DNDi, Mundo Sano and Chemo team up to register benznidazole in US and Latin America

Thursday, June 9, 2016

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.