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SemBioSys, Genetics Inc

SemBioSys Achieves Critical Apo AI Milestone

Calgary, Canada (ots/PRNewswire)

- Canadian Biotechnology Company is the First Company in the World
to  Produce Recombinant Apo AI, a Next Generation Cardiovascular
Therapy, Using  Plants
SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company, today
announced it has successfully developed commercial levels of
apolipoprotein AI and its variant apolipoprotein AI(Milano)
(collectively referred to as Apo AI) in safflower seed lines. Apo AI
is believed by many clinicians to be the basis for the next
generation of cardiovascular drugs, which represented a CDN$35
billion market in 2006. Apo AI is a major component of "good
cholesterol" or HDL (high density lipoprotein) which naturally
removes atheroscleroticplaque from arteries. This achievement is a
key milestone for SemBioSys'cardiovascular drug development program.
SemBioSys' plant-produced Apo AIoffers the potential to overcome the
manufacturing challenges of  traditionalfermentation-based
technologies that have impeded the commercial  developmentof Apo AI.
"Apo AI is a promising new therapy for the treatment of
cardiovascular disease which is the largest drug market in the world.
Unlike statins, the lead drug class in this market, which halt plaque
build-up, clinical results from Apo AI have actually demonstrated
significant plaque reduction. We believe manufacturing capacity and
cost are major commercialization issues for pharmaceutical companies
developing Apo AI. Today's announcement demonstrates that safflower
seed is an enabling production vehicle for Apo AI with the scale and
economics necessary to allow for the commercialization of this
potentially transformative therapy," said Andrew Baum, President and
CEO of SemBioSys Genetics Inc. "This is great news for the area of
cardiovascular disease therapy. With the recent setbacks reported
with other HDL modulators like torcetrapib and AGI-1067, Apo AI is
clearly positioned at the forefront of cardiovascular disease therapy
(see Nature 2006 Dec 14; pages 794-5). As an enabling manufacturing
solution, we believe our Apo AI development program represents an
attractive partnership opportunity for companies developing such
cardiovascular therapies and with these results we will initiate
formal partnering activities."
These results further validate the broad utility of SemBioSys'
seed-based production system for critical, large volume
biopharmaceuticals in short supply. SemBioSys' technology addresses
protein extraction and purification as well as bulk protein
production. SemBioSys estimates it can reduce capital costs for
protein production by up to 70% and cost of goods by 40% or more with
its rapidly scalable system. The Company has also produced authentic
human insulin in safflower, which is expected to enter clinical
trials in early 2008.
As a next step, SemBioSys expects to confirm the in vivo efficacy
of Arabidopsis-produced Apo AI in the third quarter of 2007.
SemBioSys intends to scale-up production of safflower-produced Apo AI
and perform the necessary preclinical work in 2008 in order to
initiate clinical trials in 2009.
About Apo AI
Apo AI is a developmental-stage cardiovascular therapy, designed
to rapidly stabilize and diminish atherosclerotic plaque for the
prevention and treatment of cardiovascular disease. Apo AI is the
major apolipoprotein associated with HDL, commonly referred to as
"good cholesterol", which naturally removes plaque from arteries.
In a six week clinical trial, Esperion Therapeutics (acquired by
Pfizer in 2003) demonstrated that its Apo AI(Milano)/phospholipid
formulation could reduce plaque volume at a level and speed of
atherosclerotic regression unattainable with any current drug
therapy. Similarly, both CSL Limited and Borean Pharma A/S have more
recently confirmed the strong therapeutic potential of their
respective Apo AI-based drug candidates (CSL-111 and Trimeric Apo
A-I) in clinical and preclinical trials.
High dosing (up to 20 grams per course of patient treatment)
coupled with a large patient population is expected to drive volume
demand of several tonnes of Apo AI per year, underscoring the value
of a highly scalable plant manufacturing solution.
About Cardiovascular Disease
Atherosclerotic cardiovascular diseases are the leading cause of
mortality in developed nations and by 2010 are projected to become
the leading cause of mortality worldwide. In the United States
coronary heart disease and stroke account for 70% of
cardiovascular-related deaths, which claims more lives each year than
the next four leading causes of death combined (cancer, respiratory
disease, accidents and diabetes). Drugs positioned in the cholesterol
and triglyceride management market are the single largest class of
prescription pharmaceuticals, with global sales exceeding US$35
billion in 2006.
Conference Call
SemBioSys will hold a conference call to discuss its Apo AI
production results today, July 12, 2007 at 1:30 p.m. Eastern Time.
The call will be hosted by Mr. Andrew Baum, President and CEO of
SemBioSys, and will be followed by a question and answer session. The
dial in number for the conference call is +1(800)731-5774 or
+1(416)644-3417.
A live audio webcast of the conference call will be available
through www.sembiosys.com. Please connect to this website at least 15
minutes prior to the conference call to ensure adequate time for any
software download that may be needed to hear the webcast. A replay of
the webcast will be available for 90 days at www.sembiosys.com. A
replay of the conference call will also be available by telephone on
July 12, 2007 through July 19, 2007. To access the replay, dial
+1(877)289-8525 or +1(416)640-1917 and enter reservation number
21240420 followed by the number sign.
About SemBioSys Genetics Inc. (www.sembiosys.com)
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology
company developing protein-based pharmaceuticals for metabolic and
cardiovascular diseases. The Company's lead candidate is recombinant
human insulin produced in the plant host safflower, to serve the
rapidly expanding global diabetes market and to supply insulin for
inhalation and other alternative insulin delivery technologies. The
Company is also developing Apo AI, a next generation cardiovascular
drug. In addition to its pharmaceutical products SemBioSys is
developing a series of non-pharmaceutical products addressing animal
and aquaculture health, nutritional oils and human topical markets.
This press release contains certain forward-looking statements,
including, without limitation, statements containing the words
"believe", "may", "plan", "will", "estimate", "continue",
"anticipate", "intend", "expect" and other similar expressions which
constitute "forward-looking  information" within the meaning of
applicable Canadian securities laws. Forward-looking statements
reflect the Company's current expectation and assumptions, and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially from those anticipated. These
forward-looking statements involve risks and uncertainties including,
but not limited to, changing market conditions, the successful and
timely completion of clinical studies, the establishment of corporate
alliances, the impact of competitive products and pricing, new
product development, uncertainties related to the regulatory approval
process and other risks detailed from time-to-time in the Company's
ongoing filings with the Canadian securities  regulatory authorities
which filings can be found at www.sedar.com. Given these risks and
uncertainties, readers are cautioned not to place undue  reliance on
such forward-looking statements. The Company undertakes no obligation
to publicly update or revise any forward-looking statements either as
a result of new information, future events or otherwise, except as
required by applicable Canadian securities laws.
Backgrounder
SEMBIOSYS ACHIEVES CRITICAL APO AI MILESTONE
- Canadian Biotechnology Company is the first company in the
worldto  produce recombinant Apo AI, a next generation
cardiovasculartherapy, using  plants -
Introduction
SemBioSys Genetics Inc. is developing apolipoprotein AI and its
variant apolipoprotein AI(Milano), collectively referred to as Apo
AI, to reduce and  stabilize vascular atherosclerotic plaque
associated with acute coronary syndrome (ACS), including heart attack
and unstable angina, and stroke indications.
Issues
  • Atherosclerotic cardiovascular diseases (CVD) are the leading causeof mortality in developed nations and by 2010, are projected to become the leading cause of mortality worldwide.
  • There is significant clinical need for pharmacological therapies that rapidly stabilize and diminish atherosclerotic plaque for the prevention and treatment of CVD.
  • Apo AI fulfills a critical role in natural processes of reverse cholesterol transport and offers considerable promise in the treatment of atherosclerotic disease.
  • Overwhelming epidemiological evidence demonstrates that people with low Apo AI are more susceptible to adverse cardiovascular events.
  • In a six week clinical trial, Esperion Therapeutics demonstrated that its Apo AI(Milano)/phospholipid formulation could reduce plaquevolume at a level and speed of atherosclerotic regression unattainable with any current drug therapy.
  • High dosing (up to 20 grams per course of patient treatment)coupled with a large patient population is expected to drive volume demand ofseveral tonnes of Apo AI per year.
  • Production of recombinant Apo AI using traditional fermentation- basedtechnologies have suffered from technical, economic and scalemanufacturing barriers that limit its commercial viability
Announcement
  • SemBioSys has successfully developed commercial levels of Apo AI insafflower seed lines.
  • SemBioSys' plant technology will address key Apo AI manufacturingconstraints and enable the clinical application of this promising new class of therapeutics.
  • SemBioSys is the first company in the world to produce recombinant Apo AI using plants.
Benefits
  • Targets the leading cause of global mortality through the treatment And prevention of cardiovascular disease.
  • Uses the naturally occurring protein and therefore appears to be lessprone to side effects.
  • Provides a low-cost, highly-scalable source of recombinant Apo AI to enable the clinical and commercial development of a transformativecardiovascular therapy.
  • Positions SemBioSys to participate in the CDN$35 billion cholesterolmanagement drug market.
  • Validates the broad potential of SemBioSys' transgenic technology in the production of therapeutic and industrial proteins facing cost andcapacity barriers to commercialization.
About Apo AI
Apo AI is a development-stage cardiovascular therapy, designed to
rapidly stabilize and diminish atherosclerotic plaque for the
prevention and treatment of cardiovascular disease. Apo AI is the
major apolipoprotein associated with high density lipoprotein (HDL),
commonly referred to as "good cholesterol", which naturally removes
plaque from arteries. Apo AI appears to have specific potential in
the acute treatment of patients presenting with acute coronary
syndrome or a recent stroke event, who are at high risk of a
recurrence due to unstable plaque.
In a six week Phase II clinical trial involving 47 patients,
Esperion Therapeutics, Inc. (acquired by Pfizer in 2003 for US$1.3
billion)  demonstrated that its proprietary Apo
AI(Milano)/phospholipid formulation  could reduce absolute atheroma
(plaque) volume by 4.2%; a level and speed of atherosclerotic
regression unattainable with current drug therapies Similarly, both
CSL Limited and Borean Pharma A/S have more recently confirmed the
strong therapeutic potential of their respective Apo AI-based drug
candidates (CSL-111 and Trimeric Apo A-I) in clinical and preclinical
trials.
Based upon Esperion's Phase II clinical dosing (15 to 45 mg/kg
body weight) and a large addressable patient population, SemBioSys
estimates that an Apo AI-based therapeutic could drive demand for
several tonnes of protein per year. Recombinant Apo AI is currently
produced at high-cost using microbial fermentation. This process
presents severe capacity limitations and endotoxin contamination
issues. SemBioSys' plant-based technology overcomes these
manufacturing barriers and is expected to bring significant cost and
scale benefits to Apo AI production.
Until recently, torcetrapib, a first-in-class cholesteryl ester
transfer protein (CETP) inhibitor developed by Pfizer, was viewed as
the forerunner small molecule drug designed to elicit atherosclerotic
regression. After promising early and mid-stage clinical trials,
Pfizer recently terminated their pivotal Phase III trials of
torcetrapib due to increased rates of angina, heart failure and death
in the treatment population. Unlike torcetrapib, which increased
serum HDL through dysregulation of lipoprotein metabolism, Apo AI
uses the natural mechanism of HDL particles to promote the body's
innate reverse cholesterol transport and is not expected to be
obstructed by the adverse events observed with torceptrapib. The
clinical setbacks reported with other HDL modulators like torcetrapib
and AGI-1067 clearly position Apo AI at the forefront of the
cardiovascular therapeutic candidates (see Nature 2006 Dec 14; pages
794-5).
About Cardiovascular Disease
According to the World Health Organization, atherosclerotic
cardiovascular diseases are the leading cause of mortality in
developed nations and by 2010, are projected to become the leading
cause of mortality worldwide. In the United States, coronary heart
disease and stroke account for 70% of cardiovascular-related deaths,
which claims more lives each year than the next four leading causes
of death combined (cancer, respiratory disease, accidents and
diabetes). Drugs positioned in the cholesterol and triglyceride
management market are the single largest class of prescription
pharmaceuticals, with global sales exceeding US$35 billion in 2006
(IMS Health, 2007).
Acute coronary syndrome (ACS) is associated with physiological
conditions characterized by insufficient blood flow to the heart and
describes individuals that present with either acute myocardial
infarction (heart attack) or unstable angina. Stroke is a condition
or event associated with neurological damage to the brain due to an
interruption in blood flow  resulting from either the blocking or
bursting of brain vasculature. SemBioSys believes there is a
significant clinical need for pharmacological therapies that rapidly
stabilize and diminish atherosclerotic plaque for the prevention and
treatment of ACS and stroke.
Upcoming Milestones
As a next step, SemBioSys expects to confirm the in vivo efficacy
of Arabidopsis-produced Apo AI in the third quarter of 2007.
SemBioSys intends to scale-up production of safflower-produced Apo AI
and perform the necessary preclinical work in 2008 in order to
initiate clinical trials in 2009.
About SemBioSys Genetics Inc. (www.sembiosys.com)
SemBioSys Genetics Inc. (SBS.TSX) is a Calgary-based biotechnology
company engaged in the development and commercialization of protein
pharmaceutical and non-pharmaceutical products.
Its proprietary protein production system addresses major
commercialization challenges associated with the production of
recombinant proteins including overcoming limitations in scale,
capital costs and production costs. SemBioSys' proprietary technology
harnesses the natural ability of seeds to produce, extract and purify
proteins in large quantities and at low cost, while dramatically
reducing downstream purification costs.SemBioSys estimates it can
reduce capital costs for protein production by up to 70% and cost of
goods by 40% or more with its rapidly scalable system. It is unique
as the only transgenic technology that addresses protein recovery and
purification simultaneously with bulk protein production SemBioSys'
technology is compatible with simple peptides, polypeptides and
complex proteins such as antibodies.
SemBioSys' pharmaceutical pipeline is focused on metabolic and
cardiovascular disorders. The Company's two lead pharmaceutical
products, insulin and Apo AI target the USCDN$7.3 billion insulin
market and the US$35 billion cholesterol/triglyceride therapeutic
market. SemBioSys' insulin will provide an economical alternative to
commercially available insulin to better serve developing nations and
meet the anticipated surge in demand with the advent of alternative
insulin delivery technologies. Apo AI is a novel therapy with the
ability to reduce and stabilize atherosclerotic plaque, a key risk
factor in acute coronary syndrome and stroke.
SemBioSys' non-pharmaceutical pipeline consists of products aimed
at human topical (personal care, over-the-counter and prescription
products), nutritional oil, animal health and aquaculture markets.
SemBioSys launched its first non-pharmaceutical product, the
DermaSphere(R) Oleosome Technology in 2004 with first sales being
made in mid-2005. Our second non- pharmaceutical product,
ImmunoSphere(TM), is a specialty feed additive that enhances viral
disease resistance in shrimp, a widespread and often devastating
problem for the US$7.5 billion shrimp aquiculture market.The
non-pharmaceutical segment of our business will generate short and
intermediate term income and enable us to develop the infrastructure
required to commercialize our high-value pharmaceutical product
candidates.

Contact:

For further information: SemBioSys Genetics Inc., Mr. Andrew Baum,
President and Chief Executive Officer, Phone:+1-403-717-8767, Fax:
+1-403-250-3886, E-mail: bauma@sembiosys.com, Investor Relations,
Ross Marshall, The Equicom Group Inc., Phone: +1-416-815-0700 (Ext.
238), Fax: +1-(416) 815-0080, E-mail: rmarshall@equicomgroup.com
(SBS.)

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