SemBioSys to Proceed With Abbreviated Regulatory Path for Plant-Produced Insulin After Meeting With the FDA

Calgary, Canada (ots/PRNewswire) -

- Canadian Biotechnology Company Shortens Clinical Timelines by
Eliminating Duplicative Insulin Trials

TSX symbol: SBS

SemBioSys Genetics Inc. (TSX: SBS), a biotechnology company
developing a broad pipeline of protein-based pharmaceuticals and
non-pharmaceutical products, today provided an update on the expected
regulatory strategy for the Company's plant-produced insulin after a
recent meeting with the U.S. Food and Drug Administration (FDA). The
preparatory meeting for the Company's Investigational New Drug
Application (IND) for plant-produced insulin was scheduled as part of
the normal development process. SemBioSys approached the FDA to
confirm the viability of submitting plant-produced insulin under
Section 505(b)(2) of the Food, Drug, and Cosmetic Act in order to
achieve approval for a New Drug Application.

"Based on the discussions with the FDA and the agreed upon minutes
from the meeting we will continue to pursue a 505(b)(2) regulatory
path for our plant-produced insulin," said Andrew Baum, President and
CEO of SemBioSys Genetics Inc. "When we completed our initial public
offering in 2004, the regulatory path for follow-on proteins remained
relatively uncertain. Insulin is a comparatively simple protein for
which an extensive amount of clinical data on safety and efficacy
already exists. Providing that our plant-produced insulin is
sufficiently pure and clinically equivalent to commercially available
insulin, the meeting confirmed the 505(b)(2) regulatory approach is
an appropriate path for approval. During our discussion with the
Agency we also established that there were no issues precluding the
use of safflower as a production vehicle. Now that the regulatory
path for our safflower-produced insulin candidate is established,
another element of risk has been removed from our development plan."

In July 2006, SemBioSys exceeded its targeted levels of insulin
expression in safflower, the Company's commercial crop system, by
achieving 1.2 percent insulin accumulation of total seed protein. In
November, the Company announced that it had executed a preclinical
and early stage clinical manufacturing supply agreement with Cangene
Corporation. SemBioSys expects to receive in vivo and in vitro
biochemical and functional equivalence results comparing insulin
produced from safflower to commercial insulin products early in 2007.
The biochemical and functional equivalence results together with
additional preclinical work underway will form the basis of
SemBioSys' IND which it expects to submit to the FDA in the fourth
quarter of 2007. SemBioSys intends to initiate a Phase II trial of
safflower-produced insulin in late 2007 or early 2008 with
pharmacokinetics and pharmacodynamics as the primary endpoints.

Demand for insulin for the treatment of diabetes reached an
estimated 5,500 kilograms in 2005 and is projected to increase to
16,000 kilograms by 2012. SemBioSys believes its safflower-produced
insulin can reduce capital costs compared to existing insulin
manufacturing by 70% and product costs by 40% or more. 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.

About 505(b)(2) Application

An application submitted under section 505(b)(2) of the Food,
Drug, and Cosmetic Act comprises an application for approval for a
drug for which one or more of the investigations relied on by the
applicant were not conducted by or for the applicant and for which
the applicant has not obtained a right of reference or use from the
sponsor applicant by or for whom the investigations were conducted.
The 505(b)(2) pathway is intended to encourage innovation in drug
development without requiring duplicative studies to demonstrate what
is already known about a drug while protecting the patent and
exclusivity rights for the approved drug. Eliminating the need to
conduct certain duplicative clinical studies can reduce the number of
clinical studies, number of human patients and/or clinical timelines
in comparison to the clinical program required. An example of a
505(b)(2) is a naturally derived or recombinant active ingredient
application for a drug product containing an active ingredient(s)
derived from animal or botanical sources or recombinant technology
where clinical investigations are necessary to show that the active
ingredient is the same as an active ingredient in a listed drug.

About SemBioSys Genetics Inc. (www.sembiosys.com)

Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology
company focused on the development, commercialisation 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 stage 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.

This press release contains 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, which 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.

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

Contact:
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: bauma@sembiosys.com, Internet:
www.sembiosys.com; Investor Relations, Ross Marshall, The Equicom
Group Inc., Phone: +1-416-815-0700 (Ext. 238), Fax: +1-416-815-0080,
E-mail: rmarshall@equicomgroup.com/ (SBS.)


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