FDA approves Emergent BioSolutions’ drug Anthrasil

Emergent BioSolutions Inc. (NYSE:EBS) has formally announced that the U.S. Food & Drug Administration (FDA) have approved of their drug: Anthrasil. This triggers a $7 million payment to the company, according to a developmental contract. The contract was signed with the Biomedical Advanced Research and Development Authority (BARDA). The drug received ‘Orphan Drug’ designation. The product created by them qualifies for seven years of market exclusivity.

A sterilized solution of pure human immunoglobulin G (IgG), Anthrasil contains polyclonal antibodies. These antibodies are supposed to target the anthrax toxins, which are produced by the bacteria, Bacillus anthracis. The bacterium is held responsible behind the disease. The antibodies are collected from healthy, screened donors. The donors had been earlier immunized with BioThrax (a drug released by Emergent BioSolutions, earlier) vaccine. This vaccine is the only FDA licensed vaccine for prevention of the disease.

This drug, which was a part of the $160 million contract with BARDA, was prepared to be an integral part of U.S. government’s Strategic National Stockpile in 2005. Executive Vice President and President of the Bio Defense division of Emergent BioSolutions, Adam Havey believes that the company is “committed to work collaboratively” with BARDA and CDC to “further advance” the program.

The drug is supposed to be capable to work with other anti bacterial drugs as well. Emergent Bio shall continue to collect and store anti anthrax human plasma under a $63 million contract with BARDA. The contract was signed in 2013. This contract supports the U.S government’s stockpiling strategy for AIGIV.

Moreover, earlier in this week, the U.S Department of Health and Human Services (HHS) signed a $31 million agreement with Emergent BioSolutions. Under this agreement, the Maryland based biotech company is supposed to develop such a vaccine which requires only two doses to impart immunity. Currently, the drug developed by Emergent Bio (BioThrax) needs three doses.