Aeolus produces first batch of AEOL 10150 under BARDA contract

Aeolus Pharmaceuticals, Inc., recently announced that it produced its first batch of AEOL 10150 under its advanced research and development contract from the Biomedical Advanced Research and Development Authority.

AEOL 10150 is a drug treatment against a lung sub-syndrome of Acute Radiation Syndrome. It was developed by Aeolus under a five-year, cost-plus BARDA contract worth up to $118 million. The contract also includes funding for the full capabilities of Good Manufacturing Practices for AEOL 10150.

The novel manufacturing process resulted in a 90 percent reduction in the cost of producing the drug. Aeolus expects to have finalized its production and validation processes for the drug by July 2014 and begin producing it in bulk for the filing of its New Drug Application with the U.S. Food and Drug Administration.

"The progress made by our manufacturing team and our partners at Johnson Matthey Pharma Services and BARDA has been remarkable," Aeolus Chief Executive Officer John McManus said. "The success of our manufacturing program under the BARDA contract is a testimony to the leadership of Chris Stanley, Vice President of Operations at Aeolus, and the valuable input from BARDA's subject matter experts and Johnson Matthey's chemists.

Aeolus expects AEOL 10150 to be developed as an effective treatment against lung ARS for patients undergoing radiation therapy.

"The reduction in the cost of goods could save the U.S. Government millions of dollars under a potential procurement and it positions AEOL 10150 to be an extremely attractive potential therapy for cancer patients suffering from the side effects of radiation therapy," McManus said. "This success is an excellent example of the value that BARDA brings as a partner in advanced drug development."

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Aeolus Pharmaceuticals

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