AlphaRx
is a specialty pharmaceutical company that applies
proprietary drug delivery technologies to reformulate
FDA approved drugs to achieve improved efficacy and
patient compliance.

AlphaRx
uses safe carrier components that the FDA classifies
as GRAS (generally regarded as safe) which cuts down
on approval times and costs. They are patentable,
flexible and can be modified to apply to a variety
of drugs and therapeutic products.

AlphaRx
has carefully chosen products for its’ pipeline that
maximize the therapeutic value of their discoveries
and technologies. These products have significant
market sales potential, when approved for use, and
a range of times (from months to years) which may
be necessary to achieve Government approvals. AlphaRx’s
approach anticipates a decrease in the time and capital
expense necessary to achieve drug approvals and concurrently,
a positive cash flow position for the company, enhancing
shareholder value and long-term success for the long-term.

The
emphasis on each of AlphaRx’s new technologies leverages
on the use of our advanced drug delivery systems.
Their goal is to improve the effectiveness of existing
pharmaceuticals and new chemical entities that have
exhibited poor absorption due to poor solubility or
the development of drugs of therapeutic value which
have yet to be administrable to the human body with
an acceptable delivery method.

Mission

Alpha
is the first letter of the Greek alphabet. Its’ English
language usage defines something which is pre-eminent,
at the foundation or forefront in importance and influence.

AlphaRx’s
goal is to become preminent in the development of
effective and innovative medicines and drug delivery
platforms to address the unmet needs of patients and
improve their health, longevity and quality of life.

AlphaRx
adheres to certain values in achieving this goal:
conducting their activities with the highest of ethical
standards, within the framework of an entrepreneurial
culture, in an atmosphere of partnership with their
employees and collaborators and with an unrelenting
passion and drive for excellence.

AlphaRx
aspires to the reality that these values be reflected
in all that they do, to the benefit of their patients,
shareholders and society as a whole.

Products

AlphaRx’s
research and development efforts are focused on therapies
for life threatening or chronic disease. The company’s
product development strategy is to reformulate FDA
approved drugs using proprietary, site-specific drug
delivery technology to achieve a better efficacy,
better safety profile and patient compliance. In addition,
the company is developing a number of difficult-to-formulate
generic pharmaceutical products.

Although
AlphaRx believes their development strategy of reformulating
FDA approved drugs may have less development risks
as compared to new chemical entities development,
there can be no guarantee that any product candidates
can be successfully developed and as such, AlphaRx
constantly evaluates and prioritizes their development
programs. As a result, new product candidates are
constantly added and lower priority development programs
may be discontinued or delayed. AlphaRx believes this
product development optimization process is essential
for the development of a broad portfolio of short
to long-term drug candidates, which will position
the company for stable and sustainable growth.

Research
and Development

Nosocomial
Gram Negative Pneumonia

Pneumonia,
due to gram-negative enteric bacilli, is a serious,
live threating disease, with a high crude (20-60%)
and attributable (10-20%) mortality rate. Gram-negative
bacterial pneumonias almost always occur in people
who are hospitalized or who live in nursing homes;
they rarely infect the lungs of healthy adults. Gram-negative
bacteria are a common cause of pneumonia in people
who are on ventilators (breathing machines used in
intensive care units). Other people at risk are infants,
the elderly, alcoholics and individuals with chronic
diseases, especially immune system disorders.

Pneumonia
is the second most frequent hospital-acquired infection
with ~300,000 cases occurring per year. In the United
States, the estimated annual cost of nosocomial pneumonia,
due to gram-negative bacilli, is greater than $1 billion.
AlpahRx is developing a suite of nanobiotics (antibiotic
in nanoparticles), intended for the treatment of hospitalized
patients with severe, gram negative bacterial pneumonia.

Zysolin
– a polymeric nanoparticlulate formulation of Tobramycin

Tobramycin
has been widely used in the treatment of gram-negative
and some gram-positive organisms. As with other aminoglycosides,
use is limited by risk of toxicity. In vitro tests
have shown Tobramycin to be active against Enterobacter
aerogenosa, Escherichia coli, Klebsiella species,
Pseudomonas aeruginosa, Salmonella, Shigella and Staphylococcus
species. Zysolin is specifically formulated to improve
the intracellular activity of Tobramycin – to increase
the drug concentration of tobramycin inside human
macrophages, thus improving its antibacterial activity
against intracellular Klebsiella, Pseudomondas aeruginosa
and Staphylococcus in pneumonia patients. In the biodefense
arena, Zysolin is intended for the treatment of pneumonia
caused by Francisella tularensis (rabbit fever) and
Burkholderia cepacia (cystic fibrosis).

Partnerships

AlphaRx’s
primary business strategy is to seek partnerships
with pharmaceutical companies to formulate improved
therapeutic products utilizing the company’s drug
delivery technologies.

Partnering
with pharmaceutical companies is a key component of
our business strategy. We have adopted a flexible
partnering strategy; we may partner at a very early
stage by means of research collaborations; in some
cases we may develop compounds on our own and commence
clinical trials before seeking development and/or
commercialization partners.

Licensing
and Distribution Partners

AlphaRx
has several products available for out-licensing.
The products will be jointly developed, with our partners
having responsibility for clinical testing, manufacturing
and marketing, while AlphaRx retains ownership of
the products.

Research
and Development Partners

AlphaRx has unrivalled expertise
in formulation, development, scale-up and manufacture
of proven and effective life cycle management strategies.
We offer a broad range of platform technologies that
can be applied to many existing drug compounds and
new chemical entities for multiple therapeutic opportunities.
Our drug development scientists offer additional expertise
in the custom-tailoring of drug delivery to meet client’s
needs, whether by parenteral, oral, transdermal, local
or topical administration.

Partnerships
in Place

The
following is a list of some of the partnerships AlphaRx
currently has in place.

Licensing
Partnership

Prorpius
Pharmaceuticals

License
and development agreement established in April 2006
granting Prorpius an exclusive global rights (with
the exception of Asia and Mexico) to our topical NSAID,
Indaflex™ for the treatment of osteoarthritis.
Proprius was acquired by Cypress Biosceince Inc, in
March 2008.

Gaia
BioPharma

In
October 2008, AlphaRx licensed GAI-122 to Gaia BioPharma.
Under the terms of the amended agreement, AlphaRx
is eligible to receive milestone payments of up to
$50 million for the successful development and commercialization
of GAI-122, as well as royalties on worldwide sales.
In addition, Gaia BioPharma has assumed all development
costs.

Research
Partnership

U.S.
Army Medical Research Institute of Infectious Diseases
(USAMRIID), USAMRIID and AlphaRx entered into a Material
Transfer Agreement (MTA) in February, 2008. The resulting
joint R&D effort enables USAMRIID scientists to
test the efficacy of our nanobiotics for the treatment
of severe intracellular bacterial infections in animal
models.