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FDA Grants Orphan Drug Status for Smallpox Drug


Posted on 2006-12-20 13:38:00



SIGA Technologies, Inc. announced today that the Office of Orphan Products Development (OOPD) of the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to SIGA-246, SIGA's smallpox drug, for the prevention and treatment of smallpox. In December 2005, the FDA awarded SIGA-246 fast track status to expedite the drug's review.

Orphan Drug designation will entitle SIGA to seven years of marketing exclusivity in the United States if SIGA-246 becomes the first drug of its kind to obtain marketing approval from the FDA. Historically, the approval time for orphan products as a group has been considerably shorter than the approval time for other drugs.

"This is an important step in bringing SIGA-246 to market. The drug has made significant progress since the approval of its Investigational New Drug application just a year ago. In July 2006, we successfully completed the first planned human clinical safety trial, and, in October, the drug demonstrated 100% protection against human smallpox virus in a primate trial. We believe that SIGA-246 holds great promise and will be the first drug available to prevent and treat the disease without significant side effects," said Dr. Dennis E. Hruby, Chief Scientific Officer of SIGA.

Smallpox has been designated by the Department of Homeland Security as a "material threat" to our national security, qualifying SIGA -246 for purchase for the Strategic National Stockpile under Project Bioshield. Currently, there is no effective and safe smallpox therapy available without the risk of significant complications, and the U.S. government has expressed strong interest in the development of novel smallpox therapies. Existing techniques to prevent or ameliorate smallpox have unacceptably high rates of complications, including encephalitis, myocarditis and death, and can take days or weeks to confer protection.