Generex Announces Distribution Agreement for Generex Oral-lyn™ in Chile

WORCESTER, Mass., Sept. 14 /PRNewswire/ -- Generex Biotechnology Corporation (Nasdaq: GNBT; www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has entered into an exclusive Product Licensing & Distribution Agreement with PMG S.A. (www.pmgpharma.com) for the registration, marketing, distribution and sale of Generex Oral-lyn™, the Company's proprietary buccal insulin spray product, in Chile.

PMG PHARMA is a Chilean pharmaceutical corporation located in Santiago and focused in three therapeutic areas: diabetes, nephrology and an injectable product line sold in hospitals and pharmacies.  PMG PHARMA represents fifteen international companies, all related to its core business in diabetes.  PMG PHARMA's principals include the managing board comprised of a General Manager, a Marketing Manager, and a Sales Manager, each of whom have extensive experience in the diabetes space.  Some of their achievements include successfully introducing the blood glucose monitoring system from Boheringer Manheim (now known as Roche) in Chile as well as introducing Novo Nordisk's  monocomponent insulin and human recombinant insulin (including the NovoPen®) in Chile. This long history will in the diabetes segment will provide a solid platform for Generex Oral-lyn's™ market introduction in Chile.    

Chile has a population of over 16.8 million and a diabetes prevalence of 7.2% (per the International Diabetes Federation).  Patients under insulin therapy are estimated to be approximately 85,000.

"We are delighted to have licensed Generex Oral-lyn™ to PMG PHARMA, a well-established company whose principals have a long history in marketing diabetes products," said Anna Gluskin, Generex's President and Chief Executive Officer.  "This alliance is important as it opens up another key country in South America where diabetes is a highly prevalent condition."

About Generex Biotechnology Corporation

Generex is engaged in the research, development and commercialization 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, buccal insulin (Generex Oral-lyn™), which has been approved in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world.  Antigen Express, Inc. 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 website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

Safe Harbor Statement

This release and oral statements made from time to time by Generex representatives in respect of 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 undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.  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 Corporation

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