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Profile
Phage-Biotech Ltd. was incorporated in March 2000, as a
new player in the emerging field of Phage Therapy. The Company’s
mission is to develop proprietary Phage-based anti-infective therapeutics
to combat the increasing number of antibiotic-resistant infections
worldwide. The Company has two short-term strategic objectives:
¨
To identify and formulate proprietary topical Phage preparations
from discovery through pre-clinical trials, with an initial focus on
anti-Pseudomonas therapeutics, and
¨
To develop and out-license proprietary reagents and buffers to
promote Phage stability, adsorption, and infectivity of phage-based
therapeutics.
The Opportunity. Antibiotic resistant infectious
diseases impose a significant burden on society, and surpass $30 billion
in annual direct treatment costs in the U.S. alone. The high cost stems
from several key factors: (1) Individuals infected with drug resistant
organisms usually have a poor prognosis and are more likely to require
hospitalization and (2) drug-resistant infections acquired in hospitals
nearly triple the cost of hospital stays. The cost of antibiotic
resistance is expected to grow larger as medical experts anticipate
record increases of antibacterial resistance in the next decade.
Two factors emphasize the urgent need to continue
research and development into new and innovative drugs for infectious
diseases:
¨
Today’s escalating
antibiotic crisis is the direct result of large scale and indiscriminant
over-use of anti-infective drugs. Both the FDA and the CDC recognize that
even if all antibiotic use were indeed to become appropriate, a mission
almost impossible to achieve, resistance would not disappear.
¨
Pharmaceutical companies
have exhausted the arsenal of known antibiotic classes. Currently, the launch
of new antibacterial products usually includes stronger dose formulations
of old antibiotic classes. This results in the development of more
antibiotic resistant strains and increased resistance of current strains.
New classes of antibiotics are desperately needed.
Phage Therapy. Phage Therapy offers a new effective
weapon to combat infectious diseases, for both resistant and sensitive
bacteria strains. In Eastern Europe, Phage Therapy has been routinely
used to treat a wide range of bacterial infections for over 70 years,
with high efficacy and minimal side effects.
Studies have
demonstrated that commercial phage mixtures can achieve bacterial elimination in up
to 80% or higher of clinical strains, a very high success rate compared
to currently used new generation antibiotics, which typically reach only
60% success.
Today, as the spread of antibiotic
resistance reaches a crisis point, the window of opportunity for Phage
Therapy is re-opened in the West.
Addressable Market. According to Frost & Sullivan,
pharmaceutical companies are striving to capture lucrative rewards of the
anti-infective market by developing a wealth of new therapeutic products
that will combat resistant strains of infectious pathogens. The annual
worldwide market for bacterial infection therapeutic products is expected
to reach $26 billion during 2002. The U.S. market share for new
generation antibiotics alone is anticipated to reach approximately $10
billion this year. With an expected 4.2% compound annual growth rate, the
market is expected to surpass $32 billion by 2007.
Anti-infectives
were the second leading revenue-generating category in 2000.
Collectively, anti-infective drugs that were listed among the leading 500
prescription drugs, reached sales of more than $20 billion. The
biggest-selling anti-infective drug on the market is
GlaxoSmithKline’s beta-lactamase inhibitor line, Augmentin, that
generated sales of $1.85 billion. Augmentin is indicated for the
treatment of Acute Otitis Media (middle ear infection) among other
indications.
Pseudomonas
aeruginosa. According to
Drug Discovery Today, there is an urgent need for the development of
more-effective anti-Pseudomonas therapeutics. P. aeruginosa
has the capacity to produce very diverse, often overwhelming, infections
due to its battery of virulence factors: Individuals suffering from
cystic fibrosis, severe burns, cancer, and those requiring extensive
stays in intensive care units are particularly at risk of diseases
resulting from P. aeruginosa infection. Since P.
aeruginosa has an intrinsic resistance to a wide array of existing
antibiotics, its infections are difficult to eradicate, resulting in high
treatment costs and high mortality rates.
Intellectual Property. Phage-Biotech holds an exclusive
license agreement from Immunopreparat Ufa, part of the Russian Federation
Republic of Bashkortostan. Immunopreparat Ufa is one of the most
prominent Phage Therapy leaders globally. Through this agreement,
Phage-Biotech has licensed all Immunopreparat Ufa’s intellectual
property and know-how, which includes extensive phage collections. In
addition, the Company is currently engaged in the process of filing
several more patent applications regarding:
¨
Anti-Pseudomonal phage preparations for the treatment of
Keratitis, Otitis, infected burns and surgical scars and Urinary tract infections.
¨
Phage based decontaminants for pre-treatment of contact lenses,
catheters and other invasive medical devices.
¨
Advanced buffer ingredients for enhanced phage adsorption to
bacteria in infected host tissues.
¨
High titer production process.
Short term Value Proposition. The Company is currently engaged in
the development of topical Phage preparations for the treatment of
Keratitis (severe eye infection), and for the treatment of Chronic Otitis
Media (ear infection):
Keratitis. Pseudomonas aeruginosa can cause devastating infections in
the human eye and is one of the most common causes of bacterial
Keratitis. Due to its potential to permanently impair vision or perforate
the eye, bacterial Keratitis is considered an ophthalmologic emergency.
Increased use of soft contact lenses in recent years has led to a
dramatic rise in the occurrence of bacterial Keratitis, particularly due
to P. aeruginosa.
è The addressable market
for Phage-Biotech’s anti-Pseudomonas Keratitis applications
includes around 23,000 cases annually, in the U.S. alone.
Keratitis
treatment includes hospitalization with frequent antibiotic application
to the infected eye, approximately once every 15 to 30 minutes.
This frequent treatment necessitates hospitalization with 24 hour
monitoring.
è The Company’s
Phage-based eye drops are expected to provide a significantly simpler treatment
protocol, decreasing treatment to only 3 times a day. The treatment is
expected to have clear pharmacoeconomic value and lead to shorter
hospitalization periods.
Chronic
Otitis Media. 5% to 20%
of children suffer from Recurrent Acute Otitis Media and Chronic Otitis
Media. Within the adult population, it is estimated that 1.5% has active
Chronic Otitis Media.
è The addressable market
for Phage-Biotech’s anti-Pseudomonas Chronic Otitis Media
application includes 4.5 million patients in the U.S. alone each year.
At one end of
the spectrum, over-reliance on antibiotics is the main cause for the
antibiotic resistance problem in Chronic Otitis Media. At the other end
of the spectrum, surgery for the insertion of ventilation tubes is used
for the most chronic cases, with limited efficacy in the long run. This
leaves the vast majority of patients with moderate yet persistent
problems with no appropriate treatment.
ü
Phage-Biotech’s anti-Pseudomonal eardrop
formulations are intended to eradicate Pseudomonas aeruginosa
Recurrent Acute and Chronic Otitis Media infections. These preparations
are expected to replace antibiotic use and to prevent the need for
surgery, providing a viable solution to all patient groups.
Enhancing Phage Killing. Phage-Biotech foresees its
proprietary reagents and buffers as a mid-term revenue-generating
channel, via out-licensing agreements with other Phage Therapy players in
the industry.
Long term Value Proposition. Phage-Biotech’s core competencies
include its R&D expertise in formulating topical Phage preparations
from discovery through pre-clinical trials. The Company relies on
strategic partners’ capabilities to promote clinical trials,
marketing, large-scale manufacturing and commercialization.
Potential
Strategic Partners.
Phage-Biotech is continuously seeking strategic partnerships for
co-development, out-licensing and commercialization of its Phage-based
proprietary solutions, to combat antibiotic-sensitive and antibiotic-resistant
pathogenic infections. Potential fields of collaborations include:
¨
Topical Pseudomonas solutions for treatment of infected
burns, wound infections and bacteremia.
¨
Non-topical Pseudomonas treatment.
¨
Phage-based solutions to treat other antibiotic- resistant
pathogenic bacteria.
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