Biodel reported that its two pivotal Phase III clinical trials comparing VIAject to Eli Lilly's Humulin R for patients with Type 1 and Type 2 diabetes met the primary endpoint of non-inferior mean change in HbA1c over six months of treatment. But despite the positive spin, investors fled after learning that one of the Phase III trials reportedly would have failed if researchers had not excluded results from India and that 24 patients had dropped out of the trials due to pain at the injection site.
Biodel said that the results from India were "not comparable" to the results recorded in the U.S. and Germany and aren't valid for determining non-inferiority. Shares went into a tailspin, dropping 69 percent on the news. Biodel says it plans to meet with the FDA to discuss an NDA.
- here's Biodel's release
- check out the report from Dow Jones