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Ph Baetz – US 1 – February 2006 1 Ph Baetz – US 1 – February 2006 1

Ph Baetz – US 1 – February 2006 2 Ph Baetz – US 1 – February 2006 2

Ph Baetz – US 1 – February 2006 3 Ph Baetz – US 1 – February 2006 3

Ph Baetz – US 1 – February 2006 4 Ph Baetz – US 1 – February 2006 4

Ph Baetz – US 1 – February 2006 5 Ph Baetz – US 1 – February 2006 5

sanofi-aventis Access to Medicines Program Ph Baetz – US 1 – February 2006 6 sanofi-aventis Access to Medicines Program Ph Baetz – US 1 – February 2006 6

 « Projects for Access to Medicines » Activity Within sanofi-aventis we have defined « Projects for Access to Medicines » Activity Within sanofi-aventis we have defined six fields of most importance for public healthcare in the poorest countries: Malaria Sleeping Sickness or Human African Trypanosomiasis (HAT) Tuberculosis Leishmaniasis – Kala Azar Epilepsy Vaccines Ph Baetz – US 1 – February 2006 7

 « Projects Access to Medicines » Activity Why ? Our road map is: « Projects Access to Medicines » Activity Why ? Our road map is: Our knowledge of the situation, environment and patients Information on their most urgent needs and expectations What our group can bring to contribute Implementation of solutions to bring a real assistance We must supply the indispensable products of which we are the only manufacturer. Innovation to find optimal connections and financial issues Ph Baetz – US 1 – February 2006 8

 « Projects Access to Medicines » Activity A contribution in 4 axes In « Projects Access to Medicines » Activity A contribution in 4 axes In house 1/ Research and Development to get innovative drugs for these «Neglected Diseases » 2/ Development of new combinations or formulations of existing molecules, well designed to the local needs On the ground 3/ Information, Education and Communication from the healthcare Key opinion leaders to the communities and families Because drug alone is not enough 4/ Distribution with tier pricing policy according to the income of the patients Ph Baetz – US 1 – February 2006 9

 « Projects Access to Medicines » Our Goals, our Hopes, our Dreams Malaria « Projects Access to Medicines » Our Goals, our Hopes, our Dreams Malaria : Effective action to the fight the disease in the countries It is feasible, it is done elsewhere (Vietnam, Brazil) Not only drugs, but an integrated fight who impact all parameters A general mobilization with human resources on the field Sleeping Sickness : Elimination It is feasible, it was done in 1960 A unique and efficient partnership WHO - sanofi aventis since 2001 To contribute to R&D in this field Ph Baetz – US 1 – February 2006 10

 « Projects Access to Medicines » Our Goals, our Hopes, our Dreams Tuberculosis « Projects Access to Medicines » Our Goals, our Hopes, our Dreams Tuberculosis : To be an active player to fight this “big killer”. Why: Sanofi-aventis is a key provider of rifampicine ( one of the basic treatment for TB) Sanofi-aventis is a leader in South Africa for DOT supporter program: Ø 50 000 DOTS supporter trained for a follow-up of half million patients Ø Compliance for TB treatment is a key success factor Epilepsy : Is also a public health issue in developing countries Sanofi-aventis is worldwide leader in this field Because epilepsy is a ‘scary’ disease badly known but. . . Epilepsy is treatable with success in the majority of the cases We can facilitate with partnership the affordability of treatments Ph Baetz – US 1 – February 2006 11

 « Projects Access to Medicines » Our Goals, our Hopes, our Dreams Leishmaniasis « Projects Access to Medicines » Our Goals, our Hopes, our Dreams Leishmaniasis : Present in 88 countries Sanofi-aventis has one of the basic treatments of this disease (meglumine antimoniate) Our policy is to streamline the production of this product to reduce dramatically the price Enlarge our contribution for instance in the field of research Vaccines : Sanofi-aventis is the # 1 producer of vaccines By a strong advocacy policy we want to increase the % if immunization all around the world Among our numerous actions we are a key actor for polio eradication To focus on a wider use of cheap and already financed vaccines against yellow fever, mother and child tetanus. Ph Baetz – US 1 – February 2006 12

Ph Baetz – US 1 – February 2006 13 Ph Baetz – US 1 – February 2006 13

Impact Malaria: Our Mission Contribute to reducing morbidity and mortality due to malaria, worldwide Impact Malaria: Our Mission Contribute to reducing morbidity and mortality due to malaria, worldwide Ph Baetz – US 1 – February 2006 14

Sanofi Aventis Involvement In Malaria A long-standing experience in malaria, with: Amino-4 quinolines Chloroquine Sanofi Aventis Involvement In Malaria A long-standing experience in malaria, with: Amino-4 quinolines Chloroquine (Nivaquine®), amodiaquine (Flavoquine®) Quinine (Quinimax®, Paluject®) Artemisinin derivatives Artemether (Paluther®), artesunate (Arsumax®), artesunate-amodiaquine co-blister (Arsucam®) Tomorrow: Fixed Dose Combination of artesunate-amodiaquine New R&D compounds History and expertise bring legitimacy, but also a high level of social responsibility Ph Baetz – US 1 – February 2006 15

Only Integrated Programmes Will Be Efficient Anticipate resistances Know and recognize the disease Appropriately Only Integrated Programmes Will Be Efficient Anticipate resistances Know and recognize the disease Appropriately prescribe Prevent the disease Have access to drugs Know how to manage patients Ph Baetz – US 1 – February 2006 Have appropriate drugs 16

What Is Impact Malaria ? It is a sanofi-aventis department, fully integrated in the What Is Impact Malaria ? It is a sanofi-aventis department, fully integrated in the Company’s organization Impact Malaria is part of the Projects for Access to Medicines Department It is not a foundation It contributes pharmaceutical industry’s know-how and expertise to concrete programs against malaria Ph Baetz – US 1 – February 2006 17

Impact Malaria – The Team The Core team Industrial operations Project management Clinical Development Impact Malaria – The Team The Core team Industrial operations Project management Clinical Development Regulatory Affairs Medical Affairs IEC Admin Approximately Head Total 3 2 2 2 1 3 3 persons 1 60 dedicated to malaria at sanofi-aventis 17 Other persons involved at HQ Operations (public markets) 1 API 1 R&D (discovery, project management, preclinical, regulatory, etc) ~20 Team in the field (Africa) Field persons + zone director + project managers + administration and Head 18 Ph Baetz – US 1 – February 2006 18

Our External Partners Tropical diseases Experts International Institutions (Europe, etc. ) WHO, RBM, Global Our External Partners Tropical diseases Experts International Institutions (Europe, etc. ) WHO, RBM, Global Fund Medical NGOs, Developt NGOs Ph Baetz – US 1 – February 2006 Governments, Mo. Hs Countries NMCP MMV, Institut Pasteur, IRD, etc. DNDi 19

Impact Malaria : 4 axes for a single objective New treatment strategies with existing Impact Malaria : 4 axes for a single objective New treatment strategies with existing drugs R&D for new anti-malaria treatments Information and training of all involved players Pricing and distribution policies to facilitate access to drugs Ph Baetz – US 1 – February 2006 20

Malaria R&D Ferroquine (Phase I completed) Ongoing in-house research program Contacts with external organizations Malaria R&D Ferroquine (Phase I completed) Ongoing in-house research program Contacts with external organizations Ph Baetz – US 1 – February 2006 21

Impact Malaria : 4 axes for a single objective New treatment strategies with existing Impact Malaria : 4 axes for a single objective New treatment strategies with existing drugs R&D for new anti-malaria treatments Information and training of all involved players Pricing and distribution policies to facilitate access to drugs Ph Baetz – US 1 – February 2006 22

From Monotherapy To Combotherapy Development of resistances = need to protect existing active compounds From Monotherapy To Combotherapy Development of resistances = need to protect existing active compounds WHO recommendations = Monotherapy combotherapy with artemisinin derivatives (Artemisinin-based Combination Therapy : ACT) Sanofi-aventis choice = artesunate + amodiaquine Artesunate = compound with short ½ life Amodiaquine = compound with long ½ life Ph Baetz – US 1 – February 2006 23

 From Monotherapy To Combination therapy From Co-Blisters To Fixed-Dose-Combinations Short-term : Co-blister artesunate From Monotherapy To Combination therapy From Co-Blisters To Fixed-Dose-Combinations Short-term : Co-blister artesunate + amodiaquine (Arsucam®) Middle term : Fixed Dose Combination tablets artesunateamodiaquine (Coarsucam®) Longer term : new R&D compounds Injectable artesunate Intrarectal quinine Ph Baetz – US 1 – February 2006 24

Impact Malaria : 4 axes for a single objective New treatment strategies with existing Impact Malaria : 4 axes for a single objective New treatment strategies with existing drugs R&D for new anti-malaria treatments Information and training of all involved players Pricing and distribution policies to facilitate access to drugs Ph Baetz – US 1 – February 2006 25

Axis 3 – IEC To inform and train all involved players Two complementary approaches Axis 3 – IEC To inform and train all involved players Two complementary approaches for our IEC programs : For health care professionals: medical information on new guidelines for the treatment of malaria For communities and families information programs for the prevention of malaria Ph Baetz – US 1 – February 2006 26

Information-Education-Communication (IEC) 2 case studies: how to support the anti-malaria new policy change Democratic Information-Education-Communication (IEC) 2 case studies: how to support the anti-malaria new policy change Democratic Republic of the Congo Angola Ph Baetz – US 1 – February 2006 27

IEC: Engine of the Switch Reluctance of novelty Combination I. E. C Resistance Come IEC: Engine of the Switch Reluctance of novelty Combination I. E. C Resistance Come back to monotherapy Ph Baetz – US 1 – February 2006 Drug safe and efficient Higher price 28

The Public Healthcare Pyramid In Africa > National hospitals 1/ A medical information for The Public Healthcare Pyramid In Africa > National hospitals 1/ A medical information for the whole healthcare pyramid « Why and how treat the uncomplicated malaria crisis with ACTs » > Regional hospitals Physicians > District hospitals Nurses Healthcare technicians > Dispensaries–Primary care centers > « Cases de santé » Communities and families Ph Baetz – US 1 – February 2006 2/ Information programs « Hygiène et Santé » for communities and families « How to fight against malaria, prevention and treatment » 29

Case Studies of ACT Implementation Angola: JICA decide to finance the introduction of ACT Case Studies of ACT Implementation Angola: JICA decide to finance the introduction of ACT pilot program in Benguela ACT required for treatment (artesuante+amodiaquine) Full support for IEC required from the ACT manufacturer DRC: New ACT policy financed by GFTAIM through UNDP 6. 8 millions treatments of Artesunate+amodiaquine for 2 years 188 health district within 28 area Full support for procurement- distribution and IEC required Ph Baetz – US 1 – February 2006 30

Case Studies of ACT implementation Efficient procurement and delivery of 2 million of ACTs Case Studies of ACT implementation Efficient procurement and delivery of 2 million of ACTs in partnership with Missionpharma international procurement and distribution agency 4 sessions of 2 days training performed by sanofi-aventis trainers in collaboration with National Malaria Control Program 140 health workers received key information on new ACT and how to repeat the training in their area 200 training books printed and given to participants 10 000 posters and 20 000 information leaflets dispatched in each health centers Training support is carried on by access to medicine managers at regional level Follow-up of ACT consumption to prevent shortages and avoid over stock Ph Baetz – US 1 – February 2006 31

IEC Contribution of sanofi-aventis sanofi aventis Website Journals Training Kit MEDICAL INFORMERS Medical Promotion IEC Contribution of sanofi-aventis sanofi aventis Website Journals Training Kit MEDICAL INFORMERS Medical Promotion Communication tools Selling skill Ph Baetz – US 1 – February 2006 GP’s Healthcare agents Healthcenters 32

Impact Malaria : 4 axes for a single objective New treatment strategies with existing Impact Malaria : 4 axes for a single objective New treatment strategies with existing drugs R&D for new anti-malaria treatments Information and training of all involved players Pricing and distribution policies to facilitate access to drugs Ph Baetz – US 1 – February 2006 33

Axis 4 To implement a new distribution & pricing policy for a better access Axis 4 To implement a new distribution & pricing policy for a better access to anti-malaria medicines Tier Pricing policy at sanofi-aventis The Access Card Program (CAP) with private pharmacies Ph Baetz – US 1 – February 2006 34

Background Malaria-HIV/AIDS-TB are responsible of 6 million deaths every year¹ 90% are in developing Background Malaria-HIV/AIDS-TB are responsible of 6 million deaths every year¹ 90% are in developing countries 1, 7 billions of people live without access to essential medicine² In sub-Saharan countries 50% of the population does not have regular access to medicine and spends less than 2 USD per year and per capita for healthcare Irrational use of medicines : Ø More than 50% of medicines are inappropriately prescribed and 30 to 50% of anti-malaria drugs are consumed without evidence of disease Unreliable medicines supply Ø Procurement and distribution systems are inefficient and cause shortages and wastes 1) 2) Who Medicine Strategy : Countries at the core 2004 -2007 Who : Promoting rational use of medicine Sept 2002 Ph Baetz – US 1 – February 2006 35

LDC Markets: A Complex Distribution Network National Hospital Public Sector Private sector Private MD LDC Markets: A Complex Distribution Network National Hospital Public Sector Private sector Private MD Regional hospitals Private Pharmacies District hospital Dispensaries – Health centers Informal Sector Traditional Practitioners, Street Vendors, etc… NGO Religious Centers Village nurseries Communities and Families Ph Baetz – US 1 – February 2006 36

Segmentation Of Income Per Capita In LDC Wealthy 5 to 15% Ph Baetz – Segmentation Of Income Per Capita In LDC Wealthy 5 to 15% Ph Baetz – US 1 – February 2006 Middle class 35 to 45% People under the level of poverty over 50% Population 37

Tier Pricing Policy : Methodology Which targets : Population living under the level of Tier Pricing Policy : Methodology Which targets : Population living under the level of poverty Public market, NGO, religious institutions, private sector² Which countries¹: All Sub-Saharan Africa Low income and lower middle income countries Which drugs : Medicine used in treatment for or preventions of serious endemic or neglected diseases i/e Anti-malaria Medicine where sanofi-aventis has a great expertise ¹ Countries classification WHO 2003. ² Through specific program Ph Baetz – US 1 – February 2006 38

Tier Pricing Policy : Methodology Which prices : Normal price Ä Profitable Ä Established Tier Pricing Policy : Methodology Which prices : Normal price Ä Profitable Ä Established in accordance with the local regulations Ä Affordable to the wealthy population (5 to 15 % of the total population) “No profit no loss” price, “at cost” Ä Exclude R&D costs, marketing and promotion, sales and corporate/administration costs Ä Exclude any profit margin, Ä Include fully burden production cost and cost of distribution and logistic it is not a donation so no quantity limitation Ph Baetz – US 1 – February 2006 39

Our Offer : 2 Prices And 3 Packagings For private pharmacies : Normal price Our Offer : 2 Prices And 3 Packagings For private pharmacies : Normal price for our brand in individual pack No profit no loss price for our Impact Malaria access card program in hospital packaging (blisters in bulk) For public sector : No profit no loss price, generic presentation with INN name (active substance) in hospital packaging (blisters in bulk), respecting the public sector request and minimising the black market risk For NGO, UN agencies, religious organizations No profit no loss price (Same conditions and packaging as public sector). Ph Baetz – US 1 – February 2006 40

A Selected Solution For Each Patient Group Through Specific Distribution Channels Princeps Box of A Selected Solution For Each Patient Group Through Specific Distribution Channels Princeps Box of 1 blister Normal price Available in Private Pharmacies Princeps “Impact Malaria” Blister in bulk Discounted Price : - 70 - 80 % Available in Private Pharmacies Via the “CAP PROGRAM” Generic Blister in bulk Discounted Price : - 70 - 80 % Available in the Public sector, NGO and religious health centers, financed by UN, GFTAM or others Population Wealthy 5 to 15% Ph Baetz – US 1 – February 2006 Middle class 35 to 45% People under the level of poverty over 50% 41

2005 Distribution Of Artesunate-Amodiaquine At No Profit No Loss The big distribution channels have 2005 Distribution Of Artesunate-Amodiaquine At No Profit No Loss The big distribution channels have taken part in our access to medicines programme Ph Baetz – US 1 – February 2006 4, 45 million anti-malarial Arsucam Impact malaria treatments have been distributed in 16 countries 42

Access Card program (CAP) A concrete experience in Africa for the accessibility of an Access Card program (CAP) A concrete experience in Africa for the accessibility of an antimalaria drug through a tier pricing policy with private sector Ph Baetz – US 1 – February 2006 43

Principle of CAP Program The anti-malaria drug is offered at 2 prices to private Principle of CAP Program The anti-malaria drug is offered at 2 prices to private pharmacies • Normal price with usual mark-up for patients with enough income • Preferential price for people under poverty level Tiered pricing is obtained through a solidarity chain • Sanofi-aventis is selling the drug close to “no profit no loss “ • Wholesaler imports and distributes without profit just covering transport costs • Drugstore reduces dramatically its mark-up from 30 -35% to 8% NB: depending on its engagement in the program the pharmacist receives an incentive in FG. Ph Baetz – US 1 – February 2006 All players renounce to make benefits 44

Methodology To give the patient a “service card ” giving the right for his Methodology To give the patient a “service card ” giving the right for his whole family to get the new antimalaria drug at preferential price The card is proposed by the pharmacist to used needed patients : eligibility criteria are Support of the program by the MOH, pharmacist trade union and pharmacist council Ph Baetz – US 1 – February 2006 45

Criteria of Eligibility A family will be registered only in one drugstore as close Criteria of Eligibility A family will be registered only in one drugstore as close as possible from its habitation. The income of the family per capita should be under the level of poverty I/E: 23 000 FCFA / month / capita = level of poverty in Cameroun ex. IF: 110 000 FCFA / family of 6 people = 18 333 FCFA The patient and his/her family are eligible for the CAP program Ph Baetz – US 1 – February 2006 46

Tiered Price of ARSUCAM ® Business price USD Arsucam® adult > 13 ans 8, Tiered Price of ARSUCAM ® Business price USD Arsucam® adult > 13 ans 8, 1 Arsucam® children 7 to 13 years 5, 7 Arsucam® infant up to 6 years 5 CAP price* USD 2, 2 1, 35 0, 9 Price reduction : 72 to 82% Ph Baetz – US 1 – February 2006 47

ARSUCAM® Co-Blister 3 Ages Ph Baetz – US 1 – February 2006 48 ARSUCAM® Co-Blister 3 Ages Ph Baetz – US 1 – February 2006 48

Packaging for Impact Malaria Program Box of 25 blisters Ph Baetz – US 1 Packaging for Impact Malaria Program Box of 25 blisters Ph Baetz – US 1 – February 2006 49

Patient Eligibility and Follow-up Pharmacy Card 22734 25 784 Ph Baetz – US 1 Patient Eligibility and Follow-up Pharmacy Card 22734 25 784 Ph Baetz – US 1 – February 2006 50

 « Patient Anti-Malaria Card » 22734 Ph Baetz – US 1 – February « Patient Anti-Malaria Card » 22734 Ph Baetz – US 1 – February 2006 51

The Charter Ph Baetz – US 1 – February 2006 52 The Charter Ph Baetz – US 1 – February 2006 52

Sticker for Pharmacies Ph Baetz – US 1 – February 2006 53 Sticker for Pharmacies Ph Baetz – US 1 – February 2006 53

CAP Programme in 2005 Programme launched in 3 countries : Cameroon: national extension in CAP Programme in 2005 Programme launched in 3 countries : Cameroon: national extension in April 2004 Gabon: launch of pilot in Libreville November 2004 Madagascar: launch of pilot in 3 important coast cities in November 2004 Participants to the programme: Cameroon: 167 pharmacies for a total of 230 Libreville: 32 pharmacies out of 41 Madagascar: 27 pharmacies out of 33 The drugs: Arsucam Impact Malaria Preferential price : 2, 2 USD adult dosage 1, 35 USD child dosage Ph Baetz – US 1 – February 2006 54

One Third of Patients Have Been Treated with the New ACT Through the CAP One Third of Patients Have Been Treated with the New ACT Through the CAP Program During A Period of 20 Months Anti-malaria drug (at normal price) 97 445 patients treated Anti-malaria drug® Impact Malaria (at référential price) : 38 951 low income patients treated representing 22 390 families 25% 75 % Ph Baetz – US 1 – February 2006 55

Cap Program for Enterprises Big enterprises in Africa employ thousands of workers who are Cap Program for Enterprises Big enterprises in Africa employ thousands of workers who are responsible of millions of people including their families Ø How many hours are lost because of sick workers? Ø How many employees stay at home when a baby gets a malaria crisis? Do employees get right information about prevention and treatment of malaria? Do private companies make the necessary effort to fight malaria? How much do we estimate malaria costs for enterprises? Ph Baetz – US 1 – February 2006 56

Cap Program for Enterprises Healthcare system for employees and their family in big enterprises Cap Program for Enterprises Healthcare system for employees and their family in big enterprises is taken in charge but … Ø 5 to 10% of managers have access to modern medicines Ø 90 to 95% of workers treated with old cheap drugs Sanofi-aventis proposes same methodology than for private pharmacies Ø Malaria has to be treated with effective modern drugs Ø Sanofi-aventis offers the 2 packaging at normal price for managers and subsidized price for workers Ph Baetz – US 1 – February 2006 57

What Else Sanofi-aventis will assist companies with full training for healthcare providers Sanofi-aventis will What Else Sanofi-aventis will assist companies with full training for healthcare providers Sanofi-aventis will provide scientific information Sanofi-aventis will insure pharmacovigilance Ph Baetz – US 1 – February 2006 58

Cap Program for Enterprises This program is in place in Madagascar with Port Authorities Cap Program for Enterprises This program is in place in Madagascar with Port Authorities of Magenga and Tamatave It will start in March with tea farms in Kenya We will extend it wherever it is possible Ph Baetz – US 1 – February 2006 59

Thank You For Your Attention! For Questions or Additional Information Contact: Philippe Baetz +33 Thank You For Your Attention! For Questions or Additional Information Contact: Philippe Baetz +33 01. 53. 77. 90. 38 Francois Bompart +33 01. 55. 71. 30. 55 Rene Cazetien +33 01. 53. 77. 90. 04 Christine Bugos +1 202 898 -3188 (contact in the U. S. ) Robert Sebbag +33 01. 53. 77. 47. 80 Ph Baetz – US 1 – February 2006 60