SIGA Technologies Inc. (NASDAQ: SIGA) announced it has launched an initiative to produce DNA registration batches of its leading smallpox antiviral, ST-246. The company specializes in the development of pharmaceutical agents effective against biowarfare pathogens. For the past few months, the company has consulted with the FDA to choose its final chemical formulation for large-scale production, and has chosen the market image and packaging needed to commercialize the material.
“Now that we have submitted to FDA our package supporting emergency use authorization for ST-246 and have successfully completed a multiple ascending dose human clinical safety trial, we are moving to complete the other elements necessary to get full marketing approval,” Dr. Eric Rose, CEO of SIGA stated in the press release. “Scale up of the final formulation is complete, and manufacturing of the registration batches is underway. We expect to complete all registration batches of ST-246 in the second half of 2008.”
“Every step we take toward the commercialization of ST-246 is an important, value-driving milestone for SIGA and its shareholders. Given the success that this drug has demonstrated thus far in our efficacy studies, we believe that ST-246 can be the preferred antiviral option for defending against possible bio-terror and bio-warfare attacks using the smallpox virus,” he continued.
The company has secured a contract with Albemarle Corporation (NYSE: ALB), in which Albemarle will provide its scale-up and manufacturing services to produce three registration batches in anticipation of the upcoming pivotal safety clinical trial. To win FDA marketing approval, SIGA is required to manufacture “registration batches” – commercial amounts of ST-246 produced in accordance with the FDA’s current standards for good manufacturing practices.
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