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Published On: Thu, Sep 19th, 2013

GlaxoSmithKline to supply HHS with 60,000 doses of raxibacumab, anthrax antitoxin

The US Department of Health and Human Services (HHS) has announced today the nation’s supply of anthrax antitoxin will be maintained until 2018 under Project BioShield contracts issued by the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

Anthrax image/Janice Carr-CDC

Anthrax image/Janice Carr-CDC

Orders placed today will replenish the stockpile of anthrax antitoxin as doses currently in the Strategic National Stockpile expire. The contracts also establish, for the first time, a surge capacity to produce antitoxin if an anthrax attack occurs.

Under these contracts, HHS will order approximately $196 million in raxibacumab antitoxin from GlaxoSmithKline. (GSK).

According to GSK, under the terms of the new contract, the company will provide 60,000 doses of the anthrax antitoxin to the US government over four years, at a value of approximately $196m.

Raxibacumab was approved by the FDA in December 2012 for the treatment of adult and pediatric patients with inhalation anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalation anthrax when alternative therapies are not available or are not appropriate. It has not been approved outside of the US.

Since 2001 the US Centers for Disease Control and Prevention (CDC) has classified anthrax as a Category A biothreat, as it poses a severe threat to public health and safety. Anthrax is one of the most likely agents to be used in a bioterrorist attack as its spores are easily found in nature and can be produced in a lab. It can be released into the environment quietly and remain there for a long time.

“We have been collaborating with the Biomedical Advanced Research and Development Authority (BARDA) for a number of years and raxibacumab is now an important part of the US Government’s emergency counter measures against bioterrorism. Through this agreement, we are proud to be helping protect US citizens against such threats,” said Sheri Mullen, Vice President of Immunology & Rare Diseases, US Pharmaceuticals, GSK.

Project BioShield is the chief mechanism through which the U.S. government supports the advanced development and procurement of new medical countermeasures – drugs, vaccines, diagnostics, and medical supplies – to protect health against chemical, biological, radiological and nuclear threats.

Through the Project BioShield Act of 2004, ASPR’s BARDA has supported the development and procurement of two anthrax antitoxins to treat people with anthrax disease and an anthrax vaccine, as well as drugs or medical products to protect health against smallpox, botulism, and radiation injury.

Related story: Senator Claire McCaskill questions Richard Danzig’s influence in the government’s procurement of the anthrax anti-toxin, raxibacumab

“Project BioShield’s long-term funding and planning encourage companies to partner with the federal government on products like anthrax antitoxin that they otherwise would not pursue, but that our nation would need in a crisis,” said BARDA Director Robin Robinson, Ph.D. “The acquisition of additional anthrax antitoxin to replenish expiring stocks will provide for greater national health security against this threat through 2018 and beyond.”

Raxibacumab is a monoclonal anti-toxin for the treatment of inhalation anthrax due to Bacillus anthracis and has orphan drug designation in the US.

Anthrax is a rare and lethal disease, caused by a toxin-producing bacterium. While antibiotics target the anthrax bacteria, raxibacumab offers an additional mechanism of action by blocking the activity of the anthrax toxin, which plays a key role in the progression of the disease.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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  1. US signs an agreement with GSK – Treatment for Anthrax | Know Your Drug says:

    […] GlaxoSmithKline to supply HHS with 60,000 doses of raxibacumab, anthrax antitoxin (theglobaldispatch.com) […]

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