Biotech Values

[DewDiligence]

JNJ starts phase-3 trials of Sovaldi + Olysio in GT1 patients:

http://finance.yahoo.com/news/janssen-initiates-phase-3-optimist-110000094.html

The first trial, known as OPTIMIST-1…is a Phase 3, multicenter, open-label, randomized study investigating the efficacy and safety of simeprevir 150 mg in combination with sofosbuvir 400 mg. The combination will be administered once daily for 8 or 12 weeks in chronic HCV genotype 1 infected patients without cirrhosis who are HCV treatment naive or treatment experienced.

The second trial, known as OPTIMIST-2…is a Phase 3, multicenter, open-label, single-arm study investigating the efficacy and safety of simeprevir 150 mg in combination with sofosbuvir 400 mg. The combination will be administered once daily for 12 weeks in HCV genotype 1 infected patients with cirrhosis who are HCV treatment naive or treatment experienced. Ribavirin will not be administered in the OPTIMIST trials.

The trials will enroll ~400 patients in the US and Canada. GILD is not participating in these trials.