Profile: Generex Biotechnology Corp (GNBT.O)

Generex Biotechnology Corporation (Generex), incorporated in September 1997, is a development-stage company. The Company is engaged in the research, development and commercialization of drug delivery systems and technologies. The Company is focused on its technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a hand-held aerosol applicator. Through its wholly owned subsidiary, Antigen Express, Inc. (Antigen), the Company has expanded its focus to include immunomedicines incorporating vaccine formulations. The Company’s subsidiaries include Generex Pharmaceuticals Inc., Generex (Bermuda), Inc., Generex Pharmaceuticals (USA) LLC and Generex Marketing & Distribution Inc. In April 1999, the Company completed a reorganization in which it merged with Generex Idaho. In September 2009, the Company announced the incorporation of SIA Generex Biotechnology BALTIC as a wholly owned subsidiary.

The Company’s buccal delivery technology is a platform technology that has application to many molecule drugs. It focuses its development efforts primarily on one pharmaceutical product, Generex Oral-lyn, an insulin formulation administered as a fine spray into the oral cavity using the Company’s hand-held aerosol spray applicator known as RapidMist. In March 2008, the Company initiated Phase III clinical trials for Generex Oral-lyn in the United States. Using its buccal delivery technology, the Company also has launched a line of over-the-counter glucose and energy sprays, including Glucose RapidSpray, Crave-NX 7-day Diet Aid Spray and BaBOOM! Energy Spray.

The Company’s subsidiary, Antigen, concentrates on developing vaccine formulations that work by stimulating the immune system to either attack offending agents (cancer cells, bacteria and viruses) or to stop attacking benign elements (self proteins and allergens). Its immunomedicine products are based on two platform technologies and are in the early stages of development. The Company continue clinical development of Antigen’s synthetic peptide vaccines designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene for patients with HER-2/neu positive breast cancer in a Phase II clinical trial, and patients with prostate cancer and against avian influenza in two Phase I trials. An additional Phase I trial has been initiated in patients with either breast or ovarian cancer.

The Company competes with Pfizer, Eli Lilly, Novo Nordisk, MannKind Corporation, Nektar Therapeutics, Alkermes, Inc., Amylin Pharmaceuticals, Inc., CPEX Pharmaceuticals, Inc., Cephalon, Inc., MDRNA, Inc., Novavax, Inc., Advaxis, Inc., Micromet, Inc., Sanofi Pasteur Inc., Dendreon Corporation, Cell Genesys, Inc., Pharmexa-Epimmune, Inc., Cel-Sci Corporation, Merck & Co., Inc., GlaxoSmithKline PLC, Novartis, Inc., Sanofi Pasteur, Inc. and Astra-Zeneca, Inc.