Company profile: SIGA Technologies, Inc.

SIGA Technologies, Inc. (“SIGA”) is a commercial-stage pharmaceutical company focused on the health security market. The company was founded in 1995, with corporate headquarters in New York City and operations and research and development based in Corvallis, Oregon. Since its foundation, SIGA has focused on developing countermeasures for biological, chemical, radiological and nuclear attacks, as well as vaccines and therapies for emerging infectious diseases. With years of experience in the field, the company advanced its leading product, oral TPOXX® (tecovirimat), an antiviral drug for the treatment of human smallpox disease caused by variola virus. In 2018, the United States Food & Drugs Administration (FDA) approved oral TPOXX® for the treatment of smallpox. The company has cultivated successful relationship with US federal executive agencies and legislators addressing biodefense initiatives and has obtained more than $1 billion in contract value awarded by the U.S. government, including an award with a value of more than $600 million in September 2018 by the Biomedical Advanced Research and Development Authority (BARDA, an agency within the U.S. Government). In May 2019, SIGA entered into an international promotion agreement with Meridian Medical Technologies, a Pfizer company (“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. SIGA will continue to own all rights to the product and its related intellectual property. In 2020 SIGA began deliveries to the Canadian Department of National Defense (DND) under a contract for up to $14 million, and in January 2021, the Public Health Agency of Canada awarded a contract for up to $32 million; in total, the Canadian government has issued contracts for the purchase of up to $46 million of oral TPOXX®. The current COVID pandemic has underscored how critical preparedness is to limit the potentially devastating impact of such events. SIGA’s mission is to address urgent recognized threats such as bioterrorism. The risk of a successful bioterrorist attack endangers the life of millions of citizens, and SIGA works to counter such a risk with the development of medical countermeasures.

The TPOXX® as a countermeasure for smallpox virus is one of their success stories. Smallpox virus is among the most fatal viruses of human history. During the 20th Century, this virus has been responsible for the death of 300 million people all over the world. It is highly contagious - each infected person would infect 5-7 others - and it can spread through breathing, speaking or touching. After the discovery of the vaccine, during the 1980s, the virus was completely eradicated. However, because the virus’ genetic code is publicly known and available, the risk of its reproduction and development in any laboratory is possible. Furthermore, the smallpox vaccine is no longer mandatory and up to 20% of the population is contraindicated for receiving the vaccine. This is why a medical countermeasure was necessary to treat the population in case of the outbreak of such infection, and why SIGA started the development of TPOXX®. TPOXX® is the first drug approved by the U.S. FDA that is specifically indicated for the treatment of smallpox disease in adults and pediatric patients weighting at least 13 kg. The drug inhibits viral maturation of the variola virus (and other poxviruses) by preventing the formation of a secondary viral envelope. In the absence of this envelope, viral particles remain inside the cell and cannot spread to and infect other cells. Although formal efficacy trials were not conducted in humans due to ethical concerns, TPOXX® has been administered on a compassionate use basis to treat several individuals who had complications deriving from the use of the smallpox vaccine. In such cases, thethe drug was effective, and all the subjects were able to recover from the complications.

SIGA has established an end-to-end network with over 20 partners across discovery, pre-clinical, clinical, manufacturing and supply chain that supported development of TPOXX® and the successful delivery of over 2 million courses of TPOXX® to the Strategic National Stockpile. In addition, development and approval of TPOXX® required a unique regulatory approach based on the FDA’s Animal Rule. Since the virus was eradicated from the human population, the testing of TPOXX® required innovative clinical and regulatory strategies, in which safety studies were conducted on healthy human volunteers and efficacy and toxicology studies were conducted on animal models. SIGA has developed a robust drug development capability supported through U.S government investment in Biodefense, and its highly externalized cost structure minimizes fixed costs and provides scalability, making SIGA a major player in the field of health security and medical countermeasures.

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