- Canadian Biotechnology Company updates progress and upcoming milestones
on its insulin program -
TSX symbol: SBS
CALGARY, June 26 /CNW/ - 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 plant
- Laboratory results demonstrating that safflower-produced insulin is
physically, structurally and physiologically indistinguishable from
pharmaceutical-grade human recombinant insulin.
- 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
"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 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.
For further information:
For further information: SemBioSys Genetics Inc., Mr. Andrew Baum,
President and Chief Executive Officer, Phone: (403) 717-8767, Fax: (403)
250-3886, E-mail: email@example.com, Internet: www.sembiosys.com; Investor
Relations, Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext.
238), Fax: (416) 815-0080, E-mail: firstname.lastname@example.org