Emergent BioSolutions
Emergent BioSolutions Inc. 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, the only anthrax vaccine licensed by the U.S. Food and Drug Administration and Narcan 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/Janssen and Oxford–AstraZeneca 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 Fuad 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, through 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 and voluntary action indicated ). 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.
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 was spread out over 30 months and was worth around $22 million. The vaccine was projected to 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 was one of the first companies 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. 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 Vaccine, the only FDA-approved 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, a widely used nasal spray opioid-overdose antidote, for $735 million. Adapt is headquartered in Dublin, Ireland, and operates from Radnor, PA.
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.
Leadership
Fuad El-Hibri, the founder of the company and former CEO, led the company since its founding as BioPort Inc. until his retirement on April 1, 2012. El-Hibri continued to serve as the executive chairman of Emergent BioSolutions' board of directors until shortly before his death in 2022.Robert G. Kramer Sr. became the company's president and CEO April 1, 2019. Prior to that, he was the president and chief operating officer. He has also served as Chief Operating Officer, Chief Financial Officer and other management positions within the corporation. He received his BA from Clemson University and an MBA from Western Kentucky University. In April 2021, the Washington Post reported that Kramer sold $10 million worth of company stock in January and early February 2021 under a November 13, 2020, SEC Rule 10b-5 trading plan, which allows company executives to comply with insider trading laws by setting up predetermined plans to sell company stock. The sale was executed prior to announcements in March about Johnson & Johnson vaccine doses being discarded as well as subsequent ending production of the AstraZeneca vaccine at the Baltimore plant, but the trading plan was set up after the company had experienced [|COVID-19 vaccine production issues earlier in 2020]. On April 19, 2021, the United States House Select Oversight Subcommittee on the Coronavirus Crisis announced an investigation into Emergent BioSolutions, requesting documents and testimony from El-Hibri and Kramer regarding "federal contracts since 2015, all communication with Kadlec as well as information on audits and inspections of its facilities, drug pricing and executive compensation." Later in April, shareholders filed a class action lawsuit against the company, alleging that they were misled by company executives regarding the company's COVID-19 production capacity. Kramer's previous significant sale of company stock under a SEC Rule 10b-5 plan was in April 2016, and several other Emergent executives also sold stock at that time. The share price subsequently fell, and a lawsuit was filed by investors regarding misrepresentation of the size of the U.S. government's order for anthrax vaccine from the company. Emergent denied the allegations, but paid the investors a $6.5 million settlement.
Kramer and El-Hibri testified before the United States House Select Oversight Subcommittee on the Coronavirus Crisis on May 19, 2021. Kramer acknowledged unsanitary conditions, including mold and peeling paint, at the Baltimore plant. He further initially testified that contamination of the Johnson & Johnson doses "was identified through our quality control procedures and checks and balances." But under questioning, he acknowledged that a Johnson & Johnson lab in the Netherlands, not Emergent, had discovered the contaminated doses. Executive compensation documents made public by the House subcommittee show that the company's board praised El-Hibri, who cashed in stock shares and options worth more than $42 million in 2020.
In June 2023, Kramer announced his retirement, effective immediately and was replaced as CEO on an interim basis by Haywood Miller.