In a bid to overturn a situation where less than 1% of people with Chagas disease have access to treatment, non-profit drug development organisation Drugs for Neglected Diseases initiative (DNDi), pharmaceutical company Chemo Group and non-profit foundation Mundo Sano are entering into a formal collaboration to boost affordable access to benznidazole, by registering this essential medicine in countries affected by this deadly disease, including the US. If Chemo obtains a priority review voucher from the FDA, the company commits to dedicate half of the proceeds to actions that benefit Chagas patients.
Chemo Group and its corporate social responsibility partner Mundo Sano are working to register adult (100mg) and paediatric (12.5mg) benznidazole (BZN) for Chagas treatment with the US Food and Drug Administration (FDA), as well as in Mexico, Colombia and other endemic countries in Latin America. DNDi will support this move, by sharing with Chemo Group technical and scientific expertise, as well as by providing the data gathered with partners from previous clinical trials for adult and paediatric forms.
“Our ambition is to put an end to a scandalous and unjustifiable situation where almost none of the people living with Chagas has access to existing treatments,” said Dr Bernard Pécoul, DNDi Executive Director. “Registering benznidazole with the FDA will allow us to overcome the difficulties US patients have in accessing the drug, and will facilitate the registration process for the rest of the Americas.”
As a part of the agreement, Chemo Group commits to ensuring BZN is available to the public sector in Chagas-endemic countries on an affordable basis – at a price that covers manufacturing and distribution costs plus a reasonable margin.
“Our goal is to ensure its widespread use and equitable access for all patients”, said Leandro Sigman, Chemo Group Managing Director.
“There are many barriers to Chagas treatment, but the first one to overcome is the lack of access to the prescription drug,” said Silvia Gold, President of Mundo Sano. “We are proud to have Chemo Group as a reliable industrial partner capable of scaling up quality affordable benznidazole. Our hope is to transform the dynamic of access to treatment for Chagas patients throughout the Americas.”
To help address this situation, this agreement commits DNDi and Mundo Sano to developing an ambitious access plan in collaboration with stakeholders and partners, with a view to boosting demand by national programmes for BZN, strengthening demand forecasting, as well as communication campaigns to raise awareness and stimulate adoption.
By registering BZN with the US FDA, Chemo Group may qualify for a priority review voucher (PRV), a mechanism designed to encourage R&D into neglected diseases by awarding a voucher that fast-tracks FDA registration for another product. If Chemo Group obtains a PRV, the DNDi/Mundo Sano/Chemo agreement stipulates that Mundo Sano would receive 50% of any PRV-related financing to support its non-profit activities. DNDi and Mundo Sano would manage jointly half of those funds, to be dedicated to actions that benefit patients and encourage access, by supporting not-for-profit programmes to scale up diagnosis and treatment for Chagas disease.
“Our company is based on values shared with Mundo Sano. Chemo is a group that aims to sustain and improve people’s health, but also facilitate access to pharmacological treatments. Given the alarming lack of access to Chagas medicines, we are very proud to announce our commitment to dedicate 50% of an eventual economic advantage from the PRV to helping people living with this neglected disease”, said Leandro Sigman.
“Even if an affordable treatment is available, getting patients on treatment involves many complex concerted actions, from overcoming production challenges to boosting health system uptake and seeking patients’ support,” said Dr Joël Keravec, Regional Executive Director, DNDi Latin America. “The challenge will be to capitalize on the valuable efforts underway to boost diagnosis and treatment in countries such as Colombia, Bolivia, Brazil and the US, and develop a far-reaching access plan for Chagas disease in collaboration with governments, service providers and communities.”
The agreement builds on existing collaboration between DNDi and Mundo Sano to increase access to Chagas treatment. In 2013, DNDi joined forces with Mundo Sano to secure a second quality-assured source of BZN for children. DNDi has also been providing supporting to Chemo Group’s registration of BZN in Mexico and Colombia. This new collaboration extends registration plans to other endemic countries in the region.
DNDi (Latin America): Betina Moura / +55-21-98122-2798 / email@example.com
DNDi (US): Ilan Moss / +1-646-266-5216 / firstname.lastname@example.org
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. Current treatments are still difficult to implement due to the duration of treatment and side effects associated with their use.
A not-for-profit R&D organization, DNDi works to deliver new treatments for neglected diseases, in particular leishmaniasis, human African trypanosomiasis, Chagas disease, specific filarial infections, paediatric HIV, mycetoma, and hepatitis C. DNDi is actively engaged in developing new treatments and screening new compounds for Chagas disease. DNDi and partners delivered the first paediatric dosage form of benznidazole and is running clinical trials evaluating new regimens or combinations of the drug. DNDi is also involved in early stage research for entirely new drugs for Chagas disease.
ABOUT CHEMO GROUP
Chemo is a multinational pharmaceutical company with almost four decades of experience and commitment in safeguarding and improving people’s health and well-being. As a comprehensive health sciences group, Chemo operates in all areas of the chemical/pharmaceutical industry and specialises in the research, development, manufacturing, sales and marketing of pharmaceutical active ingredients and medicinal products for human and veterinary use. Chemo’s activities are organised into three synergistic business areas: Industrial, Branding and Biotechnology. The group has offices in more than 40 countries in Europe, America, Asia and Africa and has more than 5,000 professionals, 15 factories, 10 R&D centres and 33 affiliated pharmaceutical companies that provide services to more than 1,150 customers in 96 countries around the world. Chemo fulfils its social responsibilities through Mundo Sano, a non-profit foundation whose vision is the transformation of the realities of the populations affected by neglected diseases.
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, 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.