Aeolus receives BARDA contract for AEOL 10150 drug development against ARS

Feb 16 2011

Aeolus Pharmaceuticals, Inc., a biopharmaceutical company developing a new class of broad spectrum catalytic antioxidant compounds that reduce oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure, today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS), has awarded Aeolus a contract for the advanced development of AEOL 10150 as a medical countermeasure (MCM) against the pulmonary sub-syndrome of acute radiation syndrome (ARS).

Under terms of this cost plus, fixed fee development contract, Aeolus will receive $10.4 million in the first year base period of performance and up to an additional $107.5 million in options , if exercised by BARDA, for a total contract value of up to $118 million. In addition to fully covering the cost of development of AEOL 10150 as an MCM for Lung ARS, the Company believes that the contract with BARDA will substantially cover all of the costs associated with the preclinical, chemistry, manufacturing, and controls (CMC) and toxicology necessary for the oncology indications, plus a large safety study in humans. A procurement of AEOL 10150 for the Strategic National Stockpile could occur after approval from the U.S. Food and Drug Administration, if obtained, or sooner under an Emergency Use Authorization (EUA). Under the Company's development plan, documents for submission of an EUA would be prepared and submitted to the government in approximately 2 ½ years. The value of a procurement, if any, is not included in the contract value announced herein.

"We are excited to have the support of BARDA for this important program and look forward to a highly productive relationship to develop an effective countermeasure to the pulmonary effects of ARS," said John L. McManus, Chief Executive Officer and President of Aeolus Pharmaceuticals, Inc. "This contract will allow us to accelerate the development of 10150 as a medical countermeasure, and it will also, importantly, allow us to expand its development for use in oncology indications, where it would be used in combination with radiation therapy. We believe that the dual-use, broad-spectrum characteristics of AEOL 10150 make it a very unique and exciting compound with excellent potential."

AEOL 10150 is currently also being studied by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) Radiation/Nuclear Medical Countermeasures development program as a countermeasure for radiation exposure to the gastrointestinal tract and by NIH CounterACT as countermeasure against chlorine gas and sulfur mustard gas exposure.

Aeolus is pleased to partner with HHS-BARDA, the University of Maryland, Duke University, Johnson Matthey Pharma Services, Albany Molecular Research and Symbion Research International in this comprehensive development program. Development of AEOL 10150 to submission of a New Drug Application (NDA) in the indication of the pulmonary sub-syndrome of ARS is expected to take approximately five years.