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SemBioSys' plant-produced insulin equivalent to commercial insulin
Posted by: Prof. Dr. M. Raupp (IP Logged)
Date: January 12, 2007 08:37AM

www.checkbiotech.org ; www.raupp.info ; www.czu.cz

SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a
broad pipeline of protein-based pharmaceuticals and non-pharmaceutical
products, announced that its proprietary plant-produced insulin has been
demonstrated in animal models to be chemically, structurally and
functionally equivalent to U.S. pharma grade human insulin, January 2007.

The results of analytical, in vitro and in vivo assays confirm that
insulin produced in safflower, SemBioSys' commercial crop, is
indistinguishable from human insulin analytically and physiologically.

"Establishing insulin equivalence is the second major scientific milestone
from our insulin program in the past six months. By exceeding our commercial
target levels of human insulin accumulation in safflower last July and now
confirming that safflower-produced insulin is physiologically equivalent to
human insulin we believe we have substantially lowered the scientific risk
of our insulin program," said Andrew Baum, President and CEO. "As a result
of these achievements we expect that we will be able to submit an
Investigational New Drug Application (IND) later this year and initiate a
Pharmacokinetic/Pharmacodynamic study of safflower-produced insulin late in
the fourth quarter of 2007 or early in the first quarter of 2008, leading to
an end of Phase II meeting with the FDA in 2008."

SemBioSys has confirmed the equivalence of safflower-produced insulin
through analytical, in vitro, and in vivo animal assays. Chemical and
structural authenticity have been confirmed through mass spectrometry and
peptide fingerprint analysis. Functionality of safflower-produced insulin
has been demonstrated using in vitro receptor phosphorylation assays,
confirming biological activity in human cells. Finally, SemBioSys has
demonstrated functional equivalence through conducting insulin tolerance
testing in mice, which monitors blood glucose levels as the assay variable,
confirming that there is no statistically significant difference in the
pharmacodynamic response of safflower-produced insulin in comparison to Eli
Lilly's Humulin(R) and U.S.P. insulin treatments.

"The equivalence results demonstrate that we have done what we said we were
going to do, when we said we would do it, which continues to build our
confidence in the insulin program. With the achievement of commercial levels
of insulin accumulation in safflower and confirmation of equivalence, our
ability to execute continues to be critically important, however, the
overall insulin program risk has now been significantly reduced. Insulin is
a well-characterized compound for which a great deal of data already exists.
With these high-risk scientific achievements behind us, we now transition to
the execution stage of our clinical development plan for insulin," said Mr.
Baum.

The results from the equivalence testing are the most recent achievement in
a series of four significant milestones events for the insulin program. In
July 2006, SemBioSys exceeded its target level of insulin accumulation in
safflower. In November, SemBioSys signed an agreement with Cangene
Corporation to purify safflower-produced insulin from SemBioSys' seed lines
under cGMP for clinical trials. Finally, earlier this month SemBioSys
announced that after meeting with the U.S. Food and Drug Administration
(FDA) it would proceed with an abbreviated regulatory path for
safflower-produced insulin under a 505(b)(2) application. The Company
expects to be in a position to submit an IND to the FDA in the second half
of 2007 and to initiate a PK/PD bioequivalence study in late 2007 or early
2008 to be followed by a Phase III study in support of an NDA.

Demand for insulin for the treatment of diabetes reached an estimated 5,000
to 6,000 kilograms in 2005 and is projected to increase to 16,000 kilograms
by 2012. Demand for insulin is expected to grow due to a number of issues
including; earlier diagnosis of diabetes; increased diabetes incidence in
the developed world due to demographic trends, as well as consumption and
behavioural habits; increasing incidence in the developing world due to
increasing affluence and changing dietary habits; new alternative delivery
methods that require between five and ten times the amount of insulin as
injection methods; and the use of insulin as a treatment for type 2 diabetes
patients earlier in the treatment protocol as recommended by the consensus
statement from the American Diabetes Association and the European
Association for the Study of Diabetes.

SemBioSys believes its safflower-produced insulin can reduce capital costs
compared to existing insulin manufacturing by up to 70% and product costs by
40% or more. Insulin currently produced using fermentation is estimated to
require $200 to $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.

Conference call
SemBioSys will hold a conference call to discuss its insulin results today,
January 10, 2007 at 8:30am eastern time. The call will be hosted by Mr.
Andrew Baum, President and CEO of SemBioSys, and will be followed by a
question and answer session. The dial in number for the conference call is 1
(800) 732-6179 or 1 (416) 644-3425. A live audio webcast of the call will be
available at www.sembiosys.com. The webcast will be archived for 90 days.
A replay of the conference call will also be available by telephone on
January 10, 2007 through January 17, 2007. To access the replay, dial 1
(877) 289-8525 or 1 (416) 640-1917 and enter reservation number 21215902
followed by the number sign.

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

Forward-looking statements
Certain statements included or incorporated by reference in this press
release constitute forward-looking statements. All statements contained
herein that are not clearly historical in nature are forward-looking, and
the words "anticipate", "believe", "expect", "estimate" and similar
expressions are generally intended to identify forward-looking statements.
All forward-looking statements are based on the Corporation's beliefs and
assumptions based on information available at the time the assumption was
made. These forward-looking statements are not based on historical facts but
rather on management's expectations regarding future growth, results of
operations, performance, future capital and other expenditures (including
the amount, nature and sources of funding thereof), competitive advantages,
business prospects and opportunities. Forward-looking statements involve
significant known and unknown risks, uncertainties, assumptions and other
factors that may cause the Corporation's actual results, levels of activity,
performance or achievements to differ materially from those implied by
forward-looking statements. These factors should be considered carefully and
prospective investors should not place undue reliance on the forward-looking
statements. Although the forward-looking statements contained in this press
release or incorporated by reference are based upon what the Corporation's
management believes to be reasonable assumptions, the Corporation cannot
assure investors that actual results will be consistent with these
forward-looking statements. These forward-looking statements are made as of
the date of this press release or as of the date specified in the documents
incorporated by reference into this press release, as the case may be. The
Corporation undertakes no obligation to update any forward-looking statement
or statements to reflect events or circumstances after the date on which
such statement is made or to reflect the occurrence of unanticipated events,
except as may be required by applicable Canadian securities laws.

[www.cnw.ca]

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