Liquid Potassium Iodide Contract Awarded Under Project BioShield

Fleming & Company will provide a specialized children's liquid potassium iodide (KI) formulation to the federal government as part of Project BioShield, the firm announced March 18.

The Fenton, Mo.-based company was granted a $5.7 mil. contract under the program, which was created to develop drugs and vaccines that protect against biological or chemical attacks.

This is only the second contract to be awarded under Project BioShield, HHS said; the first was granted in November to VaxGen for development of an anthrax vaccine.

The deal calls for 1.7 mil. pediatric doses of liquid KI, which will be made available to states housing nuclear power plants that have created a distribution plan.

Last year, the Interagency Weapons of Mass Destruction Medical Countermeasures Subcommittee, which includes experts from the Defense, Homeland Security, HHS and Energy Departments, approved liquid KI as a pediatric formulation.

Since Fleming already markets its liquid KI formulation as a cough/cold expectorant for congestion due to allergies, FDA encouraged the firm to submit an ANDA for a thyroid protection indication; the application was approved in January.

ThyroShield is a black raspberry-flavored liquid that is administered using a graduated eyedropper.

"Children are the most susceptible to the dangerous effects of radioactive iodine," HHS states.

"People need to take KI soon after an incident that involves the release of radioactive iodine" because the thyroid gland quickly absorbs iodine, HHS adds. Liquid KI delivers iodine to the body faster than tablets, Fleming points out.

The firm distributes the product through wholesalers. Fleming has no plans to market the product for a thyroid protection indication, but will educate pharmacists as to its availability.

Only three other KI products currently are approved by FDA.