NEW YORK, June 22, 2022 (GLOBE NEWSWIRE) — SIGA Technologies, Inc. (SIGA) (NASDAQ:SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that its CEO, Phil Gomez, and chief scientific officer, Dennis Hrubi, at a panel discussion Thursday, June 23research and development 12 noon ET to discuss recent monkeypox outbreaks in the UK, EU and US. The chat will be hosted by Alliance Global Partners and will also include representatives from Emergent Biosolutions and Tonix Pharmaceuticals.
For more information about the board, please see below:
Date and time: Thursday, June 23research and development From 12 noon to 1 pm ET
Link to join: https://us02web.zoom.us/webinar/register/WN_NQzQ-ceWTUiDpxShNw6XfA
tekovirimat (TPOXX) SIGA’s flagship product was approved in January 2022 by the European Medicines Agency (EMA) for the treatment of complications of smallpox, monkeypox, smallpox, and variola vaccine following smallpox vaccination. SIGA has also introduced TPOXX as a compassionate-use treatment for monkeypox in the UK, and in the US, where TPOXX is approved for use against smallpox, the CDC has used TPOXX to treat at least one monkeypox patient during the current outbreak. The FDA has not approved TPOXX for monkeypox in the United States.
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a commercial pharmaceutical company focused on the health security market. Health security includes measures against biological, chemical, radiological, and nuclear attacks (the biodefense market), vaccines and treatments for emerging infectious diseases, and health preparedness. Our flagship product is TPOXX®, also known as tekovirimat and ST-246®, which is an oral and IV antiviral medication for the treatment of human smallpox caused by the smallpox virus. TPOXX is a new small-molecule drug and the United States maintains supplies of TPOXX under the BioShield project. The oral formulation of TPOXX was approved by the U.S. Food and Drug Administration for the treatment of smallpox in 2018. The full poster is available by clicking here. Oral tekovirimat received approval from the European Medicines Agency (EMA) in 2022. EMA approval involves labeling oral tekovirimat indicating its use for the treatment of complications of smallpox, monkeypox, smallpox, and lupus following smallpox vaccination. The full poster 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 US Department of Health and Human Services, for the further purchase and development of both oral and intravenous formulations of TPOXX. For more information on SIGA, please visit www.siga.com.
Smallpox has been a contagious, disfiguring, and often fatal disease that has plagued humans for thousands of years. Naturally occurring smallpox was eradicated worldwide by 1980, as a result of an unprecedented global immunization campaign. Samples of the smallpox virus were kept for research purposes. This has led to concerns that smallpox could one day be used as a biological warfare agent. The vaccine can prevent smallpox, but the risk of side effects from the current vaccine is too high to justify routine vaccination of people at low risk of exposure to the smallpox virus.
Monkeypox is a rare disease caused by the monkeypox virus. Monkeypox virus belongs to the genus Corticoviruses in the family Poxviridae. The orthopoxvirus genus also includes poxvirus (which causes smallpox), vaccinia virus (used in the smallpox vaccine), and cowpox virus.
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 timelines for bringing products to market, as well as the impact of COVID-19 on SIGA’s business]. Forward-looking statements may be identified by words or phrases such as “believes,” “estimates,” “expects,” “may,” “will,” “will,” “could,” “could” and similar words and phrases. These forward-looking statements are based on current expectations and assumptions and 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. Actual results of SIGA could differ materially from those projected by such forward-looking statements due to a number of factors, some of which are outside SIGA’s control, including, without limitation, (i) the risks of advanced biomedical research and development in the United States SIGA (“BARDA”) elects, in its sole discretion as permitted under the BARDA Contracts (as defined below), not to exercise all or any of the remaining unexercised options under those Contracts, (ii) the risk that SIGA may not exercise full performance under its contracts with BARDA (“BARDA Contracts”) on schedule or on contractual terms, (iii) the risk that the BARDA Contracts will be modified or canceled at the request or requirements of the United States Government, (iv) the risk that the emerging international biodefense market will not develop to a degree that permits of SIGA’s successful marketing of TPOXX internationally, (5) potential product risks, including potential alternative uses or formulations that appear to be promising for SIGA or its collaborators, TPOXX cannot be demonstrated to be effective or safe in subsequent clinical or clinical trials, (6) ) Risk of not getting SIGA or dying assist SIGA in obtaining appropriate or necessary governmental approvals for marketing of these or other products or potential uses, (vii) the risk that SIGA will not be able to secure or enforce adequate legal rights in its products, including intellectual property protection, (8) the risk of any patent challenge SIGA and other proprietary rights, if identified, may affect SIGA’s business and, even if positively identified, may be costly, (ix) the risk that regulatory requirements applicable to SIGA products may result in the need for further testing or additional documentation that would delay or prevent SIGA from seeking or obtaining the necessary approvals to market such products, (x) the risks of the volatile and competitive nature of the biotechnology industry that may impede SIGA’s efforts o the development or marketing of its products, (x) the risks of changes in local economic and market conditions or foreign countries may affect SIGA’s ability to advance its research or may adversely affect its products, (12) the impact of federal, state, and foreign regulations, including drug regulation and international trade regulation, on SIGA’s business, (13) the risk that The COVID-19 pandemic is affecting SIGA operations by disrupting SIGA’s supply chain for manufacturing TPOXX, causing delays in SIGA’s R&D activities, causing delays or reallocating funding in connection with SIGA government contracts, or diverting the attention of government employees SIGA’s government contract supervisors, (xiv) risk US or foreign government responses (including inaction) to national or global economic conditions or infectious diseases such as COVID-19 are ineffective and may adversely affect SIGA’s business and (15) risk factors Others discussed in 1a. “Risk Factors” in SIGA’s annual report on Form 10-K for the year ended December 31, 2021, and in SIGA’s subsequent filings with the US Securities and Exchange Commission. These documents are publicly available on the SEC website at http://www.sec.gov and the SIGA website at https://investor.siga.com. Forward-looking statements are only effective as of the date such statements are made, and, except as otherwise required by law, we undertake no obligation to publicly update any forward-looking statements whether as a result of new information, future events, or otherwise.
The information in this press release does not necessarily reflect the position or policy of the United States government and no official endorsement should be inferred. The information on the websites referenced herein has not been included with reference to this press release.
Lynn Juncker, The Edison Group
Michael Crawford, The Edison Group