Profile: Emergent BioSolutions Inc (EBS)
25 Jul 2016
Emergent BioSolutions Inc., incorporated on December 19, 2003, is a biopharmaceutical company that offers specialized products to healthcare providers and governments to address medical needs and emerging health threats. The Company develops, manufactures and delivers a portfolio of medical countermeasures primarily for government agencies in the areas of biological and chemical threats and emerging infectious diseases (EID). It also develops and commercializes therapeutics, and other specialty products for hospitals and clinics in the areas of hematology/oncology, transplantation, infectious diseases and autoimmune disorders. The Company's two operating divisions include Biodefense and Biosciences.
The Biodefense division is a specialty pharmaceutical business focused on countermeasures that address public health threats, including chemical, biological, radiological, nuclear and explosives (CBRNE) threats, as well as EID. Its Biodefense division marketed products are BioThrax, which is anthrax Vaccine Adsorbed vaccine for the general use prophylaxis and post-exposure prophylaxis of anthrax disease; Anthrasil, which is an anthrax immune globulin intravenous (human), used for the treatment of inhalational anthrax; Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-Equine (BAT), for the treatment of botulinum disease; vaccinia immune globulin intravenous (human) (VIGIV) to address adverse events from smallpox vaccination, and reactive skin decontamination lotion kit (RSDL) for the removal or neutralization of chemical agents, T-2 toxin and various pesticide-related chemicals from the skin.
Biodefense division investigational stage product candidates include NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant), an anthrax vaccine; UV-4B, a novel antiviral being developed for dengue and influenza infections; GC-072, the lead compound in the EV-035 series of broad spectrum antibiotics, being developed for Burkholderia pseudomallei; VAX161C, a recombinant pandemic influenza vaccine candidate; PreviThrax (recombinant protective antigen anthrax vaccine, purified), an anthrax vaccine, and Biodefense product candidates focused on public health threats and emerging infectious diseases. Biodefense division also includes multiple platform technologies, including the MVAtor (modified vaccinia virus Ankara vector) platform technology and Emergard, a military-grade auto-injector device designed for intramuscular self-injection of antidotes and other emergency response medical treatments that can address exposure to certain chemical agents and other similar emerging threats.
BAT comprises purified polyclonal equine immune globulins (antibodies) directed to seven toxins (A through G) produced by Clostridium botulinum. BAT is approved in the United States for the treatment of suspected or documented exposure to botulinum neurotoxin A, B, C, D, E, F or G. BAT is available in the United States for treating naturally occurring non-infant botulism. VIGIV comprises purified polyclonal human immune globulins (antibodies) directed to vaccinia virus, the virus that is used in the smallpox vaccine. It helps individuals who are susceptible to vaccinia may develop an infection from the smallpox vaccination. Reactive Skin Decontamination Lotion Kit (RSDL) is a medical device that helps to remove or neutralize chemical warfare agents, including nerve agents, mustard gas and T-2 toxin (a myco toxin capable of being weaponized) and organophosphate based pesticides from the skin. The Company's principal customers for RSDL are agencies of the United States Government, including the department of defense (DoD), the Department of State and the National Guard. In addition to domestic Government sales, the Company also sells to approximately 35 foreign countries. The Company is engaged in developing NuThrax, an anthrax vaccine product candidate based on BioThrax. NuThrax is in Phase III clinical trial. The Company is also engaged in developing GC-072, a bacterial type II topoisomerase inhibitor, belonging to the chemical class of 4-oxoquinolizine as a potential oral and IV treatment for B. EV-035 molecules have also demonstrated broad-spectrum activity against pathogens, such as S. aureus, S. pneumoniae, E. faecalis, E. coli, P. aeruginosa, A. baumannii and H. influenzae, as well as several potential biodefense pathogens such as B. pseudomallei, B. anthracis, F. Tularensis, and Y. pestis. The Company is developing PreviThrax, a recombinant protective antigen anthrax vaccine product candidate. PreviThrax contains purified recombinant protective antigen (rPA), and is formulated to induce antibodies that neutralize anthrax toxins in a manner similar to BioThrax.
The Biosciences division is a specialty pharmaceutical business focused on therapeutics primarily in hematology/oncology with secondary areas of focus in transplantation, infectious disease and autoimmunity. Its Biosciences portfolio consists of over four products. Biosciences division marketed products are: IXINITY (coagulation factor IX (recombinant)) for the prevention of bleeding episodes in people with hemophilia B; WinRho SDF (Rho(D) Immune Globulin Intravenous (Human)) for treatment of autoimmune platelet disorder, also called immune thrombocytopenic purpurara (ITP), and, separately, for the treatment of hemolytic disease of the newborn (HDN); HepaGam B (Hepatitis B Immune Globulin Intravenous (Human)) for post-exposure prophylactic treatment of hepatitis-B, and VARIZIG (Varicella Zoster Immune Globulin (Human)) for post-exposure prophylactic treatment of varicella zoster virus, which causes chickenpox and shingles.
Biosciences division investigational stage product candidates include: otlertuzumab, a protein therapeutic being developed for Chronic Lymphocytic Leukemia (CLL); MOR209/ES414, an immunotherapeutic protein being developed for metastatic castration resistant prostate cancer; ES210, a protein therapeutic being developed for inflammation-related indications; 5E3, a monoclonal antibody therapeutic being developed for Alzheimer's disease, and other biosciences protein therapeutic product candidates primarily targeting immuno-oncology. Biosciences division includes its ADAPTIR, modular protein technology platform and its hyperimmune specialty plasma product manufacturing platform. WinRho SDF comprises purified polyclonal human immune globulins (antibodies) directed to Rho (D) (+) red blood cells. As antibodies that are directed to the Rho (D) antigen on these red blood cells, WinRho SDF can generally be referred to as an anti-D product. WinRho SDF is approved in the United States and Canada to treat an autoimmune platelet disorder, immune thrombocytopenic purpura (ITP), a disease in which platelets are destroyed by a patient's own immune system. WinRho SDF is also approved in the United States and Canada to prevent hemolytic disease of the newborn (HDN). HDN results from an Rho (D) (-) female giving birth to an Rho (D)(+) child. HepaGam B comprises purified polyclonal human immune globulins (antibodies) that are directed to the hepatitis B surface antigen. In the United States, HepaGam B is used for over two indications: for the prevention of Hepatitis B reinfection after liver transplantation and for use as a post-exposure prophylaxis.
VARIZIG is used for post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups, including immunocompromised children, newborns and pregnant women. In Canada, VARIZIG is used for the prevention and reduction of severity in maternal infections within approximately four days of exposure to Varicella zoster virus. IXINITY (coagulation factor IX (recombinant)) is an intravenous recombinant human coagulation factor IX therapeutic used for the prevention of bleeding episodes in people with hemophilia B. Hemophilia B, also known as Christmas disease, is a rare, inherited bleeding disorder. MOR209/ES414 is a targeted immunotherapeutic protein under development for metastatic castration resistant prostate cancer. MOR209/ES414, a biospecific protein constructed using its ADAPTIR technology platform, activates host T-cell immunity specifically against cells expressing prostate specific membrane antigen (PSMA), an antigen commonly overexpressed on prostate cancer cells. OR209/ES414 selectively binds to the T cell receptor on cytotoxic T cells and PSMA on tumor cells. MOR209/ES414 contains over two pairs of binding domains, each targeting an antigen, linked to opposite ends of an immunoglobulin (Ig) fragment crystallizable (Fc) domain to extend the half-life and enable use of a purification process typical of Ig-based molecules. Otlertuzumab is a humanized anti-CD37 ADAPTIR mono-specific protein therapeutic intended for the treatment of Chronic Lymphocytic Leukemia (CLL). CLL is a type of cancer that affects the blood and bone marrow and is caused by B-cells within the blood and bone marrow that abnormally proliferate and die. The Company completed a Phase II for the combination of otlertuzumab and bendamustine (a chemotherapy agent) versus bendamustine alone in people with relapsed CLL.
The Company competes with Amgen Inc., CSL Limited, Biotest Pharmaceuticals Corporation, Grifols USA, LLC, Baxter International Inc., Biogen Idec Inc., Pfizer Inc., Lonza Group Ltd., OSO BioPharmaceuticals Manufacturing, LLC, Par Pharmaceutical Companies, Inc., Jubilant Life Sciences Limited, Patheon Inc., Hospira Inc., Ajinomoto Co., Inc., Cook Group Inc., Albany Molecular Research, Inc., GlaxoSmithKline plc, SIGA Technologies, Inc., PharmAthene, Inc., PaxVax Inc., Vaxin Inc., Pfenex Inc., Soligenix, Inc, Immunovaccine Inc., NanoBio Corporation, Basilea Pharmaceutica Ltd., The Medicines Company, Rempex Pharmaceuticals, Inc., Cempra, Inc., AbbVie Inc., Tetraphase Pharmaceuticals, Inc., Achaogen, Inc., Sanofi Pasteur Inc., Nanotherapeutics Inc., F. Hoffmann-La Roche Ltd., Protein Sciences Corporation, Gilead Sciences, Inc., Johnson & Johnson and Novartis AG.
Emergent BioSolutions Inc
400 Professional Dr Ste 400
GAITHERSBURG MD 20879-3457
Company Web Links
- BRIEF-Emergent Biosolutions to repurchase shares for up to $50 mln
- BRIEF-FDA Accepts Emergent BioSolutions' supplemental biologics license application for large-scale manufacturing of BioThrax in Building 55
- BRIEF-Emergent Biosolutions Inc receives FDA orphan drug status for BioThrax
- BRIEF-Emergent Biosolutions reports Q1 GAAP earnings per share $0.10
- BRIEF-Emergent Biosolutions submits application for large scale manufacturing of biothrax