The Pandora Report: Special Edition

The theme of this special edition Pandora Report is medical countermeasures. Highlights include the 2012 Public Health emergency Countermeasure Enterprise Plan and Strategy (not as wordy as it sounds), raxibacumab’s approval to treat inhalation anthrax, new smallpox antivirals, and Emergent BioSolutions’ manufacturing an experimental influenza vaccine. Happy…er, Monday?

(image credit: USACE Europe District)
(image credit: USACE Europe District)

2012 HHS Public Health Emergency Medical Countermeasures Enterprise

The Department of Health and Human Services (HHS) released its 2012  Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan and Strategy last month. This version updates the orginal 2007 version of the Strategy and Plan, by expanding “efforts needed to improve national capability and capacity to respond to major public health threats.”

HHS – “The U.S. Government has a responsibility to protect the health and safety of its citizens. The American people continue to face a host of national health security threats from chemical, biological, radiological, and nuclear (CBRN) agents and emerging infectious diseases. Under the leadership of HHS, the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) is the coordinating body for the federal agencies in charge of protecting the civilian population from potential adverse health impacts through the use of medical countermeasures, which are medicines, devices, or other medical interventions that can lessen the harmful effects of these threats. The 2012 HHS PHEMCE Strategy articulates the strategic direction and will guide policies and decisions for the end-to-end mission of the PHEMCE. The companion 2012 HHS PHEMCE Implementation Plan describes the activities and programs that HHS, in collaboration with its interagency partners, is undertaking over the next five years to increase MCM preparedness for national health security threats.”

FDA approves Raxibacumab to Treat Inhalational Anthrax

Although only just being officially approved, under a special licensing agreement the US government has been steadily adding raxibacumab to the Strategic National Stockpile for a few years now. The drug’s efficacy stems from its targeting of Bacillus anthracis‘ toxins, instead of the bacteria itself. Raxibacumab is also the first adrug to be approved under the two animal rule (which I know you’re all entirely familiar with…yes? oh here).

FDA – “The U.S. Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. Raxibacumab is a monoclonal antibody that neutralizes toxins produced by B. anthracis that can cause massive and irreversible tissue injury and death. A monoclonal antibody is a protein that closely resembles a human antibody that identifies and neutralizes foreign material like bacteria and viruses. Anthrax is a potential biological terrorism threat because the spores are resistant to destruction and can be easily spread by release in the air.”

ST-246(R) to be Branded Arestvyr(TM)

Eradication has definitely not spelled the end to the smallpox debate. The argument generally falls along two lines A) As it’s eradicated, should we still be prioritizing its antivirals over other, more defined needs? Or B) As it’s eradicated, and therefore almost everyone under the age of 32 is entirely vulnerable, shouldn’t stockpiling antivirals be a top priority? SIGA clearly falls in the later camp.

Globe Newswire – “SIGA Technologies, Inc. (Nasdaq:SIGA), a company specializing in the development of pharmaceutical agents to fight pathogens capable of use as bioweapons, today announced that its smallpox antiviral, previously known as ST-246®, would be branded as Arestvyr™ for all purposes, including commercial sales and seeking full marketing approval of the antiviral as a smallpox treatment. “We are pleased to announce use of the Arestvyr™ name for our proprietary smallpox antiviral treatment,” said Dr. Eric A. Rose, Chairman and Chief Executive Officer of SIGA. “ST-246 (Tecovirimat) is becoming increasingly better known around the world as we work to deliver two million courses of our treatment to the United States Government’s Strategic National Stockpile. Adopting the Arestvyr™ name is another step in our commercial-stage transformation. SIGA is also pleased to confirm that it has received payment of the $12.3 million milestone previously invoiced to the U.S. government under SIGA’s Strategic National Stockpile contract.”

Emergent licenses flu vaccine for new federal biodefense center

Just in time for our raging flu season (well not really, because as we all know vaccines take a good long while to produce), Emergent Biosolutions, our nation’s supplier of the current anthrax vaccine, is on the way to producing an experimental flu vaccine.

Gazette.net – “Back in June, Emergent BioSolutions, the Rockville biotech that sells the only approved anthrax vaccine to the federal government, won a federal grant worth up to $220 million to establish a new biodefense development and manufacturing center in Maryland. Late last week, the company announced that it acquired the license to manufacture and sell an experimental pandemic influenza vaccine to help meet its commitment under that grant. Under its deal with VaxInnate of Cranbury, N.J., Emergent said in a statement, it gains exclusive rights to the candidate, a recombinant vaccine that has the potential to be produced quickly and cost-effectively with high yields. VaxInnate will continue to develop the candidate under its current contract with the Biomedical Advanced Research and Development Authority, while Emergent will produce it, using flexible manufacturing technology. Emergent also works with the federal authority to develop a second-generation anthrax vaccine.”

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