The Instituto Bioclon S.A. de C.V. (Bioclon Institute) was formed in 1990 to research and develop F(ab’)2 antivenoms. On May 6, 2015 they received approval from the FDA to commercialize Anavip becoming their second drug approved by the FDA after ANASCORP. Both are commercialized in the US by Rare Disease Therapeutics, Inc. The company is performing clinical trials to get approval for a third drug, ANALATRO, designed to treat black widow spider envenomation.
Operations
The Instituto Bioclon is located in Mexico City, Mexico and has a Certificación Internacional de Buenas Prácticas de Manufactura (International Certificate for Good Manufacturing Practices) which was granted to Bioclon by the , (INVIMA) (National Food and Drug Monitoring Institute), of the Ministry of Health and Social Protection of Colombia, as well as by COFEPRIS, in Mexico.
Products
Anavip – timber rattlesnake antivenom
Coralmyn – coral snake antivenom
Antivipmyn – pit viper antivenom
Antivipmyn TRI – Central and South American snakes
Antivipmyn Africa – African snakes
Alacramyn – scorpion antivenom
Reclusmyn – brown recluse antivenom
Aracmyn – black widow antivenom
The Bioclon Institute is the only Mexican company that has obtained an "orphan drug" status from the Food and Drug Administration (FDA) of the United States for its products.