Emergent BioSolutions Inc. (EBS)
Emergent BioSolutions Inc. is a life sciences company dedicated to providing vital preparedness and response solutions for a wide range of public health threats (PHTs) across the United States. These threats encompass accidental, deliberate, and naturally occurring events, including chemical, biological, radiological, nuclear, and explosives (CBRNE) incidents, emerging infectious diseases, travel-related health risks, and acute emergency care situations. The company's current product portfolio features essential vaccines and treatments such as BioThrax for anthrax and ACAM2000 for smallpox. It also offers Botulism Antitoxin Heptavalent, vaccinia immune globulin intravenous to manage smallpox vaccine complications, and inhalational anthrax therapies like raxibacumab and Anthrasil. Other key offerings include reactive skin decontamination lotion kits, the Trobigard combination drug-device auto-injector, NARCAN nasal spray for emergency opioid overdose reversal, Vivotif, an oral typhoid fever vaccine, and Vaxchora, a single-dose oral cholera vaccine. Emergent is also actively engaged in developing a robust pipeline of future solutions. This includes AP003 (a multidose naloxone nasal spray), AP007 (a sustained-release nalmefene injection for opioid use disorder), AV7909 (an anthrax vaccine), CGRD-001 (a pralidoxime chloride/atropine auto-injector), CHIKV VLP (a chikungunya virus vaccine), COVID-HIG (for SARS-CoV2 treatment), EGRD-001 (a diazepam auto-injector), SIAN (a cyanide poisoning antidote), and UniFlu (a universal influenza vaccine). Furthermore, the company extends its expertise through comprehensive contract development and manufacturing services (CDMO). These services cover drug substance and product manufacturing, packaging, along with technology transfer and advanced process and analytical development. Emergent BioSolutions Inc., founded in 1998, is headquartered in Gaithersburg, Maryland.
Sector: Pharmaceutical Preparations
Industry: Drug Manufacturers - Specialty & Generic
Emergent BioSolutions Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Enrolling by invitation
BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients
Blood sample collection
Botulism
NCT02051062Enrollment10StartOct 2014Primary CompletionJul 2028est.CompletionJul 2028est. - Phase 4Not yet recruiting
Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario
Sample Collection
Infections, Bacterial
NCT02177721Enrollment100StartJan 2027est.Primary CompletionMay 2035est.CompletionDec 2035est. - Phase 4Completed
Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed
AVA, Raxibacumab
Infections, Bacterial
NCT02339155Enrollment573StartFeb 2015Primary CompletionJan 2017CompletionJun 2017 - Phase 4Completed
VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Vaccination with ACAM2000
Smallpox Vaccine Adverse Reaction
NCT02443623Enrollment3,032StartSep 2015Primary CompletionJul 2021CompletionAug 2021 - Phase 3Completed
VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
ACAM2000
Smallpox Vaccine Adverse Reaction
NCT01158157Enrollment25StartSep 2010Primary CompletionFeb 2012CompletionFeb 2012 - Phase 3Terminated
Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
hepatitis B vaccine, hepatitis B vaccine
Healthy Volunteers
NCT01311674Enrollment141StartSep 2009Primary CompletionMar 2011CompletionMar 2011 - Phase 3Completed
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
BioThrax
Anthrax
NCT01491607Enrollment200StartNov 2011Primary CompletionMay 2012CompletionMay 2012 - Phase 3Completed
VELOCITY: An Anthrax Vaccine Clinical Study
AV7909, BioThrax
Anthrax
NCT03877926Enrollment3,689StartMar 2019Primary CompletionAug 2020CompletionAug 2020 - Phase 2/3Completed
HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma
HuMax-CD4
T Cell Lymphoma
NCT00877656Enrollment21StartAug 2005Primary CompletionJan 2006CompletionDec 2008 - Phase 2Completed
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
ACAM2000 Smallpox Vaccine, Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
Smallpox
NCT00053482Enrollment357StartJan 2003Primary CompletionApr 2003CompletionOct 2003 - Phase 2Completed
Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Vaccinia virus: ACAM2000 smallpox vaccine, vaccinia virus (calf lymph): Dryvax
Smallpox
NCT00053495Enrollment353StartJan 2003Primary CompletionJun 2003CompletionNov 2003 - Phase 2Completed
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2)
Typhoid
NCT00679172Enrollment187StartMay 2008Primary CompletionDec 2008CompletionDec 2008 - Phase 2Terminated
CD4 in Combination With CHOP in Treating Non-cutaneous Peripheral TCell Lymphoma
CHOP + CD4, CHOP
T-cell Lymphoma
NCT00893516Enrollment5StartMay 2007Primary CompletionOct 2008CompletionDec 2008 - Phase 2Completed
Ciprofloxacin BioThrax Co-Administration Study
BioThrax, Ciprofloxacin
Anthrax
NCT01753115Enrollment154StartDec 2012Primary CompletionAug 2013CompletionAug 2013 - Phase 2Completed
A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels
AV7909, BioThrax
Anthrax
NCT01770743Enrollment168StartJan 2013Primary CompletionFeb 2014CompletionDec 2014 - Phase 2Completed
Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A
FLU-IGIV
Influenza A H3N2, Influenza A H1N1
NCT03315104Enrollment65StartNov 2017Primary CompletionJun 2019CompletionJun 2019 - Phase 2Completed
Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
Ciprofloxacin 500Mg Tablet, Doxycycline 100Mg Tablet
Anthrax
NCT04067011Enrollment210StartAug 2019Primary CompletionMar 2020CompletionMar 2020 - Phase 1/2Completed
Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
AIGIV 3.5 mg/kg, Gamunex 90 mg/kg
Anthrax
NCT00845650Enrollment129StartFeb 2009Primary CompletionOct 2010CompletionOct 2010 - Phase 1Completed
Safety Study of 7 Botulinum Antitoxin Serotypes Derived From Horses
Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)
Healthy
NCT00360737Enrollment40StartJul 2006Primary CompletionDec 2006CompletionApr 2010 - Phase 1Completed
Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum
NP-015
Symptoms of Inhalational Anthrax
NCT00448253Enrollment92StartJul 2007Primary CompletionAug 2008CompletionSep 2008 - Phase 1Completed
Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle
Botulism Antitoxin Bivalent (Equine) Types A and B, Botulism Antitoxin Heptavalent (Equine) Types A-G
Healthy Volunteers
NCT00636519Enrollment36StartFeb 2008Primary CompletionOct 2009CompletionOct 2009 - Phase 1Completed
Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1
Ad4-H5-Vtn, Sanofi Pasteur Influenza Virus Vaccine, H5N1
Bird Flu, Influenza
NCT01006798Enrollment166StartOct 2009Primary CompletionSep 2011CompletionSep 2011 - Phase 1Completed
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
AVP-21D9, Placebo
Anthrax
NCT01202695Enrollment50StartAug 2010Primary CompletionJun 2011CompletionJun 2011 - Phase 1Completed
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
BioThrax, AV7909 Formulation 1
Bacillus Anthracis (Anthrax) Infection
NCT01263691Enrollment105StartDec 2010Primary CompletionMay 2012CompletionJun 2012 - Phase 1Completed
A Phase 1 Ascending Dose Study to Assess the Safety and Immunogenicity of Adenovirus Anthrax Vector Candidate Vaccines
AVA, Ad4-PA-1
Anthrax Infection
NCT01979406Enrollment120StartNov 2013Primary CompletionOct 2014CompletionSep 2015
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Enrolling by invitation | Blood sample collection | NCT02051062 |
| Phase 4 | Not yet recruiting | Sample Collection | NCT02177721 |
| Phase 4 | Completed | AVA, Raxibacumab | NCT02339155 |
| Phase 4 | Completed | Vaccination with ACAM2000 | NCT02443623 |
| Phase 3 | Completed | ACAM2000 | NCT01158157 |
| Phase 3 | Terminated | hepatitis B vaccine, hepatitis B vaccine | NCT01311674 |
| Phase 3 | Completed | BioThrax | NCT01491607 |
| Phase 3 | Completed | AV7909, BioThrax | NCT03877926 |
| Phase 2/3 | Completed | HuMax-CD4 | NCT00877656 |
| Phase 2 | Completed | ACAM2000 Smallpox Vaccine, Vaccinia virus (calf lymph) smallpox vaccine: Dryvax® | NCT00053482 |
| Phase 2 | Completed | Vaccinia virus: ACAM2000 smallpox vaccine, vaccinia virus (calf lymph): Dryvax | NCT00053495 |
| Phase 2 | Completed | Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2) | NCT00679172 |
| Phase 2 | Terminated | CHOP + CD4, CHOP | NCT00893516 |
| Phase 2 | Completed | BioThrax, Ciprofloxacin | NCT01753115 |
| Phase 2 | Completed | AV7909, BioThrax | NCT01770743 |
| Phase 2 | Completed | FLU-IGIV | NCT03315104 |
| Phase 2 | Completed | Ciprofloxacin 500Mg Tablet, Doxycycline 100Mg Tablet | NCT04067011 |
| Phase 1/2 | Completed | AIGIV 3.5 mg/kg, Gamunex 90 mg/kg | NCT00845650 |
| Phase 1 | Completed | Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE) | NCT00360737 |
| Phase 1 | Completed | NP-015 | NCT00448253 |
| Phase 1 | Completed | Botulism Antitoxin Bivalent (Equine) Types A and B, Botulism Antitoxin Heptavalent (Equine) Types A-G | NCT00636519 |
| Phase 1 | Completed | Ad4-H5-Vtn, Sanofi Pasteur Influenza Virus Vaccine, H5N1 | NCT01006798 |
| Phase 1 | Completed | AVP-21D9, Placebo | NCT01202695 |
| Phase 1 | Completed | BioThrax, AV7909 Formulation 1 | NCT01263691 |
| Phase 1 | Completed | AVA, Ad4-PA-1 | NCT01979406 |
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