SemBioSys' Plant-Produced Insulin Chemically and Physiologically Equivalent to Commercial Insulin in Animal Studies

Calgary, Alberta (ots/PRNewswire) -

- Canadian Biotechnology Company Takes Next Significant Step
Towards Advancing its Product to the Clinic -

SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company
developing a broad pipeline of protein-based pharmaceuticals and
non-pharmaceutical products, today announced that its proprietary
plant-produced insulin has been demonstrated in animal models to be
chemically, structurally and functionally equivalent to U.S. pharma
grade human insulin. The results of analytical, in vitro and in vivo
assays confirm that insulin produced in safflower, SemBioSys'
commercial crop, is indistinguishable from human insulin
analytically and physiologically.

"Establishing insulin equivalence is the second major scientific
milestone from our insulin program in the past six months. By
exceeding our commercial target levels of human insulin accumulation
in safflower last July and now confirming that safflower-produced
insulin is physiologically equivalent to human insulin we believe we
have substantially lowered the scientific risk of our insulin
program," said Andrew Baum, President and CEO. "As a result of these
achievements we expect that we will be able to submit an
Investigational New Drug Application (IND) later this year and
initiate a Pharmacokinetic/Pharmacodynamic study of
safflower-produced insulin late in the fourth quarter of 2007 or
early in the first quarter of 2008, leading to an end of Phase II
meeting with the FDA in 2008."

SemBioSys has confirmed the equivalence of safflower-produced
insulin through analytical, in vitro, and in vivo animal assays.
Chemical and structural authenticity have been confirmed through
mass spectrometry and peptide fingerprint analysis. Functionality of
safflower-produced insulin has been demonstrated using in vitro
receptor phosphorylation assays, confirming biological activity in
human cells. Finally, SemBioSys has demonstrated functional
equivalence through conducting insulin tolerance testing in mice,
which monitors blood glucose levels as the assay variable,
confirming that there is no statistically significant difference in
the pharmacodynamic response of safflower-produced insulin in
comparison to Eli Lilly's Humulin(R) and U.S.P. insulin treatments.

"The equivalence results demonstrate that we have done what we
said we were going to do, when we said we would do it, which
continues to build our confidence in the insulin program. With the
achievement of commercial levels of insulin accumulation in
safflower and confirmation of equivalence , our ability to execute
continues to be critically important, however, the overall insulin
program risk has now been significantly reduced. Insulin is a
well-characterized compound for which a great deal of data already
exists . With these high-risk scientific achievements behind us, we
now transition to the execution stage of our clinical development
plan for insulin," said Mr. Baum.

The results from the equivalence testing are the most recent
achievement in a series of four significant milestones events for the
insulin program. In July 2006, SemBioSys exceeded its target level of
insulin accumulation in safflower. In November, SemBioSys signed an
agreement with Cangene Corporation to purify safflower-produced
insulin from SemBioSys' seed lines under cGMP for clinical trials.
Finally, earlier this month SemBioSys announced that after meeting
with the U.S. Food and Drug Administration (FDA) it would proceed
with an abbreviated regulatory path for safflower-produced insulin
under a 505(b)(2) application. The Company expects to be in a
position to submit an IND to the FDA in the second half of 2007 and
to initiate a PK/PD bioequivalence study in late 2007 or early 2008
to be followed by a Phase III study in support of an NDA.

Demand for insulin for the treatment of diabetes reached an
estimated 5,000 to 6,000 kilograms in 2005 and is projected to
increase to 16,000 kilograms by 2012. Demand for insulin is expected
to grow due to a number of issues including; earlier diagnosis of
diabetes; increased diabetes incidence in the developed world due to
demographic trends, as well as consumption and behavioural habits;
increasing incidence in the developing world due to increasing
affluence and changing dietary habits; new alternative delivery
methods that require between five and ten times the amount of
insulin as injection methods; and the use of insulin as a treatment
for type 2 diabetes patients earlier in the treatment protocol as
recommended by the consensus statement from the American Diabetes
Association and the European Association for the Study of Diabetes.

SemBioSys believes its safflower-produced insulin can reduce
capital costs compared to existing insulin manufacturing by up to
70% and product costs by 40% or more. Insulin currently produced
using fermentation is estimated to require US$200 to US$250 million
in capital investment for 1,000 kilograms of production capacity. In
addition, because of the ease in scaling-up crop acreage,
plant-produced insulin offers significant improvements in the
flexibility and speed of scale-up. SemBioSys has five years of
experience growing transgenic safflower in Canada, the U.S., Mexico
and Chile under permits issued by the pertinent regulatory
authorities.

Conference Call

SemBioSys will hold a conference call to discuss its insulin
results today, January 10, 2007 at 8:30am 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)-732-6179 or
+1-(416)-644-3425. A live audio webcast of the call will be
available at www.sembiosys.com. The webcast will be archived for 90
days.

A replay of the conference call will also be available by
telephone on January 10, 2007 through January 17, 2007. To access
the replay, dial +1-( 877)-289-8525 or +1-(416)-640-1917 and enter
reservation number 21215902 followed by the number sign.

About SemBioSys Genetics Inc. (www.sembiosys.com)

Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology
company focused on the development, commercialization and production
of biopharmaceuticals and non-pharmaceutical products based on its
plant genetic engineering skills and proprietary oilbody-oleosin
technology platform - the Stratosome(TM) Biologics System. Its two
lead pharmaceutical product candidates are insulin and a
developmental stage cardiovascular drug called Apo AI. It also has a
series of non-pharmaceutical products addressing animal and
aquaculture health, nutritional oils and human topical markets.

Certain statements included or incorporated by reference in this
press release constitute forward-looking statements. All statements
contained herein that are not clearly historical in nature are
forward-looking, and the words "anticipate", "believe", "expect",
"estimate" and similar expressions are generally intended to
identify forward-looking statements. All forward-looking statements
are based on the Corporation's beliefs and assumptions based on
information available at the time the assumption was made. These
forward-looking statements are not based on historical facts but
rather on management's expectations regarding future growth, results
of operations, performance, future capital and other expenditures
(including the amount, nature and sources of funding thereof),
competitive advantages, business prospects and opportunities.
Forward-looking statements involve significant known and unknown
risks, uncertainties, assumptions and other factors that may cause
the Corporation's actual results, levels of activity , performance or
achievements to differ materially from those implied by
forward-looking statements. These factors should be considered
carefully and prospective investors should not place undue reliance
on the forward- looking statements. Although the forward-looking
statements contained in this press release or incorporated by
reference are based upon what the Corporation's management believes
to be reasonable assumptions, the Corporation cannot assure
investors that actual results will be consistent with these
forward-looking statements. These forward-looking statements are
made as of the date of this press release or as of the date specified
in the documents incorporated by reference into this press release,
as the case may be. The Corporation undertakes no obligation to
update any forward- looking statement or statements to reflect events
or circumstances after the date on which such statement is made or
to reflect the occurrence of unanticipated events, except as may be
required by applicable Canadian securities laws.

TSX symbol: SBS

ots Originaltext: SemBioSys, Genetics Inc
Im Internet recherchierbar: http://www.presseportal.de

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, Internet:
www.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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