WORCESTER, Mass., March 26, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that as a result of increased demand, the company plans to pursue the regulatory path for the submission of Generex Oral-lyn(tm) with the veterinary arms of global health agencies for therapeutic use in cats and dogs with diabetes.
Diabetes Mellitus is a relatively common metabolic disease seen in middle-aged cats and dogs. Dogs with diabetes typically suffer from Type 1, while affected cats typically have Type 2. In addition to insulin, the veterinary management of diabetes requires regular glucose testing, pet owner education and the common application of diet and exercise.
"Generex Oral-lyn(tm) is a pain-free insulin delivery method for people to better manage their diabetes," said Anna Gluskin, president and chief executive officer of Generex. "But we realize that for many people, their pets are members of the family, so with one in every 500 cats and dogs developing diabetes in its lifetime, we want to offer Generex Oral-lyn(tm) to care for them as well."
According to Pet Health: Products/Services Report, the pet health industry in the United States alone is a $21 billion market and is expected to grow by 7.1 percent annually through 2011.
Generex's anticipated timeline for submission to the appropriate health agencies for this indication is some time in the second half of calendar year 2009.
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(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in India 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. For more information, visit the Generex website at http://www.generex.com.
The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831
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.