Press release
SIGA Announces Canadian Release of the Advanced Contract Award Notice to Support Regulatory Filing for Oral TPOXX®
NEW YORK, Nov. 18, 2019 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health
About this update from Siga Technologies Inc.
[{"type":"text","content":"NEW YORK, Nov. 18, 2019 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that the Canadian Department of National Defence (CDND) has issued an advanced contract award notice (ACAN), indicating that it intends to award a contract to fund regulatory filing with Health Canada for approval of oral TPOXX®. The ACAN is required to remain open for approximately 15 days, during which time a potential alternative supplier who meets the ACAN requirements for a smallpox anti-viral therapy that has been approved by national regulatory authority may submit a competing Statement of Capabilities. SIGA is the only company currently able to fulfill this requirement.\n “The ACAN represents an important first step by the Canadian military, to ultimately provide TPOXX as a medical countermeasure for smallpox. In the past, Canada has pursued initial procurement of medical countermeasures prior to full regulatory approval and pursuant to emergency use authorization as a strategy for protecting its citizens from potential bio-threats, with additional, larger procurements typically following such approval,” said Dr. Phil Gomez, CEO of SIGA Technologies. “As a result, this ACAN is an important first step in Canada’s efforts to enhance its smallpox preparedness with an anti-viral product. We are pleased that the CDND has identified TPOXX as the only smallpox treatment qualified to fulfill its requirements. We look forward to working with the appropriate Canadian authorities on the next steps in preparation of a regulatory filing for oral TPOXX, which is initially targeted for 2020, and ultimate delivery of this important smallpox antiviral therapy to help protect the people of Canada.” The ACAN notice can be found at: https://buyandsell.gc.ca/procurement-data/tender-notice/PW-19-00896089. On July 13, 2018, the FDA approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack. TPOXX, a small-molecule antiviral treatment for smallpox, is the first therapy specifically approved for this indication, and was developed through funding and collaboration with the Biomedical Advanced Research and Development Authority at the U.S. Department of Health and Human Services, as well as early stage dev...