Biodel reports new findings from key programs for its diabetes drug candidate Linjeta

Scientists from USA-based specialty pharmaceutical firm Biodel (Nasdaq: BIOD) reported new findings from the company's Linjeta, (insulin glargine), "smart" basal insulin and stabilized glucagon development programs in poster presentations at the Tenth Annual Diabetes Technology Meeting in Bethesda, Maryland, USA, last Friday.

The US Food and Drug Administration recently issued a Complete Response Letter requesting additional late-stage information regarding Biodel’s New Drug Application for Linjeta for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control, news that caused the company’s share price slump 52% on that day (The Pharma Letter November 2).

Frank Flacke presented results of a Phase I single-center, double-blind, randomized crossover trial in 13 subjects with type 1 diabetes who received a once-daily injection of Linjeta or one of two modified formulations of Linjeta, each on a separate day ("Characterization of Pharmacokinetics and Toleration of Three Variant Formulations of Linjeta"). The purpose of the study was to compare the pharmacokinetic characteristics and toleration of Linjeta to the two modified formulations. The study found that the modified formulations were associated with improved toleration profiles and lower maximal insulin concentrations compared to Linjeta.   Modified formulation BIOD-102 was associated with a similar rate of absorption as Linjeta.