SIGA Technologies

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SIGA Technologies, Inc.
Company typePublic
Nasdaq: SIGA
Russell 2000 Component
IndustryHealthcare
Biotechnology
Health security
FoundedDecember 28, 1995 (1995-12-28)[1]
Headquarters
New York City
,
United States
Key people
Diem Nguyen, Ph.D. (CEO)
Dennis E. Hruby, Ph.D. (CSO)
ProductsPharmaceutical agents
RevenueIncrease $133.7 million (2021)
Increase $89.1 million (2021)
Increase $69.5 million (2021)
Number of employees
39 (2022)
Websitesiga.com
Footnotes / references
[2]

SIGA Technologies, Inc. is an American pharmaceutical company founded in 1995, based in New York City, which develops and sells pharmaceutical solutions for the antiviral treatment of smallpox, monkeypox, cowpox, and vaccinia complications.[3][4][5][6]

History

In September 2009, SIGA Technologies received a $1.6 million research fund from the National Institutes of Health ("NIH") for its broad-spectrum antiviral candidates.[7]

In August 2011, SIGA Technologies was awarded a $7.7 million grant from the National Institutes of Health (NIH) to develop an antiviral drug for treating and preventing Lassa fever and others of arenavirus origin.[8] That year, it sealed a contract worth over $400 million to sell its antiviral drug Tpoxx to the United States Biomedical Advanced Research and Development Authority (BARDA) for the purpose of its development and distribution.[9] Also in 2011, it was ordered to pay $232 million in damages in a legal dispute with PharmAthene over rights to the smallpox drug tecovirimat.[10][11]

In July 2013, SIGA Technologies delivered about 590,000 courses of its smallpox antiviral drug tecovirimat (Arestvy) to the United States Government's Strategic National Stockpile (SNS), meeting the requirement of Government's Biomedical Advanced Research and Development Authority (BARDA).[12]

In May 2018, a US Food and Drug Administration (FDA) advisory committee decided that the benefits of SIGA's small molecule antiviral treatment, Tpoxx, outweigh its potential risks.[9] Later in July, FDA granted the approval of Tpoxx to SIGA after the drug was evaluated in 359 healthy human volunteers.[13] In July 2019, SIGA signed a $23 million contract with the United States Department of Defense to create Tpoxx's post-exposure prophylaxis.[14] Tecovirimat was approved for medical use in the European Union in January 2022.[15]

In 2021, SIGA submitted an intravenous version of Tpoxx to the FDA for approval,[16] which was approved in May 2022.[17]

In December 2021, Health Canada approved oral Tpoxx for the treatment of smallpox in adults and pediatric patients weighing at least 13kg.[18]

In January 2022, the European Medicines Agency approved oral tecovirimat for smallpox, monkeypox, cowpox and vaccinia complications in adults and children with a body weight of at least 13kg.[4][5][6]

Intravenous (IV) Tpoxx has no lower weight cap and can be used in infants under the Investigational New Drug protocol.[19]

The Centers for Disease Control and Prevention and the FDA have relaxed regulations to make it easier for doctors in the United States to prescribe Tpoxx to treat people with monkeypox.[20][21][22]

Operations

SIGA has a well established cooperation with US federal agencies for its research and development activities. It provides countermeasures to the Strategic National Stockpile (SNS) and the Department of Defense (DoD), such as Category A pathogens using BSL-3 or -4 work.[23] In September 2018, it signed a contract with BARDA for the delivery of oral and IV formulations of Tpoxx to the Strategic National Stockpile, effective for the following years.[24]

Products and services

SIGA's products include tecovirimat, sold under the brand name Tpoxx, the first drug approved by the FDA to treat adults and children for smallpox.[14]

Recognition

In 2008, SIGA won its fourth listing on the Deloitte Tri-State Area Technology Fast 50, then at #44.[25]

References

  1. ^ "SIGA Technologies Inc". Reuters. Retrieved April 30, 2019.
  2. ^ "SIGA Technologies, Inc. FORM 10-K". U.S. Securities and Exchange Commission. Retrieved May 23, 2022.
  3. ^ "Company Business Summary".
  4. ^ a b "Monkeypox outbreak: Drugmaker SIGA says EU authorities seeking to stockpile its smallpox antiviral". Euronews Next. May 20, 2022. Retrieved May 24, 2022.
  5. ^ a b "SIGA Technologies Receives Approval from the European Medicines Agency for Tecovirimat". SIGA Technologies. Retrieved May 24, 2022.
  6. ^ a b "Summary Of Product Characteristics" (PDF). European Medicines Agency. Retrieved May 24, 2022.
  7. ^ "$1.6 Million NIH Cooperative Agreement Supports SIGA Broad Spectrum Antiviral Research".
  8. ^ "SIGA Awarded a $7.7 Million Grant for the Development of Antiviral Drugs for Arenaviruses" (Press release).
  9. ^ a b Abbott, C. C. (May 3, 2018). "SIGA Technologies: A Buy For The Smallpox Treatment". Seeking Alpha. Retrieved April 30, 2019.
  10. ^ "Smallpox Drug Maker Siga to Mediate PharmAthene Dispute". Bloomberg News. October 31, 2014.
  11. ^ "Negotiation in Good Faith—SIGA v. PharmAthene". corpgov.law.harvard.edu. January 27, 2016. Retrieved May 1, 2019.
  12. ^ "SIGA Meets Drug Delivery Condition Under BARDA Contract and Qualifies for First Payment for Delivering Arestvyr(TM)". MarketWatch. Retrieved May 1, 2019.
  13. ^ "FDA approves the first drug with an indication for treatment of smallpox". U.S. Food and Drug Administration (FDA) (Press release). February 9, 2019. Retrieved June 13, 2019.
  14. ^ a b "SIGA Technologies: Biodefense Pharma Unlocks New Value Abroad For Tpoxx". SeekingAlpha. Retrieved June 16, 2021.
  15. ^ "Tecovirimat SIGA EPAR". European Medicines Agency. November 10, 2021. Retrieved April 23, 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  16. ^ "FDA approves Chimerix's oral suspension smallpox antiviral, giving treatment option to dysphagic patients". FiercePharma. Retrieved June 16, 2021.
  17. ^ "SIGA Receives Approval from the FDA for Intravenous (IV) Formulation of Tpoxx (tecovirimat)". SIGA Technologies. Retrieved May 23, 2022.
  18. ^ "SIGA Announces Health Canada Regulatory Approval of Oral Tpoxx". SIGA Technologies. Retrieved May 24, 2022.
  19. ^ "Monkeypox Outbreak: Updates on the Epidemiology, Testing, Treatment, and Vaccination" (PDF). Centers for Disease Control and Prevention. Retrieved July 27, 2022.
  20. ^ Nathan-Kazi, Josh (August 4, 2022). "U.S. Declares Monkeypox Emergency, Weighs Step That Could Quintuple Inoculations". Barron's.
  21. ^ "U.S. declares monkeypox outbreak a public health emergency". Reuters. August 4, 2022.
  22. ^ Vishnoi Bre Bradham, Abhishek; Ekblom, Jonas (August 1, 2022). "Investors lap up shares of firms that may benefit from Monkeypox". Business Standard.
  23. ^ "Company with Government Relations".
  24. ^ in-pharmatechnologist.com (September 21, 2018). "Siga signs $629m contract with BARDA for smallpox drug stockpiling". in-pharmatechnologist.com. Retrieved June 13, 2019.
  25. ^ "SIGA Technologies Named to Deloitte Tri-State Area Technology Fast 50" (Press release).

External links

  • Official website
  • Business data for SIGA Technologies, Inc.:
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