Emergent BioSolutions

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Emergent BioSolutions Inc.
Public company
Traded asNYSEEBS
S&P 600 Component
Industrypharmaceutical industry Edit this on Wikidata
FoundedSeptember 5, 1998; 21 years ago (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)
RevenueIncrease US $782.42 million (2018)
WebsiteOfficial website

Emergent BioSolutions is a 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]

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[edit]

Anthrax Vaccine Adsorbed
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[edit]

Narcan Nasal Dispenser
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[edit]

Early history[edit]

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 became a publicly traded company in 2006, with its stock trading on the New York Stock Exchange under the symbol EBS.[44]

Mergers, acquisitions and joint ventures[edit]

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.[45] The purpose is to produce medical countermeasures in the event of a national pandemic.[46] Emergent's facility is located in Maryland and the company expects the site to be operational by the year 2020.[46]

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).[47]

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.[48][49] The vaccine could reach stage-one clinical trials by early 2017.[50] As of the end of June 2016, 60 countries and territories had reported transmission of the Zika virus from mosquitoes.[49] Emergent could become the first company to develop a vaccine for the virus.[48]

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.[51]

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.[52] 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.[53]

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.[54]

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.[55]

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.[56] 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.[57]

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.[58]

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.[59]

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.[60][61]

Leadership[edit]

The current president and CEO of Emergent Biosolutions is Robert G Kramer Sr. He has held the position since 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.[62]

R&D, manufacturing and other products[edit]

In addition to the anthrax vaccine, Emergent BioSolutions develops and manufactures vaccines and therapeutics for the prevention or treatment of several diseases and conditions.[63]

RDSL[edit]

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.[64] 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."[65] As of September 2017, RSDL is available to the regular public. Previously, it was only available to the military.[66]

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.[67]

Auto-injector diazepam[edit]

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.[68]

Chikungunya virus vaccine[edit]

The European Committee for Medicinal Products for Human Use (CHMP) granted priority medicine (PRIME) designation to the company's new chikungunya virus vaccine candidate to enhance the vaccine's maturation. Mosquitoes spread the chikungunya disease; it has struck in Africa, Asia, Europe, around the Indian and Pacific Oceans and the Caribbean. As of 2019, a successful vaccine to counter the malady did not exist. Emergent's candidate is a “virus like particle (VLP) that is licensed through the US National Institutes of Health. The PRIME designation, combined with the US Food and Drug Administration’s (FDA) “fast track” selection will, it is hoped, hasten the evaluation and development process[69]

Public affairs[edit]

Emergent Biosolutions was among many companies giving financial support to delegations at both major party political conventions in the summer of 2016. The conventions used the contributions for receptions, food and transportation, but by law could not use contributions to fund campaigns. For example, Emergent hosted a breakfast reception at the Democratic National Convention in Philadelphia. The company sent representatives to both conventions with the aim of specifically meeting with Maryland delegates to educate the delegates about medical countermeasures.[70]

Emergent runs a charitable giving program called Give Corporate Social Responsibility. The company has given money to the Lansing, Michigan school district. Prominent donations and scholarships include; $15,000 to Lansing J. W. Sexton High School for the purchase of equipment for the AP Biology program,[71] $25,000 to Sexton High School for engineering equipment,[72] and $25,000 to the Lansing Promise scholarship fund.[72]

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. [73] 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.[74]

Emergent is also a donor to the "Relentless Tour", an anti-bullying program that tries to raise awareness of autism and the problem of autistic children being bullied.[75]

On October 19, 2017, Emergent and the Alliance for Biosecurity awarded Congressman Dutch Ruppersberger (D-MD) and several other Members of Congress the "Congressional Biosecurity Champion Award" at Emergent's Maryland manufacturing facility for their work and leadership on biosecurity issues in Congress.[76]

See also[edit]

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External links[edit]