SOURCE: Generex Biotechnology

December 06, 2005 08:45 ET

Generex Biotechnology Announces Launch of Oral-Lyn™

Non-Injectable Insulin Soon Available to Patients for the First Time

TORONTO -- (MARKET WIRE) -- December 6, 2005 -- Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, announced today that Oral-lyn™, the Company's proprietary oral insulin spray product, is now being introduced to physicians in Ecuador and will soon be available through physician referrals. Oral-lyn™ is the first non-injectable form of recombinant human insulin available for commercial distribution anywhere in the world.

Oral-lyn™ is designed to improve the quality of life for patients with diabetes by allowing them to manage the disease more effectively. Oral-lyn™ is delivered by the Company's proprietary RapidMist™ device into the mouth of the patient where it is absorbed with no lung deposition. Oral-lyn™ offers a safe, simple, convenient, fast, and effective alternative to prandial insulin injections.

Following equipment validation, Oral-lyn™ will be produced for commercial distribution at the manufacturing facilities of PharmaBRAND, S.A. (www.pharmabrand.com.ec), the Company's South American joint venture partner, in Quito, Ecuador. The Company and PharmaBRAND expect the product to be widely available in Ecuador in the first quarter of 2006.

Generex, together with PharmaBRAND, has initiated education and marketing programs to support the sale of Oral-lyn™ in the country. The companies hosted symposia in the cities of Quito and Guayaquil in Ecuador from November 30 - December 1, 2005 to introduce Oral-lyn™ to South American endocrinologists, diabetologists, and other physicians. Speakers included: Dr. Arlan L. Rosenbloom, Adjunct Distinguished Service Professor Emeritus of Pediatrics at the University of Florida College of Medicine and an internationally renowned pediatric endocrinologist; Professor Paolo Pozzilli, Head of the Department of Endocrinology and Diabetes at University Campus Bio-Medico, Rome, Italy; Dr. Jaime Guevara-Aguirre of the Institute of Endocrinology, Metabolism and Reproduction in Quito, Ecuador; and Dr. Gerald Bernstein, the Company's Vice-President for Medical Affairs and a former president of the American Diabetes Association. The symposia are precursors to the Generex / PharmaBRAND training programs that will educate physicians as to the application and prescription of Oral-lyn™ for patients with Type-1 and Type-2 diabetes as well as patients at risk of developing diabetes such as those suffering from impaired glucose tolerance or obesity. Oral-lyn™ was approved for commercial marketing and sale for the treatment of patients with Type-1 and Type-2 diabetes in May 2005 by the Ecuadorian Ministry of Public Health.

Oral-lyn™, an aerosolized liquid insulin formulation, is rapidly and safely absorbed into the human body through the lining of the inner mouth (the buccal cavity) when delivered using the Company's proprietary RapidMist™ device which resembles an asthma inhaler and is therefore nondescript and easy to use. Unlike certain other alternative insulin delivery products presently under development, Oral-lyn™ does not enter the lungs; the formulation is absorbed in the buccal cavity with insignificant residual deposition in the gastrointestinal tract. Oral-lyn™ is a prandial (mealtime) insulin and numerous clinical studies have consistently demonstrated that the use of Oral-lyn™ allows the human body to mimic normal pancreatic insulin secretion and that Oral-lyn™ is a safe, effective, fast, flexible, pain-free and simple alternative to prandial insulin injections.

A New Paradigm for the Treatment of Diabetes

Oral-lyn™ is 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™ is poised to irrevocably alter the manner in which diabetes is treated.

Oral-lyn™ offers the opportunity for the establishment of a new paradigm for the treatment of patients with diabetes. Since insulin is a protein, it cannot be taken by mouth because it would be digested in the stomach like any other protein in food. People with diabetes have had to rely on injections for the delivery of insulin since 1921. Too often, patients reject appropriate treatment because of the discomfort of repeated injections. The issue of injection is a great inhibitor that keeps many 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. However, survival is not enough; blood sugar must be controlled. 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 thereby delaying the progression of the problem, 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 scientific studies 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.

Oral-lyn™ 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™ 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 across the entire diabetic spectrum.

The Impact of Diabetes in South America

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.

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™ device. The Company's flagship product, oral insulin (Oral-lyn™), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.

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 cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Contact Information

  • Shayne Gilliatt
    Generex Biotechnology Corporation
    1-800-391-6755
    +1-416-364-2551

    Ed Lewis
    CEOcast, Inc.
    +1-212-732-4300
    Email Contact
    for Generex Biotechnology Corporation