8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 25, 2008

GENEREX BIOTECHNOLOGY CORPORATION

(Exact Name of Registrant as Specified in Its Charter)

Delaware	000-25169	98-0178636
(State or Other	(Commission	(IRS Employer
Jurisdiction of	File Number)	Identification
Incorporation)	Number)

33 Harbour Square, Suite 202, Toronto, Ontario Canada	M5J 2G2
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (416) 364-2551

N/A

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01Other Events.

On August 25, 2008, Generex Biotechnology Corporation (the “Company”) is issuing a press release to announce that it has entered into a product licensing and distribution agreement with Dong Sung Pharm Co. Ltd. (“Dong-Sung”) for the importation, marketing, distribution and sale of Generex Oral-lyn™, the Company’s proprietary oral insulin spray product, in South Korea. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. Under the seven-year agreement, Dong-Sung will have an exclusive license and will pay the Company a USD$500,000 non-refundable license fee upon execution and a USD$500,000 non-refundable license fee at such time as governmental approval for the importation, marketing, distribution and sale of the product in South Korea is obtained. Under the agreement, the Company is responsible for procuring such governmental approval. In addition, when it places its first purchase order, Dong-Sung will pay the Company a pre-payment in the amount of USD$500,000, which will be applied against product purchase orders.

Item 9.01.Financial Statements and Exhibits.

(d) Exhibits.

99.1 Press Release issued by Generex Biotechnology Corporation dated August 25, 2008

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	GENEREX BIOTECHNOLOGY CORPORATION
Dated: August 25, 2008	By:	/s/ Rose C. Perri
		Chief Operating Officer and Chief Financial Officer (principal financial officer)

EXHIBIT INDEX

99.1 Press Release issued by Generex Biotechnology Corporation dated August 25, 2008

EX-99.1

Generex Biotechnology Signs Oral Insulin

Distribution Deal for Korea

Upfront Licensing Fee Included as a Term of the Arrangement

Leading Korean Pharmaceutical Company to Distribute Generex Oral-lyn™

WORCESTER, Mass., August 25, 2008 (GlobeNewswire) -- Generex Biotechnology Corporation (NasdaqCM:GNBT, www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, has entered into a product licensing and distribution agreement with Dong-Sung Pharm Co. Ltd. (www.dongsung-pharm.co.kr) for the importation, marketing, distribution and sale of Generex Oral-lyn™, the Company’s proprietary oral insulin spray product, in South Korea.

The terms of the deal call for payment of a non-refundable, up-front licensing fee and further payment of an additional non-refundable license fee of upon procurement of the requisite approval from the Korea Food and Drug Administration (KFDA, www.kfda.go.kr) for the sale of the product in South Korea. Generex will prepare, file and prosecute the approval application with the assistance of Dong-Sung and SciGen, Ltd. (www.scigenltd.com), Generex’s master licensee in the region.

Dong-Sung Pharmaceuticals, founded in 1957, is one of Korea’s leading pharmaceutical companies with more than 500 employees and the largest production facilities in the country.

“Dong-Sung Pharmaceuticals prides itself on providing innovative pharmaceutical solutions to our customers,” said Lee Yang-Goo, President of Dong-Sung. “We are proud to add Generex Oral-lyn™ to our roster.”

COSMO USA IBRC, Inc. (www.cosmo-usa.com), a life sciences industry consulting company, served an integral role in bringing Generex and Dong-Sung together for this opportunity.

The Company believes that Generex Oral-lyn™ will offer a safe, simple, fast, effective and pain-free alternative to prandial insulin injections, which will improve patient compliance with therapeutic regimes, thereby delaying the progress of diabetes and the onset of its myriad complications.

Generex Oral-lyn™ is presently approved for commercial sale in India and Ecuador and a global Phase III clinical trial is underway.

About Generex Biotechnology Corporation

Generex is engaged in the research, development, and commercialization 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™ device.  The Company’s flagship product, oral insulin (Generex Oral-lyn™), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, is in Phase III clinical trials at several sites around the world.  For more information, visit the Generex website at www.generex.com. 

Safe Harbor Statement

This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain “forward-looking statements’’ within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,’’ “plans,’’ “intends,’’ “believes,’’ “will,’’ “estimates,’’ “forecasts,’’ “projects,’’ or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any “phase’’ of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Contact:

American Capital Ventures, Inc.

For Generex:

Howard Gostfrand

1-877-918-0774

CEOcast, Inc.

Andrew Hellman

212-732-4300