Biodel shares plunge after FDA demands two new Ph3 trials

After fretting for months that Biodel (BIOD) didn't have the data needed to gain an approval for its fast-acting insulin Linjeta, analysts discovered this morning that the FDA is requiring the company to essentially go back and start a late-stage development program from scratch. Regulators say Biodel will need to conduct two late-stage studies for Type 1 and Type 2 diabetes in order to deliver the efficacy and safety data needed for an approval. The news caused Biodel's shares to plunge by more than half.

Regulators determined that Biodel's decision to exclude Indian trial data for the Type 1 study "was post-hoc and therefore not sufficient for establishing conclusive evidence of efficacy," according to the company's release. "In the Type 2 trial analysis, the FDA acknowledged that non-inferiority was established in the completer population but stated that non-inferiority was not established in the intent-to-treat population because the agency did not consider a post-hoc modification of the statistical model as establishing conclusive evidence of efficacy."

"We plan to meet with the FDA as quickly as possible to discuss their comments in the complete response letter, clarify their requests for new information and determine our path forward," said Biodel CEO Errol De Souza. "We remain committed to the development of an ultra-rapid acting injectable insulin to address an important unmet need for patients with diabetes."

Linjeta has been under a cloud for some time, with Biodel unable to deliver on a major partner to launch the product. In addition to the trial data issue, Biodel also had trouble on the manufacturing end, with the manufacturing unit that delivered vials of the insulin earning a warning letter last summer. But a number of investors had been hopeful that some clarity from the FDA would define a pathway to approval that would put the company on a straight track to the market. Wall Street took one look at Biodel's release on the agency's CRL and bailed, forcing the developer's stock down by 53 percent in pre-market trading.

- here's the Biodel release
- read the story from Reuters