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DewDiligence

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Re: DewDiligence post# 62475

Tuesday, 07/29/2008 8:14:45 AM

Tuesday, July 29, 2008 8:14:45 AM

Post# of 252096
SemBioSys Submits IND for Safflower-Produced Insulin

[Although SemBioSys’ technology is impressive, the business rationale for its plant-derived insulin program is weaker than it once was, IMO. Why? Because the demise of the inhaled-insulin programs from PFE, LLY, and NVO have reduced the expected demand for bulk insulin during the next decade or so; inhaled insulin had accounted for a disproportionally large share of anticipated demand for bulk insulin because its bioavailability was so poor.]

http://biz.yahoo.com/prnews/080729/3709576en_public.html

›Tuesday July 29, 7:00 am ET

CALGARY, July 29 /PRNewswire/ -- 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.‹


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