Sanofi-aventis’ commitment to providing “Access to Medicines” in countries in the Southern Hemisphere shows real achievements


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Robert SEBBAG
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EMBARGOED UNTIL MARCH 12, 2007 – 1:00 p.m. (CET)


Sanofi-aventis’ commitment to providing
“Access to Medicines” in countries
in the Southern Hemisphere shows real achievements


Paris, March 12, 2007 – At the plenary « Society & Politics » session of the BioVision 2007 forum – The Global Forum on Science & Life - Jean-François DEHECQ, President of the sanofi-aventis Group laid out a series of major achievements of the “Access to Medicine” Policy in the Southern Hemisphere. He covered six major focuses:

- 5 therapeutic areas, namely malaria, tuberculosis, sleeping sickness, leishmaniasis and epilepsy – as well as vaccines.

This policy was presented by Jean-François DEHECQ during his talk at the closing session of the BioVision 2005 forum.

In a world in which 80% of the population has little or no access to the most basic medicines (especially in the Southern Hemisphere where there are no social healthcare systems), the sanofi-aventis Group, notably its Access to Medicines Division, is developing concrete operations to make access to health care a central element in the Group's global strategy.

The remit of the sanofi-aventis Access to Medicines Division is to instigate and coordinate the Group's activities in the fight against certain diseases which represent major public health problems and in which the Group possesses real acknowledged expertise. The strategy is centered around three main approaches:
- differential pricing policies
- ongoing development of existing medicines
- information, education and communication campaigns targeting all relevant parties.

This commitment has resulted in concrete achievements:

- malaria: research and development for new antimalarial drugs; the development of new formulations and combinations based on existing modalities; information, education and communication campaigns targeting all parties concerned by the disease; and the establishment of special pricing policies and distribution networks.

- tuberculosis: the development of new therapeutic protocols and active participation in the Tuberculosis Free program in South Africa—associated with the regrouping of our worldwide antituberculous drug production capacities in that country.


- sleeping sickness: renewal of our partnership with the WHO focusing on diagnosis and drug supply.

- leishmaniasis: making medicines available with a differential pricing system – “no profit no loss” - and centralization of production in Brazil.

- epilepsy: launching of a training program in Mali for general practitioner in the most remote rural regions, and extension to other countries.

-vaccines: provision of vaccines to international organizations for the eradication of poliomyelitis and immunization against yellow fever; continuation of a research program into dengue fever; and establishment of a differential pricing policy within the framework of a partnership with the Global Alliance for Vaccines and Immunization (GAVI).

« All of these initiatives are being undertaken voluntarily and in keeping with the historic heritage of the sanofi-aventis Group. This is our duty as a major international player in the field of pharmaceuticals and vaccines, backed by a talent for innovation, competitive industrial facilities and a willingness to continue making the most of our mature older quality products” said Jean-François DEHECQ.

« As manufacturers too, we are dedicated to making our contribution to economic growth in the southern hemisphere, and we are doing all we can to keep our industrial facilities running in those countries. It is there that the pharmaceutical industry is playing for its future and, if it fails to meet the challenges, it will no longer exist » he concluded.



DESCRIPTION OF ACHIEVEMENTS


A. Malaria

The Impact Malaria program focuses on four main areas:
- Research and development for new antimalarial drugs;
- The development of new formulations and combinations of existing drugs;
- Education and training of health care providers at all levels;
- Distribution networks and pricing policies to ensure easier access to treatment.


1) Research and development for new antimalarial drugs
The parasite that causes malaria is known for its capacity to develop resistance to all classes of drug used against it which is why new compounds have to be developed all the time—a race against resistance. Staying ahead is the aim of this research program organized in collaboration with university-based units and subsequently developed in our own laboratories. These activities are 100% funded by the Group. For example, a project launched in 2003 in collaboration with the University of Montpellier (Professor H. Vial) to investigate the ability of a series of so-called “bis-cationic” products to disrupt parasite phospholipid synthesis has already led to the identification of a candidate compound (SAR97276).
A collaboration which began in 2002 with Palumed in Toulouse (Dr. B. Meunier) is focusing on the “trioxaquines”, compounds which might be able to attack the parasite via two different mechanisms.
Finally, a collaboration with USTL in Lille (Professor Brocard) launched in 2002 has yielded ferroquine (SAR97193), a new amino-4-quinoleine derivative. This compound is extremely active against both chloroquine-susceptible and chloroquine-resistant Plasmodium falciparum and is currently in the clinical development phase.


2) New formulations and combinations of existing drugs

I - Combination therapy: forestalling resistance
Given the worrying spread of drug-resistant Plasmodium, the WHO has been recommending since 2002 that first-line treatment be systematically based on at least two active substances, one of which should be a derivative of artemisinin (Artemisinin-based Combination Therapy, ACT).
To make it possible to meet this objective as soon as possible, sanofi-aventis has developed a combined presentation of amodiaquine and artesunate with the two oral drugs packaged in a single “co-blister” pack. This coblister product produced at one of the Group’s plants in Morocco has been on the market for a number of years in more than 20 countries in Africa

II - The two-layer artesunate/amodiaquine tablet: available in sub-Saharan Africa in 2007
To further enhance compliance, a tablet containing both these drugs in a stable form has been developed in collaboration with the Drugs for Neglected Diseases Initiative (DNDI).
In the agreement with the DNDI, sanofi-aventis set aside its patent rights and undertook to supply this novel medicinal product at prices to match income in the various targeted population groups, in particular for those at highest risk.


With cost levels less than US$ 0.5 for children under 5 years of age and less than US$ 1 for adults, the artesunate amodiaquine fixed-dose combination will be made available at a “no profit - no loss” price to public organisations of endemic countries, international institutions, NGOs, and programs promoting access to medicines in pharmacies.
To this partnership, each party is bringing its own specific expertise as well as resources, all to the common good.

This product is manufactured in Morocco and was granted Marketing Authorization on February 1, 2007. It will be licensed in most countries in sub-Saharan Africa by 2008.

III - Quinine salts: an alternative to injection
Severe malaria in children requires emergency quinine injection—as soon as possible after the first symptoms are observed. Any delay can be fatal. However, parenteral administration is often difficult in rural settings (lack of equipment, risk of infection, etc.) which is why
sanofi-aventis has developed an emergency pediatric kit for the rectal administration of quinine salts, a stop-gap option for immediate use until the patient can be transferred to a suitably equipped clinical establishment.

A number of field studies were conducted to define the best type of kit for use in this type of situation.

To simplify use of the emergency kit, a ready-to-use, pre-diluted solution of the drug is being developed and should be available in 2007.


3) Information, Education and Communication
Supplying medicines is not enough in and of itself: they also have to be used correctly. The Impact Malaria program also includes Information, Education and Communication (IEC) initiatives aimed at all those concerned by malaria.

I - IEC for health care providers
Measures targeting health care providers aim to broadcast the latest recommendations on diagnosis and treatment. These campaigns have to be adapted to each country and situation, and are organized in collaboration with the National Malaria Control Program. In this context, sanofi-aventis has been providing governments with ACT training materials for distribution to local care providers.

To ensure the broadest possible dissemination of current knowledge, Impact Malaria has also produced a 40-page manual for prescribers, “PaluTrop”, compiled by top French and African malaria specialists and aimed at doctors and nurses working in endemic areas, far from any hospital.

With Impact Malaria funding, the Marseille Military Institute of Tropical Medicine (IMTSSA) has been running a degree course on malaria control: more than 60 physicians from Africa have already graduated.

Also in collaboration with the IMTSSA as well as the Liverpool School of Tropical Medicine, a Web site has been set up (www.impact-malaria.com) to promote communication and provide ongoing education and training for all involved in malaria control.



II - IEC for local people and communities
Impact Malaria organizes and supports IEC campaigns on preventing malaria and how to use the drugs correctly, aimed at people living in at-risk areas.

In cooperation with Care Cameroon, a pilot malaria control program has been established in the Lagdo region where the incidence of malaria is particularly high because of the proximity of a lake, a river and numerous rice paddies. This project included surveys of the local population to get a better understanding of how they see the disease. On the basis of the results, specifically targeted communication tools were developed and distributed via the communities, health care centers and schools. The aim was to raise the consciousness of those in close contact with under-5 year-olds who are at particularly high risk of contracting the most dangerous forms of the disease. A parallel entomological survey provided details about the behavior of Anopheles species in Lagdo with a view to developing rationally based vector control operations. Finally, sanofi-aventis will provide ACT for the treatment of demonstrated cases of malaria.

In partnership with the NGO Actions de Solidarité and the Preventive Medicine Agency, another project in the Majoua region of Congo Brazzaville is in the preparatory stages. Such projects will help define what kind of resources have to be deployed to guarantee a real, sustainable, positive effect on malaria.

In Benin, a project conducted together with PlanetFinance and locally based NGOs is aimed at training certain health care providers how to enhance understanding of the disease in at-risk communities and families. One of the fruits of this partnership has been a series of educational materials on prevention and the symptoms of the disease, based on simple, easy-to-understand (even for the illiterate) pictograms.

These experiences will be extremely useful when it comes to establishing solid integrated control strategies in endemic countries, and also for obtaining funding for them.

Finally, together with Total and the Compagnie Française de l’Afrique Occidentale, sanofi-aventis sponsored the creation of a Practical Guide to Malaria Control. This booklet—based on stand-alone sheets addressing all the various aspects of malaria control—is intended as a reference for companies which seek to look after employees, their families and, above and beyond them, communities in which the company is operating.


4) Distribution networks and pricing policies for antimalarial drugs
To ensure that our antimalarial products are available to the greatest number of patients, we have established a differential pricing policy.

The lowest price is based on optimizing production costs (without compromising on any of the quality specifications applicable at all our manufacturing sites throughout the world). This is the price that a drug can be sold at without any profit, but also without any loss, and it is offered exclusively to the poorest populations. This approach is essential to guarantee long-term manufacturing viability.



The main channels of distribution in countries where malaria is endemic are:

· private-sector pharmacies :
sanofi-aventis sells the same antimalarial at two different prices according to the patient’s financial resources;
- the brand name (sanofi-aventis) product is sold at the normal price in the country concerned;
- the same medicinal product is sold under the Impact Malaria brand at a lower price to poorer patients through the CAP (Carte d’Accès aux Antipaludiques) program. CAP cards are distributed by the pharmacist to families whose income is below the country’s poverty threshold thus making the drugs accessible to the poorest. This has all been made possible by the commitment of the wholesale distributors and pharmacists, all of whom are, like sanofi-aventis, sacrificing their profit margin.

· public-sector outlets :
In malaria-endemic countries, supplies of antimalarial drugs are bought in after bids to tender organized by central purchasing structures, NGOs and institutions of the United Nations (among others). When responding to such tenders, sanofi-aventis puts the price of ACT at the lowest that it can.
The medicines are then distributed by the health care system to hospitals, dispensaries, clinics.

In 2005-206, sanofi-aventis distributed more than 10 million course of ACT at a special low price in 16 endemic countries.

The Group’s manufacturing plant at Casablanca in Morocco is a top-of-the-line industrial facility which is helping us satisfy the increasing demand for ACT with the convenient artesunate/amodiaquine presentation.




B. Tuberculosis

Sanofi-aventis used to be the main producer of rifampicin—the foundation stone in any course of treatment for tuberculosis—and is still one of the most important.
A number of the Group’s manufacturing units produce a range of antituberculous drugs which are distributed in many countries.
Strengthened by its experience in the field, sanofi-aventis recently redefined its contribution to tuberculosis control.
An optimization and industrial development policy was developed to extend the range and offer the most suitable products at the lowest possible prices, with a view to augmenting the accessibility of treatment to cover as many patients as possible.
This policy depends largely on existing capacity in South Africa where the Waltloo facility will eventually be producing all the Group’s antituberculous drugs.
Sanofi-aventis is already providing patients with fixed-dose combinations containing either the four active substances (rifampicin, isoniazid, pyrazinamide and ethambutol) for the initial phase of treatment or the two active substances (rifampicin and isoniazid) for the continuation phase.

The objective of the Tuberculosis Program is to provide health authorities in the countries concerned with a range of high-quality drugs, and to help them in their attempts to control this devastating disease by means of rationally targeted measures.

1) New formulations and combinations of existing drugs
In partnership with various international organizations such as the United States Centers for Disease Control and Prevention (CDC), the TB Alliance, the Consortium to Respond Effectively to the TB/AIDS epidemic (CREATE) and St. George’s Medical School, sanofi-aventis is establishing a strategy to develop and improve the treatment of tuberculosis, based on:
· Ongoing development of an existing drug, rifapentin, for the treatment of both latent and active tuberculosis, either on its own or in combination therapy together with other compounds. The aim is to cut down the length of the course of treatment as well as the number of tablets to be taken, without compromising efficacy;
· Systematic screening of the product portfolio to identify new drugs which are active against M. tuberculosis, especially drug-resistant strains;
· Research to identify new compounds, possibly in the context of collaborative projects with external experts.
The objectives of this new sanofi-aventis research and development program coincide with those of the global Stop TB program supervised by the WHO and the United Nations “Millennium Summit”, namely to arrest the increase in the rate of spread of tuberculosis and begin reducing its incidence by 2015.

2) TB Free Program
South Africa, with nearly 400,000 new cases every year and 175 deaths every day, is one of the countries that is most severely affected by tuberculosis.
The TB Free program was developed as a partnership between sanofi-aventis, the Nelson Mandela Foundation and the South African Ministry of Health.
It aims at raising consciousness about the disease, conveying the importance of diagnosis as of the onset of the first symptoms, and providing help to sufferers by training volunteer health care providers (“supporters”) to supervise DOTS.


The goal is to open nine new centers (one in each region of the country) and train 20,000 DOTS supporters across the country, each of whom will be able to supervise ten patients throughout their courses of treatment.

During 2004-206, eight training centers were open, where 10,000 “DOTS supporters” were trained, to support over 250,000 patients. Sanofi aventis committed US$ 15 million over 5 years to support this program.


C. Sleeping sickness or African Human Trypanosomiasis (AHT)

In 2001, Aventis (now sanofi-aventis) was the manufacturer of all the main drugs used to treat sleeping sickness (pentamidine, melarsoprol and eflornithin):
· Pentamidine 200 mg, intramuscular injection in the first stage of the disease;
· Melarsoprol and eflornithin, intravenous injection in the second stage.
At this time, Aventis recognized that, for such a complex disease, although drugs were indubitably essential, they could not alone win the war and so, in May 2001, the company signed an agreement with the WHO committing $25 million over five years for:
· Production of sufficient quantities of drugs to cover therapeutic needs;
· Support of WHO activities to strengthen surveillance and disease control programs in various different epidemiological contexts;
· Help to the WHO in routing drugs from the manufacturer to the patient
· Support for WHO efforts to encourage research and development of new control modalities.
Results
By virtue of this first partnership between 2001 and 2006, more than 320,000 pentamidine capsules, more than 420,000 melarsoprol capsules and more than 200,000 bottles of eflornithine produced by sanofi-aventis and donated to the WHO were distributed in endemic countries through the logistical apparatus of Médecins Sans Frontières.
The financial resources on top of the donated drugs helped reinforce national control programs. More than 300,000 field staff were trained by the WHO. The results of the personnel increases coupled with the technical and financial support for control operations were significant improvements in the numbers of people screened and the number of victims treated in time. Nearly 14 million diagnostic procedures were performed during the five-year collaboration which, as well as saving nearly 110,000 lives, also helped bring down the disease’s transmission rate and changed the whole epidemiological picture so that eradication became a real possibility.

In September 2005, the International Scientific Council for Research and Control in Trypanosomiasis (at its 28th Conference in Addis Ababa) recommended that the WHO launch a program for the elimination of sleeping sickness as a public health problem—showing that they considered this as an attainable objective.

The next steps: 2006-2011
The positive results of the 2001-2006 partnership between sanofi-aventis and the WHO in the context of sleeping sickness control incited and justified the decision of the Group’s Directors to continue and reinforce its commitment to support the WHO’s activities, as embodied in a agreement entered into on October 10 2006.


With the experience and information gained as a result of the first partnership, sanofi-aventis will continue supporting efforts in the fight against sleeping sickness for another five years, and will extend its commitment to other neglected tropical diseases such as leishmaniasis, Buruli ulcer and Chagas’ disease (American human trypanosomiasis).

This partnership and the allocated sum of 20 million euros ($25 million) will promote the WHO’s policy to foster integrated control strategies for neglected tropical diseases by maintaining and/or developing training programs as well as by providing continued support for screening and treatment in the framework of national control programs.



D. Leishmaniasis

Sanofi-aventis sells meglumine antimoniate and pentamidine which are considered by the WHO as essential first- and second-line drugs in the treatment of all forms of leishmaniasis.

Given the prevalence of this disease in certain countries and the high price of the drugs, this scourge inflicts heavy damage on many health care budgets.

This is one of the reasons why sanofi-aventis decided to extend its commitment to this disease.

Meglumine antimoniate is produced and distributed by sanofi-aventis in many countries. In order to make this drug available to as many patients as possible, an effort to optimize our production logistics was undertaken in 2005 with regrouping of all the production at a single industrial facility.
Eventually, all production will be centralized at Suzano in Brazil which will enable sanofi-aventis to offer the product with a differential pricing scheme to ensure accessibility for the maximum number of patients throughout the world.
Sanofi aventis has decided to implement a “no profit – no loss” pricing policy for Glucantime worldwide (except in Europe, USA and Japan). The price of a treatment vial will be US$ 1.20 out of Brazil for all those countries, with an objective to reach a US$ 1 price per vial.

In the context of the new five-year partnership entered into on October 10 2006 with the WHO, 25% of the donation ($6.4 million) will be dedicated to the control of leishmaniasis.

The willingness of sanofi-aventis to participate in the fight against this neglected disease is embodied in a dual strategy: Information, Education and Communication campaigns in cooperation with the WHO and initiatives of some of the Group’s subsidiaries in collaborative projects with national authorities (e.g. in Latin America).




E. Epilepsy

More than 50 million people are affected wolrdwide, 85% of whom live in developing countries where the disease is most prevalent: 49-190 new cases per annum per 100,000 people with incidence peaks among the very young and the very old. In certain societies, the convulsive fits of epilepsy are attributed to demonic possession, and the patient is referred to a traditional healer or exorcist rather than to a medical practitioner so he or she is neither diagnosed nor treated, and is often relegated to the margins of society.

Most children and adults who are diagnosed as epileptic can be successfully treated with currently available drugs. However, most people with epilepsy (80%) in the developing world are not treated and often not even diagnosed) as a result of the remoteness of health care facilities and the unavailability of the drugs that could help them. This has serious physical, psychological, social and economic repercussions for both patients and their families.

Santé Sud is a NGO concerned with medical development in the poorest countries. In Mali, it has established a training program for generalist physicians to help them set up practices in the most remote rural regions.
As there was no national epilepsy program operating in the countryside, Santé Sud in collaboration with a Rural Doctors Association decided to implement such a program. Six general practitioners were trained and set up an epilepsy-focused network. With the help of Santé Sud, volunteer neurologists from France and sanofi-aventis physicians, these local doctors are currently treating 1,000 epileptics, many with sodium valproate (200 or 500 mg) paid for according to a differential pricing system in which the company takes neither profit nor loss.

The Group’s intention is to continue this type of initiative in partnership with NGOs or universities providing high-quality training for all health care providers, with a view to establishing long-lasting commitments to the care for this chronic disease. This is also a way of ensuring that doctors receive the information they need to choose the most suitable modality from the antiepileptic drugs available.

This is embodied in recent agreements concluded by sanofi-aventis with:
· The Institute for Tropical Neurology and Epidemiology in Limoges to establish the first Association for the Fight Against Epilepsy in Cambodia;
· Santé Sud, to renew the Mali program for another two years, and launch the same type of program in Madagascar;
· The Kenyan Association for the Welfare of Epileptics, to develop training programs that are already underway, and facilitate access to antiepileptic drugs in the country


F. Vaccines

1) Vaccine provision to international bodies
Faithful to the precepts of its founders and its history, sanofi pasteur has been working for many years to promote easier access to vaccines in poor countries. By way of example, sanofi pasteur provided over 400 million doses of vaccine to UNICEF in 2005.

Poliomyelitis: sanofi pasteur is one of the WHO’s partners in the worldwide poliomyelitis eradication program. Over the years, sanofi pasteur has supplied 120 million doses of the vaccine to countries in Africa. In 2005, sanofi pasteur provided more than 350 million doses of the oral polio vaccine (OPV) and between 2004 and 2005, it licensed and produced in record time the monovalent Type 1 OPV requested by the WHO to finalize eradication of the disease in South Asia and Egypt.

Yellow fever: in the northern hemisphere, the yellow fever vaccine is only usually administered to travelers.
Nevertheless, sanofi pasteur developed a multiple-dose presentation especially designed for large-scale use in endemic regions. Sanofi pasteur is one of the main suppliers of this vaccine, both for UNICEF and to build up a stockpile to ensure a rapid response to epidemics like those that break out from time to time in Africa.
To help affected countries organize yellow fever immunization campaigns and prevent epidemics, sanofi-aventis and sanofi pasteur are supporting the actions of the Preventive Medicine Agency, such as the meeting on yellow fever vaccine use organized in collaboration with the WHO in December 2006 at Bamako in Mali, which was attended by 50 delegates from 8 West African countries. The involvement of sanofi-aventis and sanofi pasteur in this meeting is concrete evidence of our wish to go beyond simply supplying vaccines by making sure that the vaccines are being used in the right way in places where they are needed.

Dengue: with the objective of developing and producing rapidly a vaccine against this viral disease that causes over 200,000 deaths a year, particularly in children less than 15 years of age, sanofi pasteur has initiated a research program and made major investments.

2) Partnership with the Global Alliance for Vaccines and Immunization
Up until the early 1990’s, more or less the same vaccines were used throughout the world and the high prices paid in richer countries effectively subsidized supplies to poorer countries. Since then, vaccine production has become ever more technologically complex (e.g. the acellular pertussis vaccine, the conjugated pneumococcal vaccine, Haemophilus influenza Type B, etc.) and combination vaccines have been developed. The development and production costs for these new vaccines are far higher than those of the earlier generations, and immunization programs developed according to the needs and resources of the rich world cannot be extrapolated to poorer countries at a price that would be within their means.
One of the main objectives of the Global Alliance for Vaccines and Immunization (GAVI) program created in 2000 by the Bill & Melinda Gates Foundation, the World Bank, the WHO and UNICEF together with vaccine manufacturers was to avoid widening of the gap between rich and poor countries in the matter of access to the most innovative vaccines. The goal of GAVI—which is shared by sanofi-aventis—is not only to provide these vaccines at affordable prices but also to make the infrastructural improvements necessary to ensuring their administration in perfect conditions and promote research and development programs for vaccines against diseases that mainly hit developing countries.


DISEASE INFORMATION



A. Malaria

The disease
Malaria is a parasitic infection transmitted from human to human via the bite of a mosquito belonging to the genus Anopheles. The parasite, called Plasmodium, invades and destroys red blood cells and it is this destruction which leads to the malarial paroxysm characterized by sudden-onset fever, tiredness, headache, shivering and vomiting.
The paroxysm may degenerate leading to severe anemia, convulsions, coma and, in some cases, death. Young children and pregnant women are at particularly high risk of developing severe malaria.

Epidemiology
Malaria is the most common of all the major infectious diseases, being found in most of the tropical and sub-tropical countries in sub-Saharan Africa, South and South-East Asia, and some regions of South America. It is estimated that fully one-third of all human beings are living in places where malaria is present, and that every year some 500 million people experience a malarial paroxysm with 1-2 million deaths (more than half of which occur in children of under five years of age).

Malaria is linked with poverty in two ways :
• Poverty perpetuates malaria because the disease spreads where anopheline mosquitoes thrive (neglected deposits of fresh water in which these insects can breed) and where there are Plasmodium-infected humans to sustain the transmission cycle. Although such conditions no longer pertain in countries like the United States and Australia, both countries where malaria used to be endemic, they are still common in many less developed countries in the Tropics.
• Malaria perpetuates poverty as a result of the direct costs of the disease (malaria is the most expensive health care item in many countries of sub-Saharan Africa) coupled with lost productivity (in terms of both work and education).

Treatment and control strategies
These days, the treatment of uncomplicated malaria depends on combination therapy including an artemisinin derivative and another antimalarial drug (Artemisinin-based Combination Therapy, ACT ; WHO Guidelines 2006). Artemisinin is derived from a plant, Artemisia annua, and was first shown to have antimalarial activity in China in the 1970’s and 1980’s. The main point of combining two drugs at the same time is to prevent the development of resistant parasites.
Severe paroxysms and complicated malaria are usually treated with injected quinine.
Malaria control involves not only treating attacks with effective, high-quality drugs, but also preventing the disease by cutting down the number of times infective mosquitoes bite human beings. The latter can be achieved by using mosquito nets made of a fabric that has been treated with insecticide; such precautions are especially important for children of under five and pregnant women).
If it is to be effective and sustainable, any malaria control strategy will have to be based on sufficient human and material resources to manage a number of parallel initiatives at the same time:
· diagnosis of cases of malaria ;
· effective, safe treatment modalities which are available for all patients ;
· entomological surveys to understand the characteristics of the anophelines in each malaria-infested region;
· insecticide-treated mosquito nets;
· insecticide spraying operations conducted both indoors and outdoors;
· destruction of larval breeding sites;
· education of local people about how to prevent malaria and how to care for its victims;
· establishment of a system to monitor certain key epidemiological and medical parameters (including the number of cases of the disease and anopheline densities) in order to optimize the targeting of human and material resources.
This “integrated control” approach supposes the political will to provide the necessary resources and the corresponding funding. At this time, governments and international institutions are more open than ever before; huge amounts of money are available from organizations like the Worldwide Fund for AIDS, Tuberculosis and Malaria, the Bill & Melinda Gates Foundation and UNITAID as well as many other institutions, national and international, private and public.


B. Tuberculosis

The disease
Koch’s bacillus (Mycobacterium tuberculosis), the causative agent of tuberculosis is transmitted through the air in droplets of fluid coughed out by carriers of the infection. An individual can get infected if he or she inhales just a few of these droplets. Most commonly, the bacterium establishes infection in the lungs but other organs may also be involved, including the bones, the meninges and the lymph nodes.
If untreated, an infected person can infect 10-15 other people a year. Population movements (tourists, refugees, homeless people in the developed world) and the AIDS pandemic have largely contributed to the spread of the disease across the planet over the last forty years.

Not all people infected with Mycobacterium tuberculosis develop the disease. The bacillus may persist inside the body in a latent state with the carrier asymptomatic for years on end. Only 5-10% of carriers will ever develop tuberculosis although the immunodeficient—especially those with AIDS—are at high risk of full-blown disease.
HIV and Mycobacterium tuberculosis constitute a lethal combination, each of these two infectious agents exacerbating the disease syndrome caused by the other: tuberculosis is the most common cause of death among AIDS patients, responsible for one-third of these deaths across the world as a whole and 40% in Africa.

Epidemiology
Together with AIDS and malaria, tuberculosis is one of the world’s most serious infectious diseases. About one-third of the world’s population is infected with Mycobacterium tuberculosis and it has been estimated that one new person gets infected every second. Every year, about 8 million people develop the disease, and 2 million die of it.



Just 22 countries account for 80% of all cases of tuberculosis.
More than 2 million of the cases every year are seen in sub-Saharan Africa but this figure is rapidly rising because of AIDS which is particularly prevalent in this part of the world. Nearly 3 million cases are recorded in South-East Asia, and more than 250,000 in Eastern Europe.

The AIDS epidemic and the emergence of multidrug-resistant strains of the bacillus are exacerbating the impact of tuberculosis which is classified by the World Health Organization as a global health emergency.
The WHO estimates that between 2000 and 2020, nearly one billion people will be infected de novo: 200 million of these will develop the disease and 35 million will die if we do not improve how we control strategies.


Treatment and control strategies
Effective treatment kills the bacteria in infected organs. It is currently based on four antibiotics, namely rifampicin, isoniazid, pyrazinamide and ethambutol. This combination is the standard therapeutic protocol recommended by the WHO. It has to be started as soon as possible and followed for at least six months.
The WHO holds that, from a public health point of view, an incomplete or poorly followed course of treatment is worse than no treatment at all; if the infection is not sterilized, antibiotic-resistant bacilli may be selected for and in that case, treatment will be longer, more difficult and more expensive.
Moreover, people carrying such drug-resistant strains of the bacillus will spread them through the population.

In order to encourage good compliance with first-line treatment, fixed-dose combinations have been developed. In a single tablet, these contain all four antibiotics for the initial two-month phase of treatment, or the two active substances used for the subsequent four-month (or more) phase. This considerably cuts down the number of tablets patients have to take every day.

Surveillance and accompaniment throughout treatment also enhances compliance.

The internationally recommended strategy for controlling tuberculosis is called Directly Observed Treatment Short-course (DOTS). DOTS involves supervision of the patient taking the daily tablet by an external observer, the “DOTS supporter”.
Once a case of tuberculosis has been diagnosed, trained care providers, community activists or volunteers directly monitor the patient to make sure that he or she takes the entire course of the prescribed medication.

After two months of treatment and again at the end, a new sputum analysis is performed to check the infection.
The recording and reporting system means that the progress of the disease can be followed throughout treatment, and it also makes it possible to quantify the proportion of patients who are being cured which gives a measure of the program’s efficiency.

Correctly applied, this strategy could prevent millions of new cases in the next ten years.





C. Sleeping sickness or African Human Trypanosomiasis (AHT)

The disease
Sleeping sickness or AHT is one of the most complex - and most neglected - of the endemic tropical diseases. Transmitted by the bite of a tsetse fly, the diseases ravages poor rural regions. The gambiense form is predominant in West and Central Africa, and the rhodesiense form is found in East Africa.

Sleeping sickness is one the diseases for which the efficacy and safety of treatment depend on proactive screening to ensure early detection. During the initial phase of the disease, the treatment is well tolerated and likely to succeed although, because the symptoms are mild and non-specific, patients rarely present spontaneously at this stage. Once the parasite has invaded the brain, severe neurological symptoms appear, including the disturbed sleep patterns which give the disease its name. The patient rapidly deteriorates towards a comatose state which inexorably leads to death. Treatment at the neurological stage (Stage 2) is far more difficult and dangerous, and a successful outcome is by no means guaranteed.

In the absence of treatment, the progress of the disease is long and devastating, and death will inevitably ensue.

Epidemiology
In 1995, the WHO estimated that about 300,000 people had sleeping sickness. In 2001 the WHO numbered those at risk of infection at 60 million, only 4-5 million of whom were benefiting from surveillance.
In 2006, the WHO estimated the number of cases at 70,000, an improvement which is the result of WHO initiatives as well as national and NGO-organized programs.



D. Leishmaniasis

The disease
Leishmaniasis is parasitic disease transmitted by the bite of an insect belonging to the genus Phlebotomus. This highly complex disease presents in six distinct forms. Visceral leishmaniasis (VL) or kala azar which involves the internal organs is the most severe form. In the absence of treatment, it is usually fatal within two years and, in some cases, the parasite may migrate to the skin (post-kala azar cutaneous leishmaniasis). The purely cutaneous form, in which the parasite causes ulcers on the face, arms and legs, is more frequent. Although the ulcers resolve spontaneously, they induce severe disability and leave hideous, irreversible scars. The muco-cutaneous form—in which the mucous membranes of the upper airways is invaded causing severe mutilation as a result of destruction of the soft tissues of nose, mouth and throat—is even more disfiguring. Diffuse cutaneous leishmaniasis induces chronic skin lesions which never spontaneously resolve. The sixth form, leishmaniasis recidivans is a relapsing form which occurs after treatment.

Epidemiology
The leishmaniases are endemic in 88 countries across four continents, Africa, Asia, Europe and America (both North and South).
According to the WHO, the disease threatens 350 million people and it estimates that 12 million people are infected, mostly those living in poor, isolated places. Leishmaniasis affects 1.5-2 million people per year.
The disease causes thousands of deaths (70% in children) and leaves thousands of others with highly disabling sequelae.
Five hundred thousand people (i.e. 25% of all new cases) in 62 different countries contract the visceral form (which is fatal if left untreated). Every year, 50,000 people die from VL, the great majority (90%) of whom live in Bangladesh, Brazil, India, Nepal and Sudan.

One-million-and-a-half people (75% of new cases) contract the cutaneous form, 90% of whom live in just six countries, namely Afghanistan, Algeria, Saudi Arabia, Brazil, Peru, Sudan and Syria.
Eighty-six per cent of cases of muco-cutaneous leishmaniasis are found in three countries: Bolivia, Brazil and Peru.

Treatment and control strategies
For the moment there is neither a vaccine nor an effective prophylactic drug. The only really useful personal protection measures are using an insecticide-treated mosquito net or spraying insecticides (e.g. DDT). Screening and monitoring zoonotic reservoirs (dogs and small forest rodents) are also important.
Treatment depends on pentavalent antimony salts (meglumine antimoniate and sodium stibogluconate) which are today considered as the first-line treatment modality. For second line treatment, amphotericin B, liposomal amphotericin B, pentamidine isethionate, paromomycin and miltefosin are available.

Sanofi-aventis sells meglumine antimoniate and pentamidine which are considered by the WHO as essential first- and second-line drugs in the treatment of all forms of leishmaniasis.
Given the prevalence of this disease in certain countries and the high price of the drugs, this scourge inflicts heavy damage on many health care budgets.



E. Epilepsy

The disease
Epilepsy is an organic, neurological problem caused by abnormal activity in the nervous cells of the brain, the neurons. Disorganized functioning results in sudden bursts of electrical discharges which manifest as fits. An epileptic fit corresponds to a set of clinical manifestations which onset suddenly in an unpredictable manner when a group of neurons or a neural network in the cerebral cortex begins to malfunction. Fits happen suddenly but are usually of short duration. Their characteristics are highly variable depending on which part of the brain is malfunctioning.
Epileptic fits can be broken down into two types:
· Generalized fits involving both hemispheres of the brain from the outset. The fit typically entails a sudden loss of consciousness so the patient falls down, at which time he or she may sustain physical injury. The epileptic goes into convulsions, sometimes violent, in most cases for a period lasting one to two minutes (although sometimes just for a few seconds).
· Partial or focalized attacks in which just one part of the brain is malfunctioning. Such attacks can manifest on one isolated part of the body, or they can appear as temporary losses of memory or consciousness.

Having an attack does not necessarily mean that you are epileptic. Epilepsy is defined as a tendency to repeated attacks which onset more or less often or last different amounts of time over the individual’s lifetime.
Epilepsy may be due to a brain lesion which can be caused by a physical insult, postnatal distress, infection, stroke, a metabolic problem, … However, the cause remains obscure in more than half of all cases. Epilepsy rarely runs in families.

Epidemiology
Epilepsy is the most common neurological condition in the world, after migraine. This disease recognizes no geographical, ethnic or social distinctions. About 5% of the world’s population will experience an attack at some point in their life, and 0.5-1.0% suffer from epilepsy.

More than 50 million people are affected, 85% of whom live in developing countries where the disease is most prevalent: 49-190 new cases per annum per 100,000 people with incidence peaks among the very young and the very old.
In certain societies, the convulsive fits of epilepsy are attributed to demonic possession, and the patient is referred to a traditional healer or exorcist rather than to a medical practitioner so he or she is neither diagnosed nor treated, and is often relegated to the margins of society.
Most children and adults who are diagnosed as epileptic can be successfully treated with currently available drugs. However, most (80%) of sufferers in the developing world are not treated and often not even diagnosed) as a result of the remoteness of health care facilities and the unavailability of the drugs that could help them. This has serious physical, psychological, social and economic repercussions for both patients and their families.

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About sanofi-aventis
Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organisation, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).


Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expect,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
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