Generex Study Proposes Increased Reporting of Clinical Outcomes to Support Reimbursement of Non-Injectable Insulin Options

Findings Presented At International Society for Pharmacoeconomics and Outcomes Research Meeting in Toronto


WORCESTER, Mass., May 7, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has sponsored a poster presentation at this year's International Society for Pharmacoeconomics and Outcomes Research (ISPOR) meeting being held in Toronto, Canada May 3-7, 2008. The project was carried out by Pivina Consulting Inc. during 2007.

The title of the poster is "Non-injectable Insulin -- To Pay or Not to Pay." The poster is co-authored by Charles Piwko, N. Mittman, S.J. Seung, Anita Kapoor and George Markus. George Markus, M.Sc., is Generex's Vice President of Regulatory Affairs and Anita Kapoor, Ph.D., is a Regulatory Affairs Associate at the Company.

The objective of the abstract is to examine what may have contributed to minimal governmental reimbursements of non-injectable insulin costs. The report explores existing insulin treatments and future treatments and the rationales for reimbursement.

Major findings were that clinical studies for non-injectable insulins did not include adequate information and/or outcomes that are required by decision makers for reimbursement recommendations; patient satisfaction according to the HTA agencies was considered to be an important outcome, but was not well reported in the clinical studies; there is a need to include utility data.

The report concludes that, since there is a lack of adequately evaluated outcomes demonstrating the link between improved adherence and improved clinical outcomes, there exists a definite need to re-examine the rationales for the lack of reimbursement.

"We are pleased to have taken some necessary steps in the assessment of reimbursement evaluations and listing criteria," said Rose C. Perri, the Company's Chief Operating Officer. "This research will pave the way for the conduct of an upcoming utility study of our proprietary oral insulin spray product, Generex Oral-lyn(tm). These Health Economic initiatives will play a role in supporting future reimbursement recommendations."

ISPOR promotes the science of pharmacoeconomics (health economics) and outcomes research (the scientific discipline that evaluates the effect of health care interventions on patient well-being including clinical outcomes, economic outcomes, and patient-reported outcomes) and facilitates the translation of this research into useful information for healthcare decision-makers to ensure that society allocates scarce health care resources wisely, fairly and efficiently.

About Generex

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(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 and which was approved for sale in India in October 2007, is in various stages of clinical development around the world. For more information, visit the Generex website at www.generex.com.

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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 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.



            

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