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jq1234

05/07/12 7:14 PM

#141499 RE: DewDiligence #141495

I agree with the premise, BMY not reporting any data, not initiating any new study, the only study that currently is recruiting patients is INX189 with Ribavirin PK/PD and food effect study, which means there are unsettled questions, most likely safety issue.

http://clinicaltrials.gov/ct2/results?term=inx08189
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oc631

05/07/12 9:31 PM

#141509 RE: DewDiligence #141495

BMS-094 (f/k/a INX-189, a/k/a BMS-986094) is in trouble





BMY's strategy was (and still is) to combo test INX-189 at/or below the 200mg. dose and hope the nuke can provide a strong enough resistance profile without crapping out on safety (aka IDX-184). Any lack of potency testing INX-189 at lower therapeutic doses (in theory) could be overcome by the other classes of drugs within the combination. IMO BMY knew INX-189 was a impaired asset before signing off on the deal. GILD acquiring VRUS, along with the scarcity value within the nuke class, forced their hand on this deal.


INHX claimed they were waiting on regulatory approval to test the 300mg. dose of INX-189 before they were bought by BMY. As I previously pointed out this was only posturing to draw in a bidder. It was clear to me this drug was borderline unsafe and BMY knew it just as well. They just didn't have any other options.

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mcbio

05/07/12 11:22 PM

#141527 RE: DewDiligence #141495

BMS-094 (f/k/a INX-189, a/k/a BMS-986094) is in trouble, according to Nathan Sadeghi-Nejad:

www.thestreet.com/story/11523381/1/bristol-myers-missing-hep-c-data-raises-red-flags-may-boost-gilead-idenix.html

Comments from anyone? (My most recent post on this drug is in #msg-72304518, FWIW.)

Very interesting article, though I don't get why this is potentially bullish for IDX-184. Nathan references the lackluster efficacy criticisms of 184 without, IMHO, a convincing argument otherwise on that point. But, perhaps BMY would be interested in the earlier-stage IDIX nukes if there are indeed issues with BMS-094.

I would say that if BMS-094's only path forward is at sub-optimal dose for potency, then I would tend to think they may have to pair the drug with their NS5A inhibitor and probably a PI as well (especially if ribavirin is later eliminated). I risk talking my book with Medivir but that's potentially good news for Medivir (again, they are doing trials with TMC435+daclatasvir) or for ACHN. The questions will of course be there as to how competitive such a combo will be with GILD's ultimate combo.

If BMS-094 is ultimately shelved, perhaps BMY would be interested in an earlier-stage IDIX nuke or perhaps BMY would take a look at the very early-stage BCRX nuke or the similar early-stage unpartnered Medivir nuke. The issue of course is that these are all well behind in development.