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SemBioSys, Genetics Inc

SemBioSys Confirms Commercially Viable Levels of Native APO AI in Safflower

Calgary, Canada (ots/PRNewswire)

- Canadian Biotechnology Company has now Established Commercial
Levels of Both Native Apo AI and Apo AI(Milano) variant in Safflower
Seed Lines
SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company
developing a portfolio of therapeutic proteins for metabolic and
cardiovascular diseases , today announced that it has achieved the
commercial threshold of apolipoprotein AI (native Apo AI)
accumulation in safflower seed. WhileSemBioSys confirmed in a press
release dated August 22, 2007 that it had achieved commercially
viable levels of the Apo AI(Milano) variant, it has now also attained
commercial levels of native Apo AI in safflower.
"These results confirm that we have successfully achieved our
commercial threshold for native Apo AI accumulation in safflower, in
addition to achieving the Apo AI(Milano) variant threshold, which
together represent a key milestone in our cardiovascular drug
development program and which open further opportunities for
partnerships. We believe that plant-produced Apo AI will overcome the
cost and capacity challenges of manufacturing Apo AI with traditional
fermentation-based production systems , making it an attractive
candidate for any pharmaceutical company with a presence, or desire
to create a presence, in the cardiovascular market," said Andrew
Baum, President and CEO of SemBioSys Genetics Inc. "We intend to
perform the necessary preclinical work during the remainder of 2007
and 2008, and anticipate initiating clinical trials in 2009 of
safflower- produced Apo AI. In the meantime, during the fourth
quarter of 2007 we intend to perform the necessary work to confirm
that Apo AI produced in our model plant system, Arabidopsis, is
functionally equivalent to natural Apo AI in mammals."
The Company currently intends to partner one, or both, of the
native Apo AI and Apo AI(Milano) variant programs prior to or shortly
after Phase I clinical trials in 2009. SemBioSys believes its
proprietary oilbody- oleosin production system offers the potential
to overcome the manufacturing cost an capacity challenges of
traditional fermentation- based technologies that have impeded the
commercial development of Apo AI- based therapies.
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
believed by many clinicians to be the basis for the next generation
of cardiovascular drugs, which represented a $35 billion market in
2006. 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)
variant/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.
About SemBioSys Genetics Inc. (http://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 pharmaceutical
candidates, produced in the plant host safflower, are recombinant
human insulin to serve the rapidly expanding global diabetes market
and Apo AI, a next generation cardiovascular drug. In addition to its
pharmaceutical products, SemBioSys is developing a series of
non-pharmaceutical products addressing human topical, nutritional
oils and animal health 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 and market size, the
acceptance of an IND by the FDA in respect of clinical studies and
the successful and timely completion of clinical studies, the fact
that Apo AI is currently a development stage drug, 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
Internet: http://www.sembiosys.com

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

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