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In The Spotlight: SIGA Technologies

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Shares of SIGA Technologies Inc. (SIGA) are up nearly 30 percent year-to-date while the iShares NASDAQ Biotechnology Index (ETF)(IBB) has returned a mere 0.5% during the same period.

SIGA is focused on developing solutions for serious unmet medical needs like smallpox, and biothreats.

The Company's lead drug candidate is TPOXX, also known as Tecovirimat and ST-246, an orally administered and IV formulation antiviral therapy for smallpox infection.

Smallpox, one of the most deadly diseases known to humanity, is caused by Variola virus, a member of the genus Orthopoxvirus. The last known natural case of smallpox was reported in Somalia in 1977, and it was declared eradicated in 1980.

Only two labs in the world have been permitted to store the smallpox virus for research - the Centers for Disease Control and Prevention (CDC) in the United States, and the Russian State Centre for Research on Virology and Biotechnology in the Russian Federation. There have been concerns that some countries could employ smallpox in a bioterrorism attack.

There is one FDA-approved vaccine by the name ACAM2000 to prevent smallpox. Until 1972, this vaccine was given routinely in the United States, after which the practice was stopped.

Most people born in the United States after 1972 have not been vaccinated against the disease. Some people have been vaccinated through the military or because they were part of Smallpox Response Teams that were formed after the 9/11 terrorist attacks. (Source: CDC). But this vaccine is associated with significant adverse events - some of which are life-threatening.

SIGA's smallpox vaccine TPOXX was developed under the FDA "Animal Rule," in which efficacy endpoints are determined in animal studies, and human clinical studies are conducted to determine safety and confirm dosing.

The Company submitted the New Drug Application to the FDA for the oral formulation of TPOXX last December, and is under priority review, with a decision expected on August 8, 2018.

Before the FDA takes a decision on TPOXX, it is slated to be reviewed by the regulatory agency's Antimicrobial Drugs Advisory Committee on May 1, 2018.

The U.S. government's Biomedical Advanced Research and Development Authority (BARDA) funded the advanced development of oral TPOXX in partnership with SIGA. Additionally, under Project Bioshield, BARDA has purchased two million courses of oral TPOXX and such courses have been delivered to the Strategic National Stockpile, according to the Company.

An intravenous (IV) formulation of TPOXX is also under development by SIGA.

Turnaround at SIGA...

The Company's shares were delisted from the NASDAQ Stock Market on March 18, 2015, following litigation related bankruptcy filing. SIGA was involved in litigation with PharmAthene Inc. (PIP) related to TPOXX.

In December 2006, PharmAthene had filed a suit, alleging, among other things, that it had the right to license exclusively development and marketing rights for SIGA's TPOXX, pursuant to a merger agreement between the parties that was terminated in October 2006. The suit also alleged that SIGA failed to negotiate, in good faith, a license agreement for TPOXX with PharmAthene.

In August 2014, the Delaware Court of Chancery issued a ruling, which went in favor of PharmAthene, and SIGA was ordered to pay lump sum damage amount to PharmAthene. The total amount of the judgment was $195 million. The following month, i.e. September 2014, SIGA filed a voluntary petition for relief under chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Southern District of New York.

After being delisted from the NASDAQ Stock Market on March 18, 2015, SIGA shares were trading on the OTC Markets.

The Company successfully emerged from Chapter 11 Bankruptcy Protection on April 12, 2016, and continued to trade on the OTC Markets until March 21, 2018.

SIGA shares were relisted on the Nasdaq Global Market on Thursday, March 22, 2018.
SIGA has traded in a range of $2.85 to $6.78 over the last 1 year. The stock closed Wednesday's (Apr.18, 2018) trading at $6.29, up 1.45%.

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