MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_01C99B3A.33A96E00" This document is a Single File Web Page, also known as a Web Archive file. If you are seeing this message, your browser or editor doesn't support Web Archive files. Please download a browser that supports Web Archive, such as Microsoft Internet Explorer. ------=_NextPart_01C99B3A.33A96E00 Content-Location: file:///C:/9E8BDD12/2009-03-02newsletter.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="us-ascii" 2 March 2009

2 March 2009=

 =

Delivery Begins of Human Moncolonal Anthrax Antitoxin to the U.S. Strategic National Stockpile (SNS)

 =

Last month (Febru= ary) the Maryland-based company Human Genome Sciences, Inc. announced that ̶= 0;it has begun delivery of 20,000 doses of its human monocolonal antibody drug ABthrax (raxibacumab) to the U.S. Strategic National Stockpile for use in t= he treatment of inhalation anthrax”.

 =

The company repor= ts that  “ABthrax is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health a= nd Human Services.“   = They also state that human safety studies of this human monocolonal antibody have been performed in over 400 volunteers. Some of these volunteers participate= d in a study that also gave the antibiotic ciprofloxacin at the same time as the anthrax antitoxin in order to assess pharmacokinetic interactions.

 =

As described previously on this website in 2006 (see the 29 July Newsletter) the U.S. Department of Health and Human Services (HHS) had announced funding of two anthrax antitoxin products for the Strategic National Stockpile (SNS). One = was for 20,000 treatment courses of this ABthrax monoclonal antitoxin from Human Genome Sciences, Inc., while the other was for 10,000 treatment courses of a human hyperimmune plasma called anthrax immune globulin (AIG) produced by a Canadian company called Cangene corporation. 

 =

This monocolonal = anthrax antitoxin is not licensed by the Food and Drug Administration (FDA) at this time. The company reported, however, that it “plans to file a Biologi= cs License Application (BLA) with the FDA in the second quarter of 2009.”= ;

 =

 =

 =

Daniel R. Lucey, = MD

ERone Institutes, Department of Emergency Medicine

Washington Hospit= al Center

Adjunct Professor= of Microbiology and Immunology

Georgetown Univer= sity Medical Center

Washington, D.C.<= o:p>

Website for this posting (requires Internet Explorer):www.BePast.org

e-mail: Daniel.R.Lucey@Medstar.net

 

 

 

 

 

 

 

 

 

 

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