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Omni Bio Pharmaceutical, Inc's. CEO Issues Letter to Shareholders
Date:3/31/2011

Omni's opportunity provides that situation for me.

Omni is involved with the development of intellectual property related to methods of use patent applications and issued patents related to AAT, a human biological that is FDA-approved for the treatment of chronic obstructive pulmonary disease ("COPD") and emphysema in AAT deficient patients.  Because of the approximately 20 year history of AAT being used to treat COPD and Emphysema, AAT has a solid established safety record, and this assisted us in obtaining FDA clearance to begin our trial in Type 1 diabetes within 12 months of its submission to the FDA.  We believe that our method of use patent applications will control the treatment of Type 1 diabetes utilizing AAT, should we obtain the requisite FDA approval.

Our most advanced program is our Phase I/II human clinical trial in Type 1 diabetes involving AAT in recently diagnosed patients at the Barbara Davis Center for Childhood Diabetes in Denver at the Anschutz Medical Campus of the University of Colorado Denver.  For this trial, we are using a branded formulation of AAT which is being provided by an existing manufacturer.  We initiated this clinical trial this past October, and are approaching completion of the young adult population's infusion stage, before we move into pediatric patients.  

Type 1 diabetes is a large market, there are over two million individuals with Type 1 diabetes in the United States, and we believe that 25-30,000 that have been recently diagnosed have residual islet function.  There is no effective form of therapy currently available to the market to block this debilitating and life shortening disease.  Based on the addressable market size and anticipated cost of the drug, this would approximate a potential US market of $700 million annually, which is larger than the existing market for AAT for the treatment of COPD and emphysema.  Our plan is to sublicense our intellectual pr
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SOURCE Omni Bio Pharmaceutical, Inc.
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