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. 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.
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.