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Generex Biotechnology and Fertin Pharma Announce Metformin Gum Collaboration Wednesday May 31, 8:30 am ET
TORONTO--(MARKET WIRE)--May 31, 2006 -- Generex Biotechnology Corporation (NasdaqSC:GNBT - News), a leader in the area of buccal drug delivery, and Fertin Pharma A/S (www.fertin.com), a world leader in the development and manufacture of medicinal chewing gum, jointly announced today that they have established a collaboration for the development of a metformin medicinal chewing gum for the treatment of Type-2 diabetes mellitus and obesity.
ADVERTISEMENT Metformin is a generic drug used to regulate blood glucose (sugar) levels by reducing the amount of glucose produced by the liver, reducing the amount of glucose absorbed from food in the stomach, and by making the insulin produced by the body work more effectively to reduce the amount of glucose already in the blood. The total US market sales of all forms of metformin are approximately $1.8 Billion (IMS-MAT: December 2003).
The collaboration will seek to combine Generex's proprietary buccal drug delivery platform technologies with Fertin's know-how related to gum base formulations, solubilization systems, and taste masking/modification to create a metformin medicinal chewing gum that will deliver metformin into the body via the buccal mucosa (the inner lining of the mouth) rather than in its current tablet form. The companies expect that this new delivery method, in addition to being much more rapid and providing a much more specific and effective dosing regimen, will avoid some of the adverse side effects associated with taking metformin in tablet form such as nausea, vomiting, abdominal pain, diarrhea, abdominal bloating, and increased gas production. In addition, metformin gum will avoid the bitter taste and large doses associated with the tablet form thereby improving patient compliance, particularly amongst younger patients.
"We are pleased to have established this collaborative relationship with Fertin Pharma, the industry leader in medicinal gum," said Anna Gluskin, the Generex President & Chief Executive Officer. "Together, we will continue the Generex mission of improving diabetes care and the quality of life of people with diabetes."
Generex will conduct a pivotal clinical study to establish the non-inferiority of the product as a precursor to seeking regulatory approvals for the manufacturing, marketing, and sale of the product.
The metformin medicinal chewing gum will be a companion product to Generex Oral-lyn(TM), Generex's proprietary oral insulin spray product. Metformin is an important staple of the standard of care for patients with Type-2 diabetes mellitus. Generex believes that a combination therapy of Generex Oral-lyn, metformin gum, and other traditional oral agents can optimize the treatment of Type-2 diabetes thereby delaying the onset of complications associated with diabetes.
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 RapidMist(TM) device. The Company's flagship product, oral insulin (Generex Oral-lyn(TM)), which has been approved 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.
For more information, visit the Generex website at www.generex.com.
About Fertin Pharma
Fertin Pharma is a world leader in the development and manufacture of medical chewing gum and is working in partnerships with a wide range of well-respected pharmaceutical companies.
Fertin Pharma's patent protected MediChew® technology is based on unique know-how with controlled release of active substances from gum bases, fully documented release testing procedures, taste modification, and development of gum bases.
For more information, visit the Fertin Pharma website at www.fertin.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 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.
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