Aeolus is developing AEOL-10150 as a treatment for the pulmonary syndrome of Acute Radiation Syndrome (Lung-ARS) and delayed effects of acute radiation exposure (DEARE) under a five-year contract with BARDA worth as much as $118 million. The contract was awarded on February 11, 2011 and is designed to produce the data necessary for an approval under the FDA "Animal Rule" and for a pre-Emergency Use Authorization (EUA) filing. An approval or pre-EUA would allow the federal government to buy AEOL-10150 for the Strategic National Stockpile under the Pandemic All-Hazards Preparedness Reauthorization Act (PAHPRA). PAHPRA is designed to accelerate the research, development, purchase and availability of effective medical countermeasures for the Strategic National Stockpile.
The options include funding for the following development items:
- Investigational New Drug (IND) filing with the FDA for AEOL-10150 in Lung-ARS and DEARE
- Preparatory work for additional human clinical studies, including PK/PD ADME and toxicity studies
- Additional murine efficacy trials, including duration of treatment and delayed treatment studies
- Continued development of large-scale, GMP manufacturing capability for AEOL-10150
- Project management costs
As a result of the exercise of the new options, Aeolus expects revenue for fiscal year 2014 to exceed $9 million. Through the end of August 2013, Aeolus had billed or completed approximately $16.1 million of programs under the contract and had committed work in progress totaling approximately $3.4 million. Under terms of the contract, Aeolus may receive up to an additional $88.5 million in options
"BARDA's exercise of additional options reflects the significant progress our team has made during the first two years of the Lung-ARS development contract," said John L. McManus, chief executive officer and president of Aeolus Pharmaceuticals. "During this period, we delivered valuable animal models for Lung-ARS and made important progress in the manufacturing of AEOL-10150. The options that BARDA exercised will fund our IND filing for AEOL-10150 as a treatment for Lung-ARS, additional animal efficacy studies designed to optimize timing and duration of dosing and the continued development of large-scale GMP manufacturing capability to meet potential future demand. We remain grateful to BARDA for the financial support and program input that we receive."