Aid agency wants Brazil to streamline validation to combat Chagas API shortages

The French aid agency made the call after Brazilian state-owned firm Lafepe, the world’s only producer of a Chagas treatment since Swiss drugmaker Roche pulled out of the market and handed over manufacturing rights in 2003, failed to achieve expected production levels.

The problem, according to MSF​, is that Nortec Quimica, the private firm contracted to make benznidazole on Lafepe's behalf, has not been cleared by regulators despite being identified as a replacement for Roche in 2008 and entering the manufacturing validation review process shortly afterwards.

“Had the Brazilian Ministry of Health cooperated according to plan, there would have been a new API approved and available without an interruption to the production of benznidazole,” MSF said.​

“Yet despite the urgency of finalizing Nortec as the new source for the API before Roche’s products expired, little progress was made on this front. There was no effective direction from the Brazilian Ministry of Health, and there was insufficient demand forecasting from PAHO and other countries’ Ministries of Health​.”

“This crisis could have been prevented but the major player involved, the Brazilian Ministry of Health, has shirked its responsibilities and is evidently unwilling to overcome the various challenges.​” The Brazilian Health Ministry has not yet issued a statement.

MSF predicts that current supplies will start running out next year leaving the eight to 10 million Chagas sufferers worldwide without treatment.

Chagas challenge​

Such a shortage would be a major setback for the various Chagas prevention programmes that have been operating in Latin America since 1999, given that benznidazole is the cornerstone of all treatment efforts.

MSF has already stopped diagnosing new patients in Paraguay in a bid to extend suppliers for existing patients and predicts that stocks in Bolivia will run out in 2012.

A Chagas drug drought may also be a problem for the US as recent research has suggested the disease may be more prevalent in the country than previously thought.

Researchers at the University of Texas​ that have studied the disease over the last four years suggest that Chagas cases are on the increase, especially in Southern parts of the state.

They said, while more work is needed, the threat significant enough to merit “a few low-cost, low-impact changes to the way the Texas public health system​,” including designating it as a reportable disease and mandating that all blood donations are screened for Chagas.

Pharma interest​

The disease’s spread to the US, the world’s most lucrative drug market, while potentially bad news for the residents of Texas may ironically prove a boon for efforts expand production of treatment.

Pharmaceutical firms’ R&D efforts are increasingly targeting emerging markets and diseases for which there is an unmet medical need, and the ability to develop a product that meets both of these aims and may be in demand in the US is likely to prove attractive.