Generex Announces Collaboration on Medicinal Cannabis

WORCESTER, Mass. and TORONTO, Nov. 18, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today announced that it has entered into a non-binding Letter of Intent (LOI) to license the Company's proprietary RapidMist™ drug delivery technologies to CannScience Innovations Inc. (CannScience) for the delivery of medicinal cannabis derived products into the bloodstream through the buccal membrane.

The RapidMist™ drug delivery platform administers medications directly into the mouth as a metered dose spray for rapid absorption by the buccal mucosa. Generex's most advanced product in development using RapidMist™ is Generex Oral-lyn™ for the treatment of diabetes mellitus. 

This co-development arrangement with CannScience is intended to develop products initially for the Canadian medical cannabis market. The LOI contemplates a significant royalty stream to Generex. Costs to develop, manufacture, and commercialize the products will be borne by CannScience.

Since 2001, qualifying Canadians have been able to access medicinal cannabis through the Marihuana Medical Access Regulations (MMAR) program. In response to a handful of concerns, on April 1, 2014, the MMAR system was repealed and replaced with the Marihuana for Medical Purposes Regulations (MMPR) program (which came into effect on October 1, 2013), where all medicinal cannabis must be produced and procured a Licensed Producer (LP), effectively commercializing the medicinal cannabis industry in Canada.

Health Canada projects a total market of $1.3 billion by 2024 under the new MMPR system, representing a growth in number of patients of 36% CAGR over the coming five years and a further 10% CAGR over the following five years.

Further, products developed through this co-development arrangement may potentially be commercialized in international markets. In legalized marijuana markets such as Colorado, derivative product market segments have demonstrated the fastest growth as the markets become established.

CannScience is an R&D biopharmaceutical company established in Toronto, Canada to conduct research and product development for formulations and extracts related to medical cannabis and its derivatives. CannScience is developing proprietary technologies and owns know-how related to the chemistry and pharmacology of cannabinoids and potentially how they integrate with various medical devices and drug delivery technologies. CannScience intends to develop commercial ready products and obtain regulatory approval for RapidMist™ in the Canadian and international jurisdictions.

Both Generex and CannScience believe that absorption of cannabis derived products through the buccal membrane offers distinct advantages to alternative routes of administration – principally, a faster onset of activity compared to oral administration, higher level of control for dosing, and more predictable absorption and pharmacodynamics.

The discussions between Generex and CannScience are at an early stage, and the LOI does not assure that CannScience will enter into a license with Generex or utilize the RapidMist™ technologies.  CannScience does not currently have any products on the market or approved for commercialization.  Even if Generex and CannScience enter into a formal license, any benefit from that license depends upon CannScience's ability to develop a product, have it approved by the appropriate regulators, and successfully commercialize the product.

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. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency, while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of 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," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" 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 or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

SOURCE Generex Biotechnology Corporation

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