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FDA Grants Fast Track Designation to Emergent Biosolutions' Biothrax(R) for Post-Exposure

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FDA Grants Fast Track Designation to Emergent BioSolutions' BioThrax(R) for Post-Exposure Prophylaxis against Anthrax Infection

Business Wire

Emergent BioSolutions Inc. (NYSE: EBS) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BioThrax(R) (Anthrax Vaccine Adsorbed) as a post-exposure prophylaxis against anthrax infection. BioThrax is the only FDA approved product for pre-exposure prophylaxis of anthrax infection. The company plans to seek FDA approval of BioThrax for use in combination with antibiotics as a post-exposure prophylaxis for anthrax infection.

The company is targeting a three dose regimen given two weeks apart for this indication. "We are extremely pleased that the FDA has taken this step as we continue our efforts to expand the label indication for BioThrax to include, in combination with antibiotics, its use for post-exposure prophylaxis for anthrax infection," said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.

"Our ongoing BioThrax enhancement programs are critically important and are designed to address the U.S. government's requirements in protecting our front-line forces as well as to building a national stockpile of safe and effective countermeasures against the use of anthrax as a weapon of bioterrorism. "

Under the FDA Modernization Act of 1997, Fast Track designation expedites the development and review of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.

BioThrax Post-Exposure Development Program Currently, the company has an ongoing development program to expand the licensed label indications for BioThrax to include post-exposure prophylaxis when used in conjunction with antibiotics. In support of this expanded label indication, the company is conducting clinical trials, as well as non-clinical trials in accordance with the FDA's animal rule.

If the results from these studies are favorable, the company would anticipate filing with the FDA a biologics license application (BLA) supplement for marketing approval of BioThrax for this indication. The scientific information discussed in this press release related to the use of BioThrax in combination with antibiotic therapy as a post-exposure prophylaxis for anthrax infection is preliminary and investigative.

BioThrax is not currently approved by the FDA for this purpose, and no conclusions can or should be drawn regarding the safety or effectiveness of BioThrax for this purpose. Only the FDA can determine whether BioThrax is safe and effective for this purpose. Healthcare professionals should refer to and rely upon the FDA-approved labeling for BioThrax, and not the information discussed in this press release.