SemBioSys, Genetics Inc

SemBioSys' Plant-Produced Insulin Chemically and Physiologically Equivalent to Commercial Insulin in Animal Studies

    Calgary, Alberta (ots/PRNewswire) -

    - Canadian Biotechnology Company Takes Next Significant Step Towards  Advancing its Product to the Clinic -

    SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a  broad pipeline of protein-based pharmaceuticals and non-pharmaceutical  products, today 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. 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 US$200 to US$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 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. (

    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.

    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.

    TSX symbol: SBS

ots Originaltext: SemBioSys, Genetics Inc
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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:, Internet:; Investor Relations, Ross Marshall, The Equicom
Group Inc., Phone: +1-416-815-0700 (Ext. 238), Fax: +1-416-815-0080,

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