Press release
SIGA Announces Health Canada Regulatory Approval of Oral TPOXX®
NEW YORK, Dec. 01, 2021 (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, Dec. 01, 2021 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that Health Canada has approved oral TPOXX® (tecovirimat) as an extraordinary use new drug. Specifically, Health Canada has authorized the use of oral TPOXX for the treatment of human smallpox disease in adults and pediatric patients weighing at least 13 kg. “This is an important milestone in our partnership with the Canadian Department of National Defence (DND) that provided support to SIGA for the submission and regulatory review of its application. The approval ensures that we can continue to supply oral TPOXX to both the DND and the Public Health Agency of Canada (PHAC) for stockpiling as a key countermeasure,” said Dr. Phil Gomez, CEO of SIGA Technologies. ABOUT SIGA TECHNOLOGIES, INC. and TPOXX® SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in July 2018. The full label is available by clicking here clicking here. For more information about SIGA, please visit www.siga.com. In June 2019, SIGA entered into an international promotion agreement with Meridian Medical Technologies, Inc. (“Meridian”), a Pfizer company. Under the agreement, Meridian will promote the sale of oral tecovirimat for the treatment of smallpox in all international markets outside of the United States. SIGA will continue to own all rights to the product and its related intellectual property. ABOUT MERIDIAN MEDICAL TECHNOLOGIES, INC. Meridian Medical Technologies, Inc., a Pfizer company, has been putting emergency care treatment options into the hands of military and civilian defenders for more than 50 years. Meridian is committed to help de...