MISSION VIEJO, CA -- (Marketwire) -- 03/14/13 -- Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS)
•Bill Signed into Law by President Obama •Passed Senate By Unanimous Consent; Passed by Supermajority in House •$2.8 Billion Added To Procurement Budget Through 2018 •BARDA $415 Million Annual Operating Budget Authorized Through 2018
Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company leveraging significant government funding to develop a platform of novel compounds to protect against radiological and chemical threats and for use in oncology, provided an update to investors on the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The bill was signed into law today by the President. Previously, it passed the Senate by unanimous consent on February 28th, and the amended bill was passed by the House on March 4, 2013 by a vote of 370 to 28.
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 was introduced in the House by Congressman Mike Rogers and in the Senate by Senator Richard Burr, and will strengthen and reauthorize federal programs to develop medical countermeasures against chemical, biological, radiological and nuclear weapons. It will ensure that the United States is better prepared to respond to threats and that the government has the resources needed to prepare for and respond to an attack or pandemic outbreak. Co-sponsors of the bill include Senators Casey, Harkin, Enzi and Alexander, and Representatives Burgess, Eshoo, Green, Pallone and Waxman.
Aeolus is currently entering the third year of its $118 million advanced R & D contract with the Biomedical Advanced Research and Development Authority (BARDA) to develop its lead compound, AEOL 10150, as medical countermeasure (MCM) for the pulmonary sub-syndrome of Acute Radiation Syndome (Lung-ARS). The Company is also developing AEOL 10150 as an MCM for the gastrointestinal sub-syndrome of ARS (GI-ARS) as well as an MCM for exposure to chlorine gas, mustard gas, phosgene gas and nerve agents with funding from the National Institutes of Health - National Institute of Allergy and Infectious Disease and CounterACT programs.
"We are pleased to see such overwhelming bipartisan support for this important bill, which not only extends the funding for BARDA, but also provides additional emphasis on improving and expediting the development and procurement of critical medical countermeasures for the Strategic National Stockpile," stated John L. McManus, President and Chief Executive Officer.
As a result of the passage of the Pandemic and All-Hazards Preparedness Act (PAHPA) of 2006, the federal government, in partnership with state and local governments, took significant steps to strengthen our nation's medical and public health preparedness and response capabilities. This bipartisan reauthorization builds on these efforts by enhancing existing programs and authorities using lessons learned since 2006 to maximize our nation's resilience to threats, whether naturally occurring or deliberate. Important terms of this bill include:
•Emphasizes chemical, radiological, biological, and nuclear threats as part of an all-hazards approach to our National Preparedness Goals; promotes strategic initiatives to advance medical countermeasures (MCMs) development and procurement. •Enhances the Secretary's ability to make MCMs under review available in limited circumstances based on either a declared emergency or identified threat. •BioShield - Encourages further development of MCMs to address chemical, biological, radiological, and nuclear threats by reauthorizing BioShield's Special Reserve Fund. Requires HHS to report to Congress when the Special Reserve Fund falls below a certain threshold and the potential impact of such a reduction on addressing MCM priorities. •Advanced Research and Development - Enhances the Biomedical Advanced Research and Development Authority's (BARDA's) strategic focus on supporting the development of innovative and cutting-edge biodefense initiatives. •MCM Acceleration - Charges the FDA with promoting MCM professional expertise and developing regulatory science tools to advance the review, approval, clearance, and licensure of MCMs within FDA as well as enhancing scientific exchange between FDA and MCM stakeholders. •Regulatory Management Plan - Requires FDA to work with sponsors and applicants of certain eligible MCMs to develop individualized regulatory management plans to improve regulatory certainty.
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