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8-K - AEOLUS PHARMACEUTICALS, INC. | v211668_8k.htm |
99.1
Contact:
Russell
Skibsted
Sr. Vice
President and Chief Financial Officer
Aeolus
Pharmaceuticals, Inc.(949) 481-9825
AEOLUS
AWARDED CONTRACT FULLY VALUED AT $118 MILLION FROM
BARDA
TO DEVELOP TREATMENT FOR LUNG ACUTE RADIATION SYNDROME
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Contract, with options, valued
at up to $118 million over 5
years
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Funding would bring AEOL 10150
from its current stage of development to FDA
approval
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Safety, CMC and other programs
funded by BARDA can be used to support NDA in oncology or other
indications
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Funding is for Research and
Development only - Procurement, if made, would be in addition to this
contract
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MISSION VIEJO, California –
February 15, 2010— Aeolus Pharmaceuticals, Inc. (OTC: AOLS), a biopharmaceutical
company developing a new class of broad spectrum catalytic antioxidant compounds
that reduce oxidative stress, inflammation, and subsequent tissue
damage-signaling cascades resulting from radiation exposure, today announced
that the Biomedical Advanced Research and Development Authority (BARDA), part of
the Department of Health and Human Services (HHS), has awarded Aeolus a contract
for the advanced development of AEOL 10150 as a medical countermeasure (MCM)
against the pulmonary sub-syndrome of acute radiation syndrome
(ARS).
Under
terms of this cost plus, fixed fee development contract, Aeolus will receive
$10.4 million in the first year base period of performance and up to an
additional $107.5 million in options , if exercised by BARDA, for a total
contract value of up to $118 million. In addition to fully covering the cost of
development of AEOL 10150 as an MCM for Lung ARS, the Company believes that the
contract with BARDA will substantially cover all of the costs associated with
the preclinical, chemistry, manufacturing, and controls (CMC) and toxicology
necessary for the oncology indications, plus a large safety study in humans. 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 (EUA). Under the Company’s development
plan, documents for submission of an EUA would be prepared and submitted to the
government in approximately 2 ½ years. The value of a procurement, if any, is
not included in the contract value announced herein.
“We
are excited to have the support of BARDA for this important program and look
forward to a highly productive relationship to develop an effective
countermeasure to the pulmonary effects of ARS,” said John L. McManus, Chief
Executive Officer and President of Aeolus Pharmaceuticals, Inc. “This contract
will allow us to accelerate the development of 10150 as a medical
countermeasure, and it will also, importantly, allow us to expand its
development for use in oncology indications, where it would be used in
combination with radiation therapy. We believe that the dual-use, broad-spectrum
characteristics of AEOL 10150 make it a very unique and exciting compound with
excellent potential.”
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.
Aeolus is
pleased to partner with HHS-BARDA, the University of Maryland, Duke University,
Johnson Matthey Pharma Services, Albany Molecular Research and Symbion Research
International in this comprehensive development program. Development of AEOL
10150 to submission of a New Drug Application (NDA) in the indication of the
pulmonary sub-syndrome of ARS is expected to take approximately five
years.
The
Company plans to initiate a Phase I study of AEOL 10150 in oncology in the
1st
half of 2011.
About
Acute Radiation Syndromes (ARS)
Immediately
after exposure, the most critical components of acute radiation syndrome are the
hematopoietic (bone marrow) and early-onset gastrointestinal (GI) syndromes
because symptoms begin very quickly and can be lethal. However, depending
on the level and location of radiation exposure, much of the lethality of both
hematopoietic and early-onset gastrointestinal syndromes are potentially
avoidable with proper treatment, including supportive care (fluids and
antibiotics) and Neupogen, leaving
complications to later responding tissues subsequently becoming a major
problem.
In
situations of accidental exposure, it was initially assumed that a whole-body
dose exceeding 10 Gy was inevitably fatal. However, experience with
nuclear accident victims suggests that when patients survive gastrointestinal
and bone marrow syndromes, respiratory failure become the major cause of
death. This effect is known as a delayed effect of acute radiation
exposure (DEARE).
About
Cancer Radiation Therapy
According
to the American Cancer Society, cancer is the second leading cause of death by
disease representing one out of every four deaths in the United States.
According to the Radiological Society of North America, about 50 to 60 percent
of cancer patients are treated with radiation at some time during their disease.
The NIH estimates overall costs of cancer in 2008 in the United States at $228.1
billion: $93.2 billion for direct medical costs, $18.8 billion for indirect
morbidity costs (costs of lost productivity due to illness) and $116.1 billion
for indirect mortality costs (cost of lost productivity due to premature
death).
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
have been exposed, or are about to be exposed, to high-doses of radiation in the
treatment of oncology.
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 an acute radiation-induced lung injury model. 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 new class of catalytic antioxidant compounds
that protects healthy tissue from the damaging effects of radiation. Its first
compound, AEOL 10150, is being developed for oncology indications, where it is
used in combination with radiation therapy. It is also being developed, with
funding by the US Government, 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 to efficiently develop the compound
for use in oncology. For more information, please visit Aeolus’ corporate
website at www.aeoluspharma.com.
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 any potential future
submissions or applications to the FDA. 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, receipt of funding under the contract with BARDA, and competition from
other biopharmaceutical companies. 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, 2009. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof.
*****