Healthcare Industry News:  metabolic disease 

Biopharmaceuticals Drug Delivery Distribution

 News Release - April 23, 2007

Generex Biotechnology Announces Middle Eastern Licensing Agreement for Generex Oral-lyn(TM)

Leading Middle Eastern Distributor of Healthcare Products to Offer Generex Oral-lyn in 15 Countries

WORCESTER, MA--(Healthcare Sales & Marketing Network)--Apr 23, 2007 -- Generex Biotechnology Corporation (NasdaqCM:GNBT ), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has entered into an exclusive Master Product Licensing & Distribution Agreement with Leosons General Trading Company, a leading distributor of North American products in the Middle East, for the commercialization of Generex Oral-lyn, the Company's proprietary oral insulin spray product, in 15 Middle Eastern countries, including Saudi Arabia and the United Arab Emirates (UAE). In lieu of Generex receiving an upfront license fee, Leosons will bear any and all costs associated with the procurement of governmental approvals for the sale of the product, including any clinical and regulatory costs. The Agreement obligates Leosons to file all requisite applications for the approvals by the fall of 2007.

According to the International Diabetes Federation, the UAE has the second highest rate of diabetes in the world, affecting 70% of residents. Other Gulf states also have significant diabetes problems, with Saudi Arabia ranked third, Bahrain fourth, Kuwait fifth, and Oman sixth. Leosons General Trading Company, based in the United Arab Emirates, will procure all Middle Eastern governmental approvals for the importation and sale of Generex Oral-lyn. Thereafter, Leosons will market and sell the product through its extensive distribution network in the region. Leosons will, at its sole expense, design and implement plans for the education and training of patients and physicians in respect of the Company's RapidMist(TM) Diabetes Management System and the marketing, distribution, and sale of Generex Oral-lyn in the region. Leosons will also be obligated to achieve minimum quarterly sales of the product.

"We are delighted to have licensed Generex Oral-lyn to Leosons, a company with extensive Middle Eastern product distribution experience, to advance the commercialization of Generex Oral-lyn in the region," said Anna Gluskin, the Generex President & Chief Executive Officer. "Diabetes represents a major unmet medical need in the region and by securing distribution through a major distributor we believe we will be able to capitalize on this significant opportunity."

About Leosons

Leosons is a 25-year old private multinational operating company in the Middle East focusing on the pharmaceutical and healthcare industry. Leosons distributes 15 healthcare-related products which are considered category leaders.

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 (Generex Oral-lyn(TM)), which is available for 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. For more information, visit the Generex website 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.


Source: Generex Biotechnology

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