Memorandum

Biodel announces positive results from human factors study of Glucagon Emergency Management (GEM) auto-reconstitution device – April 7, 2015

Biodel announced positive results yesterday from an initial human factors study of its Glucagon Emergency Management (GEM) (we love this name!) auto-reconstitution device for severe hypoglycemia. The small study (n=24) demonstrated significantly greater usability with the GEM device compared to Lilly’s and Novo Nordisk’s marketed glucagon rescue kits: 87% of participants successfully delivered a full dose of glucagon with the GEM device vs. 6% with the marketed kits, and the average time to dose delivery was 76 seconds vs. 113 seconds (p<0.05). Notably, the success rate was comparable between trained and untrained participants, supporting Biodel’s claim that the device should require little to no training to use. Consistent with previous guidance from the company, the next step for the GEM device will be a larger pivotal human factors study scheduled to complete by the end of 2015. As a reminder, Biodel recently released positive phase 1 results showing comparable pharmacokinetics (PK) and pharmacodynamics (PD) with BIOD-961 (the stable glucagon formulation intended for use with the GEM device) vs. Lilly’s and Novo Nordisk’s marketed glucagon formulations. The company plans to request an end-of-phase 2 meeting with the FDA in 2Q15 to finalize the design of a phase 3 pivotal study for BIOD-961; the goal is to submit a New Drug Application (NDA) for the entire product in mid-2016. Based on these striking results, the GEM device should certainly represent a significant advance for patients and caregivers over current options. However, a possibly more important test for the device will be the real-world comparison with Locemia’s intranasal glucagon (phase 3 complete; usability study underway) and Xeris’ G-Pen auto-injector (slated to enter phase 3 in 2015); both have a slight advantage in terms of ease of use, though of course, pricing and other factors will play into market uptake as well.  Although we know that currently-marketed kits carry a “hassle factor” the 6% rate surprised even us – we’ll be looking for more details on this front. Yet and still – severe hypoglycemia is one of the most stressful, distressing experiences in diabetes for patients and caregivers alike and we’re very happy that multiple organizations are at work on reducing the degree of hassle factor experienced.