ph baetz – us1 – february 2006 1. 2 3 4 5 6 sanofi-aventis access to medicines program

1Ph Baetz – US1 – February 2006


sanofi-aventis Access to Medicines Program


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

« Projects for Access to Medicines » Activity


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

« Projects Access to Medicines » Activity Why ?


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 enough4/ Distribution with tier pricing policy according to the income

of the patients

« Projects Access to Medicines » Activity A contribution in 4 axes


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

« 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:

50 000 DOTS supporter trained for a follow-up of half million patients

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




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.


Impact Malaria: Our Mission

Contribute to reducing morbidity and

mortality due to malaria, worldwide


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-amodiaquineNew R&D compounds

History and expertise bring legitimacy, but also a high level of social responsibility

Sanofi Aventis Involvement In Malaria


Only Integrated Programmes Will Be Efficient

Know and recognize the disease

Prevent the disease

Have appropriate

drugs

Have access to drugs

Appropriately prescribe

Know how to manage patients

Anticipate resistances


It is a sanofi-aventis department, fully integrated in the Company’s organization

What Is Impact Malaria ?

It is not a foundation

It contributes pharmaceutical industry’s know-how and expertise to concrete programs against malaria

Impact Malaria is part of the Projects for Access to Medicines

Department


Approximately 60 persons dedicated to malaria at sanofi-aventis

The Core teamIndustrial operations 3Project management 2Clinical Development 2Regulatory Affairs 2Medical Affairs 1IEC 3Admin 3Head 1

Total 17

Other persons involved at HQOperations (public markets) 1API 1R&D (discovery, project management, preclinical, clinical, regulatory, etc) ~20

Team in the field (Africa)Field persons + zone director + project managers + administration and Head

18

Impact Malaria – The Team


WHO, RBM, Global Fund

Our External Partners

Medical NGOs, Developt NGOs

DNDiMMV, Institut Pasteur,

IRD, etc.

Countries NMCP

Governments, MoHs

InternationalInstitutions (Europe, etc.)

Tropical diseases Experts


R&D for new anti-malaria treatments

New treatment strategies with existing drugs

Information and training of all

involved players

Pricing and distribution policies to facilitate access

to drugs

Impact Malaria : 4 axes for a single objective


Ferroquine (Phase I completed)

Ongoing in-house research program

Contacts with external organizations

Malaria R&D





involved players


to drugs



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


Longer term : new R&D compoundsInjectable artesunateIntrarectal quinine

Short-term : Co-blister artesunate + amodiaquine (Arsucam®)

Middle term : Fixed Dose Combination tablets artesunate-amodiaquine (Coarsucam®)

From Monotherapy To Combination therapyFrom Co-Blisters To Fixed-Dose-Combinations





involved players


to drugs



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


Information-Education-Communication (IEC)

2 case studies: how to support the anti-malaria new policy change

Democratic Republic of the Congo Angola


Higher price

I . E . C

Come back to monotherapy

Resistance Drug safe and efficient

Reluctance of novelty

Combination

IEC: Engine of the Switch


Communities and families

> « Cases de santé »

> National hospitals

> Dispensaries–Primary care centers

> District hospitals

> Regional hospitals

Physicians

Nurses

Healthcare technicians

1/ A medical information for the whole healthcare pyramid

« Why and how treat the

uncomplicated malaria crisis with ACTs »

2/ Information programs « Hygiène et Santé » for communities and families« How to fight against malaria, prevention

and treatment »

The Public Healthcare Pyramid In Africa


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


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

Case Studies of ACT implementation


MEDICAL INFORMERS

Medical Promotion

Communicationtools

Selling skillHealthcare

agents

GP’s

Healthcenters

Website Journals Training Kit

sanofi aventis

IEC Contribution of sanofi-aventis





involved players


to drugs



Axis 4To 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


1) Who Medicine Strategy : Countries at the core 2004-20072) Who : Promoting rational use of medicine Sept 2002

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 : 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 Procurement and distribution systems are inefficient and cause

shortages and wastes


National Hospital

Regional hospitals

District hospital

Dispensaries – Health centers

Village nurseries

Communities and Families

LDC Markets: A Complex Distribution Network

Private MD

Private Pharmacies

Informal Sector Traditional

Practitioners, Street Vendors, etc…

Public SectorPrivate sector

NGOReligious Centers


Segmentation Of Income Per Capita In LDC

Housing Income

Level of poverty

50%

Wealthy5 to 15%

Middle class 35 to 45%

People under the level of poverty over 50%

Population


Tier Pricing Policy : Methodology

Which targets :Population living under the level of povertyPublic 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-malariaMedicine where sanofi-aventis has a great expertise

.¹ Countries classification WHO 2003² Through specific program


Tier Pricing Policy : Methodology

Which prices :

Normal price ProfitableEstablished in accordance with the local regulationsAffordable to the wealthy population (5 to 15 % of the total

population)

“No profit no loss” price, “at cost” Exclude R&D costs, marketing and promotion, sales and

corporate/administration costsExclude any profit margin, Include fully burden production cost and cost of distribution and

logistic

it is not a donation so no quantity limitation


Our Offer : 2 Prices And 3 Packagings

For private pharmacies :Normal price for our brand in individual packNo 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)

.


A Selected Solution For Each Patient Group Through Specific Distribution Channels

Housing Income

Level of poverty

50%Wealthy5 to 15%

Middle class 35 to 45%

People under the level of poverty over 50%

Population

PrincepsBox of 1 blisterNormal priceAvailable in

Private Pharmacies

Princeps “Impact Malaria”Blister in bulk

Discounted Price : - 70 - 80 %Available in Private Pharmacies

Via the “CAP PROGRAM”

GenericBlister in bulk

Discounted Price : - 70 - 80 %Available in the Public sector,

NGO and religious health centers, financed by UN,

GFTAM or others


UNICEF35%

MENTOR9%

WHO8%GVT(Tender)

7%

Private Pharmacies

1%

MISSIONPHARMA

35%

DIV.NGO5% Congo

CamerounMadagascar

Niger

Nigeria

Soudan

Sierra Leone

Indonésia

Congo Democratic

Guinée;Ghana

Gabon

Ivori Cost

Angola

Kenya

Liberia

4,45 million anti-malarial Arsucam Impact malaria treatments have been distributed in

16 countries

The big distribution channels have taken part in our access to medicines programme

2005 Distribution Of Artesunate-AmodiaquineAt No Profit No Loss


Access Card program (CAP)

A concrete experience in Africa for the accessibility of an anti-

malaria drug through a tier pricing policy with private sector


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 .

All players renounce to make benefits


To give the patient a “service card ” giving the right

for his whole family to get the new anti-malaria drug

at preferential price

The card is proposed by the pharmacist to

needed patients : eligibility criteria are used

Support of the program by the MOH, pharmacist

trade union and pharmacist council

Methodology


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

Criteria of Eligibility


72 to 82%

Business price USD

Arsucam® adult > 13 ans 8,1

Arsucam® children 7 to 13 years 5,7 Arsucam® infant up to 6 years 5

Price reduction :

CAP price* USD

2,2 1,35

0,9

Tiered Price of ARSUCAM ®


ARSUCAM® Co-Blister 3 Ages


Packaging for Impact Malaria Program Box of 25 blisters


25 78422734

Patient Eligibility and Follow-upPharmacy Card


22734

« Patient Anti-Malaria Card »


The Charter


Sticker for Pharmacies


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


Anti-malaria drug (at normal price)

97 445 patients treated

Anti-malaria drug® Impact Malaria (at référential price) :38 951 low income patients treatedrepresenting 22 390 families

One Third of Patients Have Been Treated with the New ACT Through the CAP Program During A

Period of 20 Months

25%

75 %

97445

38951

22390

0

10000

20000

30000

40000

50000

60000

70000

80000

90000

100000

Arsucam Arsucam IM IM Card

Arsucam

Arsucam IM

IM Card


Cap Program for Enterprises

Big enterprises in Africa employ thousands of workers who are responsible of millions of people including their families

How many hours are lost because of sick workers? 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?


Healthcare system for employees and their family in

big enterprises is taken in charge but …5 to 10% of managers have access to modern

medicines90 to 95% of workers treated with old cheap drugs

Sanofi-aventis proposes same methodology than

for private pharmaciesMalaria has to be treated with effective modern drugsSanofi-aventis offers the 2 packaging at normal

price for managers and subsidized price for workers



What Else

Sanofi-aventis will assist companies with full

training for healthcare providers

Sanofi-aventis will provide scientific information

Sanofi-aventis will insure pharmacovigilance



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


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 – us1 – february 2006 1. 2 3 4 5 6 sanofi-aventis access to medicines program

Documents

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sanofiaventis access

medicines activity slide

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medicines program slide

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field projects access

patients projects access