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Albemarle Optimizes Smallpox Drug Candidate for SIGA
Date:5/5/2008

ment 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."

New York-based SIGA Technologies applies viral and bacterial genomics
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SOURCE Albemarle Corporation
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