NANOTHERAPEUTICS AWARDED $20 MILLION NIAID/BARDA CONTRACT TO DEVELOP
INHALED GENTAMICIN FOR TREATMENT OF AEROSOL EXPOSURE TO BIOTERRORISM
AGENTS
ALACHUA, Fla.,October 11, 2007 -- Nanotherapeutics, Inc.,
today announced that it has been awarded a $20 Million 4-year contract
from the National Institute of Allergy and Infectious Diseases (NIAID),
part of the National Institutes of Health (NIH), and the Biomedical
Advanced Research and Development Authority (BARDA) to develop an
inhaled version of the injectable drug, gentamicin, a broad-spectrum
antibiotic that is used as a first-line therapy for pneumonic plague and
tularemia, Category A bioterrorism agents. Both diseases are highly
infectious and could pose a serious danger if used as an aerosolized
biological weapon.
Using its novel particle formulation, the company has developed
NanoGENT™, an inhaled dry-powder formulation of gentamicin, to provide
early treatment for exposure to biological warfare agents, as well as TB
and other respiratory infections. In the event of an accidental or
deliberate exposure to these agents, noninvasive drug delivery systems,
such as improved inhaled and nasal delivery would be especially
beneficial for administering wide-spread immediate post-exposure
prophylaxis and treatment using disposable multi-dose inhalers with
adequate shelf-life stability.
James D. Talton, Ph.D., President and C.E.O. of Nanotherapeutics and
co-founder of the company said, “We are very pleased to receive this
contract to fund this product development program. The continued support
from the NIAID and BARDA of Nanotherapeutics’ proprietary drug delivery
systems is a terrific endorsement of our technologies and manufacturing
capabilities. The continued development of NanoGENT™ with our partners
Respirics, Next Breath, Lovelace Respiratory Research Institute, and
i3Research is a strategically important milestone for the company as it
demonstrates the utility of our technology to meet a significant medical
need. We are confident we will be able to develop a novel improved
formulation that can rapidly and effectively provide therapeutic results
into a viable product.”
Gentamicin, the front-line therapy for plague and tularemia, is a
generic drug approved by the FDA for injection. For many years it has
been used in a saline nebulized version to treat Pseudomonas respiratory
infections, particularly in patients with cystic fibrosis.
Nanotherapeutics and its collaborators will continue the clinical
development of NanoGENT™ and expect to bring it to human clinical trials
to evaluate the safety and pharmacokinetics in the fourth year of its
NIAID/BARDA contract.
In 2005, Nanotherapeutics received funding from National Institute on
Drug Abuse (NIDA) to develop an oral medication to treat opiate
addiction. The company also received funding from the NIAID, as part of
the NIH research program on Medical Countermeasures against Radiological
and Nuclear Threats, to test the oral delivery of DTPA, an injectable
treatment, and from Project Bioshield for preliminary testing of
NanoGENT™. Nanotherapeutics has one approved injectable product and
several products in advanced development, manufactured in-house under
cGMP. This project has been funded in whole or in part with Federal
funds from the National Institute of Allergy and Infectious Disease,
National Institutes of Health (NIAID) and the Biomedical Advanced
Research and Development Authority (BARDA), Department of Health and
Human Services (DHHS), under Contract No. HHSN27220070030C".
About Nanotherapeutics
Nanotherapeutics Inc., an emerging specialty pharmaceutical company with expertise in the early stage development of pharmaceuticals, is a privately held corporation located in Florida. The company is a provider of specialized drug delivery systems that use the company’s discoveries in nanotechnology to develop novel drug therapies or improved formulations for existing therapies. The company employs several platform technologies to manipulate and enhance the properties of drugs. These technologies can be employed with new chemical entities or with generic drugs and can be used with the spectrum of existing drug types ranging from small synthetic molecules to large recombinant macromolecules.
Significant advances have been made in the area of nanometer-scale particle delivery, and Nanotherapeutics has created three proprietary drug delivery technologies: NanoQUAD™, NanoDRY™, and NanoCOAT™. These specialized proprietary techniques can improve the release rate and enhance both the rate and extent of drug uptake, thus increasing bioavailability. The consequences of these changes include more consistent drug therapy with potentially reduced dose and dose frequency requirements and fewer side effects.
For more information about Nanotherapeutics visit the company’s website
at www.nanotherapeutics.com.
About Respirics
Respirics Inc. is a pulmonary drug delivery and development company
located in Raleigh, North Carolina. The company is developing a line of
branded inhalation drug products in its patented Acu-Breathe™ dry powder
inhalers, and is working with pharmaceutical clients to enhance the
delivery of their own compounds or formulations. Respirics combines
proprietary inhalation technology with powder drug formulation expertise
to develop unique drug delivery solutions. The company is committed to
bringing effective, easy-to-use and affordable inhalation drug products
to the patients who need them. For more information, visit www.respirics.com.
About Next Breath LLC
Located in Baltimore, MD, Next Breath is a contract services provider
for pharmaceutical, biotech and medical device companies that bring new
inhalation and nasal products to market. Next Breath has broad
experience with drug delivery devices including nasal pumps, metered
dose inhalers, dry power inhalers, nebulizers and spacers. Next Breath
is a GMP laboratory providing an array of in vitro services ranging from
pre-clinical formulation development to analytical testing, in support
of submissions made to regulatory agencies. For more information, visit www.nextbreath.net.
About Lovelace Respiratory Research Institute
Lovelace Respiratory Research Institute (LRRI), through its wholly owned
subsidiary, Lovelace Biomedical and Environmental Research Institute
(LBERI), is a private biomedical research organization with a broad
range of research capabilities and alliances with government, industry,
universities, health advocacy organizations, and the public. LBERI
offers this team its 50+ years of internationally recognized expertise
in aerosol science and inhalation exposure technology, including aerosol
generation and delivery techniques, sampling instrumentation and
strategies, exposures, dosimetry of inhaled particles, and
characterization and behavior of airborne particles, LBERI also provides
safety, pharmacokinetic and toxicology support for products requiring
FDA oversight. LBERI has a strong focus in virology, immunology, and
infectious disease along with a complementary focus in the
pharmaceutical and biopharmaceutical contract arena. LBERI supports
national security, law enforcement, industry, and medical communities by
improving the understanding of the possible use of biological weapons,
biological agent pathogenesis, dissemination principles, and biothreat
prevention.
About i3Research
i3 Research is a full-service, global contract research organization
focused on: central nervous system; oncology; respiratory and infectious
diseases, cardiology and endocrinology and metabolic disease. i3
Research is experienced in designing, planning and executing studies of
all sizes and is driven by its therapeutic specialization; from project
staffing and talent management to quality initiatives, such as six
sigma, i3 Research relies on thought leaders in each of its therapeutic
areas to integrate teams medically, scientifically and operationally,
helping to ensure that customer needs are met or exceeded. i3 Research
is a business unit of i3, a global Ingenix company, providing integrated
scientific strategies and solutions throughout the pharmaceutical
product lifecycle. Additional i3 business units are: i3 Drug Safety,
engaged in pharmacovigilance and epidemiology; i3 Statprobe, a leader in
comprehensive data services; i3 Pharma Resourcing, a world-class
staffing partner; and i3 Innovus, delivering the science and solutions
to achieve marketplace success. i3 helps companies gain sharper insights
that lead to better patient care. For more information, visit www.i3global.com.
Nanotherapeutics
James D. Talton, Ph.D., 386-462-9663
President &
CEO