Generex Biotechnology Corp. (fka GNBTQ)

[playyyer]

Generex Inks Deal With Sanofi-Aventis for Insulin Supply

December 09, 2009


WORCESTER, Mass., Dec 9, 2009 (GlobeNewswire via COMTEX News Network) -- 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 it has signed a long-term agreement with Sanofi-Aventis Deutschland GmbH (www.sanofi-aventis.com) for the manufacture and supply of recombinant human insulin crystals for commercial and clinical trial use in Generex's proprietary buccal insulin spray product, Generex Oral-lyn(TM). The financial terms of the arrangement were not disclosed.

The API (Active Pharmaceutical Ingredient) Supply agreement will provide the Company with a source of insulin for major regulatory markets including the United States and Canada and a number of other regions where the Company is pursuing regulatory approvals for Generex Oral-lyn(TM).

The Company's regulatory team will commence the process of updating any and all current submissions to include sanofi-aventis' insulin crystal which will be formulated in the Generex Oral-lyn(TM) commercial product.

"We are very pleased to have entered into this long-term supply agreement for insulin crystal," said Anna Gluskin, Generex's President and Chief Executive Officer. "It solidifies one of our key product components which will assist in the smooth transition into commercialization of our flagship product, Generex Oral-lyn(TM), into major markets where we will seek to establish a new paradigm for the treatment of diabetes."

Thanks to almost a century of chemical, pharmaceutical, medical and industrial research, led by Hoescht and its successors, sanofi-aventis can today claim its place as the historic leader in both the production of insulin and the treatment of diabetes.

At the end of the 1990s, the site of sanofi-aventis in Frankfurt, Germany, formerly Hoechst, developed pilot units and large-scale production of human recombinant insulin from a genetically modified Escherichia Coli strain.

As part of the commercial offer provided by the Commercial and External Partnership Industrial Affairs (CEPIA) at sanofi-aventis for human recombinant insulin, Generex, in cooperation with sanofi-aventis, will benefit from sanofi-aventis' ability and expertise to offer quality and regulatory support.

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, 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.

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