Biodel developing new glucagon rescue product using dual chamber, automatic reconstitution device, NDA filing in 2015 under 505(b)(2) pathway – June 11, 2013

Late last week, Biodel announced plans to develop a new glucagon rescue product using a dual chamber, automatic reconstitution device – pictures of the device can be found at http://www.biodel.com/glucagondevicee/. The pen contains a lyophilized cake of glucagon, which can be delivered in three steps: 1) remove a cover and twist (reconstitutes the glucagon and unlocks the front needle cover; 2) remove the needle shield; 3) push plunger to give dose (the needle automatically retracts into the barrel following completion of a full dose). Biodel has signed a 15-year supply agreement with Unilife Corporation for the customized proprietary device, which provides it with worldwide exclusivity for use with glucagon.

During the current calendar quarter, Biodel expects to select a final formulation of this lyophilized glucagon and appoint a contract manufacturing partner. The submission of an Investigational New Drug (IND) application to the FDA is expected during the next 12 months, and the company expects a pivotal clinical study to start during the second half of 2014. This paves the way for a potential NDA filing under the 505(b)(2) regulatory pathway in 2015. From a patient perspective, the timeline strikes us as somewhat lengthy given that this is not a stable, liquid glucagon; however, we are encouraged to see that Biodel is pursuing an easier and less hassle-filled method of glucagon administration using the aforementioned dual-chamber device. Given the low penetration of current glucagon rescue kits and widely acknowledged difficulties with the current reconstitution process, we think this would be a very important step forward, particularly if the market looks as it currently does (there are a number of other competitive offerings in development).

Biodel is still separately developing a stable liquid glucagon presentation for pump usage (six days of stability at body temperature and 1.5-2 years of refrigerated stability) and potentially emergency usage (1.5-2 years of room temperature stability). This product has been delayed over the past year, presumably reflecting Biodel’s prioritization of ultra-fast-acting insulin and the difficulty of stabilizing the glucagon molecule in solution. For context, the timeline given in the August F3Q12 earnings call was an NDA for stabilized glucagon in early 2014; now, we would expect this stabilized product would fall behind the 2015 filing of the aforementioned pen device. In Biodel’s most recent F2Q13 call, management said it was “close to finalizing” stabilized glucagon formulations that achieve desired room temperature characteristics and user-friendly presentations. For more information on that call, see our report at http://www.closeconcerns.com/knowledgebase/r/1bf9153e we look forward to learning more about this and the rest of the competitive environment for this all-important hormone.

-- by Adam Brown and Kelly Close