Does anyone know anything about Biodel's (BIOD) VIAject? They make an ultra fast acting injectable insulin that is in phase 2 trials. They have a market cap of only $38 million.Can this be a competitor to Mannkind?From what I can see VIAJect is ultra fast because it is regular insulin with addatives that prevent it from forming hexamers.Afrezza is fast because it is insulin monomers, not hexamers.Do any of the doctors on the board have any comments on this?
http://www.tudiabetes.org/profiles/blogs/big-changes-may-be-in-store
On December 30, 2009, the first newcomer announced a significant milestone: Danbury, Connecticut-based Biodel, Inc.'s VIAject was submitted for FDA approval, and is widely expected by analysts to be approved without significant delay. Interestingly enough, VIAject isn't an insulin analogue at all, but humble, regular old insulin containing some already FDA-approved additives which prevent the molecule from forming hexamers which normally delay the insulin molecule's absorption into the bloodstream. Because of this, the company was able to apply using section 505(b)(2) of the Federal Food, Drug and Cosmetic Act which governs the review of a New Drug Application (NDA) for a modified form of a previously-approved product. Because of this, the company's VIAject is likely to encounter less scrutiny than a brand new drug filed under section 505(b)(1), which requires original clinical trial results to be submitted with the application. In addition, this saves the company significant money.
See http://www.biodel.com/pipeline/viaject.htm for a graph of VIAject versus Humulin blood concentration levels.
