SemBioSys Submits IND for Safflower-Produced Insulin to U.S. FDA

Calgary (ots/PRNewswire) -

- Submission Demonstrates Progress of Plant-Derived Insulin
Program Scheduled to Enter the Clinic Later This Year

SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company
developing a portfolio of therapeutic proteins for metabolic and
cardiovascular diseases, today announced that it has submitted an
Investigational New Drug (IND) application for safflower-produced
recombinant human insulin to the United States Food and Drug
Administration (FDA). The IND application contains a physical,
chemical and structural analysis of safflower-produced insulin to a
reference standard, results from 28-day sub-chronic toxicology
studies in two species of mammals, demonstration of pharmacodynamic
function in animals and describes a cGMP process for the production
of safflower-produced insulin. SemBioSys plans to initiate a Phase
I/II clinical study of its safflower-produced insulin in the fourth
quarter of 2008.

"The submission of the IND is a critical step toward the
initiation of a Phase I/II clinical trial with our recombinant human
insulin produced from safflower. All of our studies to date confirm
that our safflower-produced insulin is equivalent to
pharmaceutical-grade human insulin. We met our internal schedule to
submit the IND and we are on track to begin human clinical trials in
the fourth quarter of 2008 as planned," said Andrew Baum, president
and chief executive officer of SemBioSys. "While we intend to
initiate our first clinical trial for insulin in the UK, a successful
IND application will provide us with the opportunity to consult the
FDA on later stage clinical development. We believe this will allow
us to apply for European and U.S. approvals for our
safflower-produced insulin simultaneously."

SemBioSys also intends to submit a Clinical Trial Application
(CTA) to the appropriate European authorities later this quarter.
Assuming approval of the CTA, SemBioSys intends to conduct a Phase
I/II trial in the UK. The CTA requests approval to initiate a Phase
I/II human clinical trial designed to enroll up to 30 healthy
volunteers to demonstrate the bioequivalence of safflower-produced
insulin to comparator insulin products. After discussions with the
FDA in late 2006, SemBioSys was informed that safflower-produced
insulin is eligible to receive approval through an abbreviated
505(b)(2) regulatory path. The European authorities have already
published guidance documents concerning the approval of human insulin
which are consistent with this approach.

The world market 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: demographic and dietary choices in the
western world are causing an increase in the incidence of diabetes;
and at the same time, countries in the rest of the world that are
currently underserved in the insulin market, are demanding greater
access to insulin at an affordable price. By 2012, independent
estimates predict a US$15 billion insulin market. SemBioSys'
plant-made insulin is expected to offer capital and operating cost
reductions with the potential to enter the market as a low-cost,
easily expandable source of insulin to meet this exploding demand.

About SemBioSys Genetics Inc.

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. More information is
available and can be accessed at http://www.sembiosys.com.

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 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 and market size, the acceptance of an
IND by the FDA in respect of clinical studies, the submission of a
CTA to the appropriate European authorities, the successful
initiation and timely and successful completion of clinical studies,
the fact that Apo AI is currently a development stage drug, 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: SemBioSys Genetics Inc.: Andrew Baum,
President and Chief Executive Officer, Phone: +1-403-717-8767,
E-mail: bauma@sembiosys.com; The Trout Group: Ian Clements, Senior
Vice President, Phone: +1-415-392-3385, E-mail:
iclements@troutgroup.com

ots Originaltext: SemBioSys, Genetics Inc
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information: SemBioSys Genetics Inc.: Andrew Baum,
President and Chief Executive Officer, Phone: +1-403-717-8767,
E-mail: bauma@sembiosys.com; The Trout Group: Ian Clements, Senior
Vice President, Phone: +1-415-392-3385, E-mail:
iclements@troutgroup.com