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SIGA Technologies Announces FDA Submission of its New Drug Application for oral TPOXX (tecovirimat) to Treat Smallpox

NUEVA YORK, 11 de diciembre de 2017 ( GLOBE NEWSWIRE) - SIGA Technologies, Inc. (SIGA) (OTCMKTS: SIGA), una compañía de seguridad sanitaria especializada en el desarrollo y comercialización de soluciones para necesidades médicas no cubiertas y biotreacciones, anunció hoy la presentación de su Nueva Aplicación de Medicamentos (NDA) ) a la Administración de Drogas y Alimentos de los Estados Unidos (FDA) para la administración oral formulación de TPOXX® (tecovirimat). TPOXX fue desarrollado para tratar la viruela, así como otras infecciones por ortopoxvirus. No existe cura o tratamiento para la viruela. El desarrollo avanzado de TPOXX ha sido financiado por la Autoridad de Desarrollo e Investigación Avanzada Biomédica (BARDA) del gobierno de EE. UU. De conformidad con un contrato con BARDA, SIGA ha entregado con éxito dos millones de cursos de TPOXX a Strategic National Stockpile.

"Estamos muy contentos de haber logrado este importante hito en el desarrollo de TPOXX. Si se aprueba, TPOXX sería el primer tratamiento para la viruela ", dijo el Dr. Phil Gomez, Director Ejecutivo de SIGA Technologies, Inc." Basado en datos extensos de eficacia positiva en estudios con animales y datos de seguridad clínica humana sin ningún tipo de relación seria. Eventos adversos, creemos que el NDA para TPOXX oral está bien posicionado para una revisión acelerada y favorable por parte de la FDA. Este es un hito importante no solo para el SIGA, sino también un ejemplo importante de cómo las alianzas público-privadas pueden hacer avanzar nuevos medicamentos para cubrir necesidades médicas insatisfechas con la aprobación de la FDA. Esta presentación de NDA también es un paso importante para avanzar la seguridad sanitaria contra la creciente amenaza de un potencial ataque bioterrorista basado en la viruela ".

Basado en los requisitos de revisión regulatoria, a la luz de la presentación de NDA del SIGA el viernes 8 de diciembre, 2017, la compañía espera recibir en febrero de 2018 una notificación de la FDA de que la presentación fue aceptada para revisión, confirmación del estado de revisión de prioridad y notificación de su fecha de acción final. Dado que TPOXX está diseñado para tratar una condición médica grave para la cual no existe una terapia aprobada, SIGA ha solicitado una revisión acelerada de su aplicación.

TPOXX (tecovirimat) fue desarrollado bajo la "Regla de animales" de la FDA, en la cual los puntos finales de eficacia se determinan en estudios con animales, y se realizan estudios clínicos en humanos para determinar la seguridad y confirmar la dosificación. No ha habido Eventos adversos graves (EAS) relacionados con las drogas durante el desarrollo de TPOXX oral.

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.

About Smallpox

Smallpox1 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.

Etiquetas

comprar, descuento, orden, costo, pastillas, sin receta, alternativa, compra, en línea, prescripción, bajo costo, online, venta, barato, genérico, droga, precio, en farmacias, españa, efectos1 http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769

FORWARD-LOOKING STATEMENTS

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 U.S. 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. SIGA's actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA's control, including, but not limited to, (i) the risk that potential products that appear promising to SIGA or its collaborators cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (ii) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products, (iii) the risk that SIGA may not be able to obtain anticipated funding for its development projects or other needed funding, including from anticipated governmental contracts and grants, (iv) the risk that SIGA may not complete performance under the Biomedical Advanced Research Development Authority (BARDA) Contract on schedule or in accordance with contractual terms, (v) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (vi) the risk that any challenge to SIGA's patent and other property rights, if adversely determined, could affect SIGA's business and, even if determined favorably, could be costly, (vii) the risk that regulatory requirements applicable to SIGA's products may result in the need for further or additional testing or documentation that will delay or prevent seeking or obtaining needed approvals to market these products, (viii) the risk that one or more protests could be filed and upheld in whole or in part or other governmental action taken, in either case leading to a delay of performance under the BARDA Contract or other governmental contracts, (ix) the risk that the BARDA Contract is modified or canceled at the request or requirement of the U.S. government, (x) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA's efforts to develop or market its products, (xi) the risk that the changes in domestic and foreign economic and market conditions may affect SIGA's ability to advance its research or may affect its products adversely, (xii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA's businesses, (xviii) the risk that our internal controls will not be effective in detecting or preventing a misstatement in our financial statements, (xiv) the risk that some amounts received and recorded as deferred revenue may someday be determined to have been more properly characterized as revenue when received, and (xv) the risk that some amounts received and recorded as deferred revenue ultimately may not be recognized as revenue. 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.

Source: SIGA Technologies, Inc.

Posted: December 2017

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