SIGA Announces Creation of Joint Procurement Mechanism by European Commission with Anticipated Initial Orders of Approximately $18 Million for Oral TPOXX (Tecovirimat) by Participating Countries

NEW YORK, Oct. 23, 2023 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced the creation by the European Commission’s DG HERA (Health Emergency Preparedness and Response Authority) of a joint procurement mechanism under which 13 participating countries from the European Union (EU) and the European Free Trade Association (EFTA) can efficiently order oral TPOXX. Based on commitments from EU member countries, it is currently anticipated that $18 million in approximate value of oral TPOXX will be initially ordered by EU countries under this mechanism within the next 60 days. Orders through the joint procurement mechanism will result in country-level procurement of oral TPOXX. Under the joint procurement mechanism, countries in the EU will acquire courses of oral TPOXX in the near term, and be able to efficiently order additional courses of oral TPOXX in the future as long as minimum quantity thresholds are met. Separately, as announced in September of 2022, the European Commission procured oral TPOXX through the funding of a direct purchase. Both transactions were coordinated by SIGA and its international promotion partner, Meridian Medical Technologies, LLC.  

“With the creation of a joint procurement mechanism, there are now multiple paths in Europe for efficient procurement of oral TPOXX,” said Phil Gomez, CEO of SIGA. “These protocols, through which every country in the EU can access oral TPOXX, highlight the importance of addressing the long-term impact and risks of orthopox viruses such as smallpox and monkeypox.”

Orders under the joint procurement mechanism are expected to bring total TPOXX orders in 2023 to approximately $164 million. A substantial percentage of these orders are expected to be delivered in 2023. As such, as previously disclosed, 2023 pre-tax operating income is expected to be between $90 million and $100 million.

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 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 United Kingdom in 2022. The EMA and UK approvals include labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. 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 Administration for Strategic 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.