SIGA Advances ST-246 Smallpox Antiviral Development In Europe

Main Category: Infectious Diseases / Bacteria / Viruses
Article Date: 17 Apr 2008 - 5:00 PDT

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SIGA Technologies, Inc. (NASDAQ: SIGA), a company specializing in the development of pharmaceutical agents to fight biowarfare pathogens, announced that its subsidiary, SIGA Pharmaceuticals (Europe) Limited, has qualified as a 'small and medium-sized enterprise' (SME) with respect to its application for approval of ST-246 in Europe. ST-246 is a smallpox antiviral and SIGA's lead product candidate. SIGA has also initiated the process for obtaining Marketing Authorization with ST-246 with the EMEA, which is the European equivalent of the United States Food and Drug Administration.

The European Agency for the Evaluation of Medicinal Products (EMEA) established SME as a dedicated office in 2005 to provide special assistance to small and medium-sized enterprises. SME provides qualified companies with scientific advice and protocol assistance in the development of new medical products. SME status also entitles SIGA to certain fee reductions or deferrals, including reduced fees for scientific advice and certain administrative services of the EMEA, and a deferral of the fee payable for an application for marketing authorization.

"Obtaining SME status is a significant achievement in our pursuit of European regulatory approval for ST-246. The SME Office works with small companies like SIGA to assist and provide support throughout the application process. We now have access to advice from the EMEA on the approval process for ST-246 that will allow us to expedite many of the procedures during the approval path. SIGA will continue to work closely with the EMEA in the coming months as it moves forward in its efforts to obtain marketing authorization in Europe for ST-246," Dr. Eric A. Rose, Chief Executive Officer of SIGA Technologies, stated.

In addition, SIGA engaged the SME Office in a pre-submission meeting to discuss development of ST-246 in Europe. The pre-submission meeting with the SME office provided regulatory guidance with respect to the approval process for ST-246 in Europe. SIGA is in the process of scheduling a Scientific Advice Working Party (SAWP) meeting with the EMEA to discuss the development path for ST-246.

Dr. Rose added, "The SAWP meeting will help SIGA construct an appropriate development pathway for ST-246 in Europe since there is currently no European guidance available on development of a drug that cannot be tested for efficacy in human beings due to the lack of a naturally infected population."

About ST-246

SIGA believes that ST-246 is the most advanced smallpox treatment currently in development. ST-246 represents a new approach to achieve an orally active, antiviral therapeutic. It has demonstrated significant antiviral activity in various animal models of poxvirus disease, including the complete protection of primates from lethal doses of monkeypox and smallpox virus. In December 2005, the FDA granted "fast-track" status to ST-246. In December 2006, the FDA granted to ST-246 an orphan drug designation.

SIGA's development of ST-246 has been funded in whole or in part with Federal funds from the Biomedical Advanced Research and Development Authority, Department of Health and Human Services, in conjunction with the National Institute of Allergy and Infectious Disease, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN266200600014C.

In addition to smallpox, SIGA has antiviral programs targeting other Category A viral pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg).

About SIGA Technologies, Inc.

SIGA Technologies is applying viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense. SIGA believes that it is a leader in the development of pharmaceutical agents to fight potential bio-warfare pathogens. SIGA has antiviral programs targeting smallpox and other Category A pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg). For more information about SIGA, please visit SIGA's Web site at http://www.siga.com/.

Forward-looking Statements

This press release contains or implies certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the efficacy of potential products, the timelines for bringing such products to market and the continued development and possible eventual approval of such products. Forward-looking statements are based on management's estimates, assumptions and projections, and are subject to uncertainties, many of which are beyond SIGA's control. Actual results may differ materially from those anticipated in any forward-looking statement. Factors that may cause such differences include the risks that (a) 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, (b) SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products, (c) SIGA may not be able to obtain anticipated funding for its development projects or other needed funding, (d) SIGA may not be able to secure funding from anticipated government contracts and grants, (e) SIGA may not be able to secure or enforce sufficient legal rights in its products, including sufficient patent protection for its products and (f) regulatory approval for SIGA's products may require further or additional testing that will delay or prevent approval. 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, 2007, and in other documents that SIGA has filed with the Commission. SIGA urges investors and security holders to read those documents free of charge at the Commission's Web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements speak only as to the date they are made, and, except for any obligation under the U.S. federal securities laws, SIGA undertakes no obligation to publicly update any forward-looking statement as a result of new information, future events or otherwise.

SIGA Technologies, Inc.