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US Pharma Co. Granted FDA Approval for IV Smallpox Drug
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SIGA Technologies Inc. shares traded 30% higher after the company reported that the U.S. FDA has granted approval for an intravenous (IV) formulation of its TPOXX® (tecovirimat) for use in treating smallpox.

Commercial-stage pharmaceutical company SIGA Technologies Inc. (SIGA:NASDAQ), focused on the health security market centered around the development and supply of strategic medical countermeasures against chemical biological, chemical, radiological, and nuclear (CBRN) threats, and emerging infectious diseases, announced yesterday that "the U.S. Food and Drug Administration (FDA) approved the intravenous (IV) formulation of TPOXX for the treatment of smallpox."

The firm stated that it believes that the newly approved IV formulation offers an important viable alternative for individuals who are not able to swallow the oral TPOXX® (tecovirimat) capsules. Oral TPOXX® was approved by the U.S. Food and Drug Administration (FDA) in July 2018 and it is the first medicine indicated specifically for treating smallpox disease in adults and pediatric patients who weigh 13 kg or more.

Oral TPOXX has also received approval in both Canada and Europe for use in smallpox treatment and in Europe has been awarded extended approval for additional indications including cowpox, monkeypox, and complications arising from immunization with vaccinia following vaccination against smallpox.

SIGA Technologies' EVP and Chief Scientific Officer Dennis E. Hruby, Ph.D. commented, "We are grateful to the FDA for their work leading to approval of IV TPOXX, which will provide access to a broader patient population…We are also appreciative to our colleagues at BARDA who have been working with us for many years to include oral and IV TPOXX in U.S. preparedness efforts and look forward to continuing to work with them on our liquid pediatric formulation."

The company mentioned that the U.S. Government maintains a supply of TPOXX under Project BioShield. The firm listed that in September 2018, "it signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX."

The company explained that smallpox is a naturally occurring contagious, disfiguring, and often deadly disease. Thanks to global immunization efforts the disease was eradicated worldwide by 1980. The firm noted that samples of the smallpox virus have been kept in secure facilities by medical scientists for research purposes. Although, some concern exists that due to advances in synthetic biology smallpox can be recreated from published amino acid sequences.

SIGA stated that at present there is no cure or treatment for smallpox, which presents realistic concerns that in the wrong hands, smallpox might one day be utilized as an agent for biological warfare. The company pointed out that "a vaccine can prevent smallpox, but the risk of the vaccine's side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.".

SIGA Technologies is a pharmaceutical firm headquartered in New York, N.Y. with R&D facilities in Corvallis, Ore. The company concentrates its efforts on meeting unmet needs in the health security market as a provider of therapeutics and vaccines for emerging infectious diseases. The company's leading product, TPOXX®, is a novel small-molecule drug approved in oral capsules by the FDA in 2018 for treating human smallpox disease caused by the variola virus.

SIGA Technologies Inc. (SIGA:NASDAQ) started off the day with a market cap of around $626.3 million with approximately 72.4 million shares outstanding. SIGA shares opened 5% higher today at $9.11 (+$0.46, +5.32%) over yesterday's $8.65 closing price and reached a new 52-week high price this morning of $11.76. The stock has traded today between $8.8501 and $11.76 per share and is currently trading at $11.23 (+$2.58, +29.83%).

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