Lilly and Generex to develop buccal form of insulin

<%=company1%> (Indianapolis, IN) and Generex Biotechnology Corp. (Toronto, Ontario, Canada) have agreed to develop a buccal formulation of insulin to be administered as a fine spray by mouth using Generex technology. Generex will receive initial fees and milestone payments plus royalties based on product sales. In exchange, Lilly will receive exclusive worldwide rights to products resulting from the collaboration. Lilly will be responsible for clinical trials, securing regulatory approvals, and marketing any products from the venture. Clinical trials of the first product candidate are under way in North America and Europe. Lilly will also have the option to develop a number of additional products depending on the success of the initial product. The partners hope that a buccal spray formulation of insulin will provide an attractive alternative for people with diabetes.

This collaboration combines Lilly's expertise in insulin products with Generex's buccal spray technology, resulting in what Generex CEO Anna Gluskin described as "…very good news for millions of patients with diabetes." Lilly's experience with insulin spands the decades back to Banting and Best, who discovered that insulin could control diabetes in 1921.

Today, worldwide costs for treating diabetes and its complications are estimated to exceed $200 billion annually. It is also estimated that, over the next decade, the number of people diagnosed diabetes will more than double.

Buccal delivery improves rospects for large-molecule drugs
Generex's "buccal" technology is named for the medical term for the mouth—buccal cavity. Buccal delivery depends on absorption into the blood through the millions of blood vessels contained in the membranes of the mouth, as opposed to simple oral delivery, by which drugs enter the bloodstream through the gut.

Traditionally, large-molecule drugs have not been delivered in this manner because of poor absorption through the epithelial membrane, acidic and/or enzymatic degradation, and insolubility.

Generex overcame these hurdles through a combination of formulation and delivery system. The pH-neutral formulation uses HFA-134a, a non-CFC propellant, which enables the large-molecule drug to enter the mouth as a nebulized spray of active ingredient encapsulated with and protected by adsorption enhancers. Generex has shown this formulation to be stable and rapidly absorbed through the buccal mucosa.

For more information: Anna Gluskin, CEO, 33 Harbour Square, Suite 202, Toronto, ON, Canada M5J 2G2. Tel: 416-364-8288. Fax: 416-364-8782.

By Angelo DePalma
Managing Editor, Pharmaceutical Online