Emergent BioSolutions

Emergent BioSolutions is an American multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland.[1] It develops vaccines and antibody therapeutics for infectious diseases, opioid overdoses, and provides medical devices for biodefense purposes. The company's gross revenue in 2018 was $782.4 million; gross income was $438.2 million; EBITDA was $170.5 million.[2]

Emergent BioSolutions Inc.
Public company
Traded asNYSE: EBS
S&P 400 Component
Industrypharmaceutical industry 
FoundedSeptember 5, 1998 (1998-09-05) (as BioPort Inc.)
FounderFuad El-Hibri
HeadquartersGaithersburg, Maryland, U.S.
Key people
Robert G. Kramer Sr. (CEO)
Fuad El-Hibri (Executive Chairman of the Board of Directors)
Revenue US $1.3 Billion (2019)
WebsiteOfficial website

Among the company's notable products are 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.

Fuad El-Hibri, the founder of the company and former CEO,[3] led the company since its founding as BioPort Inc.[4][5] until his retirement on April 1, 2012.[6][7] El-Hibri continues to serve as the executive chairman of Emergent BioSolutions’ board of directors.[8]

BioThrax
Anthrax Vaccine Adsorbed

According to the U.S. National Library of Medicine, BioThrax was first made available in 1970.[9] BioThrax (Anthrax Vaccine Adsorbed), a vaccine licensed by the U.S. Food and Drug Administration.[10] Following a study by scientists from the Centers for Disease Control and Prevention,[11] on December 19, 2008, Emergent received final FDA licensing for use of BioThrax five doses for intramuscular injection.[12] 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.[13] BioThrax has received marketing approval in India, Singapore, and Germany.[14][15][16] 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.[17]

The FDA gave BioThrax an "orphan drug" designation in April 2014.[18] The FDA gives that status to drugs that are used to treat rare diseases.[18] BioThrax is the only anthrax vaccine licensed by the FDA.[18]

As of April 2014, Emergent has sold over 66 million doses of BioThrax to the U.S. government.[19] Three million U.S. military personnel have received the BioThrax vaccine.[19]

The main buyer of BioThrax is the U.S. Centers for Disease Control and Prevention (CDC).[20] The CDC buys BioThrax for the Strategic National Stockpile (SNS).[20] The government uses the SNS to protect the public in the event of a national emergency like a terrorist attack.[20] As of December 2016, Emergent has a $911 million contract with the CDC for BioThrax. The BioThrax vaccines will go to the SNS. The contract will supply around 29.4 million doses of the vaccine. 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.[21]

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.[22]

Narcan
Further information: naloxone
Narcan Nasal Dispenser

The early 21st century set in motion the US Opioid Epidemic, "... the most serious and most important public health crisis today,” according to the Mayo Clinic Proceedings. Nasal spray naloxone, trade name “Narcan,” use has increased markedly during the opioid emergency. The epidemic is measured in overdose deaths, and also is seen in a downturn in overall health and the population's sense of well-being. Increased employment of naloxone such as Narcan among first responders and the public as a whole has reduced mortality, but recidivism is high.[23] The US Opioid Epidemic has intensified the need for and continued use of Narcan to save those suffering from overdoses. The number of opioid deaths in the US doubled from 2010 to 2016 to 42,249 according to the FDA.[24]

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.[25]

In 2012, concerned about inconsistency of dosage, along with the need for a responder having some specialized training in making the naloxone injection in a tense, highly- charged emergency environment, Phil Skolnick, then director of the Division of Therapeutics & Medical Consequences at the National Institute on Drug Abuse and Roger Crystal, the chief executive officer of Lightlake Therapeutics (now Opiant Pharmaceuticals), teamed to develop an intranasal version of the drug. NIDA then generated a highly concentrated solution of naloxone which Lightlake was able to package in its nasal spray devices. 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.[26] Emergent Biosolutions purchased Adapt Pharma in 2018.[27]

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 delivering Narcan to consumers. Emergent is required by the FDA to make certain that the product-specific parts of the labels are understood by consumers.[28] 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. Many doctors consider this practice an opportunity to initiate a discussion between health care providers and patients about the dangers and risks of opioid pain medication.[29]

Throughout the US, Narcan and naloxone have been made available OTC in 41 states; exceptions are Delaware, Hawaii, Kansas, Maine, Michigan, Nebraska, Oklahoma, South Dakota and Wyoming. The drug can be found in major retailers like CVS, Walgreens, Walmart and Kroger, as well as independent pharmacies. Many states offer lists of retailers where Narcan can be purchased. Narcan is covered by many health insurance plans.[30]

Company history

Early history
Acquisition history
  • 2003 (2003): Antex Biologics, Inc.[31]
  • 2005 (2005): Microscience Ltd.[32]
  • 2006 (2006): Vivacs GmbH[33]
  • 2008 (2008): A group of anthrax monoclonal antibodies from Avanir Pharmaceuticals[34]
  • 2008 (2008): Anthrax vaccine program, patents and processes from VaxGen[35][36]
  • 2010 (2010): Trubion Pharmaceuticals[37]
  • 2013 (2013): Healthcare Protective Products Division of Bracco Diagnostics Inc., which includes RSDL decontamination lotion[38][39]
  • 2013 (2013): Cangene Corporation
  • 2017 (2017): ACAM2000 (smallpox vaccinia) Vaccine from Sanofi Pasteur
  • 2018 (2018): Adapt Pharma, the manufacturer of Narcan (naloxone)

Emergent BioSolutions was founded on September 5, 1998, under the name BioPort, and renamed Emergent BioSolutions in 2004.[40] 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.[41][42]

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.[43]

Emergent, under its previous identities and since, has been the subject of Congressional hearings and FDA action (official action indicated (OAI) and voluntary action indicated (VAI)) since its founding. [44][45][46][47][48]

Emergent became a publicly traded company in 2006, with its stock trading on the New York Stock Exchange under the symbol EBS.[49]

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.[50] The purpose is to produce medical countermeasures in the event of a national pandemic.[51] Emergent's facility is located in Maryland and the company expects the site to be operational by the year 2020.[51]

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).[52]

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.[53][54] The vaccine could reach stage-one clinical trials by early 2017.[55] As of the end of June 2016, 60 countries and territories had reported transmission of the Zika virus from mosquitoes.[54] Emergent could become the first company to develop a vaccine for the virus.[53]

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.[56]

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.[57] 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.[58]

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.[59]

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's manufacturing facility.[60] An expansion of the Baltimore plant, finished in 2017, had $163 million in funding from the U.S. government.[61]

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.[62] 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.[63]

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.[64]

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.[65]

Leadership

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.[66]

R&D, manufacturing and other products

In addition to the anthrax vaccine, Emergent BioSolutions develops and manufactures vaccines and therapeutics for the prevention or treatment of several diseases and conditions.[67]

RSDL

One of Emergent's medical countermeasure products is Reactive Skin Decontamination Lotion (RSDL), a lotion that clears and neutralizes chemical warfare agents. The product, used internationally, was tested in a study conducted by the US Army Medical Research Institute of Chemical Defense, where RSDL was found to provide superior protection against soman when decontamination was commenced within three minutes of exposure.[68] RSDL is made of the chemicals Dekon 139 2,3 butanedione monoxime (DAM). According to the Chemical Hazards Emergency Medical Management office within the United States Department of Health and Human Services, "RSDL is used as a medical device for the decontamination of skin exposed to chemical warfare agents such as sulfur mustard, VX, VR and certain biological toxins."[69] As of September 2017, RSDL is available to the regular public. Previously, it was only available to the military.[70]

The United States Department of Defense in September 2017 awarded the company a contract to supply the RSDL kit (RSDL) to the military. The contract is for five years and is worth $171 million. The RSDL lotion protects people's skin from various chemical warfare agents. The product contains a sponge that is filled with the decontamination lotion in and impermeable packet. When applied to the skin, the lotion reacts with the agent on the skin and quickly neutralizes it so that it becomes non-toxic.[71]

Auto-injector diazepam

The Medical CBRN (Chemical, Biological, Radiological and Nuclear) Defense Consortium, a DOD initiative within its Joint Program Executive Office for Chemical and Biological Defense has awarded the company US$20 million to develop an auto-injector to administer diazepam. The injection is designed to reverse the effects of nerve agents in military or chemical terrorism situations. The investment supports R&D, manufacturing and negotiating the approval process with the US FDA.[72]

COVID-19 pandemic

During the COVID-19 pandemic, the company teamed with Novavax Inc., a bio-technology company also based in Gaithersburg, MD., in the development and manufacture of a vaccine for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus which causes COVID-19. Emergent will produce the vaccine in one of its Maryland facilities based on technology developed by Novavax.[73] Emergent petitioned the federal government's Biomedical Advanced Research and Development Authority (BARDA) to be chosen for the project.[74] The company also signed a $135 million deal with Johnson & Johnson to provide and reserve manufacturing capacity for J&J's experimental COVID-19 vaccine candidate. Human testing is planned to begin by September 2020.[75]

In June 2020, Cambridge UK-based pharmaceutical developer and manufacturer, AstraZeneca, initiated a $174 million (US) agreement with the company to help develop and produce 300 million doses of COVID-19 vaccine promised to be administered in the United States. Co-developed with the University of Oxford (UK), the vaccine is among the first to begin mid-stage trials. AstraZeneca had also signed a previous agreement with Emergent for $87 million (US) naming Emergent a development partner for the vaccine, which will be manufactured at the company’s Bayview plant in Baltimore MD, which the US Department of Health and Human Services has designated a center for rapid manufacturing of vaccines and other treatments in large quantities.[76]

The company joined forces with New York City’s Mount Sinai Health System and ImmunoTek Bio Centers (New Orleans LA) to research, develop, conduct clinical trials, and manufacture COVID-HIG, hyperimmune globulin, also known as polyclonal antibodies, a concentrated antibody made from plasma acquired from individuals infected with and recovered from COVID-19. The research is designed to determine whether COVID-HIG could protect people at higher risk of exposure and infection (like health care and military personnel) and therefore limit the spread of the infection. The initial study is funded by a $34.6 million (US) grant from the US Dept. of Defense and the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND).[77]

Public affairs

Emergent Biosolutions was among many companies giving financial support to delegations at both major party political conventions in the summer of 2016, a practice that "watchdog groups have raised concerns about ... as corporate donors — skittish about Republican nominee Donald J. Trump — have sought new and less overt ways to give money and gain influence".[78]

In October 2018, the company donated two doses of Narcan nasal spray to all 16,568 libraries in the US. Emergent had previously donated 20,000 doses to 4,700 universities in the US in 2017. It later expanded this donation to all US high schools as well.[79] Additionally, the company donated free Narcan kits to 2,700 YMCAs across the US. Narcan and naloxone are offered at major drug retailers like Walgreens and CVS in many states without a prescription.[80]

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See also

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