Transcript Gilead Access Program

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Increasing antiretroviral treatment
access in developing countries
Malam Aboubakar
Perrine Dieusaert
Jean-Luc Hitimana
A global view of HIV infection
worldwide
16 000
40 million
2,7 million
95%
2 millionMore than 28%
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Treatment coverage worldwide
6%
84%
19%
5%
2-5%
7%
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AIDS, a real weapon of mass
destruction
75%
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- 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)
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- 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
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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…
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- 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.
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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)
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- 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
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- 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)
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The TRIPS agreement
 Harmonizes the patent rights
•Patent protection for pharmaceutical products
•20 years protection
 TRIPS provided for exceptions
•Compulsory Licence
•Parallel Importation
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- 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.
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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
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Parallel import
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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 …
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KEY PLAYERS IN THE GLOBAL HIV MARKET
Bubble Size = Relative Sales
60%
Gilead
50%
Growth (12 months to 3Q2006)
40%
30%
20%
Abbott
B. Ingleheim
BMS
10%
GSK
Roche
0%
0%
-10%
5%
Merck
10%
15%
20%
25%
30%
35%
-20%
Pfizer
-30%
Source: IMS Health (MAT 3Q2006)
Share of Global HIV Market
Source course of Pr. Jean-Pierre Osselaere
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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
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 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.
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Gilead Access Program (April 2003)
OBJECTIVE :
make available the company's new drug VIREAD
at no profit to developing world.
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TIERED PRICING
QUALITY
GILEAD ACCESS PROGRAM
PRINCIPLES
PROTECTION
OF
INTELLECTUAL
PROPERTY
PARTNERSHIPS
IMPLEMENTING THE GILEAD ACCESS PROGRAM
FOR HIV DRUGS
IN DEVELOPING COUNTRIES
2 KEY CONSIDERATIONS
PRICING
DISTRIBUTION
THE ACCESS PROGRAM
First approach
Gilead and AXIOS (2003-2004)
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Price issue
Affordable price for every patient.
USA / EU / JAPAN
High income
VIREAD priced taking into account:
•Therapeutic value
•Innovation
Price : $360 / month
68 least developed countries
Widespread poverty
VIREAD priced:
at NO PROFIT
 Price: $ 39 /month ( $1.30/day)
Gilead strategy: generate sufficient volume to bring the price down
Over time GILEAD lowered price to $ 17 / month.
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Distribution issue
LOCAL
AUTHORITIES
GILEAD
SCIENCES
Import
waivers
•LOCAL CLINICS
•TREATMENT
PROGRAMS
Import
waivers
Import
waivers
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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
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THE ACCESS PROGRAM
Second approach
(2005-2007)
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GILEAD ACCESS PROGRAM
EXPANSION
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GILEAD's tiers
Economic
Tier
Low income
Lower-middle
Upper-middle
High income
status
<$ 826
$826-$2.999
$ 3.000-$ 10.065
> $ 10.065
Number
of
countries
98
(Uganda,
Bangladesh,
Haïti)
23
(India, Thaïland)
13
(Brazil,
Malaysia,
Russia)
>40
(US, EU, Japan)
Price
of
Truvada
Price of Viread
$ 26.25/mo
$ 17/mo
About $ 45/mo
About $ 30/mo
Up to a 70%
discount relative
to high income
countries
Up to a 70%
discount relative
to high income
countries
$ 934.50/mo in
the U.S
$ 578.87/ mo in
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
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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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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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• 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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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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Thank you for your attention !