SIGA Announces Deliveries of Oral TPOXX® to HHS Valued at Approximately $32 Million
First Deliveries of Contract Option Exercises Announced in April 2020
NEW YORK, June 25, 2020 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced the deliveries of oral TPOXX® (tecovirimat) to the U.S. Department of Health and Human Services (HHS). These deliveries, valued at approximately $32 million, are the initial deliveries of the contract option exercises announced in April 2020. The previously-announced option exercises under the 2018 contract (“19C BARDA Contract”) with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at HHS, are worth a total of approximately $101.3 million for the procurement of oral TPOXX. Deliveries of oral TPOXX to maintain national preparedness under these option exercises are expected to be completed by April 2021. SIGA’s full 19C BARDA Contract has up to approximately $414 million of procurement-related options remaining for future exercise.
“SIGA is pleased to continue to deliver TPOXX to HHS to ensure robust preparedness for a potential smallpox outbreak,” said Dr. Phil Gomez, CEO of SIGA. “As the ongoing COVID-19 pandemic has demonstrated, preparing in advance to address potential biologic threats is essential for rapid and effective response. Maintaining a supply of treatments, like TPOXX, to combat smallpox is part of a long-standing global commitment to a smallpox emergency response. Smallpox remains one of the most horrific and devastating diseases ever known.”
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 asupply of TPOXX under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018. The full label is available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208627s000lbl.pdf. In September 2018, SIGA signed a $51.6M contract with $577M in options 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, for additional procurement and development related to both oral and intravenous formulations of TPOXX. For more information about SIGA, please visit www.siga.com.
Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally-occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. A vaccine can prevent smallpox, but the risk of the current vaccine's side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.
This press release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such 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. More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in SIGA's filings with the Securities and Exchange Commission, including SIGA's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and in other documents that SIGA has filed with the SEC. SIGA urges investors and security holders to read those documents free of charge at the SEC's web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements are current only as of the date on which such statements were made, and except for our ongoing obligations under the United States of America federal securities laws, we undertake no obligation to update publicly any forward-looking statements whether as a result of new information, future events, or otherwise.
The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.