Biodel Announces Removal of Partial Clinical Hold for BIOD-531 and Plans for Potential Expansion of Target Patient Population

Biodel Inc.

today announced that the United States Food and Drug Administration (FDA) has removed the partial clinical hold for Biodel's previously initiated Phase 2b Study 3-250, a randomized, open-label, parallel group study in patients with insulin-treated type 2 diabetes comparing the use of BIOD-531 to Humalog® Mix 75/25. The correspondence from the FDA clears the use of Biodel's investigational U-400 syringes in the clinical trial. Additionally, in the fourth calendar quarter of 2015, the Company will begin a Phase 2a standardized meal challenge study and independent market analysis to determine whether the target diabetes populations and market segments for BIOD-531 can be further expanded. The Phase 2a standardized meal challenge study will evaluate the hypothesis that treatment with BIOD-531 can reduce the injection burden and achieve glucose control at least as effective as that with separate basal and prandial insulins in patients with type 2 diabetes. The market analysis will assess the optimal target patient populations and commercial opportunity for BIOD-531, including patients who are on intensive basal/prandial insulin therapy. In anticipation of this potential expanded market opportunity, the Company has decided to continue Study 3-250 to allow completion of patients currently in the trial while deferring recruitment of new patients until the optimal target population(s) have been selected following review of top-line data from the new Phase 2a meal study and the results of the market analysis in the first calendar quarter of 2016. Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "We are pleased that the FDA has cleared our investigational U-400 syringes for use in an outpatient Phase 2b study and look forward to new data which will further inform later stage multi-dose clinical trials with the optimal patient population and comparators early next year."