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News Release

FOR IMMEDIATE RELEASE
Monday, Feb. 13, 2006

Contact: HHS Press Office
(202) 690-6343

HHS Awards BioShield Contract for Two Additional Medical Countermeasures for Radiological or Nuclear Incidents

The Department of Health and Human Services (HHS) today awarded a $21.9 million contract to Akorn, Inc. of Buffalo Grove, Ill., for the manufacture and delivery of two medical countermeasures for radiological or nuclear incidents. Akorn, Inc. will deliver 390,000 doses of Ca-DTPA (Pentetate Calcium Trisodium Injection Sterile Solution) and 60,000 doses of Zn-DTPA (Pentetate Zinc Trisodium Injection Sterile Solution).

The initial number of doses being purchased under the new contract is based on the Department of Homeland Security's threat assessment and the interagency Weapons of Mass Destruction Medical Countermeasures Subcommittee's evaluation of medical consequences of a radiological or nuclear incident. Under the terms of the five-year contract HHS has the option to purchase up to 500,000 additional doses of Ca-DTPA and 500,000 additional doses of Zn-DTPA.

"Protecting the American public in a radiological or nuclear incident is a major priority of my office and Project BioShield in particular," said HHS Assistant Secretary for Public Health Emergency Preparedness Stewart Simonson. "Today's contract award is part of our effort to expand the nation's stockpile of medical countermeasures against this threat."

Akorn, Inc. has an exclusive marketing and distribution license agreement for the United States with Hameln Pharmaceuticals, Gmbh, of Hameln, Germany. Hameln Pharmaceuticals is the only manufacturer with Food and Drug Administration (FDA) approval for Ca-DTPA and Zn-DTPA to treat internal contamination from radioactive elements. FDA granted Hameln Pharmaceuticals orphan drug exclusivity for seven years beginning Aug. 11, 2004, the date of approval of its New Drug Application.

Ca-DTPA and Zn-DTPA are chelators used to treat internal contamination with radioactive isotopes of plutonium, americium, or curium. Chelators are compounds that react with metals and form stable ionic complexes, allowing the body to safely expel the metal-chelator complex. Ca-DTPA and Zn-DTPA will be used to treat those exposed through contamination from the detonation of a radiological dispersal device ("dirty bomb"), improvised nuclear device, or terrorist attack against stored radioactive material.

HHS' Office of Public Health Emergency Preparedness, which oversees the research and procurement efforts under the Project BioShield program through its Office of Research and Development Coordination, will manage the DTPA contract.

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Last revised: February 13, 2006