GENEREX BIOTECHNOLOGY CORPORATION

GENEREX BIOTECHNOLOGY CORPORATION

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Company Overview
Generex Biotechnology Corporation is a development stage company engaged in the research, development and commercialization of injection-free methods (systems and technologies) for delivery of large molecule drugs. The company’s headquarters is located in York, Pennsylvania in the United States.
Generex Biotechnology is the leader in drug delivery for metabolic diseases through the inner lining of the mouth. Its primary focus is its technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a hand-held aerosol applicator, RapidMist, a small and lightweight aerosol applicator that administers a metered dose for absorption of large molecule drugs, including proteins, peptides, monoclonal antibodies, hormones, and vaccines. The company’s products include morphine, fentanyl, heparin, and flu vaccine, which are used medically for pain relief and as a sedative. The company also offers Oral-lyn product, a proprietary insulin formulation used for diabetes management.
The company primarily operates in the United States and markets its products worldwide.
The company’s mission is to develop innovative drug delivery technologies and drugs that will improve the quality of life for people who suffer from disease.
Antigen Express, Inc., a subsidiary of Generex Biotechnology, is a platform and product-based company that develops proprietary vaccine formulations for large, unmet medical needs. Vaccine formulations’ focus is on stimulating critical members of the immune response, known as T helper cells.
Business Summary
Generex Biotechnology Corporation (Generex) is a development-stage company. The Company is engaged in the research, development and commercialization of drug delivery systems and technologies. The Company focuses at the technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a hand-held aerosol applicator. In October 2009, it received approval from the United States Food and Drug Administration (FDA) to charge to recover costs for the treatment use of Generex Oral-lyn in patients with Type 1 or Type 2 diabetes mellitus in the FDA’s Treatment Investigational New Drug (IND) program that provides for access to investigational treatments for life-threatening or otherwise serious conditions. Using its buccal delivery technology, it 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.
Description and history
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 focuses at the 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), it focuses on immunomedicines incorporating vaccine formulations. As of July 31, 2010, it had received regulatory approval in Ecuador, India, Lebanon and Algeria for the commercial marketing and sale of Generex Oral-lyn. In October 2009, it received approval from the United States Food and Drug Administration (FDA) to charge to recover costs for the treatment use of Generex Oral-lyn in patients with Type 1 or Type 2 diabetes mellitus in the FDA’s Treatment Investigational New Drug (IND) program that provides for access to investigational treatments for life-threatening or otherwise serious conditions. Using its buccal delivery technology, it 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, such as cancer cells, bacteria and viruses or to stop attacking benign elements, such as self proteins and allergens. Its immunomedicine products are based on two platform technologies and are in the early stages of development. It continues 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 clinical trials. It initiated an additional Phase I clinical trial in patients with either breast or ovarian cancer.

The Company’s buccal delivery technology involves the preparation of formulations, in which an active pharmaceutical agent is placed in a solution with a combination of absorption enhancers and other excipients classified generally recognized as safe (GRAS) by the FDA when used in accordance with specified quantities and other limitations. The resulting formulations are aerosolized with a pharmaceutical grade chemical propellant and are administered to patients using its RapidMist brand metered dose inhaler. The device is a small, lightweight, hand-held, easy-to-use aerosol applicator consists of a container for the formulation, a metered dose valve, an actuator and dust cap. Using the device, patients self-administer the formulations by spraying them into the mouth. The device contains multiple applications, the number being dependent, among other things, on the concentration of the formulation. Absorption of the pharmaceutical agent occurs in the buccal cavity, through the inner cheek walls.

Buccal Insulin Product-Generex Oral-Lyn

The Company initiated Phase III clinical trials in North America for Generex Oral-lyn with the first patient screening in Texas. Other clinical sites participating in the study are located in the United States (Texas, Maryland, Minnesota and California), Canada (Alberta), Europe and Eastern Europe, including Russia, Ukraine, Romania and Bulgaria. As of July 31, 2010, over 450 patients have been enrolled in the program at 70 clinical sites globally. The Phase III protocol calls for a six-month trial with a six-month follow-up with the objective to compare the efficacy of Generex Oral-lyn and the RapidMist Diabetes Management System with that of standard regular injectable human insulin therapy as measured by glycated haemoglobin (HbA1c), in patients with Type-1 diabetes mellitus. It has engaged a global clinical research organization to provide many study related site services, including initiation, communication with sites and documentation; a global central lab service company that will arrange for the logistics of kits and blood samples shipment and an Internet-based clinical data management company to assist us with global project management of the Phase III clinical trial and regulatory processes.

Buccal Glucose and Energy Products – Glucose RapidSpray, BaBOOM! Energy Spray and Crave-NX

Using the Company’s buccal delivery technology, it has developed several formulations of glucose sprays that are available over-the-counter. Its RapidSpray product uses its RapidMist brand metered dose inhaler platform technology to provide an alternative for people who require or want additional glucose in their diet and delivers a fat-free, low-calorie glucose formulation directly into the mouth. Glucose RapidSpray is available in the United States and Canada through a range of retail chains, wholesalers and online. It is also available wholesale in the Middle East through Generex MENA. It is pursuing European registrations for these products. Glucose RapidSpray offers another aid to diabetics who require or need additional glucose to their diets or daily intake. With its RapidSpray bottle, individuals can add glucose to their diets and serves as a medium for first signs of low blood sugar levels.

Its Crave-NX is a fat-free glucose spray that is marketed as an aid for dieters and can be used between meals as part of a daily diet routine, during exercise and before bedtime. BaBOOM! Energy Spray is a instant energy spray designed to enhance energy levels for sports, work, study, travel and overall fatigue. Its ingredients include glucose, caffeine, ginseng and Vitamins B and C. It is fat-free and has fewer than five calories per serving. BaBOOM! Energy Spray and Crave-NX are being offered through a range of retail chains, wholesalers and online. Glucose RapidSpray is being marketed in the Middle East through the Generex MENA office in Dubai and in South Africa and six neighboring countries through the Master Distributor Agreement with Adcock Ingram Limited and Adcock Ingram Healthcare (Pty) Ltd.

Metformin Gum Product/Strategic Alliance

The Company has a collaborative alliance with Fertin Pharma A/S, a manufacturer of medicinal chewing gum, for the development of a metformin medicinal chewing gum for the treatment of Type-2 diabetes mellitus and obesity. Metformin is a generic drug used to regulate blood glucose levels by reducing the amount of glucose produced by the liver, reducing the amount of glucose absorbed from food in the stomach, and by making the insulin produced by the body work more effectively to reduce the amount of glucose already in the blood. Fertin Pharma A/S produced clinical materials for a bioequivalence study of its metformin chewing gum, MetControl. It plans to market it as a companion product to Generex Oral-lyn.

Immunomedicine Technology and Products

The Company’s wholly owned subsidiary Antigen is developing vaccine formulations based upon two platform technologies Using active stimulation, it is focusing on diseases, such as breast, prostate and ovarian cancer, melanoma, influenza and human immunodeficiency virus (HIV). Autoimmune disease, such as diabetes and multiple sclerosis are the focus of our antigen-specific immune suppression work. As of July 31, 2010, Antigen’s immunotherapeutic vaccine AE37 was in Phase II clinical trials for patients with HER-2/neu positive breast cancer. The trial is being conducted with the United States Military Cancer Institute’s (USMCI) Clinical Trials Group and will examine the rate of relapse in patients with node-positive or high-risk node-negative breast cancer after two years. The Phase II trial follows a Phase I trial that demonstrated safety, tolerability, and immune stimulation of the AE37 vaccine in breast cancer patients.

The Company has filed a Physician’s Investigational New Drug application for the Phase I and Phase II trials in patients with stage II HER-2/neu positive breast cancer with the FDA. The Phase I trial was completed at the Walter Reed Army Medical Center in Washington and the Phase II trial is taking place at 13 sites, including 11 in the United States, one in Germany and one in Greece. A Physician’s Investigational New Drug application for a Phase I trial in patients with breast or ovarian cancer also has been filed with the FDA, and this Phase I trial is being conducted in Dallas, Texas at the Mary Crowley Cancer Center.

The Company competes with Pfizer, Eli Lilly, Novo Nordisk A/S, MannKind Corporation, Nektar Therapeutics, Alkermes, Inc., Eli Lilly, Amylin Pharmaceuticals, Inc., CPEX Pharmaceuticals, Inc., Oramed Pharmaceuticals, Emisphere Technologies, Inc., Biocon Limited, Cephalon, Inc., MDRNA, Inc., Novavax, Inc. , Apthera, 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. and MedImmune Inc.

Business Line
Engaged in the research, development and commercialization of injection-free methods (systems and technologies) for delivery of large molecule drugs
Subsidiary
ANTIGEN EXPRESS INC
Advisor
MSCM LLP
IPO date
2/1/1998
US SIC Code
8731
Company Address

City province or state postal code
DE
Phone: +1 416 364 2551
Fax: +1 416 364 9363
Country address: UNITED STATES OF AMERICA
Website url: www.generex.com