Emergent BioSolutions

Emergent BioSolutions Inc.
Public company
Traded as NYSE: EBS
S&P 600 Component
Founded 1998
Headquarters Gaithersburg, Maryland, US
Key people
 Daniel J. Abdun-Nabi (CEO)
Fuad El-Hibri (Executive Chairman of the Board of Directors)
Revenue Increase US $445–$500 million (2014)
Increase US $42.8 million (2014)
Increase US $53–$55 million (2014)
Website Official website
Footnotes / references
[1][2][3][4][5][6][7][8]

Emergent BioSolutions is a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, USA.[9] 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.[10]

Fuad El-Hibri, the founder of the company and former CEO,[11] led the company since its founding as BioPort Inc.[10][12] until his retirement on April 1, 2012.[13][14] El-Hibri continues to serve as the executive chairman of Emergent BioSolutions’ board of directors.[15]

BioThrax

Anthrax Vaccine Adsorbed
Anthrax Vaccine Adsorbed

According to the U.S. National Library of Medicine, BioThrax was first made available in 1970.[16] BioThrax (Anthrax Vaccine Adsorbed), a vaccine licensed by the U.S. Food and Drug Administration.[17] Following a study by scientists from the Centers for Disease Control and Prevention,[18] on December 19, 2008, Emergent received final FDA licensing for use of BioThrax five doses for intramuscular injection.[19] 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.[20] BioThrax has received marketing approval in India, Singapore, and Germany.[21][22][23]

The FDA gave BioThrax an "orphan drug" designation in April 2014.[24] The FDA gives that status to drugs that are used to treat rare diseases.[24] BioThrax is the only anthrax vaccine licensed by the FDA.[24]

As of April 2014, Emergent has sold over 66 million doses of BioThrax to the U.S. government.[25] Three million U.S. military personnel have received the BioThrax vaccine.[25]

The main buyer of BioThrax is the U.S. Centers for Disease Control and Prevention (CDC).[26] The CDC buys BioThrax for the Strategic National Stockpile (SNS).[26] The government uses the SNS to protect the public in the event of a national emergency like a terrorist attack.[26] 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.[27]

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.[28]

Company history

Acquisition history
  • 2003 (2003): Antex Biologics, Inc.[29]
  • 2005 (2005): Microscience Ltd.[30]
  • 2006 (2006): Vivacs GmbH[31]
  • 2008 (2008): A group of anthrax monoclonal antibodies from Avanir Pharmaceuticals[32]
  • 2008 (2008): Anthrax vaccine program, patents and processes from VaxGen[33][34]
  • 2010 (2010): Trubion Pharmaceuticals[35]
  • 2013 (2013): Healthcare Protective Products Division of Bracco Diagnostics Inc., which includes RSDL decontamination lotion[36][37]
  • 2014 (2014): Cangene Corporation[38][39]

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 following the terrorist attacks on September 11, BioPort worked with the U.S. government to supply anthrax countermeasures.[43]

Emergent became a publicly traded company in 2006, with its stock trading on the New York Stock Exchange under the symbol EBS.[43]

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

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.[46][47] The vaccine could reach stage-one clinical trials by early 2017.[48] As of the end of June 2016, 60 countries and territories had reported transmission of the Zika virus from mosquitoes.[47] Emergent could become the first company to develop a vaccine for the virus.[46]

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.[49] 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.[50]

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."[51] 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.[51]

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.[52]

In October 2017, Emergent announced that it had completed its acquisition of the ACAM2000 smallpox vaccine.[53]

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.[54][55]

Leadership

The current president and CEO of Emergent Biosolutions is Daniel J. Abdun-Nabi. He has held the position since April 1, 2012.[56] 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.[57]

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.[58] 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.[59] 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."[60] As of September 2017, RSDL is available to the regular public. Previously, it was only available to the military.[61]

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.[62]

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.[63]

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,[64] $25,000 to Sexton High School for engineering equipment,[65] and $25,000 to the Lansing Promise scholarship fund[65]

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.[66]

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.[67]

See also

References

  1. ↑ "Emergent BioSolutions Corporate Governance". Emergent BioSolutions. Retrieved 8 July 2013.
  2. ↑ "Emergent BioSolutions, Inc. (EBS)". Yahoo! Finance. Retrieved 1 May 2014.
  3. ↑ "Emergent BioSolutions – Key Statistics". Yahoo! Finance. Retrieved 1 May 2014.
  4. ↑ "Emergent BioSolutions – Income Statement". Yahoo! Finance. Retrieved 1 May 2014.
  5. ↑ "Emergent BioSolutions – Balance Sheet". Yahoo! Finance. Retrieved 1 May 2014.
  6. ↑ "Emergent Solutions". BioSpace. Dice Holdings, Inc. Retrieved 1 May 2014.
  7. ↑ Ramstack, Tom (16 October 2007). "BioSolutions posts healthy progress". The Washington Times. p. C10.
  8. ↑ "Emergent Biosolutions Inc". Google Finance. Retrieved 1 May 2014.
  9. ↑ "Contact Us". Emergent BioSolutions. Retrieved 13 May 2015.
  10. 1 2 "Lansing laboratory may begin anthrax vaccine shipments". The Michigan Daily. 23 January 2002. Retrieved 19 March 2015.
  11. ↑ Shapiro, Andy (29 May 2008). "Md. firm to buy Protein Sciences". New Haven Register.
  12. ↑ "Emergent BioSolutions CEO joins board of U.S. Chamber of Commerce". The Washington Business Journal. 13 June 2011. Retrieved 19 March 2015.
  13. ↑ Overly, Steven (21 December 2011). "Emergent CEO to step down in 2012". The Washington Post. Retrieved 19 March 2015.
  14. ↑ Eckert, Barton (21 December 2011). "Emergent BioSolutions Fuad El-Hibri to retire as CEO". The Washington Business Journal. Retrieved 19 March 2015.
  15. ↑ \Kevin James Shay (30 March 2012). "Emergent's Fuad El-Hibri, an entrepreneur at heart". Gazette. Archived from the original on 1 August 2013. Retrieved 19 March 2015.
  16. ↑ Meyer Weiss, Martin; Weiss, Peter D.; Weiss, Joseph B. (November 2007). "Anthrax Vaccine and Public Health Policy". American Journal of Public Health. American Public Health Association. 97 (11): 1945–1951. doi:10.2105/AJPH.2006.102749. ISSN 1541-0048. PMC 2040369. PMID 17901434.
  17. ↑ Echols, Tucker (14 July 2010). "Emergent BioSolutions wins $107M HHS contract". Washington Business Journal.
  18. ↑ Lauerman, John (30 September 2008). "Emergent's Anthrax Vaccine Effective With Fewer Doses in Study". Bloomberg. Retrieved 11 July 2011.
  19. ↑ "Emergent BioSolutions Gets FDA Nod For Anthrax Vaccine supplemental BLA – Update", RTT News, December 19, 2008. Retrieved August 13, 2013.
  20. ↑ "Emergent BioSolutions Gets FDA Nod For Anthrax Vaccine supplemental BLA – Update". RTT News. 19 December 2008. Retrieved 11 July 2011.
  21. ↑ "Emergent BioSolutions Receives Paul-Ehrlich-Institut Approval to Market BioThrax in Germany" Archived 2013-08-13 at Archive.is, Yahoo Finance press release, July 1, 2013. Retrieved August 13, 2013.
  22. ↑ Clabaugh, Jeff (24 June 2011). "Emergent gets entry to Singapore". Washington Business Journal. Retrieved 22 July 2011.
  23. ↑ "Local Briefing". The Washington Post. 13 February 2009. Retrieved 11 July 2011.
  24. 1 2 3 Bryan, Cohen (21 April 2014). "Emergent BioSolutions' BioThrax receives orphan drug designation for PEP". BioPrepWatch. Chicago, Illinois. Retrieved 1 May 2014.
  25. 1 2 "Emergent BioSolutions Receives Orphan Drug Designation for BioThrax for Post-Exposure Prophylaxis of Anthrax Disease". MarketWatch.com. Wall Street Journal. Dow Jones & Company. 21 April 2014. Retrieved 1 May 2014.
  26. 1 2 3 PropThink, P. (2014). "Emergent BioSolutions Is Building An Enviable BioDefense Portfolio". Seeking Alpha. Retrieved 1 May 2014.
  27. ↑ "Emergent Biosolutions secures $911 mln contract to supply anthrax vaccines to Strategic National Stockpile". Homeland Preparedness News. 2016-12-09. Retrieved 2016-12-14.
  28. ↑ Lovelace, Jr., Berkeley (2016-06-21). "Emergent BioSolutions moves closer to facility approval for anthrax vaccine". CNBC. Retrieved 2016-06-24.
  29. ↑ Tinder, Paul (10 November 2009). "Emergent BioSolutions appoints Jackson as chief scientific officer". Vaccine News Daily. Retrieved 30 April 2014.
  30. ↑ "Emergent acquires vaccine company". BIOTECH Patent News. 1 June 2005. ISSN 0898-2813.
  31. ↑ "Emergent BioSolutions mit verstärkter Präsenz in Deutschland". bionity.com (in German). Bionity. August 7, 2006. Retrieved 30 April 2014.
  32. ↑ "Avanir Divests Anthrax mAb Program to Emergent BioSolutions in Deal Worth $1.75M". Genetic Engineering & Biotechnology News. 6 March 2008. Retrieved 12 October 2011.
  33. ↑ "VaxGen sells anthrax vaccine candidate to Emergent BioSolutions". Forbes. Thomson Reuters. 5 May 2008. Retrieved 11 July 2011.
  34. ↑ "VaxGen wraps up sale of anthrax assets". San Francisco Business Times. 5 May 2008. Retrieved 11 July 2011.
  35. ↑ "Emergent BioSolutions Completes Acquisition Of Trubion Pharmaceuticals". The Street. 28 October 2010. Retrieved 30 April 2014.
  36. ↑ Cohen, Bryan (6 August 2013). "Emergent BioSolutions closes on acquisition of Bracco Diagnostics division". Vaccine News Daily. Retrieved 1 May 2014.
  37. ↑ "Emergent BioSolutions Closes on Its Acquisition of Healthcare Protective Products Division from Bracco Diagnostics Inc". Yahoo! Finance. 2 August 2013. Retrieved 1 May 2014.
  38. ↑ "Cangene Receives Court Approval of Plan of Arrangement for Acquisition by Emergent BioSolutions". Wall Street Journal. 2014-02-18 (Retrieved 2014-02-21)
  39. ↑ Overly, Steven. "Emergent BioSolutions pays $222M to acquire life sciences firm Cangene Corp." The Washington Post. 2013-12-11 (Retrieved 2014-02-21)
  40. ↑ "EMERGENT BIOSOLUTIONS INC (EBS:New York): Company Description". Bloomberg Businessweek. Retrieved 28 September 2012.
  41. ↑ "Lansing laboratory may begin anthrax vaccine shipments". The Michigan Daily. 23 January 2002. Retrieved 30 April 2014.
  42. ↑ Williams, Thomas D. (18 May 2001). "Shays: Pentagon Acted Inappropriately". The Hartford Courant. Retrieved 30 April 2014.
  43. 1 2 "History". Emergent BioSolutions. Retrieved 1 May 2014.
  44. ↑ "Emergent licenses flu vaccine for new federal biodefense center". Gazette.net. 4 January 2013. Retrieved 25 January 2013.
  45. 1 2 Sievers, Lisa (15 April 2014). "First of three pandemic manufacturing sites could be ready by 2016". Chicago, Illinois. Retrieved 1 May 2014.
  46. 1 2 Leong, Tracey (2016-07-10). "Md. Company To Develop Early-Stage Zika Vaccine". CBS-Baltimore. Retrieved 2016-07-13.
  47. 1 2 "Emergent BioSolutions receives BARDA order to develop, manufacture Zika vaccine". Homeland Preparedness News. 2016-06-27. Retrieved 2016-07-13.
  48. ↑ Gregg, Aaron (2016-06-27). "Emergent BioSolutions wins contract to develop Zika vaccine". Washington Post. Retrieved 2016-07-13.
  49. ↑ "Emergent BioSolutions Receives Health Canada Approval for Botulism Antitoxin". investors.emergentbiosolutions.com. Emergent Biosolutions. 2016-12-06. Retrieved 2017-01-11.
  50. ↑ "Health Canada approves Emergent BioSolutions' botulism antitoxin". Homeland Preparedness News. 2016-12-13. Retrieved 2017-01-11.
  51. 1 2 "Emergent BioSolutions Signs $53 Million Modification to BARDA Contract for the Manufacture of Botulism Antitoxin". Emergent Biosolutions. 2017-03-31. Retrieved 2017-04-25.
  52. ↑ "Soligenix, Emergent Biosolutions extend development agreement for RiVax drug substance protein antigen". Homeland Preparedness News. 2017-01-05. Retrieved 2017-01-20.
  53. ↑ "Emergent BioSolutions Completes Acquisition of ACAM2000® Business From Sanofi". GlobeNewswire News Room. 2017-10-06. Retrieved 2018-06-22.
  54. ↑ "Our Members". Alliance for Biosecurity. Retrieved 2017-02-02.
  55. ↑ "Our Mission". Alliance for Biosecurity. Retrieved 2017-02-02.
  56. ↑ "Executive Profile. Daniel J. Abdun-Nabi". Bloomberg. Retrieved 2016-06-17.
  57. ↑ "Corporate Governance – Biography | Emergent". investors.emergentbiosolutions.com. Retrieved 2016-06-17.
  58. ↑ "Emergent BioSolutions Secures Orphan Drug Designation for Its Investigational Monoclonal Antibody for the Treatment of Inhalation Anthrax". Health & Beauty Close-Up. 9 November 2010.
  59. ↑ http://www.rsdl.com/chemical-decontamination-protection/first-responders/
  60. ↑ https://chemm.nlm.nih.gov/countermeasure_RSDL.htm
  61. ↑ Riley, Kim (2017-09-12). "Emergent BioSolutions launches chemical warfare decontamination lotion to civilian market". Homeland Preparedness News. Retrieved 2017-09-18.
  62. ↑ Murtha, Alex (2017-09-25). "Emergent BioSolutions awards renewed five-year contract to supply chemical agent-neutralizing lotion to US military". Homeland Preparedness News. Retrieved 2017-09-26.
  63. ↑ Fritze, John (2016-07-20). "State issues, money follow delegates to conventions". The Baltimore Sun. Retrieved 2016-08-01.
  64. ↑ "Lansing Students Get AP Credits Thanks To Emergent Biosolutions". WLNS Channel 6 (CBS). Lansing, Michigan. 28 March 2014. Retrieved 1 May 2014.
  65. 1 2 Lavey, Kathleen (28 October 2014). "$50K gift will pay for science, scholarships in Lansing". Lansing State Journal. Retrieved 28 October 2014.
  66. ↑ "Anti-Bullying 'Relentless Tour' To Visit Lansing Area". Fox 47 News. 31 March 2014. Retrieved 1 May 2014.
  67. ↑ Riley, Kim (2017-10-23). "Alliance for Biosecurity hails Rep. Ruppersberger's champion efforts around bioterrorism prevention". Homeland Preparedness News. Retrieved 2017-10-25.
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