Having previously signed a long-term commercial supply agreement for bulk glucagon, Biodel expects to select a final formulation of its novel glucagon therapy and appoint a contract manufacturing partner during the current calendar quarter. The submission of an Investigational New Drug application to the FDA is expected during the next 12 months. Initiation of a pivotal clinical study is expected to occur during the second half of 2014, putting the Company in a position to file an NDA to the FDA under the 505(b)(2) regulatory pathway in 2015.
In preparation for the anticipated regulatory filing and commercial launch of its glucagon rescue product, Biodel has signed a 15-year supply agreement with Unilife Corporation for a customized proprietary device from its EZMix™ platform of dual-chamber devices with worldwide exclusivity for use with glucagon. The device has been customized for convenient portability and ease of use to enable rapid treatment during emergency situations with little to no training. The device automatically reconstitutes lyophilized glucagon when prepared for injection and features automatic, user-controlled retraction of the needle upon full dose delivery, virtually eliminating dosing errors and the risk of needle stick injuries.