Drug candidate to treat smallpox scaled up by new partnership

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.

"Under the leadership of Dr. Shanthakumar Tyavanagimatt, SIGA's Director CMC operations & Formulations, Albemarle's R&D group have helped us flesh out a robust crystallization step that consistently delivers the most desired polymorph for this advanced API," said Dr Hruby. "Together we have developed a process that is suitable for commercial production, and can be used to create substantial quantities of the drug for stockpiling for emergency use."

"We have been very happy with the working relationship with Albemarle and the value that they have added to this important antiviral program," Dr. Hruby added.

"We are honored that SIGA has entrusted Albemarle with this significant new compound," said Dr. David Clary, Albemarle Division Vice President of Fine Chemistry Services. "Our ability to support our customers' most important and sensitive needs from pre-clinical trials into commercialization has resulted in a positive response from the pharmaceutical industry, as evidenced by the steady growth in our chemistry services business. Our success with SIGA's program underlines our proven abilities to support the chemistry needs of developing pharmaceutical companies."

http://www.albemarle.com/ and http://www.siga.com/