Company Also Provides Milestone Updates
NEW YORK, March 20, 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 that The Nasdaq Stock Market LLC has approved SIGA’s application to list its common stock on The Nasdaq Global Market. SIGA’s common stock is expected to commence trading on The Nasdaq Global Market at the opening of trading on Thursday, March 22, 2018 under the ticker symbol “SIGA”. SIGA’s common stock will continue to trade on the OTC Pink Sheets until market close on March 21, 2018 under the ticker symbol "SIGA".
Pending TPOXX NDA
As previously announced, in December 2017, SIGA submitted a New Drug Application (NDA) for oral TPOXX® (tecovirimat) developed to treat smallpox. No FDA-approved cure or treatment for smallpox exists. In February 2018, the FDA set the target action date for this NDA at August 8, 2018. Should the FDA change the announced target date, SIGA will provide an additional update.
BARDA RFP Update
SIGA also announced today that it intends to submit a response to a Request for Proposal (RFP) by the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA) related to the procurement and late-stage development of oral and intravenous (IV) treatment for smallpox. While it is anticipated that competitors of SIGA will also submit responses, SIGA believes that TPOXX®, its smallpox antiviral drug candidate, is well-positioned to meet the requirements set forth in this RFP. The RFP seeks to purchase oral and IV drug to meet a stockpile requirement of 1.7 million courses. The RFP outlines a 5-year base contract, along with options for a potential 5 year extension. The RFP also includes a provision for the immediate purchase of available courses of product meeting technical specifications outlined in the RFP. The RFP sets forth the minimum criteria for a qualifying response, including a requirement to have demonstrated efficacy in at least two FDA approved animal models for evaluation of smallpox countermeasures, data demonstrating the candidate is safe and well tolerated in human subjects, and the ability to supply both IV and oral drug, all of which SIGA believes it can demonstrate based on work under its existing BARDA contracts.
“We look forward to responding to the RFP and to the opportunity presented by the RFP to augment our strong partnership with BARDA to ensure TPOXX® is part of a sustainable stockpile to mitigate the threat of a bioterror attack with smallpox,” added Dr. Gomez. “The addition of an IV formulation would be critical in an outbreak to treat those too sick to take the oral capsules, and the advancement and procurement of the IV formulation would represent an important next step in building our preparedness for smallpox.”
Pursuant to the RFP, responses are due by April 23, 2018. Any award under the RFP would be subject to negotiation of final contract terms and specifications. Once final negotiations are completed, BARDA will issue a formal Notification of Award. There can be no assurance that SIGA will receive the award under the RFP, or, if it does, that it will be able to successfully negotiate final contract terms and specifications with BARDA.
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, 2017, 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.
Source: SIGA Technologies, Inc.