SOURCE: Generex Biotechnology

May 23, 2006 07:30 ET

Generex Biotechnology Augments R&D Teams With Two New Hires

TORONTO -- (MARKET WIRE) -- May 23, 2006 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that it has augmented its research and development teams with the hiring of two new employees.

Generex has hired Mr. George Markus as its Manager of Regulatory Affairs. Mr. Markus will be responsible for the day-to-day operations of the Company's Regulatory Affairs Department, with specific emphasis on the preparation, review, and evaluation of documents for submission to regulatory authorities including but not limited to the United States Food and Drug Administration (FDA), Health Canada, and the European Agency for the Evaluation of Medicinal Products (EMEA). Mr. Markus will be responsible for assuring that all regulatory requirements/commitments are met with respect to the development and approval of the Company's drug products and maintenance of applications for products approved for marketing. Mr. Markus will also provide regulatory advice and counsel to other functional areas with regard to the regulatory aspects of drug development and marketing and interact directly with governmental regulatory personnel.

Mr. Markus holds a B.Sc. (Honours) in theoretical chemistry from Dalhousie University and an M.Sc. in analytical chemistry from McGill University. He is an instructor at the Academy of Applied Pharmaceutical Sciences in Toronto, Canada. In his more than 20 years in the industry, he has been President & Chief Executive Officer of Consolidated Clinical Research of Canada Inc., a site management organization (SMO) that manages the coordination of clinical research sites, and has worked in Quality Assurance / Special Projects / Clinical Operations and as a Director, Regulatory Affairs for Dimethaid Research Inc. Mr. Markus has also held regulatory affairs positions with Pasteur Merieux Connaught, Biovail Corporation International, Sanofi Winthrop, Genpharm Inc. Pharmaceuticals, and Sandoz Canada Inc.

In addition, Antigen Express, Inc., the Company's wholly owned immunotherapeutics subsidiary, has hired Ms. Margaret Sposato as a Senior Research Associate. Ms. Sposato will bring her extensive expertise in flow cytometry, molecular biology, cell culture, and animal handling to the Antigen Express vaccine programs for avian influenza and HIV.

Ms. Sposato holds a B.Sc. from Worcester Polytechnic Institute. She has held scientific research positions with PharmaMar USA, Phylogix, Inc., and ViaCell, Inc.

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 RapidMis™ device. The Company's flagship product, oral insulin (Generex Oral-lyn™), which has been approved and is available 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. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.

For more information, visit the Generex website at or the Antigen Express website at

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 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 Information

  • Contact:
    Shayne Gilliatt
    Generex Biotechnology Corporation
    Phone: (800) 391-6755
    (416) 364-2551

    Andrew Hellman
    CEOcast, Inc.
    Phone: (212) 732-4300