Emergent BioSolutions

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Group.png Emergent BioSolutions  
(Big pharmaWebsiteRdf-entity.pngRdf-icon.png
Emergent biosolutions.jpg
Formation1998
FounderFuad El-Hibri
HeadquartersGaithersburg, Maryland
Staff11,800
InterestsCOVID-19/Vaccine, anthrax, 2001 anthrax attacks, biological warfare, Germ attack/Preparation
"One of the most politically-connected yet scandal ridden vaccine companies in the United States"

Emergent BioSolutions (formerly BioPort) is an American multinational biopharmaceutical company specializing in selling vaccines and antibody therapeutics for infectious diseases, opioid overdoses, and provides medical devices for biodefense purposes, in many cases as a monopoly supplier to the government. It collaborates with the Defense Advanced Research Projects Agency (DARPA). [1] Whitney Webb termed them "one of the most politically-connected yet scandal ridden vaccine companies in the United States"[2]

Among the company's notable products are BioThrax, the only anthrax vaccine licensed by the U.S. Food and Drug Administration (FDA) and Narcan (naloxone) for the emergency treatment of opioid overdoses. The company spent $4 million dollars on lobbying politicans in 2020 alone.[3]

During the 2019-20 coronavirus pandemic, the company teamed with Novavax Inc., a bio-technology company also based in Gaithersburg, Maryland, in the development and manufacture of a vaccine for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The partners plan on preclinical testing and a phase 1 clinical trial by July 2020. Human testing is planned to begin by September 2020.

Founding

Emergent BioSolutions was founded on September 5, 1998, under the name BioPort, and renamed Emergent BioSolutions in 2004. The Lebanese financiers Ibrahim El-Hibri “an international telecom magnate” and his son Fuad El-Hibri were the founders, through a network of companies, one of which was headquartered in the Dutch Caribbean.[4] Fuad El-Hibri led the company until his retirement on April 1, 2012. Fuad El-Hibri continues to serve as the executive chairman of Emergent BioSolutions’ board of directors

At the time, the Michigan Department of Public Health, though its Michigan Biologics Products Institute, owned an anthrax vaccine manufacturing facility in Lansing, Michigan. BioPort purchased the facility and the rights to manufacture the vaccine for the U.S. military for a bargain $24 million. The plant “held the exclusive contract to provide the U.S. government with the anthrax vaccine, and that in addition to the physical plant, the Michigan sale included $130 million in contracts with the Department of Defense.”

The El-Hibris had a decade earlier participated in the privatization of portions of the United Kingdom’s leading biodefense facility, Porton Down. With the acquisition of the Michigan plant, the family had planted stakes in the only two leading anthrax vaccine producers in the Western world. According to Bob Coen and Eric Nadler, makers of the documentary Anthrax War, what makes this particularly troubling according to Coen and Nadler, is the fact that the “El-Hibris did not have science backgrounds or biotech business experience before the Porton takeover–but were clearly canny investors.”

Emergent is a member of the Alliance for Biosecurity, a group of companies and organizations that work towards improving the ability to respond to biological threats with vaccines and other countermeasures.

Anthrax

After the 2001 anthrax attacks that caused the deaths of five Americans and made 17 others ill, with anthrax spores so fine that they only could have come from a state program or one operating under contract to a government agency, Bioport began providing its anthrax vaccine, BioThrax, to US biodefense agencies.

According to the U.S. National Library of Medicine, BioThrax was first made available in 1970.[5] BioThrax (Anthrax Vaccine Adsorbed), a vaccine licensed by the U.S. Food and Drug Administration.[6] Following a study by scientists from the Centers for Disease Control and Prevention,[7] on December 19, 2008, Emergent received final FDA licensing for use of BioThrax five doses for intramuscular injection. Later in 2009, Emergent received approval from the FDA to extend the shelf life of its anthrax vaccine from three to four years.

BioThrax was approved for distribution in the United States in the US in 2015.[8] BioThrax has received marketing approval in India, Singapore, and Germany.[9][10][11] Health Canada, under the agency's Extraordinary Use New Drug Regulations, approved BioThrax for exclusive use against anthrax for an eight-year period. The Regulations provide a dual track for products allowing human usage while gathering clinical data on the effects of that usage. Additionally, the company has applied for approval of BioThrax in France, Poland, United Kingdom, Italy and the Netherlands.[12]

The FDA gave BioThrax an "orphan drug" designation in April 2014.[13] The FDA gives that status to drugs that are used to treat rare diseases. BioThrax is the only anthrax vaccine licensed by the FDA.

As of April 2014, Emergent has sold over 66 million doses of BioThrax to the U.S. government.[14] Three million U.S. military personnel have received the BioThrax vaccine.

The main buyer of BioThrax is the U.S. Centers for Disease Control and Prevention (CDC).[15] The CDC buys BioThrax for the Strategic National Stockpile (SNS). The government uses the SNS to protect the public in the event of a national emergency like a terrorist attack. As of December 2016, Emergent has a $911 million contract with the CDC for BioThrax. The contract will supply around 29.4 million doses of the vaccine to the stockpile. Additionally, the Biomedical Advanced Research and Development Authority (BARDA) released a notice of intent to purchase around $100 million of BioThrax for the SNS in 2017.[16]

Emergent submitted an application to the FDA for use of a large facility in Lansing, Michigan to produce BioThrax. On June 21, 2016, Emergent announced that it had moved a step forward in the process: the FDA completed the pre-approval phase of its inspection.[17]

Other bioweapons vaccines

In June 2012, Emergent, along with Novartis and the Texas A&M University System was selected by the U.S. Department of Health and Human Services as one of the three Centers for Innovation in Advanced Development and Manufacturing. The public-private partnership granted Emergent $163 million over eight years to assist in the development of countermeasures for health, nuclear and radiological epidemics. The purpose is to produce medical countermeasures in the event of a national pandemic.

On March 31, 2017, Emergent signed a modification to its contract with BARDA to "manufacture and store bulk drug substance for its botulism antitoxin, BAT." The contract is valued at approximately $53 million for five years. The contract modification was technical in nature; it allows Emergent to file and deliver the final drug product to the Strategic National Stockpile in the future.

Soligenix Inc. and Emergent agreed to establish a “commercially viable production technology” for the development of RiVax, a potential vaccine aimed to protect against ricin exposure. Currently, there are no treatments for ricin poisoning that have been proven effective. Soligenix is a late-stage biopharmaceutical company that specializes in the development of treatments for rare diseases. A product of castor oil production, the ricin toxin can be a useful biological weapon due to its extreme potency, stability, and accessibility. The National Institute of Allergy and Infectious Diseases funded the development of RiVax costing an estimated $24.7 million. The organization also financially backed the contract between Emergent and Soligenix. Most of the work will be conducted in Baltimore, Maryland, at Emergent Biosolutions's manufacturing facility. An expansion of the Baltimore plant, finished in 2017, had $163 million in funding from the U.S. government.

On June 27, 2016, the US Biomedical Advanced Research and Development Authority contracted with Emergent Biosolutions to develop a vaccine for the Zika virus. The contract is spread out over 30 months and is worth around $22 million. The vaccine could reach stage-one clinical trials by early 2017.As of the end of June 2016, 60 countries and territories had reported transmission of the Zika virus from mosquitoes. Emergent could become the first company to develop a vaccine for the virus.

In December 2016, Health Canada approved the purchase of Emergent's new botulism antitoxin called Botulism Antitoxin Heptavalent (BAT). The CDC and Public Health Agency of Canada both identified botulism, a type of food poisoning, as a likely biological threat. Emergent already has a ten-year contract with the Canadian military and national health service to supply BAT that began in 2012. Emergent also provides BAT to the U.S. Strategic National Stockpile. BAT was first licensed in the U.S. in 2013 and is the only botulism antitoxin available in the U.S. for naturally-occurring cases of non-infant botulism.

In 2018, Emergent purchased the specialty vaccine manufacturer PaxVax, whose product line includes FDA-approved typhoid vaccine Vivotif and cholera vaccine Vaxchora, from its owner, Cerebus Capital Management, a private equity fund. Vaxchora is the only oral vaccine against cholera approved by the FDA in the US. The acquisition also includes rights to vaccines in development. One of these vaccines is being tested as a prophylactic against the acute-respiratory disease adenovirus. Another is focused on the chikungunya virus which is transmitted by mosquitoes. The transaction provides Emergent with a Swiss R&D facility.

Narcan

The early 21st century, pharmaceutical companies created the US Opioid Epidemic. The nasal spray naloxone, trade name “Narcan,” use has increased markedly during the opioid emergency. Increased use of naloxone such as Narcan among first responders and the public as a whole has allegedly reduced overdose mortality, even though the number of opioid deaths in the US doubled from 2010 to 2016 to 42,249 according to the FDA.

Narcan is mostly used as a “rescue drug” for individuals suffering from opioid overdose. Narcan, related to morphine, is an opioid antagonist that was originally synthesized and patented by Mozes J. Lewenstein and Jack Fishman in the US in 1961. The drug was patented in the UK by the Japanese company Sankyo (now Daiichi Sankyo). The US FDA approved the drug in treatment of opioid overdose in 1971.

In 2012, the National Institute on Drug Abuse and Lightlake Therapeutics (now Opiant Pharmaceuticals), teamed to develop an intranasal version of the drug. After successful clinical trials, Lightlake entered into a partnership with Adapt Pharma to manufacture the product, Narcan. The FDA approved Narcan nasal spray in November, 2015. Emergent Biosolutions purchased Adapt Pharma in 2018.

In January 2019, the FDA initiated a policy that allows the distribution of naloxone over-the-counter through the use of consumer-friendly labels that Emergent Biosolutions uses in promoting Narcan to consumers. By 2019, seven states - California, Virginia, Arizona, Ohio, Washington, Vermont and Rhode Island – required physicians to provide patients who receive opioid prescriptions (e.g., as a pain killer) to co-prescribe or, at minimum, offer Narcan to high risk patients.



References

  1. https://globalbiodefense.com/2014/08/14/cdc-emergent-biosolutions-smallpox-drug/
  2. https://unlimitedhangout.com/2020/04/investigative-series/a-killer-enterprise-how-one-of-big-pharmas-most-corrupt-companies-plans-to-corner-the-covid-19-cure-market/
  3. https://www.opensecrets.org/orgs/summary?id=D000025674
  4. 1
  5. Anthrax Vaccine and Public Health Policy|date = November 2007 Martin Meyer Weiss, Peter D. Weiss, Joseph B.Weiss |journal = American Journal of Public Health|pages = 1945–1951 |publisher = American Public Health Association|pmc=2040369|pmid=17901434 |doi=10.2105/AJPH.2006.102749|volume=97|issue=11
  6. https://www.bizjournals.com/washington/stories/2010/07/12/daily29.html
  7. url=https://www.bloomberg.com/apps/news?pid=newsarchive&sid=aVi7uxzenRnY&refer=home
  8. https://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm133822.htm
  9. url=https://www.pei.de/SharedDocs/arzneimittel/impfstoffe/Mono/Milzbrand/PEI-H-04350-01-1.html
  10. url=http://www.bizjournals.com/washington/news/2011/06/24/emergent-gets-entry-to-singapore.html
  11. https://www.washingtonpost.com/wp-dyn/content/article/2009/02/12/AR2009021203623.html
  12. https://homelandprepnews.com/stories/31806-health-canada-approves-emergent-biosolutions-new-anthrax-vaccine/
  13. http://bioprepwatch.com/featured/emergent-biosolutions-biothrax-receives-orphan-drug-designation-for-pep/337168/
  14. http://www.marketwatch.com/story/emergent-biosolutions-receives-orphan-drug-designation-for-biothrax-for-post-exposure-prophylaxis-of-anthrax-disease-2014-04-21
  15. http://seekingalpha.com/article/2092943-emergent-biosolutions-is-building-an-enviable-biodefense-portfolio
  16. https://homelandprepnews.com/biological-threats/20427-emergent-biosolutions-secures-911-mln-contract-supply-anthrax-vaccines-strategic-national-stockpile/
  17. https://www.cnbc.com/2016/06/21/emergent-biosolutions-clears-hurdle-for-anthrax-vaccine-facility.html
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