Biotech Values

[mcbio]

Given that the only improvement that Biodel is advertising is injection comfort why would the alternate formulations be more efficacious than Linjeta?

The alternate formulations don't necessarily need to be more efficacious than Linjeta; they need to be more tolerable. Linjeta seemed to work reasonably well in its prior trials; the issue seemed to be to some degree with the trial designs of the Phase 3 trials, namely the portion of the trials run in India. rkrw posted on this in #msg-61671484. But, Linjeta did have tolerability issues that needed to be addressed above and beyond the clinical trial design. They showed that they have addressed the tolerability issue in their new recombinant human inuslins (105 and 107) in the recently reported Phase 1 trials (#msg-67446709 ) , but the new issue with these formulations had to do with the fact that these drugs did not "wash out" quickly. (Note that these new drugs did work quicker than Humalog but not as quickly as the prior Linjeta formulation.) BIOD disclosed that they were scrapping these recombinant formulations and it appears they are pretty much focused on their insulin analog (again, I think they are trying to develop a better Humalog) and they are supposed to disclose the path forward here by the end of the year.

So, it seems BIOD had addressed the tolerability issues with their new formulations but the logical question now is whether or not what BIOD did to address the tolerability issues is going to have a detrimental impact on how quickly their new versions work or in the PK properties (long wash out). BIOD did disclose recently that a failure to wash out quickly is not an issue with big pharma's insulin analogs; but the question will remain whether or not what they have done to address tolerability will result in their analogs not really working much quicker than the existing analogs. (Their pre-clinical data in diabetic swine supports the rapid action but there is no guarantee this will translate to humans.)

All told, I'm still going to hold on to my position here because I think there is some potential, market cap is so tiny, BIOD has cash till March 2013, and I believe the big pharmas, such as LLY, have an incentive to develop better versions of their existing analogs since they are set to go generic in a few years. The question, of course, is whether or not big pharma agrees that this is a need and whether or not one sees BIOD as a company with a potential solution. Boom or bust for sure, but I'm willing to continue to hold right now.