Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS)
- BARDA exercise options valued at $6.0 million effective
September 16, 2013 under Aeolus' advanced development contract
worth up to $118 million over five years
- Options will fund additional efficacy, manufacturing and
regulatory work for AEOL-10150
- Conference Call: Thursday, September 19, 2013 @ 10 AM Pacific/1
PM Eastern
Aeolus Pharmaceuticals, Inc., a biotechnology company developing
compounds to protect against radiological and chemical threats,
announced today that the Biomedical Advanced Research and
Development Authority (BARDA) exercised $6.0 million in additional
contract options under its advanced research and development
contract for AEOL-10150. BARDA is a division of the U.S. Department
of Health and Human Services that manages the advanced development
and purchase of medical countermeasures for public health
threats.
Aeolus is developing its lead compound, AEOL-10150, as a
treatment for the pulmonary syndrome of Acute Radiation Syndrome
(Lung-ARS) and delayed effects of acute radiation exposure (DEARE)
under a five year contract with BARDA worth up to $118MM. The
contract was awarded on February 11, 2011. The contract is designed
to produce the data necessary for an approval under the FDA "Animal
Rule" and for a pre-Emergency Use Authorization (EUA) filing. An
approval or pre-EUA would allow the federal government to buy AEOL
10150 for the Strategic National Stockpile under the Pandemic
All-Hazards Preparedness Reauthorization Act (PAHPRA). PAHPRA is
designed to accelerate the research, development, purchase and
availability of effective medical countermeasures for the Strategic
National Stockpile.
The options include funding for the following development
items:
- Investigational New Drug (IND) filing with the FDA for
AEOL-10150 in Lung-ARS and DEARE
- Preparatory work for additional human clinical studies,
including PK/PD ADME and toxicity studies
- Additional murine efficacy trials, including duration of
treatment and delayed treatment studies
- Continued development of large-scale, GMP manufacturing
capability for AEOL-10150
- Project management costs
As a result of the exercise of the new options, the Company
expects revenue for fiscal year 2014 to exceed $9 million.
"BARDA's exercise of additional options reflects the significant
progress our team has made during the first two years of the
Lung-ARS development contract," said John L. McManus, Chief
Executive Officer and President of Aeolus Pharmaceuticals, Inc.
"During this period, we delivered valuable animal models for
Lung-ARS and made important progress in the manufacturing of AEOL
10150. The options that BARDA exercised will fund our IND filing
for AEOL-10150 as a treatment for Lung-ARS, additional animal
efficacy studies designed to optimize timing and duration of dosing
and the continued development of large-scale GMP manufacturing
capability to meet potential future demand. When combined with our
ongoing studies in non-human primates and our completed work in GMP
manufacturing development, these options will help Aeolus meet the
requirements for a pre-EUA filing for AEOL-10150. We remain
grateful to BARDA for the financial support and program input that
we receive."
In February 2011, BARDA awarded Aeolus a five-year Advanced
Research and Development Contract to support the development of
AEOL 10150 as a medical countermeasure against the pulmonary
effects of acute radiation syndrome (ARS) and delayed effects of
acute radiation exposure (DEARE), valued up to $118 million.
Through the end of August 2013, Aeolus had billed or completed
approximately $16.1 million of programs under the contract and had
committed work in progress totaling approximately $3.4 million.
Under terms of the contract, Aeolus may receive up to an additional
$88.5 million in options, if exercised by BARDA, for a total
contract value of up to $118 million.
On July 29, 2013, Aeolus presented the results and deliverables
that had been produced during the first 28 months of the contract
at an "In-Progress Review" meeting with BARDA, and requested the
exercise of additional contract options. BARDA's exercise of the
options is in response to the presentation of the deliverables and
progress made under the contract at this meeting.
Conference Call
Aeolus will host a conference call provide investors with an
update on the progress of the BARDA program.
Date: Thursday, September 19, 2013 Time: 10 AM
Pacific/1 PM Eastern Dial-in Number: 855-803-7921 Conference ID:
65093103
The conference call will be available on the same number for
telephone replay through September 26th or at
www.aeoluspharma.com
About the BARDA Contract
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 existing 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.
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Contact: John McManus President and Chief Executive Officer
Aeolus Pharmaceuticals, Inc. 1-(949) 481-9825
Aeolus Pharmaceuticals (CE) (USOTC:AOLS)
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