Aeolus Files International Patent Application for New Patent on AEOL 10150

MISSION VIEJO, CA--(Marketwired - December 03, 2014) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS)

• Filing covers synthesis, formulation and pharmaceutical composition
• Could significantly increase term of patent protection for AEOL 10150

Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against radiological and chemical threats with significant funding from the US Government, announced today that it has filed an international patent application under the Patent Cooperation Treaty (PCT) with the United States Receiving Office (US/RO) thereby preserving the right to seek patent protection in all PCT contracting countries for new patents covering new inventions resulting from research and development on its lead compound, AEOL 10150. Patents resulting from this application, if granted, would cover novel synthesis routes, crystal forms and pharmaceutical compositions of AEOL-10150 and related porphyrin compounds. The intellectual property underlying this new patent filing is a direct result of work performed under Aeolus' contract with the Biomedical Advanced Research and Development Authority ("BARDA"). The five year, $118 million, cost-plus contract, awarded in February 2011, includes funding for the development of large-scale, Good Manufacturing Practice production capacity for AEOL 10150. 

"These new patents, if granted, would substantially increase the life of the patent protection surrounding AEOL 10150 throughout the world," stated John McManus, Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "Extended patent life would open up new potential strategic options for our AEOL 10150 radiation therapy and lung fibrosis development programs. The work that led to this filing is an excellent example of the value that BARDA brings as a partner in advanced drug development."

About AEOL 10150

AEOL 10150 is a broad-spectrum catalytic antioxidant specifically designed to neutralize reactive oxygen and nitrogen species. The neutralization of these species reduces oxidative stress, inflammation and subsequent tissue damage resulting from radiation exposure. The Company believes that AEOL 10150 could have a profound beneficial impact on people who are exposed to high doses of radiation.

AEOL 10150 has already performed well in animal safety studies, was well tolerated in two human clinical trials and has demonstrated statistically significant survival efficacy in multiple Lung-ARS studies in animals. Aeolus has received "Orphan Drug" designation for the use of AEOL 10150 in treating lung ARS, and will file an IND to allow for human safety testing in patients receiving radiation and chemotherapy for cancer within the next several months. 

About Aeolus Pharmaceuticals

Aeolus Pharmaceuticals is developing a new class of broad-spectrum, catalytic-antioxidant compounds that protect healthy tissue from the damaging effects of radiation. Its first compound, AEOL 10150, is being developed, with funding from the U.S. Department of Health and Human Services, as a medical countermeasure against chemical and radiological weapons. Its initial target indications are as a protective agent against the effects of acute radiation syndrome and delayed effects of acute radiation exposure. Aeolus' strategy is to leverage the substantial investment in toxicology, manufacturing and preclinical and clinical studies of AEOL 10150 made by U.S. government agencies, including the contract with BARDA valued, with options, at up to $118.4 million, to efficiently develop the compound for use in oncology. For more information, please visit Aeolus's corporate website at www.aolsrx.com

Forward-Looking Statements

The statements in this press release that are not purely statements of historical fact are forward-looking statements. Such statements include, but are not limited to, those relating to Aeolus' product candidates, as well as its proprietary technologies and research programs, and the Company's initiation or potential initiation of a phase 1 study in oncology patients. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities; difficulties or delays in development, testing and obtaining regulatory approval; the need to obtain funding for pre-clinical and clinical trials and operations; the scope and validity of intellectual property protection for Aeolus' product candidates, proprietary technologies and their uses; competition from other biopharmaceutical companies; and whether BARDA exercises one or more additional options under the its contract with Aeolus. Certain of these factors and others are more fully described in Aeolus' filings with the Securities and Exchange Commission, including, but not limited to, Aeolus' Annual Report on Form 10-K for the year ended September 30, 2013. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.