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Sembiosys achieves major insulin milestone
Posted by: Dr. Manfred G. Raupp (IP Logged)
Date: November 25, 2006 02:46PM

www.raupp.info

SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a
broad pipeline of protein-based pharmaceuticals and non-pharmaceutical
products, today announced that the Company has achieved its commercial
target levels of human insulin (insulin) accumulation in safflower with
1.2 percent of total seed protein, November 2006.

The results from the Company's commercial plant system exceeded its
target of one percent accumulation and confirm the potential of
plant-produced insulin to fundamentally transform the economics and
scale of insulin production.

"These results demonstrate that we have produced an authentic insulin
molecule in safflower at commercially viable levels. Achieving our goal
of one percent insulin accumulation in safflower confirms that SemBioSys
has the potential to dramatically impact the economics of insulin
manufacturing," said Andrew Baum, President and CEO of SemBioSys
Genetics Inc. "At these levels we can produce over one kilogram of
insulin per acre of safflower production, which is enough to supply
2,500 patients for one year of treatment. We believe that we could meet
the world's total projected insulin demand in 2010 with less than 16,000
acres of crop production. Our plan is to continue to scale-up production
for sufficient material to initiate clinical trials and file an
Investigational New Drug (IND) application in the second half of 2007."

SemBioSys intends to continue its preclinical program with
safflower-derived insulin and assemble the components of its IND
application including toxicology, immunology profiles and demonstration
of efficacy in animal models. The Company expects to be in a position to
submit an IND to the U.S. Food and Drug Administration in the second
half of 2007 in preparation for a clinical trial in late 2007 or early
2008.

"Achieving our commercial insulin targets is the most significant
milestone for our Company to date. The production of insulin at
commercial levels in safflower significantly reduces the risk of our
insulin development program and, from a broader perspective, provides us
with confidence that our core technology and plant-made pharmaceuticals
have a role as an enabling technology in the future of biopharmaceutical
manufacturing," continued Mr. Baum.

Demand for insulin for the treatment of diabetes reached an estimated
4,000 to 5,000 kilograms in 2005 and is projected to increase to 16,000
kilograms by 2010. Demand for insulin is expected to grow due to earlier
diagnosis and increased incidence based on demographic trends, as well
as, consumption and behavioural habits. Significant growth in demand is
also expected from new alternative delivery methods, including inhaled
insulin devices that require between five and ten times the amount of
insulin as injection methods. Earlier this year the first inhaled
insulin delivery technology, Pfizer's Exubera(R) Inhalation Powder,
received approval in the U.S. and EU. Pfizer expects to launch the
product in the U.S. later this year.

SemBioSys believes its safflower-produced insulin can reduce capital
costs compared to existing insulin manufacturing by 70% and product
costs by 40%. SemBioSys believes safflower-produced insulin would
require approximately $80 million in capital investment for 1,000
kilograms of insulin production capacity. Alternatively, insulin
currently produced using fermentation is estimated to require $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.

Insulin Production

Existing commercial insulin production methods typically rely on yeast
(Saccharomyces cerevisiae) or bacteria (E. coli) genetically engineered
to produce synthetic human insulin. These organisms are grown in large,
capital-intensive steel bioreactors and the insulin is then extracted
and purified for final formulation.

SemBioSys uses safflower to produce human insulin. Through its
proprietary technology, SemBioSys is able to accumulate recombinant
proteins, like insulin, in safflower. As the plant grows and the seed
develops, the insulin protein is produced in the seed. Safflower
production is based on conventional farming practices that have been
adapted to ensure product integrity and confinement. The harvested seed
is then processed using SemBioSys' proprietary extraction process.
Conventional enzymatic or chemical cleavage techniques and downstream
processing methods are employed to produce purified insulin.

The selection of safflower as its commercial plant system was based on
safflower's superior technical profile as well as the advantages it
offers to address the strict regulatory criteria expected for plant-made
pharmaceuticals. Safflower is a low acreage crop that can be easily
segregated from other safflower production. This, in combination with
the biology of the crop's pollination patterns facilitates containment
of the crop.

Conference Call

SemBioSys will hold a conference call to discuss its insulin
accumulation results today, July 18, 2006 at 11:00am 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) 814-4857 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 starting on July 18, 2006 at
www.sembiosys.com. A replay of the conference call will also be
available by telephone on July 18, 2006 through July 25, 2006. To access
the replay, dial 1 (877) 289-8525 and enter reservation number 21196950
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
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. SemBioSys currently has
funded partnership agreements with Martek Biosciences Corporation, Lonza
Inc. and Arcadia Biosciences, Inc.

This press release contains 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,
which 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.


www.checkbiotech.org

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