Diapositive 1

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Increasing antiretroviral treatment access in
developing countries
Malam Aboubakar Perrine Dieusaert Jean-Luc
Hitimana
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• A global view of HIV infection worldwide

16 000
40 million
2,7 million
95
2 million
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• Treatment coverage worldwide

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• AIDS, a real weapon of mass destruction

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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 SustivaEmtrivaViread)

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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 years treatment costs the equivalence of 4
or 6 months salary. - In developing countries,
it would consume 30 years income.
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The WHOs 35 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 Presidents 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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Lets 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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Lets 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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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
  (EmtricitabineEfavirenzTenofovir) 2006
• - Truvada
  (EmtricitabineTenofovir) 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
PARTNERSHIPS
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IMPLEMENTING THE GILEAD ACCESS PROGRAM FOR HIV
DRUGS IN DEVELOPING COUNTRIES
2 KEY CONSIDERATIONS
PRICING
DISTRIBUTION
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THE ACCESS PROGRAM
First approach Gilead and AXIOS (2003-2004)
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Price issue
Affordable price for every patient.
Over time GILEAD lowered price to 17 / month.

• 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
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Distribution issue

LOCAL AUTHORITIES
GILEAD SCIENCES
Import waivers
Import waivers
Import waivers

• LOCAL CLINICS
• TREATMENT PROGRAMS

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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
Tier Economic status Number of countries Price of Truvada Price of Viread
Low income lt 826 98 (Uganda, Bangladesh, Haïti) 26.25/mo 17/mo
Lower-middle 826-2.999 23 (India, Thaïland) About 45/mo About 30/mo
Upper-middle 3.000- 10.065 13 (Brazil, Malaysia, Russia) Up to a 70 discount relative to high income countries Up to a 70 discount relative to high income countries
High income gt 10.065 gt40 (US, EU, Japan) 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
• SourceBioCentury, The Bernstein Report on
  BioBusiness September 3, 200715-26

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Managing infrastructure development

• IDENTIFY AND PARTNER WITH A LOCAL DISTRIBUTOR IN
  EVERY COUNTRY
• BUILD AWARENESS IN AFRICAN AND ASIAN MARKETS

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
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Managing Registration of VIREAD

• After AXIOS management transition
• VIREADs 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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Gileads third approach

• Non exclusive licence
• - Indian generic
  manufacters
• - Free pricing
• - 5 royalties
  for Gilead.
• Gileads objective
• - Generate competition
• Bring the price down over time.

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Thank you for your attention !
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• Treatment coverage in December 2007
• Sub-Saharan Africa, 30
• Latin America and the Caribbean 62
• East, South and South-East Asia 25
• Europe and Central Asia 17
• North Africa and the Middle East 7
• All developing and transitional countries 31