Calgary, Alberta, Canada
September 16, 2008
SemBioSys Genetics Inc.
(TSX:SBS), a biotechnology company developing a portfolio of
therapeutic proteins for
metabolic and cardiovascular diseases, today announced that it
is eligible to proceed with its planned Phase I/II human
clinical trial of plant-produced insulin now that the 30-day
review period of its Investigational New Drug
(IND) application has passed. SemBioSys submitted the
application in July to the U.S. Food and Drug Administration
(FDA), which has now completed its review of the file. As
previously announced, SemBioSys intends to conduct the Phase
I/II insulin trial in Europe. Prior to proceeding with the
planned trial in the United Kingdom, the company's Clinical
Trial Application (CTA) must be reviewed by the appropriate
European regulatory authorities.
"The company continues to achieve its insulin development
milestones on time. Our recent accomplishments confirm our
confidence in our regulatory and development strategy using
plants as a low-cost production host for insulin. Plant-produced
human recombinant insulin represents a major step forward in
insulin production. We believe, furthermore, that these upcoming
studies could prove to be the greatest achievement in insulin
production since the advent of recombinant human insulin in the
early 80's," said Andrew Baum, president and
chief executive officer of SemBioSys. "The purpose of filing an
IND in the U.S., even though we intend to conduct the trial in
Europe, is to ensure that we can pursue U.S. and European
regulatory approval of our plant-produced
insulin contemporaneously. Conducting the planned insulin trial
in Europe allows us to establish the bioequivalence of our
safflower-produced insulin to commercially available insulin
products from both the U.S. and Europe in a single trial."
SemBioSys plans to initiate a Phase I/II human trial of its
safflower-produced insulin in the United Kingdom during the
fourth quarter of 2008. Prior to proceeding with the trial the
company must await clearance from
the Medicines and Healthcare products Regulatory Agency (MHRA)
in the United Kingdom. SemBioSys' planned Phase I/II human
clinical trial is designed to enroll up to 30 healthy volunteers
in a three-arm study to demonstrate the bioequivalence of
safflower-produced insulin to comparator insulin products.
The European authorities are the first major healthcare
regulators to have published guidance documents that ensure
insulin is eligible to receive approval through an abbreviated
regulatory path. Separately, the U.S. FDA has advised SemBioSys
that safflower-produced insulin is eligible to receive approval
through an abbreviated 505(b)(2) approval process.
The world market value for insulin is estimated to be in excess
of US$7.1 billion today and the demand for insulin is projected
to increase due to two factors. The growing incidence of
diabetes combined with the expanded use of insulin therapy is
expected to almost double insulin demand over the next five
years and increase the global insulin market to over $15 billion
by 2012. SemBioSys' plant-made insulin is expected to offer
substantial capital and cost-of-goods reductions with the
potential to enter the market as a low-cost, easily expandable
source of insulin to meet exploding global demand.
Calgary, Alberta-based SemBioSys Genetics Inc. is a
biotechnology company developing protein-based pharmaceuticals
for metabolic and cardiovascular diseases. The Company's lead
pharmaceutical candidates, produced in the plant host safflower,
are recombinant human insulin to serve the rapidly expanding
global diabetes market and Apo AIMilano, a next generation
cardiovascular drug. In addition to its pharmaceutical products,
SemBioSys and its subsidiary, Botaneco Specialty Ingredients
Inc., are developing a series of non-pharmaceutical products
addressing human topical, nutritional oils and agricultural
biotechnology markets. |
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