Magazin

2008-09-16

SemBioSys Eligible to Proceed With Phase I/II Plant-Produced Insulin Trial After Submission of IND


Calgary, Canada (ots/PRNewswire) -

- TSX symbol: SBS

SemBioSys Genetics Inc. (TSX:SBS), a biotechnology companydeveloping a portfolio of therapeutic proteins for metabolic andcardiovascular diseases, today announced that it is eligible toproceed with its planned Phase I/II human clinical trial ofplant-produced insulin now that the 30-day review period of itsInvestigational New Drug (IND) application has passed. SemBioSyssubmitted the application in July to the U.S. Food and DrugAdministration (FDA), which has now completed its review of the file.As previously announced, SemBioSys intends to conduct the Phase I/IIinsulin trial in Europe. Prior to proceeding with the planned trialin the United Kingdom, the company's Clinical Trial Application(CTA) must be reviewed by the appropriate European regulatoryauthorities.

"The company continues to achieve its insulin developmentmilestones on time. Our recent accomplishments confirm ourconfidence in our regulatory and development strategy using plantsas a low-cost production host for insulin. Plant-produced humanrecombinant insulin represents a major step forward in insulinproduction. We believe, furthermore, that these upcoming studiescould prove to be the greatest achievement in insulin productionsince the advent of recombinant human insulin in the early 80's,"said Andrew Baum, president and chief executive officer ofSemBioSys. "The purpose of filing an IND in the U.S., even though weintend to conduct the trial in Europe, is to ensure that we canpursue U.S. and European regulatory approval of our plant- producedinsulin contemporaneously. Conducting the planned insulin trial inEurope allows us to establish the bioequivalence of oursafflower-produced insulin to commercially available insulinproducts from both the U.S. and Europe in a single trial."

SemBioSys plans to initiate a Phase I/II human trial of itssafflower- produced insulin in the United Kingdom during the fourthquarter of 2008. Prior to proceeding with the trial the company mustawait clearance from the Medicines and Healthcare productsRegulatory Agency (MHRA) in the United Kingdom. SemBioSys' plannedPhase I/II human clinical trial is designed to enroll up to 30healthy volunteers in a three-arm study to demonstrate thebioequivalence of safflower-produced insulin to comparator insulinproducts. The European authorities are the first major healthcareregulators to have published guidance documents that ensure insulinis eligible to receive approval through an abbreviated regulatorypath. Separately, the U.S. FDA has advised SemBioSys thatsafflower-produced insulin is eligible to receive approval throughan abbreviated 505(b)(2) approval process.

The world market value for insulin is estimated to be in excessof US$7.1 billion today and the demand for insulin is projected toincrease due to two factors. The growing incidence of diabetescombined with the expanded use of insulin therapy is expected toalmost double insulin demand over the next five years and increasethe global insulin market to over US$15 billion by 2012. SemBioSys'plant-made insulin is expected to offer substantial capital andcost-of-goods reductions with the potential to enter the market as alow- cost, easily expandable source of insulin to meet explodingglobal demand.

About SemBioSys Genetics Inc.

Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnologycompany developing protein-based pharmaceuticals for metabolic andcardiovascular diseases. The Company's lead pharmaceuticalcandidates, produced in the plant host safflower, are recombinanthuman insulin to serve the rapidly expanding global diabetes marketand Apo AIMilano, a next generation cardiovascular drug. In additionto its pharmaceutical products, SemBioSys and its subsidiary,Botaneco Specialty Ingredients Inc., are developing a series ofnon-pharmaceutical products addressing human topical, nutritionaloils and agricultural biotechnology markets. More information isavailable 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 whichconstitute "forward-looking information" within the meaning ofapplicable securities laws. Forward- looking statements reflect theCompany's current expectation and assumptions, and are subject to anumber of risks and uncertainties that could cause actual results todiffer materially from those anticipated. These forward- lookingstatements involve risks and uncertainties including, but not limitedto, changing market conditions and market size, the acceptance of anIND by the FDA in respect of clinical studies, the submission of aCTA to the appropriate European authorities, the successfulinitiation and timely and successful completion of clinical studies,the fact that Apo AI is currently a development stage drug, theestablishment of corporate alliances, the impact of competitiveproducts and pricing, new product development, uncertainties relatedto the regulatory approval process and other risks detailed fromtime-to-time in the Company's ongoing filings with the Canadiansecurities regulatory authorities which filings can be found atwww.sedar.com. Given these risks and uncertainties, readers arecautioned not to place undue reliance on such forward-lookingstatements. The Company undertakes no obligation to publicly updateor revise any forward-looking statements either as a result of newinformation, future events or otherwise, except as required byapplicable 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, SeniorVice President, Phone: +1-415-392-3385, E-mail:iclements@troutgroup.com

ots Originaltext: SemBioSys, Genetics IncIm 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

SemBioSys, Genetics Inc

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