WORCESTER, Mass., May 5, 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, announced today that Generex Oral-lyn(tm), its proprietary oral insulin spray product, has been approved by the Ministry of Health, Populations and Hospitals Reform of Algeria for importation and commercial marketing and sale for the treatment of diabetes in the People's Democratic Republic of Algeria.
Generex Oral-lyn(tm) once again becomes first-in-class as the only non-injectable buccal insulin approved in Algeria. Generex Oral-lyn(tm) is delivered via the Company's proprietary RapidMist(tm) device into the mouth, where it is absorbed by the inner lining of the mouth and does not reach the lungs.
This approval follows other regulatory approvals achieved in India and Lebanon.
The market size for pharmaceuticals in Algeria is approximately 1.6 billion Euros among a population of 34 million. The estimated number of patients living with diabetes in Algeria is 3 million; the International Diabetes Federation (IDF) quotes a diabetes rate of 8.4 percent with a national prevalence for impaired glucose tolerance (IGT) at 5.7 percent.
Through the efforts of the business development team, in association with the Generex MENA branch office located in the Dubai Healthcare City Center, Generex has entered into a marketing sub-distribution relationship with Algerian company Continental Pharm Laboratoire. Continental Pharm has over 100 employees and is focused on pharmaceutical manufacturing and distribution. A number of multinational pharmaceutical and European manufacturing companies are established partners of Continental Pharm.
Commercial launch of Generex Oral-lyn(tm) in Algeria is expected to take place before the end of the year.
"We are pleased that we have been able to add this regulatory approval to our growing marketing portfolio," said Anna Gluskin, Generex's President & Chief Executive Officer. "The effective correlation between the Company's regulatory and business development activities and that of its Generex MENA branch office is a winning formula to gain ground in the Middle Eastern territory, with the common goal of offering a safe, simple, fast, flexible, familiar, convenient and pain-free alternative to prandial insulin injections to patients living with diabetes."
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 www.generex.com.
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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.