Anthrax is a lethal disease affecting humans as well as animals such as goat, sheep, horses, and cattle. The causative agent is a gram positive, rod shaped bacterium Bacillus anthracis. Anthrax can spread through three main routes which include aerial route, digestive route and contact through skin. Common symptoms in human beings for respiratory infection include pneumonia and severe respiratory collapse. Gastrointestinal infection is associated with symptoms such as vomiting, severe diarrhea, loss of appetite and digestive tract infections. Anthrax skin infection develops an ulcer with black center called as eschar which is a painless necrotic patch.
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This form of disease is not fatal if proper treatment is provided. Diagnosis of anthrax infection is done through X-ray and CT scan of lungs, biopsy skin test and blood test for anthrax antigens. Chemiluminescence and Enzyme Linked Immunosorbent Assay (ELISA) based kits are available for diagnosis of anthrax. Anthrax has gained popularity because of its use in bioterrorism. Since long the spores of anthrax have been used for mass infection and in biological warfare. This has led countries across the world to spread awareness about the disease, and also be prepared for any biological attack. In light of past events, as a precaution, the U.S. Postal Service has also installed a biohazard detection system at major distribution centers in order to actively scan for anthrax spores being transported via mail.
Anthrax can be cured if treated in early stages of infection. Cutaneous or skin infection can be treated with common antibiotics such as ciprofloxacin, erythromycin, tetracycline, and penicillin. There is only one vaccine for treating anthrax which is FDA approved. BioThrax manufactured by Emergent BioSolutions, Inc. is provided as pre exposure protection from anthrax infections. Elusys Therapeutics is conducting clinical trials for ETI- 204 for inhalational anthrax. Currently the study (NCT01932437) is under phase I clinical trial. In 2012, U.S. FDA approved drug for treatment of anthrax which is manufactured by GlaxoSmithKline. Raxibacumab, a human IgG1λ monoclonal antibody can be prescribed to adults as well as pediatrics with inhalational anthrax. Various governments are also backing research for anthrax with funding and grants.
PharmAthene, Inc. announced in 2010 that the Department of Health and Human Services (HHS) modified the development contract with the company by providing up to USD 78.4 million for development of anthrax vaccine SparVax. SparVax is sub unit vaccine, which comprises of a recombinant protein manufactured in E.coli. Currently the study is in phase II clinical trial. The company is also trying to develop an anti toxin under the brand name Valortim. Valortim is a human monoclonal antibody which targets PA a component of anthrax toxin. By targeting PA, Valortim is believed to protect healthy cells from being damaged by the toxins. Currently the study is under phase I clinical trial.
As majority of the studies are under phase II or phase I trials, outcome of such studies cannot be ascertained. With a keen eye on anthrax infection in humans by government, and existence of few market players have restricted the market growth. Although the treatment for skin infection is cost effective, inhalational and gastrointestinal anthrax treatment is expensive. Moreover the market for anthrax is concentrated to countries under threat for terrorist attacks. The market for diagnosis of anthrax also holds potential in rural areas for diagnosis of cutaneous anthrax, where animal breading is widely practiced.