SIGA SIGA Technologies Inc

SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that the Canadian Department of National Defence (CDND) has awarded a contract to Meridian Medical Technologies, Inc. (“Meridian”, a Pfizer Company) (Canadian Contract), in which it will purchase up to 15,325 courses of oral TPOXX (tecovirimat) over four years for a total value of $14.3 million, with an initial purchase of 2,500 courses for $2.3 million. 

“The current COVID-19 pandemic has reminded us all that preparedness with medical countermeasures is critical for responding effectively to any infectious disease outbreak,” said Dr. Phil Gomez, CEO of SIGA Technologies. “Smallpox remains a key threat, and TPOXX is an important component of any smallpox response plan.  This procurement by the Canadian military is an important first step, and we look forward to continuing to work with Meridian to support potential future procurements with both the CDND and Health Canada to protect Canada’s military and civilian population.”

SIGA expects delivery of up to an additional 12,825 courses under the Canadian Contract to occur after regulatory approval in Canada.  SIGA previously received a contract from the CDND to fund this regulatory submission.  The Company is currently targeting a Canadian regulatory filing in the second half of 2020, with regulatory approval anticipated in 2021.  This contract represents the first international order for TPOXX. As part of a previously announced promotion agreement, Meridian is the counterparty to the Canadian Contract and SIGA is responsible for the manufacture and delivery of product.

On July 13, 2018, the FDA approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack. TPOXX, a small-molecule antiviral treatment for smallpox, is the first therapy specifically approved for this indication, and was developed through funding and collaboration with the Biomedical Advanced Research and Development Authority at the U.S. Department of Health and Human Services, as well as early stage development supported by the National Institutes of Health, U.S. Centers for Disease Control and Prevention, and Department of Defense.  The US currently maintains a stockpile of 1.7 million courses of TPOXX.

In June 2019, SIGA entered into an international promotion agreement with Meridian.  Under the agreement, Meridian will promote the sale of oral TPOXX for the treatment of smallpox in all international markets, except the United States and South Korea.  SIGA will continue to own all rights to the product and its related intellectual property.

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 stockpile of 1.7 million oral courses in the Strategic National Stockpile under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox on July 13, 2018. In September 2018, SIGA signed a contract with Biomedical Advanced Research and Development Authority (BARDA) for additional procurement and development related to both oral and intravenous formulations of TPOXX. For more information about SIGA, please visit www.siga.com.

ABOUT MERIDIAN MEDICAL TECHNOLOGIES, INC.

Meridian Medical Technologies, Inc., a Pfizer company, has been putting emergency care treatment options into the hands of military and civilian defenders for more than 50 years. Meridian is committed to help defend against critical, time-sensitive, life-or-death situations by providing medical countermeasures to the United States Department of Defense, Emergency Medical Services, Homeland Security, and more than 30 nations around the world.

Meridian holds a federal SAFETY Act designation and certification from the Department of Homeland Security for its portfolio of auto-injectors. The SAFETY Act is intended to provide critical incentives for the development and deployment of anti-terrorism technologies by providing liability protections for sellers of qualified anti-terrorism technologies.

About Smallpox1

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.

FORWARD-LOOKING STATEMENTS

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.

Contacts:

InvestorsDavid Carey 212-867-1768david.carey@finnpartners.com

MediaStephanie Seiler206-713-0124stephanie.seiler@finnpartners.com

__________________________1 http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769