April 24, 2013

Highlights of presentations from Bristol-Myers, J&J, Gilead and AbbVie at EASL meeting

Article | 24 April 2013

Among a number of drug and biotech majors planning to present at the 2013 annual meeting of the European Association for the Study of the Liver (EASL), in Amsterdam (April 24 to 28), the USA’s Bristol-Myers Squibb (NYSE: BMY) will report additional interim Phase II data demonstrating that 12- and 24-week Triple DAA treatment regimens of daclatasvir + asunaprevir + BMS-791325 achieved high rates of sustained virologic response of up to 94%, in treatment-naive, genotype 1 hepatitis C virus (HCV) patients, at time points ranging from four to 36 weeks post-treatment. These data support the continued development of the interferon alfa-, RBV- and RTV-free triple DDA regimen, with Phase III study initiation anticipated to begin by late 2013, the company says.

Health care giant Johnson & Johnson (NYSE: JNJ) will announce primary efficacy and safety results from two Phase III studies - QUEST-1 (n=394) and QUEST-2 (n=391) demonstrating that simeprevir (TMC435) achieved sustained virologic response 12 weeks after the end of treatment (SVR12) in 80 and 81%, respectively, in treatment-naïve genotype 1 chronic hepatitis C adult patients with compensated liver disease, including all stages of liver fibrosis. In both studies, 50% of patients receiving pegylated interferon and ribavirin alone achieved SVR12. Detailed results will be presented at The International Liver Congress 2013 of the European

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Biotech firm Gilead Sciences (Nasdaq: GILD) will report detailed results from four Phase III studies - NEUTRINO, FISSION, POSITRON and FUSION evaluating sofosbuvir for chronic hepatitis C virus infection. In all the four trials, sofosbuvir was administered to about 1,000 patients. Overall SVR12 rates were observed at 50% to 90% in the studies. Analysts at Credit Suisse have a worldwide net present value for sofosbuvir of $10.65 per share (26% of total) for Gilead.

Also, AbbVie (NYSE: ABBV) will report new data from the Phase IIb Aviator trial showing that its investigational direct-acting antivirals (ABT-450/r, ABT-267, ABT-333) continue to demonstrate high sustained viral response rate against genotype 1 HCV infection, across patient types. Results also indicated that >90% SVR was achieved in patients new to treatment and in patients who had previously failed treatment with pegylated interferon and ribavirin. In addition, similar high SVR rates observed after 12 and 24 weeks of treatment in the study. The triple-DAA combination is currently being studied in Phase III studies.


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