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jq1234

06/26/11 7:48 PM

#122386 RE: DewDiligence #122380

If the tweaking offered no advantage, for example, SNY's glulisine, over lispro and aspart, then there wouldn't be a market. If the tweaking offered advantage, like HALO and BIOD's if confirmed in phase III, there would be a market.

Look, the new developments on insulin are very straightforward, either ultra fast acting as meal time insulin like HALO/BIOD's or ultra long acting like NVO's degludec.
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mcbio

06/26/11 9:01 PM

#122387 RE: DewDiligence #122380

You evidently see strong prospects for continued insulin tweaking, while I think the wide array of choices has already reached the point of severely diminishing returns for new aspirants.

BIOD's Web site is a little bit outdated as they still refer to Linjeta/VIAject, their prior ultra-fast acting insulin candidate, and fail to yet disclose their two new replacement candidates. That said, their Web site shows Phase 1 pharmacokinetic data comparing what was then VIAject to Humulin and Humalog (http://biodel.com/content/pipeline/linjeta.htm ), which shows how much quicker VIAject worked compared to Humulin and Humalog to raise insulin levels and prevent hypoglycemia.

In the Phase 3 trials, which clearly had issues making the results difficult to interpret, they showed in Type 1 diabetes patients a stat sig decrease in the incidence of severe hypoglycemic events (6.1% vs. 14.3%). There was also a stat sig improvement in weight control compared to patients receiving regular human insulin. Clearly they need to show how these results stack up to Humalog, which they will attempt to do in the ongoing trials with one of their new formulations.