Access to ARVs in Developing Countries

1
Access to ARVs in Developing Countries
Dr. Arun Purohit Ranbaxy Laboratories Limited
2
The global need
Bridge the treatment gap
2 million
Ideally 6.5 million
10-15 million
WHOs 10x10 or Pepfars 2x8
directional/motivational
Media reports, June, 2007
3
The challenges

• Externally
• Several million patients to be started on
  therapy1st line/2nd line/Paeds
• Large volume of high quality drugs, when
  required, where required
• Fragmented demands, more initially
• Drugs tailored for compliance and longevity of
  treatment fixed dose combinations co-packs
• Limited Funding gt Each dollar counts
• Internally
• Limited setup time
• gt Existing facilities and skilled human
  resources for developed markets to be allocated

4
Ranbaxy response.Corporate will!.

• Opportunity
• Create a significant difference in treatment
  landscape in DCs LDCs
• Establish Ranbaxy credentials as a responsible
  MNC generic company
• gt In 2001, Ranbaxy decided to use its
  infrastructure to facilitate access to affordable
  quality generic ARVs
• Today
• Over 400,000 patients worldwide on Ranbaxy ARVs
• Leading supplier of ARVs to global NGOs,
  institutions government programs
• Agreement with Clinton Foundation to provide
  affordable ARVs in 62 countries
• First in the world Pediatric 3-in-1 ARV
  dispersible tablet for children
• 15 WHO pre-qualified and 3 USFDA approved ARVs
• Over 380 approvals of ARVs across 50 countries,
  with 300 more in pipeline

5
How we delivered?

• RD competence to develop various innovative
  fixed dose combinations and generics
• ARVs manufactured at very large manufacturing
  facility approved by the most stringent of
  regulatory agencies
• Modular facility gt capacity ramp-up
• High volumes gt economies of scale gt Affordable
  ARVs
• Regulatory capacity ability to register
  products on all continents esp. in affected
  countries
• e.g., gt1000 approvals in Africa with an equal
  number in the pipeline
• Access Marketing and distribution
  infrastructure in the most affected countries gt
  pre post sales support
• Ranbaxy has ground presence in more than 125
  countries

6
ARVs Product Portfolio
FDCs KITS Lamivudine 150mg Zidovudine 300mg tabs Lamivudine 150mg Stavudine30/40mg tabs Lamivudine 150mg Stavudine30/40mg Nevirapine 200mg tabs Lamivudine 150mg Zidovudine 300mg Nevirapine 200mg tabs Abacavir 300mg Lamivudine 150mg Zidovudine 300mg tabs 2Lamivudine 150mg Stavudine 30/40 mg Efavirenz 600mg KIT 2Lamivudine 150mg Zidovudine 300 mg Efavirenz 600mg KIT
Individuals Lamivudine 150?/300mg tabs Zidovudine 100/300mg ? tabs Stavudine 30/40mg tabs Nevirapine 200mg ? tabs Indinavir 400mg tabs Efavirenz 200mgcaps/600mg tabs Didanosine Enteric Coated 250/400mg caps Abacavir 300mg Tabs
Pediatrics Lamivudine 20/40mg Stavudine 5/10mg Nevirapine 35/70mg DISTABS
WHO pre-qualified ? USFDA Approved
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Availability across the globe
RANBAXY ARVs have been exported to
South East Asia India Cambodia China Hong
Kong Malaysia Myanmar Philippines Thailand Vietnam
AFRICA Zambia Ethiopia Mauritius Central Africa
Republic Mozambique Nigeria Mali Senegal Benin Ken
ya Botswana Burkina Faso Cameroon Chad Congo Gabon
Guinea Ivory Coast Madagascar
AFRICA contd South Africa Tanzania Burundi Morocc
o Togo Uganda Zimbabwe Ghana Egypt Malawi Mauritan
ia Namibia Niger
Latin/Central America Columbia Dominican
Republic El Salvador Guatemala Honduras Jamaica Me
xico Peru Trinidad Tobago Venezuela
CIS Ukraine Kazakhstan
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The road ahead

• The required capability, capacity and domain
  knowledge for facilitating access and delivery is
  here
• What could be improved
• Harmonization of regulatory requirements across
  countries
• Common goal for various treatment/funding
  agencies
• Consolidation of demand
• Centralization of procurement processes
• Funding generic research and development for
  innovation
• Innovator-Generic partnering to enhance access
  for newer treatments

Our commitment continues