If IDX899 at some point proves superior to Sustiva, what then happens to Truvada and Atripla? Does Gilead drop the deal with BMY (?) for Sustiva and license IDX899 from GSK and add it to its combination drug? Or does GSK try to put a formulation together to rival Atripla?
How do you see the GSK/PFE plans evolving in relation to Truvada and Atripla?
[Updated for 4Q09 CC on 2/25/10; the main change is that I’ve listed the IDX184 partnership signing as a midyear rather than 1H10 event.]
HCV
Apr 2010 at EASL: Report IDX184 phase-2a data from the 100mg qD cohort. (Full data from the 50mg qD cohort were reported on the 4Q09 CC, and it appears that 50mg qD is too low a dose: #msg-47110029.)
Apr 2010 at EASL: Report additional phase-1 data for IDX375. (Interim data were reported at the JPM conference on 1/11/10: #msg-45350536.)
Mid 2010: Complete all dosing cohorts of IDX184 phase-2a trial.
Mid 2010: Complete 3-month animal-tox study of IDX184.
Timing uncertain (likely around midyear, IMO): Ink IDX184 partnership. (See #msg-47110029 for musings on the partnership timing.)
Mid 2010: Start phase-1b monotherapy trial for IDX375.
Mid 2010: Start phase-1b monotherapy trial for IDX320.
Nov 2010 at AASLD: Present complete phase-2a data for IDX184.
2H10: Start phase-2b trial of IDX184 (after inking partnership deal).
2H10: Select lead compound from NS5A program. Start phase-1 trial in 1H11.
HIV
Mar 2010: GSK* completes IDX899 PK/food study testing multiple formulations at 100mg qD (#msg-44790049).
2Q10: Start phase-2b trials for IDX899 in treatment-naïve and treatment-experienced settings using the preferred 100mg formulation from the PK/food study.
*GSK is the operator of ViiV Healthcare, the joint venture with PFE that is the licensee of IDX899 (#msg-43254006).
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