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  14. [verwijderd] 1 november 2007 14:28

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    ZEER GOED NIEUWS




    Generex Biotechnology Receives Regulatory Approval to Sell Generex Oral-lyn in India

    Thursday, November 01, 2007




    Generex Oral-lyn Becomes First Non-Injectable Buccal Insulin Approved in India; Generex Enters Into Product Licensing & Distribution Agreement With Indian Pharmaceutical Company Shreya Life Sciences Pvt. Ltd.
    Company to Hold Conference Call at 11 a.m. Eastern Today

    WORCESTER, Mass., Nov. 1, 2007 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (NasdaqCM:GNBT - News), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that Generex Oral-lyn, its proprietary oral insulin spray product, has been approved for importation and commercial marketing and sale in India for the treatment of diabetes by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India. CDSCO is responsible for authorizing marketing approval of all new pharmaceutical products in India.

    Generex Oral-lyn becomes the first non-injectable buccalinsulin approved in India. Generex Oral-lyn is delivered via the Company's proprietary RapidMist(tm) device into the mouth. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn does not reach the lungs.

    In connection with the approval, Generex has entered into a Product Licensing and Distribution Agreement with Shreya Life Sciences Pvt. Ltd. (http://www.shreya.co.in), a leading Indian-based pharmaceutical company. Shreya is the fourth largest distributor of insulin in the Indian insulin product market with a compound annual growth rate of 38% (per C MARC market research). Shreya has interests in both pharmaceutical and biopharmaceutical products in key therapeutic segments including cardiology, neuropathy, and diabetes. The company has business operations in India, Russia, the Commonwealth of Independent States, and African countries. The parties are making arrangements for the expansion of extant production facilities to meet the anticipated demand for the product in India and other jurisdictions where governmental approvals are pending.

    India has a significant and growing number of people with diabetes. According to the Diabetes Atlas 2007, there are approximately 40.8 million diagnosed patients with diabetes in India. There are also an estimated 35.9 million people who have pre-diabetic conditions which, if not properly treated and managed, could lead to full-blown diabetes. Generex believes that early intervention with insulin therapy could delay the onset and progression of diabetes and its numerous complications. Generex Oral-lyn, as a convenient and pain-free alternative to insulin injections, could encourage prandial insulin therapy among those patients who presently avoid injections.

    ``This approval in a market with one of the largest numbers of patients with diabetes comes after the Indian health regulatory agency conducted a rigorous review of clinical data demonstrating the safety and efficacy of Generex Oral-lyn,'' said Anna Gluskin, Generex's President & Chief Executive Officer. ``This represents the first major jurisdiction to provide approval and offers the prospect of a new treatment paradigm for diabetes and pre-diabetic conditions. We look forward to working with Shreya to offer a safe, simple, fast, flexible, familiar, convenient, and pain-free alternative to prandial insulin injections.''

    Generex's in-house regulatory department along with Nectid Clinical Services, a Princeton, NJ based contract research company that provides clinical and regulatory consultation services in respect of the Indian market, spearheaded the regulatory effort. Indian approval was granted after a long and intensive review of the Generex Oral-lyn dossier by the Drugs Controller General (India) office. Indian government approved Generex Oral-lyn only after Generex submitted satisfactory responses to a series of regulatory interrogatories. As a result of this approval, Generex and Shreya are making preparations for the commercial launch of Generex Oral-lyn in the country in early 2008. Preparations include manufacturing scale-up, marketing plans, and post-approval clinical studies.

    Conference Call:

    The Company will hold a conference call and webcast to discuss additional details on the Indian approval. The conference call will take place at 11 a.m. Eastern time today. Interested participants should call 1888 935 4577 within the United States or 718 354 1388 internationally. Please use passcode 1673847. A playback of the conference will be available two hours after the completion of the call. To listen to the playback, please call 1866 883 4489 within the United States or 718 354 1112 internationally. Please use passcode 9286485#. The call will also be webcast and will be available on the Company's web site at www.generex.com.


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