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Subject: Generex Biotechnology (Nasdaq: GNBT) - April26, 2005



 

  SmallCapReview News  
  April 26, 2005  
 

Generex Biotechnology (Nasdaq: GNBT) 

After 10 years of development Oral-lyn has been found to be as effective as injected insulin for treatment of diabetes and is ready for commercialization.

Website: www.generex.com

For the Complete Profile please visit www.smallcapreview.com/gnbt.htm


GNBT Investor Highlights:

  • GNBT has developed Oral-lyn(TM), an oral insulin spray for the treatment of diabetes that replaces insulin injections.

  • After 10 years of development Oral-lyn has been found to be as effective as injected insulin and is ready for commercialization.

  • Sales could start as early as the first half of 2005 in South America. Canada and Europe is the next target market with the U.S. to follow.

  • GNBT's delivery system known as RapidMist(TM), has the potential to replace injected drugs, including Morphine, Fentanyl, Heparin and flu vaccines.

  • The market for injectable drugs in a non-injectable form is estimated to be $15 billion.

  • Proven Drug Delivery Technology Platform: RapidMistTM allows for the buccal delivery of large molecule drugs.

  • ORAL-LYN is currently in Phase IIB of ongoing clinical studies and has shown similar results as compared to injection.

  • Antigen Express, Inc. ??“ Generex subsidiary, focused on the development of immunomedicines. Received grants totaling $1.85 million.

  • GNBT has 18 patents and 60 patent applications.

  • Recently had its first publication demonstrating that Oral-lyn is able to replace subcutaneous insulin in treating patients with type 1 diabetes.

  • Announced that University Campus Bio-Medico and other centres in Europe are poised to commence Phase III studies aimed at demonstrating that Oral-lyn can achieve optimal metabolic control evaluated via glycosylated hemoglobin, a well-known parameter for determining optimization of glucose metabolism.


Profile

Generex Biotechnology (Nasdaq: GNBT) 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 potential benefits are compelling. Pain-free, needle-free, noninvasive drug delivery. Dosages administered accurately and conveniently. Improved quality of life for people who currently depend on regular, painful injections to maintain their health.

The Company's flagship product, oral insulin (Oral-lyn(TM)), is in late stage clinical trials around the world. 

In August 2003, Generex acquired Antigen Express, Inc. Antigen Express is a platform and product-based company developing proprietary vaccine formulations for large, unmet medical needs. The focus is on stimulating critical members of the immune response, known as T helper cells.


Overview

Generex Biotechnology has a market ready solution to a central challenge in diabetes treatment ??“ ending the pain and hassle of insulin injections. Ever since scientists early in the 20th century learned that diabetes was caused by the body??™s inability to produce a normal supply of insulin, patients have had to administer insulin by injection. Alternatives that have been developed in recent years ??“ pumps or needle-less ???pens??? ??“ are still invasive and/or expensive. Pharmaceutical companies have tried to develop a truly non-invasive insulin product that is pain-free, easy to use and free from serious side effects.

Among today??™s competing technologies, only Oral-lyn, an insulin spray for treatment of diabetes, meets all those tests. After 10 years of development, Oral-lyn is ready for market and could produce enormous revenue growth for the company. Generex is little known outside a small community of investors focused on drug delivery and diabetes treatment. In the next few months, however, the expected commercial entry of Oral-lyn in South America could raise Generex??™s profile sharply, and may see a commensurate rise in their share price. Small companies in drug and medical-device development are, of course, inherently high-risk investments. But aggressive investors who take an early stake in these firms can profit several times over. Generex has the profile of being one such potential winner.


Recent News and Press Releases

Generex Biotechnology Collaborator Reports an Advance in Intra-Tumor Gene Therapy for Cancer

Generex Biotechnology & University Campus Bio-Medico Announce Publication Of Oral Insulin Research Study


For the Complete Profile please visit www.smallcapreview.com/gnbt.htm


Disclaimer  

SmallCapReview.com feature stock reports are intended to be stock ideas, NOT recommendations. Please do your own research before investing. It is crucial that you at least look at current SEC filings and read the latest press releases. For continuing coverage of GNBT, please sign up for our free newsletter. Information contained in this report was extracted from current documents filed with the SEC, the company web site and other publicly available sources deemed reliable. For more information see our disclaimer section, a link of which can be found on our web site. This document contains forward-looking statements, particularly as related to the business plans of the Company, within the meaning of Section 27A of the Securities Act of 1933 and Sections 21E of the Securities Exchange Act of 1934, and are subject to the safe harbor created by these sections. Actual results may differ materially from the Company's expectations and estimates. The information provided herein is not intended for distribution to, or use by, any person or entity in any jurisdiction or country where such distribution or use would be contrary to law or regulation or which would subject us to any registration requirement within such jurisdiction or country.

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We encourage our readers to invest carefully and read the investor information available at the web sites of the Securities and Exchange Commission (SEC) at: http://www.sec.gov and/or the National Association of Securities Dealers (NASD) at: http://www.nasd.com . Readers can review all public filings by companies at the SEC's EDGAR page. The NASD has published information on how to invest carefully at its web site.

 
 








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