Emergent BioSolutions is a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, USA. It develops vaccines and antibody therapeutics for infectious diseases, oncology and autoimmune disorders, and provides medical devices for biodefense purposes.
Among the company's notable products is BioThrax (Anthrax Vaccine Adsorbed), the only anthrax vaccine licensed by the U.S. Food and Drug Administration (FDA). The company also manufactures pharmaceuticals for adults and children with acute blood disorders, people undergoing certain liver transplants, palliative care for chemo or radiation therapy patients, hemophilia B and a varicella (Chickenpox) vaccine for high risk patients.
The company has two divisions: a Biodefense division for medical countermeasures and a Biosciences division to treat infectious disease, autoimmune diseases, and cancer.
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 continues to serve as the executive chairman of Emergent BioSolutions' board of directors.
Video Emergent BioSolutions
BioThrax
According to the U.S. National Library of Medicine, BioThrax was first made available in 1970. BioThrax (Anthrax Vaccine Adsorbed), a vaccine licensed by the U.S. Food and Drug Administration. Following a study by scientists from the Centers for Disease Control and Prevention, 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. BioThrax has received marketing approval in India, Singapore, and Germany.
The FDA gave BioThrax an "orphan drug" designation in April 2014. 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. 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). 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 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.
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.
Maps Emergent BioSolutions
Company history
Emergent BioSolutions was founded on September 5, 1998, under the name BioPort, and renamed 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.
After the 2001 anthrax attacks following the terrorist attacks on September 11, BioPort worked with the U.S. government to supply anthrax countermeasures.
Emergent became a publicly traded company in 2006, with its stock trading on the New York Stock Exchange under the symbol EBS.
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.
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.
On March 31, 2017, Emergent said it 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's manufacturing facility.
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.
Leadership
The current president and CEO of Emergent Biosolutions is Daniel J. Abdun-Nabi. He has held the position since April 1, 2012. Prior to that, he was the president and chief operating officer. He holds an M.L.T. from Georgetown University, J.D. from the University of San Diego, and B.A. from the University of Massachusetts, Amherst.
In addition to running Emergent, Abdun-Nabi speaks publicly on matters related to national security. For example, on April 1, 2015, he spoke as a panelist before the Hudson Institute think tank about how to prepare and respond to threats from biological and chemical weapons. The event was part of the Blue Ribbon Study Panel on Biodefense, a group of experts that analyzed the United States' defense capabilities against biological threats. In 2015, Abdun-Nabi organized a visit by former Florida Governor Jeb Bush to Emergent's Lansing facility to speak to employees about ways the government and companies such as Emergent could work with each other to help defend the U.S. against terrorist attacks. Abdun-Nabi sits on the board of directors at BioHealth Innovation, a public-private partnership that helps bring bio-health products to the marketplace.
Financial information
Forbes recognized Emergent as the top performing company in the state of Maryland for the 2015-2016 fiscal year. Forbes tracked the return of every public company between from June 8, 2015 to June 8, 2016. Emergent had a total return during that time period of 38.2 percent. In 2015, Emergent had revenue of $522 million.
Preliminary 2017 financial results
As of January 8, 2018, Emergent released the following preliminary full 2017 financial results:
2014-2015 activity and financial figures
According to ZACKs, Emergent's acquisition of Cangene made both of Emergent's divisions (Biosciences and Biodefense) stronger. In addition to the Cangene acquisition, Emergent and the German human antibody developer MorphySys AG in 2014 began collaborating on a prostate cancer drug called ES414. As of January 2015, the drug is in the pre-clinical stage.
In early January 2015, Emergent publicly released its preliminary financial totals for the 2014 year. The company saw an increase in revenue, GAAP net income, and adjusted net income. Revenue amounted to between $445-$450 million, which is 43% higher than revenue earned in 2013. GAAP net income was between $36 and $38 million (a 19% increase). Adjusted net income increased by 49 percent to between $53 and $55 million.
Also in January, the company gave what is known as "guidance" (an accounting term meaning a company tells the public what it expects to earn in the future) for 2015. Emergent expects $90-105 million in sales in the first three months of 2015; and between $510-540 million for the full year. Emergent sold more BioThrax in 2014 than in the previous year (BioThrax sales amounted to approximately $246 million). According to company statements, Emergent believes that the growth in BioThrax sales along with stronger sales of other products from its Biodefense division will drive growth in 2015. The Motley Fool, an investment information company characterized in its Yahoo! Finance profile as "the king of personal investing tips", believes that Emergent's drug to treat hemophilia B, called Ixinity, will also drive growth in 2015. As of January 21, 2015, the FDA was reviewing Emergent's application for Ixinity approval.
Key financial figures, current as of January 21, 2015, are listed in the table:
R&D and manufacturing operations
In addition to the anthrax vaccine, Emergent BioSolutions develops and manufactures vaccines and therapeutics for the prevention or treatment of several diseases. One of Emergent's medical countermeasure products is RSDL, a lotion that clears and neutralizes chemical warfare agents. The product is used in over 20 countries around the world. 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." As of September 2017, RSDL is available to the regular public. Previously, it was only available to the military.
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.
On September 18, 2017, Emergent announced that BARDA had awarded the company a $63 million contract to develop an antidote spray device for acute cyanide poisoning. Under the contract, Emergent would create a "single-use intranasal spray . . . intended for use by first responders and medical personnel . . . [which would work] . . . by delivering a single-use dose of a stabilized form of isoamyl nitrite (SIAN)."
As of 2017, Emergent manufactures the following products:
- BioThrax (Anthrax Vaccine Adsorbed)
- Anthrasil (Anthrax Immune Globulin Intravenous)
- BAT (Botulism Antitoxin Heptavalent)
- VIGIV (CNJ-016) (Vaccinia Immune Globulin Intravenous)
- RSDL (Reactive Skin Decontamination Lotion)
Products in development include:
- NuThrax (Anthrax Vaccine)
- In phase II clinical trials, expected to enroll patients in phase III studies in 2018.
- FLU-IGIV (Seasonal Influenza Therapeutic)
- In phase II clinical trials
- UV-4B (Dengue Therapeutic)
- ZIKV-IG (Zika Therapeutic)
- GC-072 (Burkholderia Therapeutic)
- FILOV (Pan-filovirus Therapeutic (Ebola, Marburg, Sudan virus))
On December 12, 2017 the company announced that it was awarded a contract by the Canadian Department of National Defence (DND) valued at approximately $8 million to deliver Anthrasil to the Canadian government.
Public affairs
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.
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, $25,000 to Sexton High School for engineering equipment, and $25,000 to the Lansing Promise scholarship fund
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.
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.
See also
- Anthrax attacks of 2001
- Anthrax toxin
- Anthrax Vaccine Immunization Program
- Biotechnology
- List of pharmaceutical companies
- List of vaccine topics
- Pharmaceutical industry
References
Notes
External links
- Official website
- Food and Drug Administration license for BioThrax
Source of the article : Wikipedia
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