Calgary, Canada (ots/PRNewswire) -
- Canadian Biotechnology Company Updates Progress and Upcoming
Milestones on its Insulin Program
- TSX symbol: SBS
SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company
developing a portfolio of therapeutic proteins for metabolic and
cardiovascular disease, today announced positive preclinical data
supporting the development of plant-derived recombinant human
insulin. The Company presented its findings at the 67th Scientific
Sessions of the American Diabetes Association (ADA) in Chicago.
Specifically, the Company's abstract and poster presentation
highlighted its recent accomplishments in the development of a
highly-scalable, low-cost source of insulin, including:
- Results demonstrating that the Company exceeded its commercial
target levels of insulin accumulation in safflower, its commercial
- Laboratory results demonstrating that safflower-produced
insulin is physically, structurally and physiologically
indistinguishable from pharmaceutical-grade human recombinant
- Laboratory results from competitive receptor binding assays
demonstrating the functional equivalence of the Company's safflower-
produced insulin to insulin reference standard.
- Animal results from insulin tolerance test assays demonstrating
the pharmacodynamic equivalence of safflower-derived insulin to
pharmaceutical- grade insulin.
"These results validate the feasibility of our plant production
technology for the large-scale manufacture of human insulin. Plants
are a transformative platform for the production of
biopharmaceuticals. They are ideally suited to large volume products
such as human insulin, where capacity is in short supply. Plants
offer unprecedented capacity and flexibility for low-cost
biopharmaceutical manufacturing and provide by far the most
attractive economics, both in terms of capital and cost of goods,"
said Andrew Baum, President and CEO of SemBioSys Genetics Inc. "We
have confirmed our intention to pursue an abbreviated clinical trial
under the 505(b)(2) rules of the Food and Drug Act after a meeting
with the U.S. Food and Drug Administration late last year. We expect
to enter directly into a Phase II trial in early 2008 with
commercialization of safflower-produced insulin scheduled for as
early as 2010."
During the Scientific Sessions on Sunday June 24th, Dr. Larry C.
Deeb , ADA President, Medicine and Science, highlighted the need for
increased access to insulin and insulin treatment as part of his
presidential address . Dr. Deeb described the dire situation facing
those suffering from type 1 diabetes in parts of Africa where the
cost of insulin is a primary barrier to treatment.
Insulin is the largest volume recombinant biopharmaceutical
product on the market today with production estimated at
approximately 6,000 kilograms in 2006 and sales in excess of US$7.5
billion worldwide. SemBioSys estimates that the demand for insulin
will increase to nearly 16,000 kilograms in 2012; fuelled by an
increasing incidence of diabetes, increasing demand for access to
insulin treatment in the developing world and adoption of alternate
insulin delivery technologies, which require between 5 to 20 times
more insulin than injection methods, in the developed world.
The scientific poster and abstract SemBioSys presented at the ADA
were entitled: "Chemical and Biological Characterization of
Recombinant Human Insulin Produced in Transgenic Plants." Abstract
Number 0459-P by Joseph Boothe and colleagues at SemBioSys.
About SemBioSys Genetics Inc. (www.sembiosys.com)
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology
company developing insulin and other 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's other protein-based
pharmaceutical candidate is a cardiovascular drug called Apo AI.
SemBioSys is also developing a series of non- pharmaceutical products
addressing animal and aquaculture health, nutritional oils and human
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.
ots Originaltext: SemBioSys, Genetics Inc
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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: email@example.com; Investor Relations,
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