GSK wins anthrax terrorism deal

pharmafile | September 20, 2013 | News story | Sales and Marketing GSK, anthrax, terrorism 

GlaxoSmithKline has cemented its links with counter-terrorism efforts in the US by entering a four-year agreement with a key government agency to supply an anti-anthrax drug.

Raxibacumab, a treatment to negate the effects of anthrax, will be provided to the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services.

Anthrax can be a lethal disease, caused by a toxin-producing bacterium.

GSK will provide 60,000 doses – worth $196 million – over four years: the drug was approved by the FDA last December to treat children and adults with inhalation anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs.

GSK has strong links with the US establishment: earlier this year the company entered a $200 million deal with BARDA to develop new antibiotics as worries grow over the increasing threat of antimicrobial resistance.

And in 2012 it was one of three companies, along with Novartis and Emergent BioSolutions, to share a £400 million contract from the US government to provide vaccine manufacturing capacity in the event of a pandemic or bioterrorism.

The US takes the threat from an anthrax attack seriously since anthrax spores are easily found in nature and can also be laboratory-produced – and the country also has experience of them, when five people were killed by spore-infected letters sent a week after the 9/11 attacks.

A measure of US resolve, apart from the fact that anthrax is deemed a ‘Category A’ bio-threat by the US Centers for Disease Control and Prevention, is that raxibacumab is not approved anywhere else in the world.

The drug is a monoclonal anti-toxin which has orphan designation from the FDA, and works by blocking the activity of the anthrax toxin – a different mode of action to antibiotics, which target the anthrax bacteria.

Proof of its efficacy rests on animal models of inhalation anthrax, where the drug demonstrated an improved survival rate when administered both in combination with antibiotics and as monotherapy.

Safety has been tested on more than 300 adult volunteers.

“We have been collaborating with BARDA for a number of years and raxibacumab is now an important part of the US government’s emergency counter measures against bioterrorism,” said Sheri Mullen, GSK’s vice president of immunology & rare diseases, US pharmaceuticals.

Adam Hill

 

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