Source: SIGA Technologies Inc.
NEW YORK, May 01, 2018 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ:SIGA), a health security company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, today announced a favorable outcome of the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee meeting on oral TPOXX®, a small molecule antiviral treatment for smallpox. The panel, comprised of independent medical experts, voted unanimously, 17 to 0, that the benefits of TPOXX outweigh its risks.
“We are pleased that the advisory panel believes strongly in the benefits of TPOXX. We are confident that the robust data package and safety profile with no drug-related serious adverse events positions TPOXX for favorable FDA review of its pending New Drug Application (NDA).” said Dr. Phil Gomez, Chief Executive Officer of SIGA Technologies, Inc. “The support of the independent medical experts that comprise the advisory committee panel provides valuable additional feedback reflecting the strength of our application for TPOXX. We believe that safety and efficacy data contained in the NDA support TPOXX’s future use as a medical countermeasure in response to a smallpox outbreak.”
The FDA has previously announced that its target final action date for the oral TPOXX NDA is August 8, 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 acquired two million courses of oral TPOXX and such courses have been delivered to the Strategic National Stockpile (SNS).
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats. The company’s lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug that targets orthopoxvirus infections. While TPOXX is not yet approved as safe and effective by the U.S. Food & Drug Administration, it is a novel small-molecule drug of which 2 million courses have been delivered to the Strategic National Stockpile under Project BioShield. For more information about SIGA, please visit www.siga.com.
Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. No cure or treatment for smallpox exists. 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.
This press release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to the submission and approval of TPOXX® by the FDA. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in SIGA's filings with the Securities and Exchange Commission, including SIGA's Annual Report on Form 10-K for the fiscal year ended December 31, 2016, and in other documents that SIGA has filed with the SEC. SIGA urges investors and security holders to read those documents free of charge at the SEC's web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements are current only as of the date on which such statements were made, and except for our ongoing obligations under the United States of America federal securities laws, we undertake no obligation to update publicly any forward-looking statements whether as a result of new information, future events, or otherwise.