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[december]

Generex Biotechnology Completes Positive Pre-NDS Meeting With Health
Canada for Generex Oral-lyn(TM)
Friday March 3, 8:45 am ET


Company Now Has Clear Roadmap to NDS


TORONTO--(MARKET WIRE)--Mar 3, 2006 -- Generex Biotechnology
Corporation (NasdaqSC:GNBT - News) announced today that on March 1,
2006 the Company concluded a positive Pre-New Drug Submission (NDS)
meeting with the Regulatory Affairs Division of the Biologics and
Genetic Therapeutics Directorate of Health Canada in respect of
Generex Oral-lyn(TM), the Company's proprietary oral insulin spray
product for the treatment of diabetes.
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The purpose of the Pre-NDS meeting was to review the current status
of Generex Oral-lyn(TM) with a view to determining what will be
required for a successful New Drug Submission which will allow
Generex Oral-lyn(TM) to be marketed and distributed in Canada.

"The informed and vigorous engagement of the Health Canada
representatives in our meeting was most gratifying," said Anna
Gluskin, Generex President & Chief Executive Officer. "We now have
clearly defined objectives in a roadmap to a successful New Drug
Submission for Generex Oral-lyn(TM) and we will move expeditiously
to achieve those objectives and prepare the NDS." The NDS will
include all clinical data, bio-statistical analyses, sample batches,
chemistry, manufacturing and controls (CMC), production schedules,
and medical device licensing."

The Company expects that the NDS documentary package, together with
the April, 2005 approval of Generex Oral-lyn(TM) by the Ecuadorian
Ministry of Public Health, will advance similar filings for
regulatory approvals with the United States Food and Drug
Administration (FDA) and the European Agency for the Evaluation of
Medicinal Products (EMEA).

About Generex

Generex is engaged in the research and development 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 (Oral-lyn(TM)),
which has been approved for commercial sale in Ecuador for the
treatment of patients with Type-1 and Type-2 diabetes, is in various
stages of clinical trials around the world.