Photo Release -- Generex Launches Oral Insulin for Diabetes Management in India; Retail Availability Coincides With World Diabetes Day

Shreya Life Sciences to Sell Product Through Sales Force of More Than 1,000 People


WORCESTER, Mass. and MUMBAI, India, Nov. 14, 2008 (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, and Shreya Life Sciences Pvt. Ltd. (www.shreya.co.in), the Company's importation, marketing and distribution licensee in India and the fourth largest marketer of insulin in India, jointly announced today the launch of commercial retail sales of Generex Oral-lyn(tm) in India. Generex Oral-lyn is approved in India for the treatment of adults and children with Type 1 and Type 2 diabetes and will be marketed and sold in India under the brand name "Oral-Recosulin".

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5607

Shreya will offer the product through its sales force of more than 1,000 people and will implement a continuing medical education program to introduce the product to endocrinologists, diabetologists and physicians in India and expects that the product will eventually be available in more than 2,500 pharmacies in the country.

The launch of Oral-Recosulin, which offers a simple, convenient, fast, effective, flexible, familiar and pain-free alternative to prandial injections of insulin, coincides with the United Nations' World Diabetes Day, celebrated annually on November 14. The product is expected to be widely available for retail purchase in India before the end of the month.

"It is with great anticipation and enthusiasm that we launch this innovative new product for the Indian diabetes market. Diabetes is reaching epidemic proportions in India, with over 40.8 million diagnosed patients and an estimated 35.9 million additional people with pre-diabetic conditions which, if not properly treated and managed, could lead to full-blown diabetes," said Sujit Kumar Singh, the Chairman & Managing Director of Shreya. "Early intervention with insulin therapy could delay the onset and progression of diabetes and its numerous complications. Generex Oral-lyn(tm), as a convenient and pain-free alternative to prandial insulin injections, could encourage insulin therapy among those patients who presently avoid injections. We look forward to our collaboration with Generex to revolutionize the treatment of diabetes in India."

Generex Oral-lyn(tm) is Generex's flagship product, a proprietary oral insulin spray that has been approved in India by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, for importation, commercial marketing and sale for the treatment of Type 1 and Type 2 diabetes. Generex Oral-lyn(tm) is the first non-injectable buccal insulin approved in India. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn(tm) does not have pulmonary side effects. Generex Oral-lyn(tm) is safely and efficiently delivered without pain via the Company's proprietary RapidMist(tm) device, which looks like a simple asthma inhaler, but provides complete absorption through the buccal mucosa (lining of the mouth) with no deposit in the lungs.

Press conferences in respect of the commercial launch have been scheduled in India's principal commercial districts as follows:



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 Date                  City                  Venue
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 Nov. 15               Delhi                 Hotel Intercontinental
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 Nov. 16               Kolkata               Oberoi Grand Hotel
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 Nov. 18               Mumbai                JW Marriott Hotel
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 Nov. 19               Bangalore             Taj Residency Hotel
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 Nov. 20               Chennai               Taj Coromandal Hotel
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 Nov. 21               Hyderabad             Taj Banjara Hotel
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 Nov. 30               Hyderabad             Taj Krishna Hotel
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Generex representatives Dr. Gerald Bernstein, MD, Vice-President for medical affairs, and Dr. Jaime Davidson, MD, Medical Director, will participate in each press conference and be available to answer questions about Generex Oral-lyn(tm) and its approval in India.

Type 2 diabetes was once seen as a disease of adults, but today it is growing at alarming rates in children and adolescents. Incidence of Type 1 diabetes is growing by 3 percent per year in children and adolescents, and at an alarming 5 percent per year among pre-school children. It is estimated that 70,000 children under the age of 15 develop Type 1 diabetes each year - a rate of almost 200 children each day. Currently, an estimated 440,000 children globally live with Type 1 diabetes.

World Diabetes Day is the primary global awareness campaign of the diabetes world. Introduced in 1991 by the International Diabetes Federation and the World Health Organization in response to the alarming rise in diabetes around the world, World Diabetes Day became an official United Nations World Health Day in 2006. World Diabetes Day is a campaign that features a new theme chosen by the International Diabetes Federation each year to address issues facing the global diabetes community. While the themed campaigns last the whole year, the day itself is celebrated on November 14, to mark the birthday of Frederick Banting who, along with Charles Best, first conceived the idea which led to the discovery of insulin in 1922. In 2008, the theme of World Diabetes Day is Diabetes in Children and Adolescents.

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, oral insulin (Generex Oral-lyn), 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

About Shreya Life Sciences Pvt. Ltd.

Shreya is a leading Indian-based pharmaceutical company ranked 38th as per C-MARC and 41st as per ORG September 08. Shreya is the fourth largest marketer of insulin in terms of growth with a compound annual growth rate of 33% as per C MARC market research August 08. Shreya has interests in both pharmaceutical and biopharmaceutical products in key therapeutic segments including cardiology, neuropathy, and diabetes. The company has business operations in India, Russia, the Commonwealth of Independent States and African countries. For more information, visit the Shreya website at http://www.shreya.co.in.

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.

The photo is also available via AP PhotoExpress.



            
Generex Biotechnology Corp.

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