SIGA'S SMALLPOX DRUG GRANTED ORPHAN DRUG DESIGNATION

Siga Technologies announced that the FDA has granted orphan drug designation to SIGA-246 for the prevention and treatment of smallpox. In 2005 the FDA had awarded SIGA-246 fast-track status to expedite the drug's review.

Orphan drug designation will entitle Siga to seven years of marketing exclusivity 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, the company said.

In July the company completed the first human clinical safety trial of SIGA-246, and in October the drug demonstrated 100 percent 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," Dennis Hruby, chief scientific officer of Siga, said.

Smallpox has been designated by the Department of Homeland Security as a threat to 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, according to Siga, 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, the company said.