WORCESTER, Mass. and TORONTO, Oct. 13, 2015 /CNW/ — Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today announced that it has entered into a non-binding Letter of Intent (LOI) with MediTemp Ltd. (MediTemp) (www.meditemp-varicure.com), a private Israeli company that has developed a proprietary cooling technology designed to improve sperm quality in men rendered infertile due to varicoceles.
In 2007, there were approximately two million men in the United States and three million men in Europe between the ages of 25 and 44 diagnosed as infertile. For 42% of those men, the cause of infertility was varicoceles.
A varicocele (VAR-ih-koe-seel) is an enlargement of the veins in the scrotum. A varicocele is similar to a varicose vein that can occur in the legs. Varicoceles are a common cause of low sperm production and decreased sperm quality, which can cause infertility.
MediTemp’s Varicure product, which as been patented in the United States, Europe, and Canada, is a compact, portable, and comfortable device that facilitates localized cooling of the testicles to enhance male fertility by improving sperm quality.
The anticipated per-unit cost of the Varicure™ device will be dramatically lower than traditional treatments for male infertility and will obviate surgical intervention, such that the value of the target market is significant. In addition, the device will be targeted as a preventative measure for men employed in industries such as transportation and manufacturing where there is a higher risk of varicocele development.
The LOI contemplates that Generex will acquire a 51% equity interest in MediTemp in exchange for a purchase price of US$5,000,000 to be paid in accordance with a MediTemp business plan identifying a timeline, milestones, and a budget. Generex will also receive a royalty on sales of the products.
This proposed acquisition, together with the previously announced proposed acquisitions of equity interests in Hema Diagnostic Systems, LLC and Alfa Rhythm Ltd., are being pursued by Generex with a view to expanding the product opportunities for the Company.
The discussions between Generex and MediTemp are at an early stage, and the LOI does not assure that the arrangements contemplated thereby will be achieved. Valuation and other due diligence exercises must be completed. Even if Generex and MediTemp enter into formal arrangements, any benefit from those arrangements will depend upon the ability of MediTemp to execute its business plan to achieve successful commercialization and on the ability of Generex to raise the requisite funding for the acquisition of the equity.
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.