It is currently sold as an acidic dry powder which must be reconstituted into a liquid by a care-giver for injection into the patient. Biodel plans to seek FDA approval of this compound under section 505(b)2 of the Federal Food, Drug and Cosmetic Act which governs the review of an NDA for a modified form of a previously approved product.
We are also working with physicians at leading U.S. medical centers to develop a more stable form of glucagon for use in bi-hormonal pumps to enable more aggressive treatment of diabetes with insulin. Bi-hormonal pumps are being developed to replace current insulin pumps and continuous glucose monitoring devices and allow for more effective continuous regulation of blood glucose. We are currently conducting preclinical studies to evaluate this exciting new approach to diabetes management.
In March 2012, we announced that we had received feedback from the FDA regarding regulatory requirements for the development of a liquid formulation of glucagon for use as a rescue treatment for diabetes patients experiencing hypoglycemia. Subject to successful completion of clinical trials, we intend to submit an NDA for this product candidate in the fourth calendar quarter of 2013 or the first calendar quarter of 2014.