– IV TPOXX is an important option for people unable to swallow –
– Option to finance post-marketing field study for IV TPOXX also exercised –
NEW YORK, Aug. 09, 2022 (GLOBE NEWSWIRE) — SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company, today announced the exercise of supply options under of its contract 75A50118C00019 (19C) with the U.S. Department of Health and Human Services for the delivery to the U.S. government of the intravenous (IV) formulation of TPOXX treatment courses worth approximately $26 million. These option exercises represent the first procurement option exercises for IV TPOXX under contract 19C. Deliveries of IV TPOXX products under these contract options are scheduled for 2023. IV TPOXX is an important option for those unable to swallow.
“These option exercises for the purchase of the IV formulation of TPOXX as well as the funding of a post-marketing field study for IV TPOXX underscore the growing importance of a large-scale response to the substantial risks posed by the family of orthopox viruses, including smallpox and monkeypox,” said SIGA CEO Phil Gomez. As such, we will continue to coordinate with the U.S. government for future purchases of oral TPOXX and IV TPOXX.”
The procurement options, which have been exercised by the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services’ Office of the Administration for Strategic Preparedness and Response, include manufacturing bulk drug substance and the use of such substance to manufacture and deliver the final IV TPOXX drug product.
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health safety market. Health security includes countermeasures to biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies against emerging infectious diseases and health preparedness. Our main product is TPOXX®, also known as tecovirimat and ST-246®, an oral and intravenous antiviral drug for the treatment of human smallpox caused by the variola virus. TPOXX is a new small molecule drug and the United States maintains a supply of TPOXX through Project BioShield. 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 tecovirimat received approval from the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK in 2022. Approvals from the EMA and the United Kingdom include labeling of oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox and vaccinia complications following smallpox vaccination. The full label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to purchases and additional developments related to both oral and intravenous formulations of TPOXX. This project was funded in whole or in part by federal funds from the Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number HHSO100201800019C. For more information about SIGA, visit www.siga.com.
Smallpox is a contagious, disfiguring and often fatal disease that has affected humans for thousands of years. Natural smallpox was eradicated worldwide in 1980, thanks to an unprecedented global vaccination campaign. Smallpox virus samples were retained for research purposes. This led to fears that smallpox could one day be used as a biological warfare agent.
Monkeypox is a disease caused by infection with the monkeypox virus, which belongs to the same family of viruses as smallpox. Symptoms of monkeypox are similar to those of smallpox, but not as severe and with historical mortality of less than 1% to 10% depending on region and clade. The first human case of monkeypox was recorded in 1970. Since then, monkeypox has been reported in several countries in Central and West Africa, with the number of cases increasing dramatically in recent years as the virus is endemic in these countries. Prior to the ongoing 2022 outbreak, nearly all cases of monkeypox in people outside of Africa were linked to international travel to countries where the disease is common, or to imported animals, including two cases in the States. States in 2021. These cases are currently occurring on multiple continents. On July 23, 2022, the World Health Organization (WHO) declared the monkeypox outbreak a public health emergency of international concern. On August 4, 2022, the U.S. government declared the monkeypox outbreak a public health emergency.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to the progress of SIGA’s development programs and time to market. of products, delivery of products to the strategic reserve, the enforceability of our supply contracts, such as the BARDA 19C contract (the “BARDA Contracts”), with BARDA, the impact of the COVID pandemic and the response to the global monkeypox epidemic. The words or expressions “may be”, “expect”, “may affect”, “may depend”, “believe”, “estimate”, “project” and similar words and expressions are intended to identify such forward-looking statements. . These forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any 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 by these forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted by the BARDA contracts, not to exercise any or all of the remaining unexercised options under such contracts, (ii) the risk that SIGA may not be able to perform the BARDA contracts within time or in accordance with contract terms, (iii) the risk that BARDA contracts will be modified or canceled at the request or demand of the U.S. government, (iv) the risk that the nascent international biodefense market will not develop to a degree that allows SIGA to successfully market TPOXX® internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX ® that appear promising to SIGA or its collaborators, may not be demonstrated effective or safe in subsequent preclinical or clinical trials, (vi) the risk that SIGA or its collaborators may not obtain appropriate or necessary government approvals to market such products or potential uses, (vii) the risk that SIGA may not be able to obtain or enforce sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any patent challenge and other proprietary rights of SIGA, in the event of an unfavorable ruling, may affect SIGA’s business and, even if deemed favorable, may be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may result in the need for additional or additional testing or documentation that will delay or prevent SIGA from requesting or obtaining approvals. ations necessary to commercialize these products, (x) the risk that the volatile and competitive nature of the biotechnology industry may impede SIGA’s efforts to develop or commercialize its products, (xi) the risk that changes in economic conditions and domestic or foreign market conditions may affect SIGA’s ability to advance its research or may adversely affect its products, (xii) the effect of federal, state and foreign regulations, including drug regulation and regulation of the international trade, on SIGA’s business, (xiii) the risk of disruptions to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the reassignment of funding tied to SIGA government contracts, or diverting the attention of government personnel overseeing government contracts SIGA’s business, (xiv) the risk that U.S. or foreign government responses (including inaction) to domestic or global economic conditions or infectious diseases, such as COVID-19, will be ineffective and could harm SIGA’s business. SIGA, and (xv) the risks associated with responding to the current monkeypox outbreak, together with the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended on December 31, 2021 and SIGA’s subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read these materials free of charge on the SEC’s website at http://www.sec.gov. All such forward-looking statements speak only as of the date such statements were made. SIGA undertakes no obligation to publicly update any forward-looking statement to reflect events or circumstances after the date such statement is made or to reflect the occurrence of unforeseen events.
The information in this press release does not necessarily reflect government position or policy and no official endorsement should be inferred.
Yonker Wool, Edison Group
Michael Crawford, Edison Group
Holly Stevens, Berry & Company