Biodel slumps as US FDA calls for more data on diabetes drug candidate Linjeta

Shares of US specialty pharmaceutical firm Biodel (Nasdaq: BIOD) plunged 52% to $1.74 in early trading yesterday, after the US regulator said it could not approve the firm’s lead drug candidate without considerable further late-stage clinical data.

The Food and Drug Administration issued a Complete Response Letter (CRL) requesting additional information regarding Biodel’s New Drug Application for Linjeta (human insulin [rDNA origin]) injection 100IU/mL for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control.

Linjeta is a more rapid-acting form of injectable human insulin for meal-time use by patients with type 1 or type 2 diabetes and has previously been hailed as a product that could revolutionize the $29 billion global diabetes treatment market. The product provides quicker glucose control than standard insulin, and also carries the benefits of reducing the usual weight gain and life-threatening hypoglycemic events seen in insulin users. Current insulin therapies are not delivered quickly enough to simulate the desired meal-time insulin spike.