Annual Shareholders Meeting 2012 (Gilead) - May 10, 2012 - Anticipated FDA approval in H1 2014; Anticipated composition of matter patent expiry in 2029; Anticipated completion of P3 trials for HCV in Q1/Q2 2013; Anticipated NDA submission in H1 2013; Anticipated initiation of P2 combination trial with GS-5885 + RBV in GT-1 HCV null responders in Q2 2012; Anticipated initiation of P2 combination trial with GS-9669 + RBV in GT-1 HCV null responders in Q2 2012; Anticipated initiation of P3 trial in GT-1 HCV patients in H2 2012
Anticipated FDA approval • Anticipated NDA submission • Anticipated P2 trial initiation • Anticipated P3 trial completion • Anticipated P3 trial initiation • Anticipated patent expiry • Hepatitis C Virus
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GS-7977
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Accelerates timeline to availability of the first oral regimen, GS-7977 and ribavirin, for the treatment of HCV
– GS-7977 is the most potent, advanced nucleotide in clinical development
– Targeted U.S. FDA approval in 1H 2014
– Composition of matter patent protection for GS-7977 into 2029
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GS-7977: Phase 3 clinical development
Studies will be completed in 1Q/2Q 2013
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On track for NDA submission 1H 2013
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Anticipated key pipeline milestones in 2012
Initiate Phase 2 combo study with GS-5885 + RBV in GT-1 HCV null responders (new cohort added to Electron) in Q2 2012
Initiate Phase 2 combo study with GS-9669 + RBV in GT-1 HCV null responders (new cohort added to Electron) in Q2 2012
Initiate Phase 3 program in GT-1 HCV patients in H2 2012
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