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Re: DewDiligence post# 103574

Tuesday, 09/07/2010 6:30:36 PM

Tuesday, September 07, 2010 6:30:36 PM

Post# of 257262
IDIX 2010-2011 News Flow

[Updated for clinical hold on IDX184 and IDX320 programs and
release of data in today’s PR on the IDX184, IDX320, and IDX375
programs; removed entry for IDX184 and/or IDX320 partnerships
insofar as this must now await the lifting of clinical hold.]



HCV

Oct 2010/AASLD: Present complete datasets from IDX184, IDX320, and IDX375 studies for which top-line data was reported in IDIX’s 9/7/10 PR (#msg-54120531).

4Q10: Start IDX375 phase-1b 3-day monotherapy trial.

Late 2010/early 2011: Possible lifting of clinical hold on IDX184 and/or IDX320 programs following FDA review of combination animal-tox study and all clinical data to date.

Late 2010: Select lead NS5A compound. Start phase-1 trial in 1H11.


HIV

Sep 2010/ICAAC: Three poster presentations for IDX899.

Late 2010: Start IDX899 phase-2b trial in first-line settings, testing IDX899+Truvada vs Sustiva+Truvada.* (IDIX will receive a sizable milestone payment from GSK when the first patient is dosed in a phase-2b study—see #msg-49743057.)

Late 2010: Start IDX899 phase-2b trial in second-line setting, testing IDX899+Truvada vs Intelence+Truvada.*

1H11: Start IDX899 phase-2b “nuke sparing” trial, testing IDX899 + GSK1349572 (GSK’s integrase inhibitor) vs a comparator to be determined.* (The DDI study described in #msg-48915175 is a prerequisite for starting this trial.)

*These trials will be conducted by IDIX’s partner, GSK.

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