Generex Biotechnology Prepares for 2005 Product Launch; Company Target

    Business Editors/Health/Medical Writers

    TORONTO--(BUSINESS WIRE)--May 5, 2005--Generex Biotechnology Corporation (Nasdaq:GNBT), a leader in the area of buccal drug delivery, today announced plans to launch sales of Oral-lyn(TM), its proprietary oral insulin spray formulation, this year.
    The Company recently announced that Instituto Nacional de Higiene y Medicina Tropical "Leopoldo Izquieta Perez" of the Ecuadorian Ministry of Public Health has approved Oral-lyn(TM) for commercial marketing and sale for the treatment of patients with Type-1 and Type-2 diabetes, the first time a regulatory body has approved the commercial sale of alternative-delivery insulin for human use. The Company expects that approval to be a springboard for similar approvals in the coming months in the balance of the "Andean Community" region of South America, consisting of Venezuela, Colombia, Peru, and Bolivia. The Company is working in the region in joint venture partnership with PharmaBrand S.A. of Quito, Ecuador (www.pharmabrand.com.ec).
    Oral-lyn(TM), the Company's proprietary aerosolized liquid insulin formulation, is rapidly and safely absorbed into the human body through the lining of the inner mouth (with no pulmonary deposition) when delivered using the Company's proprietary RapidMist(TM) device. The Company believes that Oral-lyn(TM) offers the opportunity for the establishment of a new paradigm for the treatment of patients with diabetes.
    Every once in a while, something comes along that has the potential to change lives for the better. In 1921 insulin was discovered in Toronto, Canada (the discovery was announced on May 3, 1922) and life for people with diabetes was irrevocably altered. Insulin is a protein and, as such, cannot be taken by mouth as it would be digested in the stomach like all other proteins that we find in our food. People with diabetes have been pushing countless needles into their bodies since 1921 or, in some cases, not doing so at all when they should be because of the discomfort of repeated injections. At many major diabetes meetings it is not uncommon for a teenager to start a discussion by enumerating how times he has stuck himself, usually numbers like 20,000-30,000 times. The issue of injection is a great inhibitor that keeps people with Type-1 or Type-2 diabetes from taking the insulin that they need.
    Type-1 diabetes is a condition where all insulin production in the body is destroyed and people must take insulin to survive. What we know is that survival is not enough. If the blood sugar is not adequately controlled, the risk for complications rises and blindness, kidney failure, heart disease and loss of limb are some of the results. Thus patients with Type-1 diabetes need to take multiple daily insulin injections (6-10 daily) with an ensuing risk of hypoglycemia (low blood sugar). Patients with Type 2 diabetes have a more complex situation. Significant data is emerging that suggests that early use of insulin alone or with oral medications in Type-2 diabetes would be of great advantage in controlling blood sugar and preserving Beta cells, but again, the reluctance of patients to submit to injections acts as a treatment inhibitor.
    A particular issue, especially in Type-2 diabetes, has to do with the associated syndrome now known as "The Metabolic Syndrome" (high lipids, hypertension, coronary artery disease). In the natural evolution of Type-2 diabetes, the first observable abnormality is a rise in blood sugar levels after meals. This is associated with the onset of increased risk for cardiovascular disease. This stage is called "Impaired Glucose Tolerance" (IGT). It is defined by post-meal blood glucose above 140mgm/dl and less than 199mgm/dl. This is just short of the definition of actual diabetes. Regardless of whether or not full-blown diabetes ever develops, people with IGT have an increased risk for cardiovascular disease. Many important scientists have shown that every post-meal rise in blood glucose beyond 140mgm/dl results in an oxidative stress to the endothelium, the lining of the blood vessels.

    A New Paradigm

    Oral-lyn(TM) offers the potential for both INTERVENTION and PREVENTION. People with Type-1 diabetes will feel less constrained about taking extra insulin when they know there is NO NEEDLE and the likelihood of low blood sugar is reduced because of the more precise management offered by Oral-lyn's(TM) rapid absorption. Both patients with Type-2 diabetes and their physicians will feel more comfortable using insulin before meals knowing there is NO NEEDLE and especially when the delivery system is a familiar asthma-like device. The potential for use in IGT is to lower post-meal glucose and reduce cardiovascular risk. Compliance can be improved all across the diabetic spectrum.
    As an effective, safe, simple, fast, convenient, flexible and pain-free alternative to the traditional method of subcutaneous insulin injection, Oral-lyn(TM) is designed to improve the quality of life for people with diabetes by allowing them to manage the disease more effectively. It is also designed to improve patient compliance, thereby delaying the progression of diabetes and the onset of complications associated with diabetes (such as amputation, retinopathy, cardiovascular disease, nephropathy, neuropathy and peripheral vascular disease). As such, Oral-lyn(TM) is poised to irrevocably alter the manner in which diabetes is treated.
    According to International Diabetes Federation statistics for 2003, there were more than 3.2 million patients with diabetes in the Andean Community, almost 700,000 of which were insulin users.
    A bulletin of the World Health Organization (2003;81:19-27) issued in connection with the measurement of the economic burden associated with diabetes in Latin America and the Caribbean in the year 2000 reported that permanent disability caused a loss of more than $50 billion and temporary disability caused a loss of more than $763 million. Costs associated with insulin and oral medications were $4.72 billion, hospitalizations $1.01 billion, consultations $2.51 billion and care for complications $2.48 billion. The total annual cost associated with diabetes was estimated at $65.22 billion.
    To be added to Generex's investor email list, please contact Zack Noory of Investor Relations International at znoory@irintl.com.

    About Generex

    Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), is in various stages of clinical trials around the world.
    For more information, visit the Generex Web site at www.generex.com.

    Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

--30--MTB/la*

CONTACT: Investor Relations International Zack Noory, 818-382-9718 znoory@irintl.com

KEYWORD: COLOMBIA VENEZUELA INTERNATIONAL CANADA LATIN AMERICA INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL DEVICES BIOTECHNOLOGY PRODUCT SOURCE: Generex Biotechnology Corporation

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