BioCentury
ARTICLE | Clinical News

Biodel falls on Phase II data for rapid-acting insulin

September 10, 2013 12:28 AM UTC

Biodel Inc. (NASDAQ:BIOD) fell $1.50 (30%) to $3.53 on Monday after reporting Phase II data for BIOD-123 that met the primary endpoint but raised questions about the commercial prospects of the ultra rapid-acting formulation of recombinant human insulin. BIOD-123 plus Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY) met the primary endpoint of non-inferiority to Humalog insulin lispro from Eli Lilly and Co. (NYSE:LLY) plus Lantus in reducing HbA1c from baseline to week 18 in the Phase II Study 3-201, which enrolled 132 Type I diabetics. However, there was an imbalance of injection-site pain in the trial, with nine (13.8%) patients in the BIOD-123 arm reporting one or more episodes of mild injection-site pain vs. one patient (1.5%) in the Humalog arm. ...