During the course of this presentation, data from certain clinical studies may be shown. These studies were sponsored independently by Generex.
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1 GENEREX BIOTECHNOLOGY 2009 Annual General Meeting July 30, 2009
2 Forward Looking Statements During the course of this presentation, it is possible that statements that could be construed as forward-looking statements within the meaning of federal securities laws and regulations may be made. The eventual outcomes of our various research and development activities could differ substantially from those anticipated in any forward-looking statements made today. You should not rely on any forward-looking statements and you should consider any such statements in light of the cautionary statements thataresetforth fromtimeto timeinourfilingswiththesecuritiesand Exchange Commission. During the course of this presentation, data from certain clinical studies may be shown. These studies were sponsored independently by Generex. The Company Assumes no obligation to update the information contained in this presentation.
3 Management Team Anna Gluskin President and CEO& Chairman Rose Perri Chief Financial Officer and COO & Director Dr. Gerald Bernstein, MD VP, Medical Affairs Dr. Jaime Davidson, MD Medical Director Eric Von Hofe, PhD VP, Product Development & Scientific Affairs Mark Fletcher Executive VP, General Counsel Bill Abajian Senior Executive Advisor, Global Strategic Alliances & Business Development
4 Generex Oral-lyn lyn Treatment of Type-1 & Type-2 Diabetes. Insulin sprayed into mouth (NOT THE LUNGS). Control of postprandial (post-meal) glucose. Fast onset, reproducible, linear dose response. Result: Improved compliance, decreased complications, increased satisfaction, reduced complications. Goal: Pain free, convenient, glycemic control comparable to injected insulin.
5 Confidential Generex
6 Phase III Glucose Control With Generex Oral-lynlyn TM (Red) Vs. Regular Insulin (Black) MEAN-GLUCOSE-HUMULIN MEAN-GLUCOSE- ORAL-LYN G L U C O S E m g /d L n = 10 p = :55 +8:00 +9:55 +12:55 +14:00 +16:25 +20:25 +21:30 +22:10 TIME n = number of patients in study
7 Generex Oral-lyn Update (Other markets) InitiatedGlobal Phase III Clinical Trials for insulin. (352 patients enrolled) Launchedin India with Shreya Life Sciences. Approved in Lebanon. Approved in Ecuador. GrantedSpecial Access Program from Health Canada and Netherlands. Registrationstaking place in South America, Middle East and Asia.
8 Generex is Global
9 Generex Distribution and Marketing Partners Marketing, distribution in Russia, CIS, India, South East Asia and African countries. Marketing and Distribution in South Korea Marketing and Distribution in South Africa, Lesotho, Swaziland, Botswana, Namibia, Mozambique and Zimbabwe Marketing, distribution in China, Hong Kong, Indonesia, South Korea, Malaysia, the Philippines, Singapore, Thailand, and Vietnam Marketing, distribution in Lebanon Marketing, distribution Ecuador and Andean Pact Regions
10 Fully-owned subsidiary. Education, Sales, Marketing and Distribution for the Middle East and North Africa. Located Dubai Healthcare City Countries distributed to: Kingdom of Bahrain State of Kuwait Sultanate of Oman State of Qatar Kingdom of Saudi Arabia United Arab Emirates Republic of Yemen Islamic Republic of Iran Republic of Iraq Syrian Arab Republic Hashemite Kingdom of Jordan Arab Republic of Egypt Great Socialist People's Libyan Arab Jamahiriya People's Democratic Republic of Algeria Kingdom of Morocco
11 Regulatory Path for Veterinary Application & Partnering Partnered with Butler Animal Health Supply. Largest distributor to veterinarians in the USA. Serves over 29,000 veterinary clinics in USA Has ~ 400 inside and outside sales reps.
12 MetControl Metformin Metformin Gum 250 mg MetControl Metformin Gum Tablets. Metformin Market Sales $2 billion. Rapid absorption compared to tablets. Avoids side effects associated with tablets such as nausea, bloating, vomiting & diarrhea. Improves patient compliance & efficacy. Pharmacokinetic profile similar to tablets. Submission to be made end of the year in UK
13 CONSUMER PRODUCTS AVAILABLE IN RETAIL CHAINS
14 Generex Oral-lyn lyn Milestones Achieved Enrolled over 350 subjects in Global Phase 3 Trial. Partnership with Dong-Sung Pharm Co. for South Korea. Granted Special Access Program by Health Canada and Netherlands. Commercial Launch in India. Partnership with SciGen for China. Partnership with Adcock Ingram Healthcare (Pty) Ltd. For South Africa. Filed Generex Oral-lyn dossier in Kuwait, Qatar, Jordan, Yemen, UAE, Middle East. Approved in Algeria & Lebanon Launched in Lebanon
15 Milestones Achieved Partnership with Fertin Pharma for MetControl Metformin Gum. National Retail Distribution for Glucose RapidSpray. Commenced Enrollment of Breast and Ovarian Cancer Patients for Combination Therapy Trial. Early-Phase II Clinical Trials for Breast Cancer Vaccine. Initiated Phase I Clinical Trials for Prostate Cancer Vaccine. Commercial Launch of BaBOOM! Energy Spray, Crave-NX Diet Aid Spray, Glucose RapidSpray for Animal Health sector.
16 Generex Biotechnology Corporation Antigen Express Annual General Meeting Update
17 Antigen Express Management Team Eric von Hofe, Ph.D. President MinzhenXu, M.D., Ph.D. Vice President of Biology Douglas Powell, Ph.D. Director of Immunobiology Nikoletta Kallinteris, M.S. Project Leader
18 Antigen Express Mission Make widely applicable cancer immunotherapy a part of standard cancer treatment Develop next generation immunotherapeutic and prophylactic vaccines Provide more sensitive diagnostic tools for autoimmune diseases
19 Antigen Express Technology Proprietary vaccine technology for antigen-specific stimulation of T helper cells CD4 + T Helper cell T Helper cell Essential in establishing an acquired immune response Involved in activating and directing other immune cells Critical role in immunological memory
20 Antigen Express Pipeline Ii-Key Hybrid Vaccines Cancer Her-2/neu + Breast Cancer Her-2/neu + Prostate Cancer Her-2/neu + Combo Vaccine Melanoma Infectious Disease Avian Influenza (H5N1) Swine flu (H1N1) HIV Diagnostic/Therapeutic Diabetes Allergy Ii Suppression Acute Myelogenous Leukemia HIV (DNA Vaccine) Research Preclinical Phase I Phase II Phase III
21 Antigen Express 2008 Achievements Enrolled over 100 patients in our AE37 Phase II breast cancer efficacy trial Completed Phase I prostate cancer study with AE37 demonstrating potent immune stimulation and suggestions of PSA decrease Initiated a Phase I study of AE37 with another immunological agent in breast and ovarian cancer patients
22 Antigen Express New Developments for 2009 Completion of patient enrollment for the Phase II breast cancer trial Initiation of Phase II prostate cancer study Completion of Phase I combination peptide trial in breast and ovarian cancer patients Advance our synthetic peptide vaccine platform for both avian and pandemic swine flu
23 Summary Strong clinical advancements Phase II breast cancer efficacy trial Phase I prostate cancer trial Phase I avian influenza trial Phase I breast & ovarian (novel strategy) Continued publication of Antigen Express science in peer-reviewed journals; technology validation by collaborators
24 Thank You for attending the Generex Biotechnology Corp Annual General Meeting
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