Two American companies are teaming up for second-round test-phase production of a FDA-designated "fast track" drug candidate to treat smallpox, a deadly virus that is feared to be able to reach people through acts of bio-warfare or bio-terrorism.
Albemarle Corporation, a leading global provider of custom pharmaceutical manufacturing services, was selected by SIGA Technologies, a company specializing in the development of pharmaceutical agents to fight bio-warfare pathogens, to provide scale-up and manufacturing services for ST-246, SIGA's leading smallpox antiviral candidate.
Caused by the variola virus, smallpox is no longer found generally in the environment, but it is considered a formidable bio-warfare threat. SIGA's ST-246 has shown evidence of safety and high levels of efficacy against poxvirus disease in multiple animal trials, as well as continued success in human safety studies.
As a result of success in early trials and in one emergency compassionate use case, the FDA has designated ST-246 for "fast track" status. Activities supporting a New Drug Application (NDA) are currently in process.
Under its existing manufacturing agreement with SIGA, Albemarle's Fine Chemistry Services division will scale up the manufacturing process for SIGA's active pharmaceutical ingredient (API) to produce three cGMP registration batches at Albemarle's facility in South Haven, Mich. in anticipation of pivotal human safety trials.
Albemarle has already optimized and demonstrated a process for producing ST-246 in commercial quantities using SIGA's small-scale process as a starting point, and Albemarle recently proved the optimized process at pilot plant- scale with great success under cGMP conditions. Some of this material will be used to manufacture emergency-use capsules of ST-246, according to Dr. Dennis E. Hruby, SIGA's Chief Scientific Officer.