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mcbio

06/26/11 12:58 PM

#122355 RE: DewDiligence #122354

BIOD/HALO—I’m modestly bearish on the various fast-acting insulin programs. I posted the following three years ago (#msg-32024599) and my view hasn’t changed much:

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The various insulin analogs (what Novo-Nordisk calls “modern insulins”) are steadily gaining market share at the expense of ordinary insulin. A tweaked formulation of ordinary insulin, even if it works, is not exactly a winning business idea, IMO.

Thanks for the comments. Clearly lots of issues for BIOD in the prior Phase 3 trials, which is presumably why the stock is sub-$100M market cap. I would think there could be a role for these ultra-fast acting insulins compared to the fast acting insulins such as Humalog, if it is demonstrated in clinical trials that the ultra-fast acting insulins work even quicker than the fast acting insulins to the degree that there is a material reduction in hyperglycemia and hypoglycemia. That seems to be the rationale for these ultra-fast acting insulins. Whether or not this will be proven in clinical trials remains to be seen of course.

BIOD claims that its two new ultra-fast acting insulins work better than the prior Linjeta formulation (based on pre-clinical work) and they will be comparing these directly to Humalog in clinical trials, including the ongoing Phase 1 trials. So, we should get an answer to whether or not there is any benefit of the ultra-fast acting insulins over the fast acting insulins, and the degree of any such benefit, in due time.
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jq1234

06/26/11 3:31 PM

#122363 RE: DewDiligence #122354

The various insulin analogs (what Novo-Nordisk calls “modern insulins”) are steadily gaining market share at the expense of ordinary insulin. A tweaked formulation of ordinary insulin, even if it works, is not exactly a winning business idea, IMO.



The reason the analogs are gaining market share is because they were engineered to be either fast acting (lispro, aspart, Glulisine) or long acting (Glargine insulin, Detemir insulin), thus have advantage over regular human insulin. If human insulin can be modified to become ultra fast, it wouldn't be a problem because it wasn't human insulin itself, rather its profile for loss of market share.

In addition, BIOD's ultra fast insulin is tweak on regular human insulin, HALO's ultra fast insulin program is for both regular human insulin and insulin analogs in combination with PH20 hyaluronidase enzyme.