BioFactura, Inc. products

BioFactura develops and commercializes high-value biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFastTM Biomanufacturing Platform, the optimal choice for bringing these drug to market with faster, lower cost, superior-quality manufacture. The global biosimilars market is projected to grow from $4.5B in 2017 to over $23B by 2023 with a Compound Annual Growth Rate of >31%. Key drivers of future growth include the significant market share enjoyed by first generation monoclonal antibodies and their imminent patent expiries. In addition, the global market seems highly favorable due to increasing pressure felt by countries of all development stages to control the spiraling costs of healthcare and provide access to lifesaving medicines to their populations. BioFactura has identified a niche in the biosimilars market with current innovator revenues of over $24 billion. 

With a mortality rate of over 30%, smallpox is one of the most dangerous biological threats. It is person-to-person airborne communicable, highly contagious and exhibits a long pre-symptomatic phase (12-14 days) allowing undetectable spread worldwide. While smallpox was declared eradicated in 1980 by the World Health Organization after an extensive vaccination campaign, the threat of bioterrorism and/or inadvertent release remains. Although TPOXX (Tecovirimat, SIGA Technologies, Inc.) received FDA approval for smallpox treatment in 2018, orthopoxviurses, like Variola Virus (VARV), the causative agent of smallpox, can become resistant to treatment suggesting that the best medical countermeasure approach would utilize complementary therapeutics.

BioFactura is developing a Marburg therapeutic in close collaboration with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). Marburg virus (MARV) was first described in 1967 as the causative agent of a hemorrhagic fever illness that occurred in laboratory workers at a primate facility in Germany and Yugoslavia. Since its discovery, marburgviruses have caused at least 13 outbreaks of Marburg virus disease (MVD) in humans, primarily in sub-Saharan Africa.