[ Geneva; Switzerland and Recife, Brasil – July 21st, 2008]
An agreement between Drugs for Neglected Diseases initiative (DNDi) and the Pharmaceutical Laboratory of Pernambuco (Lafepe) will deliver the first pediatric formulation of benznidazole, the most widely used drug for the treatment of Chagas disease, at cost and for worldwide distribution.
Children infected by Chagas disease, endemic in 21 countries in Central and South America, will soon have access to a treatment tailored to their needs. As a result of the new partnership between Lafepe and DNDi, the first pediatric formulation of benznidazole will be made available to patients by the end of 2009. The drug will be sold at cost, with no profit to the institutions involved in its development, and will be available for distribution worldwide.
Although benznidazole has been available since the 1970’s as a treatment for Chagas disease in endemic countries, until now there has been no formulation for pediatric use that meets the needs of children according to their ages and weights. Currently, children with Chagas disease are treated with a fraction of an adult-strength tablet of benznidazole. To treat infants, a single tablet may be divided into as many as 12 fractions, increasing the likelihood of errors that can affect the efficiency, quality, compliance, and safety of the medication.
“The partnership between DNDi and Lafepe has responded to one of the most important priorities set by the international community for combating Chagas disease: the development of a pediatric formulation of benznidazole,” said Isabela Ribeiro, DNDi’s senior project manager in Brazil. “The current use of the adult treatment may put children with Chagas disease at risk.”
According to the agreement, Lafepe will produce the pediatric formulation of benznidazole. DNDi will assist Lafepe in registering the drug with government authorities, developing distribution strategies for endemic countries, and providing assistance for the pre-qualification of the product by the Pan American Health Organization (PAHO).
“We are happy to have DNDi’s technical and managerial support. This agreement will render the product available in sufficient quantity to meet the needs of endemic countries affected by Chagas disease,” commented Lafepe’s President, Luciano Vasquez.
“This agreement is good news for children suffering from Chagas disease, and is a major step forward towards treating the disease more effectively,” added Bernard Pécoul, DNDi’s Executive Director, “This agreement is part of a broader set of scientific strategies to research and develop new and improved treatments for Chagas disease.”
About Chagas Disease
Human American trypanosomiasis, known as Chagas disease, is endemic in 21 countries in Central and South America, from Mexico to Chile, and threatens 25 percent of the population living in the region. An estimated 8 million people currently carry the parasite in their blood and 50,000 patients die every year in Latin America due to Chagas disease. The people most affected by the disease are very poor, and many live in houses built on stilts, a perfect habitat for kissing bugs, the insects that transmit the parasite (trypanosoma cruzi) to humans. When they bite, kissing bugs deposit feces on the skin of the person; scratching the bite allows the parasite to penetrate the skin and enter the bloodstream. Chagas disease can also be transmitted through contaminated blood transfusions or from mother to child during pregnancy. Currently, Lafepe is the only laboratory in the world that is capable of producing benznidazole, following Roche’s transfer of the rights and technology to manufacture the drug to the government of Brazil.
The second largest public laboratory in Brazil, Lafepe was created in 1966 to produce medicines at low cost for people with limited purchasing power. Based in Recife, the capital of the state of Pernambuco in northeastern Brazil, Lafepe has average annual revenues of R$63 million, equivalent to approximately USD 21 million. Lafepe focuses on developing, producing, and marketing drugs to support the needs of public health policy. For example, in 1994, it became the first official laboratory in Brazil to produce the antiretroviral zidovudine (AZT). The Pernambuco laboratory invests in the modernisation of its facilities, with high-tech industrial equipment. Its pioneering program Popular Pharmacy set up in popular market areas in different regions of the state, serves as a model for the federal government. For more information, see: www.lafepe.pe.gov.br.
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 2 post-registration, 5 clinical and 4 preclinical projects. In 2007 and 2008 DNDi and its public and private partners within the FACT Project successfully launched 2 new fixed-dose artesunate-based combination therapies (ACTs) for malaria, ASAQ and ASMQ. These new ACTs are easier to use, more affordable than current treatments, and non patented. For further information, please consult www.dndi.org.
Álvaro Claudino, Brazil, (81) 9156-9670, firstname.lastname@example.org
Flávio Guilherme Pontes –DNDi Rio de Janeiro, Brasil, (21) 8123-4133; (21) 8298-6294, www.dndi.org.br
Sadia Kaenzig, DNDi Geneva, +41 (0)22 906 92 30 or +41 (0)79 819 99 71, email@example.com
Ann-Marie Sevcsik, DNDi Geneva, +41 (0)79 814 9147, firstname.lastname@example.org
Michelle French, DNDi North America, (212) 298-3743 or (646) 552-4600, email@example.com