March 12, 2013
SIGA Delivers First Courses of Arestvyr(TM) Under BARDA Contract
NEW YORK, March 12, 2013 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (Nasdaq:SIGA), a company specializing in the development of pharmaceutical agents to fight pathogens capable of use as bioweapons, today announced the first of a series of deliveries of its proprietary smallpox antiviral drug, Arestvyr™, to the United States Government's Strategic National Stockpile under SIGA's contract with the Biomedical Advanced Research and Development Authority (BARDA).
"The men and women of SIGA are proud of their longstanding partnership with BARDA, taking this important step forward in protecting our fellow citizens against the threat of bioterrorism," declared Dr. Eric A. Rose, SIGA's Chairman and Chief Executive Officer. "This first commercial delivery marks a major milestone in SIGA's transformation from a research company to a commercial biopharmaceutical enterprise. While SIGA continues to research and develop pharmaceutical agents to fight other lethal pathogens, and concurrently seeks approval and licensing of Arestvyr from the U.S. Food and Drug Administration, this first delivery of Arestvyr to the Stockpile is evidence of our ability to oversee the manufacture and delivery of large quantities of high-quality pharmaceutical product. It gives us great confidence in SIGA's capabilities and aspirations, and moves us well down the path to generating substantial contractual payments from BARDA later this year and beyond."
BARDA, part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health emergencies. SIGA may begin to obtain payment under the BARDA contract once it has delivered 500,000 of the 2,000,000 contracted-for courses of Arestvyr. This first delivery of approximately 190,000 courses moves SIGA much closer to that moment.
Arestvyr (Tecovirimat) is one of the first novel drugs to be developed, procured and now delivered to the Strategic National Stockpile under the post-9/11 legislative authority known as Project BioShield. Developed to serve as a therapeutic drug for treatment of smallpox, whether resulting from a terrorist attack, biowarfare or a new natural outbreak, Arestvyr is an investigational new drug not yet approved or licensed as safe and effective by the U.S. Food and Drug Administration (FDA). Arestvyr was formerly known as ST-246®.
