Aeolus Pharmaceuticals, Inc., a biopharmaceutical company, develops a platform of novel compounds in biodefense and oncology. The company’s platform consists of approximately 200 compounds licensed from the University of Colorado (UC) Duke University (Duke) and National Jewish Health (NJH). AEOL 10150 The company’s main compound, AEOL 10150 (10150), is developed under contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services (HHS), as a medical countermeasure (MCM) against the pulmonary sub-syndrome of acute radiation syndrome (‘Pulmonary Acute Radiation Syndrome’ or ‘Lung-ARS’) and the delayed effects of acute radiation exposure (DEARE). 10150 is also being developed as a MCM for the gastrointestinal sub-syndrome of acute radiation syndrome (GI-ARS) with grant money from the National Institute for Allergy and Infectious Diseases (NIAID). Both syndromes are caused by acute exposure to high levels of radiation due to a nuclear detonation or radiological event. The company develops 10150 as a MCM for exposure to chemical vesicants (e.g., chlorine gas, sulfur mustard gas and phosgene gas) and nerve agents (sarin gas and soman gas) with grant money from the National Institutes of Health (NIH) Countermeasures Against Chemical Threats (NIH-CounterACT) program. The company also develops 10150 for use in combination with radiation therapy for cancer as a treatment to reduce side effects caused by radiation toxicity and improve local tumor control. A significant portion of the development work funded by the BARDA contract is applicable to the development program for radiation oncology, including safety, toxicology, pharmacokinetics and Chemistry, Manufacturing and Controls (CMC). Other Products A second and a third compound AEOL 10113 (Ethyl) and AEOL 10171 (Hexyl) have been the focus of an NIH NIAID center grant to study their potential as radiation mitigators. The company has a pipeline of approximately 180 additional compounds. Four of these compounds have demonstrated efficacy as treatments for epilepsy and Parkinson’s disease. Strategy The company’s strategy is to use non-dilutive capital wherever possible to develop its platform of broad-spectrum, catalytic antioxidant compounds in important unmet medical indications of clinical and national strategic importance. Research and Development The company’s expenditure for research and development activities was $3,360,000, as of September 30, 2013. Patents and Proprietary Rights As of December 20, 2013, the company’s catalytic antioxidant small molecule technology base is described in 12 issued United States patents and 5 United States pending patent applications. These patents and patent applications cover soluble manganic porphyrins as antioxidant molecules, as well as targeted compounds obtained by coupling such antioxidant compounds to molecules that bind to specific extracellular elements. The pending U.S. patent applications and issued U.S. patents include composition of matter claims and method claims for several series of compounds. Corresponding international patent applications have been filed, 88 of which have issued, and 1 of which has been allowed, as of December 20, 2013. Its 12 issued U.S. patents would expire between 2015 and 2023. As of November 22, 2013, the company filed a provisional patent application with the United States Patent and Trademark Office entitled ‘Synthesis and Formulation of Porphyrin Compounds.’ Other Regulations In the United States and elsewhere, the research, manufacturing, distribution, sale and promotion of drug and biological products are subject to regulation by various federal, state and local authorities in addition to the U.S. Food and Drug Administration, including the Centers for Medicare and Medicaid Services; other divisions of Health and Human Services (HHS), such as the Office of Inspector General: the U.S. Department of Justice and individual U.S. Attorney offices within the Department of Justice and state and local governments. Collaborations Duke Licenses: Pursuant to license agreements with Duke, the company has obtained exclusive worldwide rights from Duke to products using antioxidant technology and compounds developed by other scientists at Duke. National Jewish Medical and Research Center and National Jewish Health: The company has obtained a worldwide license from the National Jewish Medical and Research Center to develop, make, use and sell products using proprietary information and technology developed under a previous Sponsored Research Agreement within the field of antioxidant compounds and related discoveries. History Aeolus Pharmaceuticals, Inc. was founded in 2004. The company was incorporated in the State of Delaware in 1994.
aeolus pharmaceuticals inc
26361 Crown Valley Parkway
Mission Viejo, CA 92691
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