TORONTO—Generex Biotechnology Corporation , a buccal drug delivery company, and Fertin Pharma A/S, a developer and manufacturer of medicinal chewing gum, recently announced that the two companies established a collaboration for the development of a metformin medicinal chewing gum for the treatment of Type-2 diabetes mellitus and obesity.
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 estimated at $1.8 billion
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," says Anna Gluskin, Generex president and CEO. "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, 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.