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FACT SHEET

Ticker Symbol Company Profile


GNBT (OTC:BB)
Generex Biotechnology Corporation is engaged in the research, development and
Share Price (Oct. 25, 2010) commercialization of drug delivery systems and technologies. Generex has developed a
$0.365 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
52-Week High/Low (Oct. 25, 2010) allow drugs typically administered by injection to be absorbed into the body by the lining of
$0.73/$0.26 the inner mouth using the Company's proprietary RapidMist™ device. The Company's
flagship product, buccal insulin, Generex Oral-lyn™, which has been approved in India,
Avg. Volume (3-months) Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2
~ 3,200,000 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
Market Value (Oct. 25, 2010) Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic,
~ $98,900,000 and autoimmune diseases.

Cash (July 31, 2010) Technology Platforms


$13.80 million +
Drug Delivery
Fiscal Year End RapidMist™, an advanced buccal drug delivery technology, is
July 31 comprised of a proprietary formulation and a proprietary
device design that is able to deliver drugs through the buccal
mucosa safely, thereby eliminating the pain from and need for
Recent Operating Highlights
multiple injections. RapidMist™ has been shown to have a
rapid onset of action with no lung deposition, precise dosage
Oct ‘10: Agreement to Acquire 51%
control, easy use and handling, and improved patient
Stake in Global Medical Direct.
compliance.
Oct ‘10: Corporate Update to Address
Management’s Strategic Initiatives for Immunomedicines
Growth. Immunomedicines focuses on modulating immune responses
mediated by T helper (Th)cells, a class of lymphocytes that
Sept ‘10: Appoints Mark Fletcher as play a multifaceted role in the immune system, both
Interim President and CEO, and John enhancing and suppressing immune responses. The cells are
P. Barratt as Chairman. essential both for obtaining a robust and long lasting
Sept ’10: Distribution Agreement for response against infectious agents or cancer cells and for
Generex Oral-lyn™ in Chile. down regulating immune responses when the immune
system becomes inappropriately stimulated, for example in
Sept ‘10: Marketing & Distribution
autoimmune disease and allergy.
Agreement for Glucose RapidSpray™
with Merck in Mexico.
Aug ‘10: Names Dr. Craig Eagle to
Product Pipeline
Scientific Advisory Board to assist with
Cancer Vaccines Programs.
Jul ‘10: Positive Generex Oral-lyn™
Pivotal Phase 3 Clinical Trial.
Jul ‘10: Glucose RapidSpray™ Made
Available in Boots, large UK retailer.
June ‘10: Reports Preliminary
Outcomes & Trends from Phase 3
Clinical Trial of Generex Oral-lyn™.
May ‘10: Achieves Enrollment of Over
400 Subjects in Phase 3 Clinical Trials
of Generex Oral-lyn™.
Jan ‘10: Launch of Crave-NX™ in
Major US 7,000+ store Drug Chain.
Dec ‘09: Presented Results of Phase
2 Breast Cancer Study.
Dec ‘09: Signed Insulin Supply
Agreement with Sanofi-Aventis.
Sept ‘09: Approval of Generex Oral-
lyn™ Under USFDA Treatment IND.
FACT SHEET

Flagship Product – Generex Oral-lyn™

Generex Oral-lyn™ is an oral insulin spray for the treatment of diabetes. The
insulin does not enter the lungs rather it is absorbed in the buccal cavity with
insignificant residual deposition in the gastrointestinal tract. Generex Oral-
lyn™ is a prandial (mealtime) insulin and numerous clinical studies have
consistently demonstrated that the use of Generex Oral-lyn™ allows the
human body to mimic normal pancreatic insulin secretion and is a safe,
effective, fast, flexible, pain-free and simple alternative to prandial insulin
injections. Generex Oral-lyn™ is also designed to improve patient
compliance, thereby delaying the progression of diabetes and the onset of
complications associated with diabetes such as: amputation, retinopathy,
cardiovascular disease, nephropathy, neuropathy and peripheral vascular
disease.

Strategic Partners
Opportunity in Diabetes
• Global insulin market ~ $8-10 billion.
• Diabetes affects over 246 million
people globally and 23.6 million
people in USA.
• By 2025, 380 million people will have
diabetes (a 54% increase) globally.
• Over 1.6 million new cases of
diabetes diagnosed in USA (2007).
• Total cost of diabetes in the USA is
>$170 billion total (2007).
Investment Summary

• Flagship Product: Generex Oral-lyn™ in Global Phase 3 clinical trials and


has obtained approvals in India, Lebanon, Algeria, and Ecuador.
• Proven Technology Platforms: RapidMist™ (buccal delivery of large
molecule drugs) and Immunomedicines (developing proprietary vaccines).
• Broad Product Pipeline: Generex Oral-lyn™, MetControl™ Metformin Gum,
Glucose RapidSpray™, Fentanyl & Morphine Oral Spray, Low Molecular
Weight Heparin Oral Spray and Novel Vaccines (Breast Cancer, Prostate
Cancer, Avian Influenza, SARS).
• Growth in Oncology: Phase II Clinical Trials for Breast Cancer Vaccine &
Phase I Clinical Trials for Prostate Cancer Vaccine; other in pre-clinical.
• World-class Partnerships: Commercial and development partners such as
Sanofi-Aventis; opportunities to expand partnerships leveraging company’s
technologies.
• Experienced Management Team and Prominent Scientific Advisors:
Includes Dr. Gerald Bernstein (former ADA president), Dr. Rubinfeld (Co-
founder of Amgen) and Dr. Craig Eagle (VP, Oncology at Pfizer).
• Strong Intellectual Property: 160 patents & 103 patent applications globally.

Contact Information The information on this Fact Sheet contains forward-looking statements about
Generex Biotechnology Corporation the Company, which involve risks and uncertainties. The Company’s actual
results could differ materially from those in this Fact Sheet, due to risks and
33 Harbour Square, Suite 202 uncertainties regarding the drug discovery and development process, the
Toronto, Ontario Canada M5J 2G2 results of the Company’s clinical studies, the submission of regulatory filings
Toll Free: 800-391-6755 | Local: (416) 364-2551 including applications for marketing approvals and the ability of the Company to
commercialize its drug candidates, whether through sales, distribution,
Fax: 416-364-9363 marketing and/or corporate partnering agreements on terms acceptable to the
Email: info@generex.com Company otherwise. Additional risks and uncertainties are described in the
Website: www.generex.com Company’s most recently filed SEC documents (www.sec.gov).

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