ultra-rapid-acting recombinant human insulin (BIOD-123) / Ipsen - LARVOL DELTA

A study evaluating safety and efficacy of BIOD-123 compared to insulin lispro (Humalog) (clinicaltrials.gov) - P2, N=130; Sponsor: Biodel; Recruiting; New P2 trial

New P2 trial • Diabetes

Biodel: JMP Securities Healthcare Conference (Biodel) - Anticipated intellectual property protection in EU through 2025; Anticipated intellectual property protection in US through 2026

Anticipated patent expiry • Diabetes

Biodel's BIOD-123 achieves primary endpoint in phase 2 clinical trial demonstrating glycemic control comparable to Humalog(R) (Biodel Press Release) - P2, N=132; NCT01686620; Sponsor: Biodel; "...announced preliminary results from Study 3-201...achieved the primary endpoint of non-inferiority for HbA1c relative to insulin lispro, a widely prescribed rapid acting mealtime insulin analog marketed as Humalog®."

P2 data • Diabetes

Biodel: JMP Securities Healthcare Conference (Biodel) - "Primary endpoint on injection site tolerability was measured as an 100 mm Visual Analog Scale (VAS): 0 = no discomfort; 100 = worst possible discomfort; 3 = usual injection"

P1 data • Diabetes

Biodel completes enrollment in phase 2 clinical trial of ultra-rapid-acting insulin candidate BIOD-123 for the treatment of diabetes (Biodel) - P2, N=130; "...announced the completion of patient enrollment in a Phase 2 clinical study of ultra-rapid-acting prandial insulin candidate BIOD-123 for the treatment of diabetes... top line data from this trial in the third calendar quarter of 2013."

Anticipated P2 data • Enrollment closed • Diabetes

Biodel: BIOD-123 Study 3-201 Top Line Data Conference Call (Biodel) - P2, N=130; "HbA1c and Insulin Doses During 0-6 Weeks (Titration Period) Compared to 6-18 Weeks (Stable Dosing Period); "Study 3-201: BIOD-123 Phase 2 Trial Preliminary Results"

P2 data • Diabetes