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Generex Biotechnology Provides a Corporate Update to Address Management's Strategic Initiatives for Growth
Date:10/5/2010

er studies we have conducted.  As we move through the remainder of our Phase III trial, we intend to focus our regulatory approval efforts in the United States, the European Union, and Canada.  Generex Oral-lyn™ has been approved for sale in India by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.  We entered into a Product Licensing & Distribution Agreement with Shreya Life Sciences Pvt. Ltd. (www.shreya.co.in) pursuant to which Shreya is responsible for the marketing, distribution, and sale of Generex Oral-lyn™ in India.  The terms of the Indian government approval required that a post-approval marketing surveillance study be undertaken in India.  The CDSCO reviewed the protocol in respect of the study and granted permission for the commencement and prosecution of the study.  The study, involving as many as 200 subjects, is well underway and is being undertaken and managed by Shreya.  Upon completion of the study, the results will be submitted to the CDSCO in support of Shreya's intention to commence commercial distribution of Generex Oral-lyn™ in India.

The second prong to our strategy is to work with strategic partners to further the development and distribution of Generex Oral-lyn™ as well as other applications of our buccal drug delivery platform.  Our recent long-term marketing and distribution agreement with Merck, S.A. de C.V. in Mexico for the distribution of one of our proprietary consumer/over-the-counter products, Glucose RapidSpray™ (www.glucoserapidspray.com), is just the beginning of what we believe is a tremendous commercialization opportunity for this platform.  We continue to be in discussions with a number of companies with regard to potential strategic relationships in
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