VIAdel™ Technology

VIAdel™ technology is based on the interaction between peptide hormones and small molecules. Peptide hormones are valuable in treating a variety of important human diseases. Peptides are typically given by subcutaneous injection because they are relatively unstable and poorly absorbed by the gastrointestinal tract. However, the absorption of peptide hormones from subcutaneous injection is still inhibited and slowed because they are charged molecules. Because of their charge, peptide hormones meet resistance when attempting to cross through charged membranes. This resistance impedes absorption of the peptide hormone reducing clinical efficacy. Slow absorption decreases the efficacy of many peptide hormones, particularly insulin.

VIAdel™ technology reformulates existing peptide drugs utilizing small molecules that are Generally Regarded As Safe (GRAS) by the FDA, and improves their therapeutic effect. Biodel's novel technology forms weak and reversible bonds between the specific GRAS ingredients and the peptide hormone, temporarily neutralizing its charged surface and potentiating more rapid and efficient absorption. Peptide hormone drugs which have been reformulated by VIAdel™ technology are able to enter the bloodstream rapidly and in greater quantities. Increasing the rate of absorption of peptide hormones improves the therapeutic efficacy whether administered orally or by injection. Administration by non-invasive means, such as orally, improves ease of use, patient acceptability and patient compliance.

VIAdel™ technology application in diabetes

Current insulin products deliver insulin as a hexamer which is a large complex of six insulin molecules assembled around two zinc atoms. Insulin hexamers are slowly absorbed into the blood due to their size. To be well absorbed into the blood, insulin hexamers must first disassociate to yield three smaller double insulin molecules called dimers and then must further disassociate to six single insulin molecules called monomers. This process of disassociation slows insulin's absorption into the blood, reducing the efficacy of insulin in controlling glucose levels and increasing the risk of patients experiencing both hyperglycemia and hypoglycemia. VIAdel™ technology promotes a more rapid dissociation of insulin from the hexameric form to the monomeric form and inhibits insulin's re-association to the hexameric form. We believe that VIAdel™ technology will lead to faster delivery of human insulin into the bloodstream, which will better mimic a healthy body's normal insulin release and thus reduce the risk of hyperglycemia and hypoglycemia.
Below are cross-sections of human sublingual epithelial cell cultures. The cells on the left received VIAject™ insulin; the cells on the right received Humulin® R insulin (the comparator used in VIAject™'s phase III clinical trials). Both cultures were photographed five minutes after administration and show insulin penetration in green.

Regulatory 505(b)(2)

Using the VIAdel™ technology, we seek to reformulate existing drugs with ingredients that are generally regarded as safe by the FDA.  This approach to drug development will allow the Company to use the abbreviated review process of Section 505(b)(2) of the Food, Drug, and Cosmetic Act, which can result in substantially less time and cost in bringing a new drug candidate to market.  Biodel intends to continue to focus its efforts on reformulating new product candidates for which the Company will be able to seek regulatory approval pursuant to Section 505(b)(2).