9 & Soon 11 New HCV Drugs in Phase 3

Provided by NATAP

Shortly before AASLD Abbott announced the start of their phase 3 studies which will examine the coformulation of ABT450/r (protease) + ABT267 (NS5A) + their non-nuc + rbv. In addition Gilead is starting a phase 3 study looking at their coformulation of GS7977+ GS5885 (NS5A) + rbv.

• Abbott Phase 3 Study - (10/17/12)
• AASLD: A 12-week Interferon-free Treatment Regimen With ABT-450/r, ABT 267, ABT-333, and Ribavirin Achieves SVR12 Rates (Observed Data) of 99% in Treatment-naïve Patients and 93% in Prior Null Responders With HCV Genotype 1 Infection - (11/13/12)
• AASLD: Once Daily Sofosbuvir (GS-7977) Regimens in HCV Genotype 1-3: The ELECTRON Trial - (11/14/12)
• BMS052 HCV-NS5A Monotherapy in Phase 3 Now
• GS-7977 HCV Nucleotide in Phase 3 Now
• Peginterferon Lambda: new interferon in phase 3 now
• BI1335 HCV Protease in Phase 3 Now
• TMC-435 HCV Protease in Phase 3 -
• BMS032 HCV Protease in Phase 3 Now -

"Rapid progress has been made with the HCV Research Program and we now have a comprehensive Phase III development program" John Martin CEO Gilead........"In May and June of this year, discussions were held with the U.S. FDA and 3 European regulatory agencies, and agreement has been achieved on a comprehensive Phase III development plan for GS-7977 and on a Phase III plan for GS-7977 in combination with the NS5A inhibitor, GS-5885.......we anticipate being able to file for regulatory approvals for GS-7977 by the middle of next year.......If successful, the initial indication will for 12 to 16 weeks of treatment with GS-7977 and Ribavirin in genotype 2/3 infected patients, and for 12 weeks of treatment with GS-7977, peg-interferon and Ribavirin in genotype 1, 4, 5 and 6 infected patients......we plan to advance the fixed dose combination of GS-7977 and 5885, currently in Phase I clinical testing, into Phase III in the fourth quarter of this year.....GS-7977 and GS-5885 were successfully co-formulated into a single pill, fixed dose combination......The fixed dose combination regulatory filings could, in that case, follow the initial GS-7977 filings a year later by mid-2014"....."The Food and Drug Administration is allowing a nonstandard-of-care controlled phase III study for 7977/5885" from Barron's online [we know the FDA is allowing this for all IFN-free therapy development studies from all companies]

Gilead Begins Single Pill Hepatitis C Study for 2014 Approval - (07/27/12)

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