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Wednesday, 08/17/2022 2:45:33 PM

Wednesday, August 17, 2022 2:45:33 PM

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This NIAID Developed Drug Had 2021/Sales of $125M

NIAID funded preclinical studies of tecovirimat [TPOXX] to determine its mechanism of action, safety, and efficacy. Subsequently, NIAID and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, funded Phase 1, and Phase 2 clinical trials to test the safety and pharmacokinetics of an oral formulation of the investigational drug. The Food and Drug Administration (FDA) approved tecovirimat in 2018 for the treatment of smallpox


https://www.niaid.nih.gov/diseases-conditions/monkeypox-treatment

“SIGA’s fourth quarter and annual financial results are highlighted by approximately $113 million of product sales in connection with deliveries of oral TPOXX® to the U.S. government,” said Phil Gomez, CEO of SIGA. “With many industries, including the pharmaceutical industry, facing significant supply chain challenges, the delivery of approximately $125 million of oral TPOXX to the U.S. and Canadian governments...


https://www.globenewswire.com/en/news-release/2022/03/03/2396703/9738/en/SIGA-Reports-Financial-Results-for-Three-and-Twelve-Months-Ended-December-31-2021.html

One might think tecovirimat's 2021 U.S. sales of $113M are unimpressive, but consider that , the last natural outbreak of smallpox in the United States occurred in 1949 and, further that the WHO declared smallpox eradicated in 1980

In 2021 the U.S. bought $113M worth of NIAID developed tecovirimat and Canada bought $12M. Clearly, these countries are stockpiling this drug, which indicates to me, that they believe "eradicated" really means eradicated for now.

Tecovirimat is also a good example of what happens after NIAID takes a drug successfully to a Phase 2A. The company that owns the drug completes the rest of the development through FDA approval/authorization.

In the case of B-AV, Leo will be in the driver's seat, not only because "B" will have the data. thanks to NIAID. but also because the potential partner will know that after a successful Phase 3 and FDA approval/authorization: the U.S. gov't, as well as other gov'ts will be the first customers in line placing orders in the hundreds of millions for B-AV (broad spectrum), B-COVID, Monkeypox or any other family of viruses that threaten the U.S. and other populations around the world.

It is very important that NIAID has latched onto Brilacidin and after 2.5 years is still investigating the scope of its antiviral attributes. NIAID's is responsible for finding and initially developing vaccines and therapeutics that address viral pathogens that are threatening or could threaten the U.S. population. NIAID is the playmaker, who coordinates and collaborates with other similarly concerned U.S. gov't agencies and gov't-funded, private research institutions.

NIAID has a high-degree of interest in Brilacidin and I can't wait to see which direction they move in. Will it be "B" as a COVID prophylactic, broad-spectrum antiviral or possibly something involving mokeypox?

One thing's for sure, the antiviral sector is Brilacidin's most lucrative area ($67B) and IPIX is in collaboration with an agency of the U.S. government (NIAID) that is extremely interested in investigating "B" ,as an antiviral, for all that it can do. AT NO CHARGE TO IPIX.

NIAID, operating in its own interest with Brilacidin, could be a very, very, financially rewarding collaboration for IPIX. This is what NIAID's drug development track record suggest.
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