A Worldwide Public Partnership Makes Available a New, Once-a-Day Fixed-Dose Combination against Malaria

[ Rio de Janeiro – April 17, 2008 ]
An innovative partnership between the Brazilian public pharmaceutical company, Farmanguinhos/Fiocruz, and the non-profit drug development organization, Drugs for Neglected Diseases initiative (DNDi), announced today that ASMQ, the new fixed-dose combination of artesunate (AS) and mefloquine (MQ), is now registered and available in Brazil.
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Artemisinin-based combination treatments (ACTs) are considered to be the best treatments for uncomplicated P. falciparum malaria and are a key element of the global malaria control strategy.
Safe, rapid, and reliably effective, the combination of AS and MQ is one of four World Health Organization (WHO)-recommended ACTs as first-line antimalarial treatment since 2001.

ASMQ, the first new product for neglected diseases to be developed and registered in Brazil, is the second drug made available by the partners of DNDi’s FACT (Fixed-Dose ACT) Project. ASMQ is the fixed-dose formulation of the association of AS and MQ, which has been widely used in Latin America and Southeast Asia over the past decade.

Thanks to the collaboration between public partners in Brazil and Southeast Asia within DNDi’s FACT Project, this innovative fixed-dose formulation is now available in Brazil, where national control program authorities have found that the new fixed-dose ASMQ in programmatic use could have a significant impact in reducing reported malaria cases and malaria-related hospitalizations, as reported in preliminary results of a 1-year analysis of over 17,000 patients.1

”In 2006, the Brazilian Ministry of Health registered 145,000 cases of uncomplicated falciparum malaria, 99% of which were located in Legal Amazon. In 2007, we registered a reduction to 93,000 cases. Malaria-related hospital admissions also dropped from 9,500, in 2006, to approximately 6,000 in 2007. Basic health network expansion, early diagnosis, and the use of the new treatment – fixed-dose ASMQ – each played a critical role in obtaining such a positive impact,” said Dr. Gerson Penna, Brazil’s Health Surveillance Secretary in the Ministry of Health.

ASMQ, which combines 2 drugs (AS and MQ) into 1 small blue tablet, simplifies treatment for adults and children with a single daily dose of 1 or 2 tablets for 3 days, by reducing the number of tablets, and by ensuring that the combination of drugs are taken together and in the correct proportions. The needs of children, the primary victims of malaria worldwide, are addressed with ASMQ: 3 presentations of ASMQ are available for children; tablets are small and easily crushable.

Packaging is color-coded to easily identify the different dosage for each range and to allow for ease-of-use of patients and prescribers, and ASMQ is the first fixed-dose ACT to have a shelf-life of 3 years in tropical conditions.

According to Dr. Paolo Buss, Fiocruz President, the project has two main characteristics: “The role of Fiocruz is to develop knowledge, goods, products, and services that are of benefit to Brazilian society and its health system. In the specific case of ASMQ, not only did we reach this objective in collaboration with DNDi, but this Brazilian-developed product will also provide benefit to other countries. This drug will be used in Brazil, and in many other countries in Latin America and Southeast Asia.”

As a public good, ASMQ will be available at cost to the public sector of endemic countries at a target price of US$2.50 for the full adult treatment. This new treatment will be made available to children and adult patients throughout Latin America and Southeast Asia over the course of 2008 and 2009. Facilitated by DNDi, the principles of technology transfer have been agreed between Farmanguinhos and the Indian generic pharmaceutical company, Cipla, so that patients in Southeast Asia will have a local manufacturer.

According to Dr. Eduardo Costa, Chairman of Farmanguinhos/Fiocruz, “This project demonstrates that it is possible to develop innovative, needs-driven R&D technologies that will deliver new drugs. We were able to combine different facilities in many countries into a great public-private, intercontinental partnership. And now, we will transfer the technology of this product to a private laboratory in India (Cipla),” said Costa.

“This new fixed-dose combination is a public good that has been developed according to patients’ needs by being easy to use, more affordable and a quality product,” said Dr. Bernard Pecoul, Executive Director of DNDi. “The fact that ASMQ has been successfully developed, funded, and delivered by public partners in Brazil, Europe, and Southeast Asia as part of DNDi’s FACT Consortium shows an alternative way to develop drugs for neglected diseases.”

ASMQ is targeted as first-line treatment for children and adults suffering from uncomplicated P. falciparum malaria cases in Latin America and Asia. Every year, there are approximately 1 million cases of malaria in Latin America (25% of which are P. falciparum cases, and the majority of which are in Brazil), and approximately 3 million cases in Asia, where 30% of the global malaria-related mortality is found.

“This is good news for patients around the world as more affordable and easy-to-use fixed-dose treatment for malaria are needed,” Prof Nick White, Professor of Tropical Medicine at Oxford University. “With effective, safe, easier to use, and better tolerated treatments like this becoming available, it’s ever more urgent that we make sure these treatments reach the patients who actually need them.”


Malaria in Figures
puce Malaria is a major cause of morbidity and mortality worldwide: malaria slows economic growth by 1.3% per year in endemic areas.
puce The disease is present in over 100 countries and threatens half of the world’s population.
puce Every year, 350 to 500 million cases of malaria occur worldwide, with over 1 million deaths.
puce 99% of malaria cases in Brazil are found in the Amazonian basin, where the Brazilian national control program authorities have conducted the intervention study with ASMQ in programmatic use.

About Farmanguinhos/Fiocruz
A part of the Oswaldo Cruz Foundation (Fiocruz) of the Government of the Federative Republic of Brazil, Farmanguinhos/Fiocruz is one of the largest pharmaceutical laboratories in Brazil and has a long history of drug production in the field of neglected diseases, particularly for the treatment of AIDS.  Farmanguinhos/Fiocruz produces more than two billion pharmaceutical components per year, not just for AIDS but also for the treatment of endemic diseases such as malaria (ASMQ; primaquine and chloroquine), leprosy, tuberculosis, and filariasis. Farmanguinhos is located in the state of Rio de Janeiro. For further information, please consult www.far.fiocruz.br.

About DNDi
The Drugs for Neglected Diseases initiative (DNDi) is an independent, not-for-profit product development partnership working to research and develop new and improved treatments for neglected diseases such as malaria, leishmaniasis, human African trypanosomiasis, and Chagas disease. With the objective to address unmet patient needs for these diseases, DNDi was established in 2003 by Institut Pasteur and Médecins Sans Frontières along with four publicly-funded research organizations in neglected disease-endemic countries. Working in partnership with industry and academia, DNDi has the largest ever R&D portfolio for the kinetoplastid diseases and currently has 6 clinical and 4 preclinical projects. In 2007, DNDi delivered its first product, a fixed-dose antimalarial “ASAQ”, in partnership with sanofi-aventis; now in 2008, DNDi is delivering its second product, fixed-dose “ASMQ”.
For further information, please consult www.dndi.org.

The Fixed-Dose Artesunate-based Combination Therapies (FACT) Project, initiated in 2002, demonstrates the efficacy of public partnerships in the field of drug R&D for neglected diseases. Fast-track development, testing, and registration of the two fixed-dose combinations, artesunate-amodiaquine (ASAQ) and artesunate-mefloquine (ASMQ), were the primary objectives of the project and have been achieved.

The multi-partner FACT Project Consortium consists of DNDi; Farmanguinhos/Fiocruz, Brazil; Tropival of the Bordeaux II University, France; Oxford University, UK; Universiti Sains Malaysia; Mahidol University, Thailand; TDR in Switzerland; and the Centre National de Recherche et de Formation sur le Paludisme (CNRFP) in Burkina Faso. Consistent with DNDi’s mission of collaboration based on relative strengths, the FACT Project capitalizes on the skills and know-how of a broad range of partners in both developing and developed countries. Thus far, the FACT Project has received financial support from the European Union; Agence Française de Développement (AFD); the Dutch, the Spanish, and the UK governments; and MSF.

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