Emergent, CRO, in deal to develop Anthrax therapy
Emergent BioSolutions to develop immune globulins for treatment
exposure of anthrax infection, signifying another step in the
worldwide drive to bring an effective treatment for this killer
disease.
Anthrax disease is an infection caused by the spore forming Bacillus anthracis and is considered a likely biological warfare agent because of its ability to infect via the respiratory route, the high mortality of inhalational anthrax, and its use as a bioterror agent in 2001.
The US Department of Health and Human Services (HHS) has taken action to stockpile anthrax vaccine (BioThrax) and antimicrobials to fend against and combat future attacks.
Since any delay in antimicrobial therapy and/or an overwhelming exposure of anthrax may result in toxemia and increased mortality rates, it is important to have additional treatments for actual cases of inhalation anthrax.
As a result, the HHS is evaluating the use of immune globulins directed at anthrax as a treatment for toxemia resulting from inhalation anthrax infection.
Under the contract, valued at $1.2 million (€1 million), Covalent will support Emergent BioSolutions' AIG development program by providing project management, study site management, field operations, data management, biostatistical services, and medical writing services.
The AIG product being developed by Emergent is expected to be an intravenous formulation with high titers of antibodies to protect against anthrax infection.
Immune globulins are being used increasingly in the treatment of diseases mediated by circulating toxins (e.g. tetanus, botulism) and specific infections (e.g. hepatitis B, cytomegalovirus, Staphylococcus aureus).
"This agreement represents a step in our effort to bring an effective anthrax treatment to market," said Dr. Steven Chatfield, chief scientific officer of Emergent BioSolutions.
"The resources being provided by Covalent are intended to facilitate a near term expansion of our program and provide us with an opportunity to leverage our own supply chain and build a large scale production base."
The current contract represents Covalent's fourth counter-bioterrorism development program and highlights a direction that pharma has been heading towards since the events of 2001, in which the death of five innocent people resulted.
"Covalent has expertise and experience in the development of biologics for the prevention/treatment of disease. We recently made important operational and consulting contributions to Merck's Phase III Shingles (Herpes Zoster) Prevention Study which involved more than 38,500 subjects," said Kenneth Borow, Covalent Group's President and Chief Executive Officer.
Spores of the bacterium Bacillus anthracis cause anthrax. B. anthracis is considered to be one of the top (CDC Category A) biothreat agents by the US government. The bacteria secrete toxins that paralyse the immune system, damage tissues and lead to death.
