[Geneva, Switzerland – 11 November 2013]
Strategic agreement signed today to ensure crucial second source of pediatric formulation of benznidazole for millions of children in need of treatment
Today the Mundo Sano Foundation and the Drugs for Neglected Diseases initiative (DNDi) signed a wide-ranging accord to collaborate closely on a vital second source of the drug benznidazole for children affected by Chagas disease. From production to patient access, securing affordability and accessibility, the agreement unites the two not-for-profit organizations, highly involved in advocacy and drug research and development, in their common effort to fill treatment gaps for Chagas disease patients worldwide.
Benznidazole, the main drug used to treat Chagas disease today, is one of the only two currently available drugs to treat the disease. Mundo Sano, leading an Argentinian drug development consortium, partnered notably with ELEA to develop ABARAX (100 mg and 50 mg) in 2012. ABARAX is the second source of benznidazole after the one developed by Lafepe, a Brazilian public pharmaceutical company. DNDi collaborated with Lafepe to develop the only existing child-adapted formulation of benznidazole (12.5mg), registered in Brazil in 2011.
Under the agreement, Mundo Sano and DNDi will work together to deliver a second source of appropriately child-adapted benznidazole treatment for young children. Together, they will work to lower the cost of the basic product required to produce benznidazole treatments at an affordable price to Chagas patients in need of treatment. The organizations will also carry out any studies, clinical or other, needed to ensure regulatory approval and maximize use of benznidazole, both for adults and children, in support of current efforts to increase the chances of treatment coverage, as still today over 99% of people living with Chagas disease are in need of treatment.
‘We are very pleased to formalize this agreement because Mundo Sano and DNDi are two institutions that work for this matter with seriousness and perseverance for many years. This partnership involves sharing efforts and combining research strategies for Chagas, maximizing the strengths of each of the institutions and creating a transcending reality’, said Dr Silvia Gold, president of Mundo Sano.
In addition, both organizations will advocate, notably within the Global Chagas Disease Coalition, for the policy changes within governments of endemic and non-endemic countries necessary to achieve greater ‘test and treat’ strategies to lower the grave public health and economic burden caused by the disease.
‘Discovered over a century ago, Chagas disease is incredibly still among the world’s most neglected diseases, with millions waiting to receive treatment and care’, said Eric Stobbaerts, Director of DNDi Latin America. ‘Growing scientific evidence shows that benznidazole should be widely used to treat Chagas disease with no delay, while we continue to actively search for newer treatments.’
About Chagas disease
The leading parasitic killer of the Americas, Chagas disease (American trypanosomiasis) infects an estimated 8 million people, mostly in Latin America, where it is endemic in 21 countries and kills some 12,000 people each year. The most affected people are very poor, live in inadequate housing conditions, and often have little access to healthcare. Cases of Chagas disease are increasingly recognized in North America, Europe, Japan, and Australia. Caused by the parasite Trypanosoma cruzi, Chagas disease starts with an early, acute stage lasting about two months, and is followed by a late, chronic stage lasting a lifetime, in which up to 30% of patients develop life-threatening heart damage and up to 10% may have severe damage to their digestive system. The Chagas parasite is primarily transmitted via the bite of the blood-sucking triatome bug, sometimes called the ‘kissing bug’. Chagas is also transmitted by blood transfusion, organ transplantation, oral ingestion, or during pregnancy from mother to newborn, in which an estimated 14,000 new cases occur annually. Current treatments are still difficult to implement due to the duration of treatment and side effects associated with their use. DNDi is working to develop a new, safe, effective, and affordable drug specifically to treat Chagas disease.
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization working to deliver new treatments for the most neglected diseases, in particular sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filaria, and paediatric HIV/AIDS. Since its inception in 2003, DNDi has delivered six new treatments: two fixed-dose antimalarials (ASAQ and ASMQ); nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness; sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa; a set of combination therapies for visceral leishmaniasis in Asia; and a paediatric dosage form of benznidazole for Chagas disease. DNDi was founded by Médecins Sans Frontières/Doctors Without Borders (MSF), Indian Council of Medical Research, Kenya Medical Research Institute, Brazil’s Oswaldo Cruz Foundation, Ministry of Health of Malaysia, and Institut Pasteur in France, with the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) as a permanent observer.
About Mundo Sano
Mundo Sano is a civil society organization that since 1993 aims to reduce the impact caused by neglected diseases, such as Chagas disease, dengue, leishmaniasis and various geoparasitosis, among others. In pursuit of achieving greater equity, the institution works alongside the public and private sectors, academia and other international organizations. In order to provide solutions to the affected communities and generate scientific knowledge, Mundo Sano led a public private consortium in 2012 to produce benznidazole in Argentina, one of the main drugs to treat Chagas disease.
It is also the only civil society organization of Latin American origin that integrates the global alliance Uniting to Combat NTDs – led by the Bill & Melinda Gates Foundation, which aims to reduce the impact of a set of neglected diseases by 2020.
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