Description
Emergent BioSolutions is an American multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland. It develops vaccines and antibody therapeutics for infectious diseases and opioid overdoses, and it provides medical devices for biodefense purposes.
Among the company's products are the controversial BioThrax (Anthrax Vaccine Adsorbed), the only anthrax vaccine licensed by the U.S. Food and Drug Administration (FDA) and Narcan (naloxone) for the emergency treatment of opioid overdose. The company also manufactures pharmaceuticals for infectious diseases like cholera and typhoid.
During the COVID-19 pandemic, Emergent BioSolutions also produced Johnson & Johnson and AstraZeneca/Oxford vaccines at one of its plants; however, this was marked by contamination and other production issues, and millions of doses of vaccine had to be discarded.
History
Early history
Emergent BioSolutions was founded on September 5, 1998, by Faud El-Hibri, under the name BioPort, which had formerly operated as a state owned entity named Michigan Biological Products Institute and was privatized as Emergent BioSolutions in 2004. 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.
In 2000, operating as Bioport, the company was the subject of Congressional hearings and FDA action (official action indicated (OAI) and voluntary action indicated (VAI)). After the 2001 anthrax attacks that caused the deaths of five Americans and made 17 others ill, Bioport began providing its anthrax vaccine to US biodefense agencies.
Emergent became a publicly traded company in 2006, with its stock trading on the New York Stock Exchange under the symbol EBS.
Mergers, acquisitions and joint ventures
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. Emergent's facility is located in Maryland and the company expects the site to be operational by the year 2020.
The company purchased Winnipeg, Manitoba's Cangene Corporation in 2013. Cangene's leading product is WinRho, which treats the blood disease immune thrombocytopenic purpura, as well as hemolytic disease of the newborn. Cangene also produces pharmaceuticals that treat Hepatitis B and varicella (chickenpox).
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.
Emergent spun off its biosciences division in August 2016, forming a new company, Aptevo Therapeutics in Seattle, WA.The new company continues its focus on developing treatments for cancer and blood diseases using its technology of dual-ended molecules that assault cancer cells, each end attacking the cancer in a different way. Aptevo had four products available at its inception.
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.
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 was conducted in Baltimore, Maryland, at Emergent's manufacturing facility. An expansion of the Baltimore plant, finished in 2017, had $163 million in funding from the U.S. government. In January 2020, Emergent informed Soligenix of manufacturing issues, having provided doses of RiVax that were "out of specification", causing the study to be suspended even after two trial participants had received doses. In April 2020, the Department of Health and Human Services announced that it would not provide further funding for RiVax clinical trials, although the agency did not announce whether this was related to previous issues. In subsequent securities filings, Soligenix stated that it was pursuing $19 million in damages from Emergent in arbitration proceedings.
In 2017, the company purchased the ACAM2000 (smallpox vaccinia) Vaccine, the only FDA-approved (2007)vaccine for active immunization against smallpox for those at a medical high risk of contracting the disease, from Sanofi Pasteur. Two years later, the Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, has signed a contract with the company worth an estimated US$2.8 billion for the company to provide ACAM2000 over a ten-year period.
In 2018, Emergent acquired Adapt Pharma, the manufacturer of Narcan (naloxone), a widely used nasal spray opioid-overdose antidote, for $735 million. Adapt is headquartered in Dublin, Ireland, and operates from Radnor, PA.
Emergent purchased (also in 2018) 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.
