2012 Annual Report - Prometic - Life Science, Inc.

PROMETIC’S BUSINESS IS ORGANIZED AND BASED UPON 2 DISTINCT BUSINESS SEGMENTS.
AT PBI, SCIENTISTS ARE FOCUSED ON DEVELOPING DRUGS THAT CAN EMULATE THE ACTIVITY
OF PROVEN BIOLOGICS WITH IMPROVED PHARMACO-ECONOMICS AND SAFETY PROFILE.
2- SMALL MOLECULE THERAPEUTICS
THERAPEUTICS
PBI drug discovery program has generated
a strong pipeline of orally active drug
candidates, with efficacy and high safety
profiles confirmed in several in vivo
experiments and solid proprietary positions.
The unmet medical applications targeted are
fibrosis, inflammation, autoimmune diseases,
oncology and hematopoietic disorders.
Fibrosis
In 2012, PBI continued to focus on IND
enabling activities for its anti-fibrotic drug
candidates. Fibrosis is a very complex process
by which inflammation leads to the deposit
of fibrous material to repair the damaged
area. This is the process whereby vital organs
gradually lose their functionality as normal
and functional tissue is replaced by fibrotic
scarring tissue.
The proof of concept data generated to
date confirms our lead drug candidates’
anti-fibrotic activity in several key organs
including the kidneys, the heart, the lungs
and the liver. For example, following a
myocardial infarctus or long standing
chronic conditions such as hypertension or
chronic kidney diseases (CKD), the buildup
of scarring tissue in the heart will lead to
congestive heart failure (CHF).
Twenty six million patients in the U.S. alone
are diagnosed with chronic kidney diseases
(“CKD”). Patients with severe CKD stages
(3 and 4) suffer from a gradual and
accelerated loss of their renal function (end
stage renal disease or ESRD) leading to
the need for hemodialysis. Cardiovascular
complications for ESRD patients on
hemodialysis are a common cause of death.
The positive effects of PBI-4050 observed
in several different animal models designed
to reproduce chronic kidney diseases have
been presented at the American Society of
Nephrology Annual meeting in San Diego
and can be summarized as follows:
GFR (improvement of the renal
function)
Proteinuria (reduction of protein found
in urine)
Serum creatinine (reduction of
creatinine in blood)
Serum urea (reduction of urea in
blood)
Histological lesions (reduction of
fibrosis & lesions, leading to a more
functional and normal renal tissue)
of collagen deposition in the tissue
several biomarkers confirming the
reduction of inflammation and fibrosis
MEDICARE POPULATION 2010
General Medicare: population, 2010
(n=31,484,849; mean age 69.2)
DM 26.9%
CKD 11.9%
CHF 13.2%
ESRD 1.3%
During the past year, ProMetic scientists
have been performing a series of test
to help validate whether the clinical
benefits observed in animals will also
translate to humans. This was achieved by
demonstrating the superior performance
of Prometic’s compounds compared to
commercially available drugs and by
demonstrating equivalent efficacy on human
cells. Furthermore a series of tests were
performed to ensure that our lead drug
candidates would tick the box on safety.
Finally, our scientists have been optimizing
the manufacturing process and performing
technical transfers to GMP manufacturers
so that the Corporation can be in a state of
readiness to move into the clinical trials in
2013.
As a result of the performance and quality
of data generated so far by our lead
compounds, we now have several medical
experts helping us prepare and design
clinical trial programs that will maximize our
chances to obtain regulatory approval for the
targeted indications. We intend to initially
target smaller indications before proceeding
with broader medical conditions and more
lucrative markets as a strategy to increase
market acceptance and recognition.
MEDICARE COSTS 2010
General Medicare: costs, 2010
($343 billion)
DM 43.1%
CKD 27.5%
CHF 36.7%
CKD Chronic kidney diseases
ESRD End stage renal disease
CHF Congestive heart failure
DM Diabetes Mellitus
ESRD 7.5%
CKD, ESRD and CHF represented over $175 billion
or over 50% of the General Medicare costs in the
USA alone in 2010.
Source: USDRS 2012 Annual Data Report
PROMETIC LIFE SCIENCES INC.
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