Doctors Without Borders (MSF) recently noted the one of the best products to treat deadly snakebites has ended production and the remaining supply will soon be exhausted. FAV-Afrique can be used to treat bites from ten venomous snakes, and has been a mainstay in sub-Saharan Africa. At the root of this incredible situation is the fact that Sanofi Pasteur had stopped producing FAV-Afrique years before due to cost competitiveness. The World Health Organization (WHO), MSF, and other related organizations knew of this production stoppage and advocated for transfer of IP from Sanofi to another company to continue production. Yet, this life-saving products remains shelved and would be at least a few years from replenishment even under the most ideal circumstances. 

 

In the United States, under Health and Human Services, an organization exists whose charter is to produce late stage therapeutics  -especially in therapeutic areas that Big Pharma has largely exited. In fact, Peptineo had lobbied to employ this same resource to produce a late stage Ebola vaccine that had been shelved. This process was successfully engaged for MAPP Pharmaceuticals (producers of ZMapp) to produce its Ebola antibody cocktail -and BARDA has a pipeline of other products that it is producing. Under BARDA, a virtual pharmaceutical manufacturing capability has been established to take a therapeutic into production and complete all required regulatory milestones for FDA licensure. While BARDA may not be positioned to produce this desperately needed anti-venom, the model for producing late-stage or previously approved regulatory products is worth consideration. Given that modern manufacturing of pharmaceuticals has experienced a significant reduction in infrastructure costs and physical footprints to produce products (example: NNE Pharmaplan flexible manufacturing designs), perhaps the WHO and others should consider establishing rapid manufacturing capabilities similar to BARDA. Not only can products be made, but a streamlined process has also been developed to move products quickly through necessary regulatory efforts. The following links directly to additional background on the incredible stoppage and shelving of the FAV-Afrique anti-venom and is found here

image.jpg