SIGA Technologies Announces First International Delivery of Oral TPOXX®
- 2,500 Courses Delivered to the Canadian Department of National Defence -
NEW YORK, June 01, 2020 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced its first international delivery of TPOXX® (tecovirimat), with 2,500 courses delivered to the Canadian Department of National Defence (CDND). On April 3, 2020, the Company previously announced that the CDND is expected to purchase up to 15,325 courses of oral TPOXX® over four years for a total value of $14.3 million. Remaining purchases of 12,825 courses, at the option of the CDND, are expected to occur after regulatory approval of oral TPOXX® by Health Canada. Meridian Medical Technologies, Inc. (“Meridian”, a Pfizer Company), SIGA’s partner for international promotion of TPOXX, is the counterparty to the Canadian Contract and SIGA is responsible for the manufacture and delivery of oral TPOXX.
In addition to the Canadian product delivery, SIGA also expects to make deliveries of oral TPOXX to the U.S. Government this month. As previously disclosed, SIGA expects to deliver $101.3 million of oral TPOXX to the U.S. Government by April 2021, with deliveries starting this month. These deliveries will be in connection with the recent option exercises under its 2018 Biomedical Advanced Research and Development Authority (BARDA) contract (“19C BARDA Contract”). In addition to the options recently exercised, SIGA’s full 19C BARDA Contract has up to $414 million of procurement-related options remaining for future exercise.
“We are pleased to be moving quickly to deliver on our new U.S. and international orders of TPOXX and we look forward to continuing to work with BARDA and CDND on future options and deliveries,” said Dr. Phil Gomez, CEO of SIGA. “We are working on the filing of our regulatory submission to Health Canada later this year and delivery of additional courses to CDND under this contract following product approval. Meridian’s ability to secure this opportunity to support smallpox preparedness in Canada is evidence of its leadership in international health security and of TPOXX’s importance for international biodefense preparedness. The COVID-19 pandemic has highlighted the importance for governments around the world to quickly build robust stockpiles in order to protect the health and economic well-being of the general population from other biological threats, and we look forward to working with Meridian to address the global need for TPOXX as a critical component of robust smallpox preparedness strategies.”
Dr. Gomez added, “I would like to thank everyone at SIGA, all of whom have been working hard with our supply chain partners to ensure continued manufacturing and delivery of TPOXX during the COVID-19 pandemic, demonstrating the resiliency our U.S.-based supply chain during these difficult times.”
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 courses in the Strategic National Stockpile under Project BioShield. The oral formulation of TPOXX® was approved by the FDA for the treatment of smallpox in 2018. The full label is here: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fce826ab-4d6a-4139-a2ee-a304a913a253. In September 2018, SIGA signed a contract potentially worth more than $600 million with 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.
Recently, SIGA announced in April 2020 that BARDA exercised an option under the 2018 Contract for delivery of approximately 363,000 courses or oral TPOXX as SIGA continues to replenish the US government’s stockpile of its smallpox antiviral treatment.
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 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:
Investors
David Carey
212-867-1768
david.carey@finnpartners.com
Media
Stephanie Seiler
206-713-0124
stephanie.seiler@finnpartners.com
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1 http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
