Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : SIGA Technologies Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Steve Lokness who wrote (46)	12/20/2006 3:38:49 PM
From: caly	Read Replies (1) \| Respond to of 160

FDA Approves Orphan Drug Designation for SIGA's Smallpox Drug, SIGA-246 Wednesday December 20, 2:30 pm ET The Designation is for Both Treatment and Prevention of Smallpox NEW YORK--(BUSINESS WIRE)--SIGA Technologies, Inc. (NASDAQ: SIGA - News) 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. 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 and vaccines to fight potential biowarfare pathogens. In addition to smallpox, SIGA has antiviral programs targeting other Category A pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg). SIGA's product development programs also emphasize the increasingly serious problem of drug resistant bacteria.