONSIDERATIONS
PRICING DISTRIBUTION

25. THE ACCESS PROGRAM
First approach
Gilead and AXIOS (2003-2004)
25

26. Price issue
Affordable price for every patient.
USA / EU / JAPAN
68 least developed countries
High income
Widespread poverty
VIREAD priced taking into account:
VIREAD priced:
•Therapeutic value
at NO PROFIT
•Innovation
 Price: $ 39 /month ( $1.30/day)
Price : $360 / month
Gilead strategy: generate sufficient volume to bring the price down
Over time GILEAD lowered price to $ 17 / month. 26

27. Distribution issue
LOCAL
AUTHORITIES
GILEAD
SCIENCES
Import
waivers
Import
waivers
Import
•LOCAL CLINICS waivers
•TREATMENT
PROGRAMS 27

28. After one year...
 Gilead discovered that simply offering VIREAD at
low prices did not result in orders.
- AXIOS never received any large order
 3 main problems :
- Clinics and government regulators awareness
- No working experience with the drugs
-The WHO medicine lists
28

29. THE ACCESS PROGRAM
Second approach
(2005-2007)
29

30. GILEAD ACCESS PROGRAM
EXPANSION
30

31. GILEAD's tiers
Economic Number Price
of of Price of Viread
Tier
status countries Truvada
98
(Uganda,
Low income <$ 826 Bangladesh, $ 26.25/mo $ 17/mo
Haïti)
23
Lower-middle $826-$2.999 (India, Thaïland) About $ 45/mo About $ 30/mo
Up to a 70% Up to a 70%
13
discount relative discount relative
Upper-middle $ 3.000-$ 10.065 (Brazil, to high income to high income
Malaysia, countries countries
Russia)
>40 $ 934.50/mo in $ 578.87/ mo in
High income > $ 10.065 (US, EU, Japan) the U.S the U.S
•: Price calculations used 2007 average wholsale prices and the recommended dosing in the drug labels;
Source:BioCentury, The Bernstein Report on BioBusiness; September 3, 2007:15-26 31

32. Managing infrastructure development
 IDENTIFY AND PARTNER WITH A LOCAL DISTRIBUTOR IN EVERY
COUNTRY
GILEAD SCIENCES
ASPEN PHARMACARE ( SOUTH AFRICA)
Licence to manufacture VIREAD
And Sell VIREAD to clinics in Access program countries
At no profit price + 5% markup for Aspen
 BUILD AWARENESS IN AFRICAN AND ASIAN MARKETS
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33. Managing Registration of VIREAD
 After AXIOS management transition:
VIREAD’s country by country registration
- Gilead first focused on 15 countries (PEPFAR targets)
 Anecdotes
- Gambia: immediate approval
- Botswana and Zambia: rejected application
- Nigeria requested more data.
- South Africa returned application : too much data.
- Uganda: $ 2 million shipment refused by customs!
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34. • Managing corruption
 Gilead as a corporate policy, refused to pay bribes!
 As result :
- Delays in registration
- Generic manufacturers influence
• Managing Non Government Organization
 Major role influencing international policy.
 2 main problems :
- Gilead was late to recognize WHO as a regulatory authority.
- NGOs natural suspicion on the motives of pharmaceutical
companies.
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35. Gilead’s third approach :
 Non exclusive licence
- Indian generic manufacters
- Free pricing
- 5% royalties for Gilead.
 Gilead’s objective :
- Generate competition
 Bring the price down over time.
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37. Thank you for your attention !