SIGA Announces Health Canada Regulatory Approval of Oral TPOXX®

Rhea-AI Summary

SIGA Technologies, Inc. (SIGA) announced that Health Canada has approved oral TPOXX® (tecovirimat) for treating human smallpox in adults and children over 13 kg. This approval marks a significant milestone, facilitated by support from the Canadian Department of National Defence, ensuring the continued supply for stockpiling as a key countermeasure. SIGA's TPOXX is a vital antiviral drug that was previously FDA-approved in July 2018. The partnership with Meridian Medical Technologies will promote international sales of TPOXX outside the U.S.

Positive

• Health Canada approval for oral TPOXX® enhances market presence.
• Continued supply for the Canadian Department of National Defence and Public Health Agency of Canada ensures stable demand.
• International promotion agreement with Meridian Medical Technologies expands TPOXX's market reach.

Negative

• None.

NEW YORK, Dec. 01, 2021 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that Health Canada has approved oral TPOXX® (tecovirimat) as an extraordinary use new drug. Specifically, Health Canada has authorized the use of oral TPOXX for the treatment of human smallpox disease in adults and pediatric patients weighing at least 13 kg.

“This is an important milestone in our partnership with the Canadian Department of National Defence (DND) that provided support to SIGA for the submission and regulatory review of its application. The approval ensures that we can continue to supply oral TPOXX to both the DND and the Public Health Agency of Canada (PHAC) for stockpiling as a key countermeasure,” said Dr. Phil Gomez, CEO of SIGA Technologies.

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 July 2018. The full label is available by clicking here clicking here. For more information about SIGA, please visit www.siga.com.

In June 2019, SIGA entered into an international promotion agreement with Meridian Medical Technologies, Inc. (“Meridian”), a Pfizer company. Under the agreement, Meridian will promote the sale of oral tecovirimat for the treatment of smallpox in all international markets outside of the United States. SIGA will continue to own all rights to the product and its related intellectual property.

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.

On November 1, 2021, Pfizer entered into an agreement with Altaris Capital Partners, LLC (collectively with its affiliates, “Altaris”), a healthcare investment firm based in New York, for Altaris to purchase Meridian. The transaction is expected to close in the coming months, subject to customary closing conditions including the receipt of regulatory approvals.

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, 2020, 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 of Canada and no official endorsement should be inferred.

Contacts:

Investor Contact
Laine Yonker, Edison Group
lyonker@edisongroup.com

Michael Crawford, Edison Group
mcrawford@edisongroup.com

____________________________
¹ http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769

FAQ

What is the significance of Health Canada's approval of oral TPOXX for SIGA?

Health Canada's approval of oral TPOXX allows SIGA to treat smallpox in Canada, enhancing its market position and ensuring supply for national stockpiling.

What clinical indications does oral TPOXX have following Health Canada's approval?

Oral TPOXX is approved for the treatment of human smallpox disease in adults and pediatric patients weighing at least 13 kg.

How does the partnership with Meridian Medical Technologies benefit SIGA?

The partnership allows Meridian to promote TPOXX sales internationally, expanding SIGA's market presence outside the U.S.

When was TPOXX previously approved by the FDA?

TPOXX was previously approved by the FDA in July 2018 for the treatment of smallpox.

What does the term 'extraordinary use new drug' mean in the context of TPOXX?

The term 'extraordinary use new drug' indicates that TPOXX is granted approval for use in emergency or special conditions, specifically for smallpox treatment.