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– Approximately $10 million contract funded by the European Commission –
– Received orders worth approximately $6 million from two countries in Asia Pacific –
NEW YORK, Sept. 26, 2022 (GLOBE NEWSWIRE) — SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the healthcare security market, today announced the receipt of approximately 16 Millions of US dollars in international funds announced Procurement orders for oral TPOXX® (Tecovirimat) in August and early September, including a European Commission order for approximately orders from two countries in Asia Pacific, one of which is a new customer.
The European Commission’s order concerns the short-term emergency stockpiling and/or use of oral TPOXX (Tecovirimat) in connection with the monkeypox outbreak. In addition to sourcing oral TPOXX through direct purchase funding, the European Commission is also coordinating sourcing at country level through the use of a joint sourcing mechanism. SIGA and its international promotional partner, Meridian Medical Technologies, LLC, will continue to pursue multiple avenues to coordinate health security in the European Union.
SIGA expects to complete delivery of these latest orders in 2022. To date, this year, including recent orders, SIGA has received approximately US$76 million in international orders for oral TPOXX (Tecovirimat) from twelve international customers. Currently, at least $65 million of those orders are expected to ship in 2022.
“With over 64,000 monkeypox cases worldwide since May 2022, there is increasing focus on individual countries, international governmental organizations and non-governmental organizations (NGOs) on combating the monkeypox outbreak,” said Phil Gomez, CEO of SIGA. “The procurement of TPOXX by the European Commission and by individual countries represents important steps to address the near-term risks of the monkeypox outbreak and to recognize and prepare for the longer-term risks posed by the orthopoxvirus family.”
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the healthcare security market. Health security includes countermeasures against biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and preventive health care. Our lead product is TPOXX®, also known as Tecovirimat and ST-246®, an orally administered and intravenously formulated antiviral drug for the treatment of smallpox in humans caused by the variola virus. TPOXX is a novel small molecule drug and the US maintains a stockpile of TPOXX as part of the BioShield project. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018 and the IV formulation was approved for the same indication in 2022. The full label is available by clicking here. Oral tecovirimate received approval from the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK in 2022. EMA and UK approvals include labeling of oral tecovirimate indicating its use to treat smallpox and monkeypox, cowpox and vaccinia complications following vaccination against smallpox. The full label is available by clicking here. In September 2018, SIGA signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX. Further information on SIGA can be found at www.siga.com.
ABOUT MERIDIAN MEDICAL TECHNOLOGIES, LLC
Meridian Medical Technologies, LLC is a leader in the global healthcare protection market with more than 60 years of experience providing medical countermeasures to military and civilian defense personnel. Meridian has extensive experience working with government agencies in the United States and around the world addressing chemical and biological threat preparedness and inventory requirements. Meridian is committed to protecting those protecting others, whether they are military personnel or civilian responders/healthcare workers, by providing medical countermeasures for rapid and effective response in time-sensitive, life-or-death situations.
Smallpox is a contagious, disfiguring, and often fatal disease that has afflicted humans for thousands of years. Naturally occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global vaccination campaign. Samples of the smallpox virus were kept for research purposes. This has raised concerns that smallpox could one day be used as a biological warfare agent. A vaccine can prevent smallpox, but the risk of side effects from the current vaccine is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.
Monkeypox is a disease caused by infection with the monkeypox virus. The monkeypox virus belongs to the same virus family as smallpox. The symptoms of monkeypox are similar to those of smallpox but are not as severe and with historical deaths in Africa ranging from less than 1% to 10% depending on the region and group. The first human case of monkeypox was recorded in 1970. Since then, monkeypox has been reported in several Central and West African countries, with the number of cases increasing sharply in recent years. Before the sustained outbreak in 2022, almost all human cases of monkeypox outside of Africa were linked to international travel to countries where the disease is common or through imported animals, including two cases in the United States in 2021. These cases are occurring currently on several continents.
FORWARD LOOKING STATEMENTS
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the progress of SIGA’s development programs and timings for product launches and delivery of products to the Strategic Stockpile that Enforceability of our procurement contracts, such as the 19th Century BARDA Contract (the “BARDA Contracts”), with BARDA, the impact of the COVID pandemic and the response to the global monkeypox outbreak. The words or phrases “may be,” “expect,” “may affect,” “may depend,” “believe,” “estimate,” “project” and similar words and phrases are intended to identify such forward-looking statements. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated in such forward-looking statements as a result of a number of factors, some of which are beyond SIGA’s control, including but not limited to (i) the risk that BARDA, in its sole discretion, elects, as permitted under the BARDA Contracts, not to exercise all or some of the remaining unexercised options under those Contracts, (ii) the risk that SIGA may not complete performance under the BARDA Contracts in a timely manner or in accordance with the terms of the Contracts, ( iii) the risk that the BARDA contracts will be modified or terminated at the request or request of the US government, (iv) the risk that the emerging international biodefense market will not develop to a degree that enables SIGA to successfully market TPOXX® internationally to market, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX® that appear promising to SIGA or its collaborators cannot subsequently be proven to be effective or safe t pre-clinical or clinical studies, (vi) the risk that SIGA or its collaborators may not obtain appropriate or necessary regulatory approvals to commercialize these or other potential products or applications, (vii) the risk that SIGA may not be able or enforce sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any Challenges to SIGA’s patent and other proprietary rights, if decided negatively, could adversely affect SIGA’s business and, even if decided positively, could be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may further or require additional testing or documentation, ie e delay or prevent SIGA from applying for or obtaining the necessary approvals to commercialize these products, (x) the risk that the volatility and competitive nature of the biotechnology industry may impede SIGA’s efforts to develop or commercialize its products, (xi ) the risk that changing domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or adversely affect its products, (xii) the impact of federal, state and foreign regulations, including drug regulations and international Trade regulations, on SIGA’s business, (xiii) the risk of disruption to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, delays or the reallocation of funds related to government contracts caused by SIGA or distracts the attention of government employees who oversee SIGA’s government contracts, (xiv) the risk that US or foreign government responses (including inaction) to national or global economic conditions or infectious diseases such as COVID-19 will be ineffective, and could adversely affect SIGA’s business, and (xv) risks related to the response to the current monkeypox outbreak and the risks and uncertainties discussed in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the December Listed are the year ended December 31, 2021 and SIGA’s subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to review these documents free of charge at the SEC’s website at http://www.sec.gov. Any such forward-looking statements speak only as of the date such statements are made. SIGA undertakes no obligation to publicly update any forward-looking statement to reflect events or circumstances after the date such statement was made or to reflect the occurrence of unanticipated events.
The information contained in this press release does not necessarily reflect government position or policy and no official endorsement should be inferred.
Contacts:Investor ContactLaine Yonker, Edison Group[email protected]
Michael Crawford, Edison Group[email protected]
Public RelationsHolly Stevens, Berry & Company[email protected]
Source: SIGA Technologies Inc.