-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, F2N0UfM2tb5md7xInJqqvvMyZTuuhpwiDhWuPE2H2kpw6YxsCxm7wcoqIhyYz1oc 9E2q1DLmQzKYtxEFNLFTXw== 0000950116-03-002854.txt : 20030527 0000950116-03-002854.hdr.sgml : 20030526 20030527134255 ACCESSION NUMBER: 0000950116-03-002854 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030523 ITEM INFORMATION: Other events FILED AS OF DATE: 20030527 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENEREX BIOTECHNOLOGY CORP CENTRAL INDEX KEY: 0001059784 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 820490211 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-25169 FILM NUMBER: 03719618 BUSINESS ADDRESS: STREET 1: 33 HARBOUR SQ STREET 2: STE 202 CITY: TORONTO ONTARIO CANADA STATE: A1 ZIP: M5J 2G2 BUSINESS PHONE: 4163642551 MAIL ADDRESS: STREET 1: 33 HARBOUR SQ STREET 2: STE 202 CITY: TORONTO ONTARIO CA STATE: A1 ZIP: M5J 2G2 8-K 1 eightk.txt EIGHTK.TXT SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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) May 23, 2003 ---------------------------------------------------------------- Generex Biotechnology Corporation ------------------------------------------------------ (Exact name of registrant as specified in its charter) Delaware 000-25169 82-049021 - ---------------------------- --------------- -------------------- (State or other jurisdiction (Commission (IRS Employer of Incorporation) File Number) Identification No.) 33 Harbor 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 --------------------------------------------------------------- ------------------------------------------------------------- (Former name or former address, if changed since last report) Item 5. Other Events On May 23, 2003, Generex Biotechnology Corporation issued a press release announcing that Generex and Eli Lilly and Company have agreed to end their development and license agreement for the development and commercialization of buccal delivery of insulin. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. (c) Exhibits Exhibit No. Description ----------- ----------- 99.1 Press release dated May 23, 2003. 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: May 27, 2003 By: /s/ Rose C. Perri -------------------------- Rose C. Perri Chief Operating Officer (principal financial officer) Exhibit Index ------------- Exhibit No. Description - ----------- ----------- 99.1 Press release dated May 23, 2003 EX-99 3 ex99-1.txt EX99-1.TXT Exhibit 99.1 Generex Biotechnology Corporation (ticker: GNBT, exchange: NASDAQ) News Release - 23-May-2003 - -------------------------------------------------------------------------------- Lilly and Generex Biotechnology Agree to End Diabetes Collaboration; Parties Working on Terms for Lilly to Continue Insulin Supply Arrangement TORONTO, May 23 /PRNewswire-FirstCall/ -- Generex Biotechnology Corporation (Nasdaq: GNBT) announced today that Generex and Eli Lilly and Company (NYSE: LLY) have agreed to end their development and license agreement for the development and commercialization of a buccal delivery of insulin. Generex also announced today that, pursuant to the provisions of the development and license agreement, both parties are working on terms for Lilly to continue to supply a specified amount of insulin for Generex's further development work. All of Generex's intellectual property and commercialization rights with respect to the buccal spray drug delivery technology will revert to Generex, which will have the continuing right to develop and commercialize the product at its own expense. Anna Gluskin, President & CEO of Generex, stated: "This is a positive development for Generex. Generex will continue to advance Oralin(TM) through the regulatory process in Canada and, once appropriate partners are in place, in the United States and elsewhere. We continue to have absolute confidence in our drug delivery technology as Oralin(TM) repeatedly demonstrates positive results in terms of safety and efficacy in patients with diabetes." Generex anticipates that the next stage of the clinical development of Oralin(TM) will commence in the third quarter of 2003. About Generex Generex is engaged in the research and development of drug delivery systems and technology. To date, it has focused on developing a platform technology for the buccal delivery -- delivery to the oral cavity for absorption through the inner mouth mucosa -- of drugs that historically have been administered only by injection. Generex's buccal delivery technology has application to a large number of drugs. 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 claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act. -----END PRIVACY-ENHANCED MESSAGE-----