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     132  0 Kommentare SIGA Announces Canadian Department of National Defence Intent to Purchase Up To 15,325 Courses of Oral TPOXX

    • Contract Would Represent First International Order of TPOXX 
    • Canadian Military Intends Firm Delivery of 2,500 Courses, with Additional Option Quantities of 12,825 Courses

    NEW YORK, Dec. 05, 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 the CDND intends to purchase up to 15,325 courses of oral TPOXX (tecovirimat) over four years as specified in the ACAN, with an initial purchase of 2,500 courses.  The ACAN is required to remain open for at least 15 days, during which time a potential alternative supplier may submit a competing Statement of Capabilities. The contract would represent the first international order for TPOXX. As SIGA previously announced, the CDND intends to award a contract to support regulatory approval for TPOXX by Heath Canada. The Company is currently targeting a Canadian regulatory filing in the second half of 2020, with regulatory approval anticipated in 2021.

    “This type of initial procurement by the Canadian military, in advance of Canadian regulatory approval, would be a natural first step in our efforts to build an international business for oral TPOXX. We are pleased that the value of TPOXX as an important component of smallpox preparedness is being recognized outside the United States,” said Dr. Phil Gomez, CEO of SIGA Technologies. “Historically, the military is often the first governmental department to acquire a medical countermeasure for national preparedness, with health departments often following at a later date with significantly larger contract awards. Specifically with respect to Canada, we are working collaboratively with our partner, Meridian Medical Technologies, Inc., and both the Department of Defence and Health Ministries to support procurement needs for TPOXX to protect Canada’s military and civilian population.”

    The value of courses to be sold to Canada will be disclosed upon any final award by the Canadian government. In any contract issued by Canada, Meridian will be the counterparty to the contract and SIGA will be responsible for the manufacture and delivery of product.

    The ACAN notice can be found at:  https://buyandsell.gc.ca/procurement-data/tender-notice/PW-PH-893-7816 ...

    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 development supported by the National Institutes of Health, U.S. Centers for Disease Control and Prevention, and Department of Defense.  The US currently maintains a stockpile of 1.7 million courses of TPOXX.

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    SIGA Announces Canadian Department of National Defence Intent to Purchase Up To 15,325 Courses of Oral TPOXX Contract Would Represent First International Order of TPOXX Canadian Military Intends Firm Delivery of 2,500 Courses, with Additional Option Quantities of 12,825 Courses NEW YORK, Dec. 05, 2019 (GLOBE NEWSWIRE) - SIGA Technologies, Inc. (SIGA) …