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Emergent Seeks OK for Human Trials of New Drug

Emergent seeks OK for human trials of new drug

Treatment based on Lansing-made anthrax drug
By Jeremy W. Steele Lansing State Journal

Emergent BioSolutions Inc. wants to start human tests soon on what it hopes will become a marketable anthrax drug.

The Rockville, Md.-based company, which operates a vaccine manufacturing facility in Lansing, has filed an investigational new drug application with the Food and Drug Administration for the drug.

Emergent is scheduled to release its first annual earnings report as a publicly traded company before the stock market opens today.

The "Anthrax Immune Globulin" is a therapeutic treatment for patients who present symptoms of anthrax exposure.

The treatment is developed from the blood of donors who have been vaccinated with Emergent's BioThrax anthrax vaccine, which is made in Lansing.

The therapeutic is made for Emergent by a third-party contractor.

"Everything starts with BioThrax," spokesman Robert Burrows said.

If its application is approved, Emergent would conduct a clinical trial this year on 105 healthy volunteers to test the drug's safety and how the body reacts to it.

The trial would take one year, company officials said, and no other human trials would be needed before submitting an application to begin marketing the drug.

However, Emergent plans to conduct two animal trials.

The new drug is being developed partly with a $3.7 million grant from the National Institute of Allergy and Infectious Diseases.

Fuad El-Hibri, chairman and chief executive officer of Emergent, called the treatment "a significant step as we continue to expand our anthrax biodefense product franchise."

BioThrax is the only FDA-approved vaccine for anthrax. It's also Emergent's only marketable product.

Others are in various stages of clinical testing.

Emergent makes it BioThrax anthrax vaccine at its Lansing facility, the former BioPort Corp.
It employs more than 300 workers there and is building a $75 million expansion at the vaccine manufacturing facility.