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Replies to #97552 on Biotech Values
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dewophile

06/21/10 12:34 AM

#97565 RE: DewDiligence #97552

i think the ribavirin column is misleading
gild and roche both have a lead-in portion of therapy without rib in some arms, but all pts will ultimately recieve ribavirin. given the main MOA of ribavirin is to prevent relapse, any exposure to ribavirin prior to an SVR endpoint doesn't mean much in assessing if ribavirin can be dropped from the regimen altogether
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DewDiligence

07/20/10 5:42 PM

#99152 RE: DewDiligence #97552

VRTX/BMY/GILD/VRUS/ITMN/IDIX: According to GILD’s 2Q10 today, the all-oral combination of GS9256 (a PI) and GS9190 (a non-nuke) is not producing adequate antiviral efficacy even when ribavirin is added to the mix.

GILD’s slip ought to be bullish for the other all-oral HCV players: VRTX, Roche/VRUS/ITMN, BMY, Boehringer Ingelheim, and IDIX.
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iwfal

03/13/11 2:48 PM

#116360 RE: DewDiligence #97552

HCV - Update to all orals programs:

VRTX Telaprevir VX-222 non-nuke some BID clinicaltrials.gov/ct2/show/NCT01080222

SVR trial in treatment naive - RIP - Killed for breakthroughs
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Roche ITMN-191 RG7128 nuke none TID/BID clinicaltrials.gov/ct2/show/NCT00801255

INFORM 1 - 14 day trial (in all comers) - Results:

http://investor.pharmasset.com/releasedetail.cfm?ReleaseID=421306
.
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BMY BMS-650032 BMS-790052 NS5A some BID clinicaltrials.gov/ct2/show/NCT01012895

SVR Trial in G1 Nulls - Interim results >50% breakthroughs thru SVR12. Results:

http://www1.easl.eu/easl2011/program/Orals/429.htm
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GILD GS9256 GS9190 non-nuke some BID clinicaltrials.gov/ct2/show/NCT01072695

Treatment naive, 28 day response (followed up by SOC) - inadequate viral efficacy

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=52470566
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B-I BI 201335 BI 207127 non-nuke all TID/BID clinicaltrials.gov/ct2/show/NCT01132313

Treatment naive dose ranging with Rib for 24 or 48 weeks. Not scheduled to finish until 2014.
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IDIX IDX320 IDX184 nuke TBD qD

On hold (or killed) due to tox.

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NEW TRIALS initiated more recently:

VRUS 7977/938 Ph 1 trial 14 day trial - results http://www1.easl.eu/easl2011/program/Posters/Abstract8.htm

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RO5024048 (aka RG7128) And Danoprevir (aka ITMN-191)
Treatment naive G1 - 12 or 24 weeks +/- Rib - results due in 2012
http://clinicaltrials.gov/ct2/show/NCT01278134?term=RO5024048+danoprevir&rank=1

Any others I am missing?