AOLS Aeolus Pharmaceuticals Inc (CE)

MISSION VIEJO, CA--(Marketwired - Dec 5, 2013) - 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 a provisional application covering new inventions resulting from research and development on its lead compound, AEOL 10150, with the United States Patent and Trademark Office. Patents resulting from this provisional 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," stated John McManus, Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "Extended patent life would open up new potential strategic options for the future development of AEOL 10150 in multiple indications. The work that led to this filing is an excellent example of the value that BARDA brings as a partner in advanced drug development. We are very grateful for both their financial support and their technical input."

Aeolus plans to preserve international patent rights to these new inventions by filing a subsequent PCT application in 2014 claiming priority to the already-filed provisional application. Resulting international protection for these inventions covering AEOL 10150 would be expected to extend to at least 2034 in many jurisdictions.

Potential for AEOL 10150 as a Countermeasure Against Radiological and Chemical Threats

AEOL 10150 has shown significant protective effects against radiation, mustard gas, chlorine gas, phosgene gas and nerve agents in animal models. A compound with the potential to protect against multiple threats would be of significant benefit in both the military and civilian efforts to protect citizens against potential threats. The United States Food and Drug Administration (FDA) has a special "Animal Rule" under which compounds may be approved for use against chemical and nuclear threats on the strength of animal efficacy studies, which allows the potential for an accelerated approval path versus conventional pharmaceutical applications. Additionally, the legislation that created Project Bioshield, provides BARDA with the authority to acquire drugs under development, but not yet approved, for use in an emergency with Emergency Use Authorization (EUA) from the FDA. 

About the BARDA Contract

On February 11, 2011, the Company announced it had signed a five year advanced research and development contract with BARDA worth up to $118 million to develop AEOL 10150 as a medical countermeasure for the lung effects of Acute Radiation Syndrome ("Lung-ARS") and the delayed effects of acute radiation exposure ("DEARE"). In addition to supporting the cost of development of AEOL 10150 as an MCM for Lung-ARS, the Company believes that the preclinical, chemistry, manufacturing and controls, toxicology, and safety studies completed or planned under the BARDA contract will be supportive of the Company's oncology development program. 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. The value of a procurement, if any, is not included in the contract value announced herein.

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.

About Acute Radiation Syndromes (ARS)

Acute Radiation Syndrome is a series of potentially lethal syndromes that develop after exposure to acute, high-dose radiation from nuclear detonations, "dirty" bombs or nuclear plant accidents. Two acute syndromes, the hematopoietic (bone marrow) and early-onset gastrointestinal (GI) syndromes, develop within the first 1-7 days following exposure. Depending on the level and location of radiation exposure, lethality from the hematopoietic and GI syndromes can be reduced or avoided with proper treatment, including supportive care (fluids and antibiotics) and G-CSF administration.

Experience with nuclear accident victims suggests that for patients who survive the gastrointestinal and bone marrow syndromes, the lung syndrome (Lung-ARS) and delayed effects of acute radiation exposure (DEARE) become the primary cause of death. There are no current treatments for Lung-ARS. AEOL 10150 is the only compound in advanced development for this syndrome.

About BARDA

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA was established to provide funding and coordination to address challenges in medical countermeasure development.

BARDA was created to increase funding for advanced research and development and to better coordinate the U.S. government's medical countermeasure development and acquisition process. BARDA manages Project BioShield, which includes the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the scope of Project BioShield.

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-signaling cascades 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. AEOL 10150 is also currently in development for use as both a therapeutic and prophylactic drug in cancer patients.

About Aeolus Pharmaceuticals

Aeolus Pharmaceuticals is developing a platform of 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 by the US Department of Health and Human Services, as a medical countermeasure against chemical and radiological weapons, where 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 made by US Government agencies in AEOL 10150, 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.aeoluspharma.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, the Company's potential initiation of large efficacy studies in mice and NHPs, as well as a phase 1 study in healthy normal volunteers, the BARDA Contract, and the expected use of proceeds from the financing. 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, 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, and competition from other biopharmaceutical companies, and whether BARDA exercises one or more additional options under the BARDA Contract. 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, 2012. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.

Contact: John McManus President and Chief Executive Officer Aeolus Pharmaceuticals, Inc. 1-(949) 481-9820

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