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December 10, 2013
08:07 EDTENTA, ABBVEnanta says trial demonstrated SVR12 in 96% of treated HCV patients
Enanta Pharmaceuticals (ENTA) announced results from the SAPPHIRE-II study, the second of six phase 3 registrational studies being conducted by AbbVie (ABBV) for the treatment of hepatitis C virus genotype 1 infection, using a regimen containing Enanta’s lead protease inhibitor ABT-450. ABT-450 is part of AbbVie’s investigational three direct-acting antiviral regimen, consisting of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. The SAPPHIRE-II study used this 3D regimen plus ribavirin. Results from the 394-patient SAPPHIRE-II trial demonstrated a sustained virologic response at 12 weeks post-treatment, orSVR12, of 96% in chronically infected GT1 HCV treatment experienced adult patients who had previously failed pegylated interferon and ribavirin treatment. Approximately 49% of these patients were prior null responders, namely patients defined as not achieving a significant reduction in the HCV virus during their prior treatment. The majority of patients were GT1a, considered the more difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 96% and 97%, respectively. These results were based on an intent-to-treat analysis and were achieved after 12 weeks of treatment. Virologic relapse or breakthrough was noted in 2% of patients receiving the 3D regimen plus ribavirin. The treatment regimen was well tolerated, with 1% of patients discontinuing treatment due to adverse events. “The high SVR rates in this SAPPHIRE-II trial and the previously reported SAPPHIRE-I trial further validate this 3D regimen plus ribavirin for both treatment-naive and treatment-experienced patients. We look forward to the remaining phase 3 studies reading out using the same 3D regimen with and without ribavirin, as well as in the treatment of HCV patients with cirrhosis,” the company said.
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April 23, 2014
11:34 EDTABBVGilead climbs after hep C drug sales top $2B in Q1
Shares of drug maker Gilead (GILD) are surging after the company reported better than expected first quarter results and noted that its Hepatitis C drug had generated sales of $2.27B during the quarter. WHAT'S NEW: Gilead reported Q1 earnings per share of $1.48, versus analysts' consensus estimate of 89c. The company's revenue came in at $5B, versus the consensus forecast of $3.9B. Gilead obtained $2.27B of revenue from its Hepatitis C treatment, Solvaldi, which was launched in December. There was strong demand for Sovaldi from U.S. hepatitis C patients, Gilead Executive VP, Commercial Operations Paul Carter said on the company's results conference call. ANALYST REACTION: A number of analysts reacted positively to Gilead results. In a note to investors earlier today, Robert W. Baird analyst Brian Skorney wrote that last quarter, Sovaldi tied Lipitor for the highest U.S. quarterly sales of any drug in history. In light of Sovaldi's performance, analysts' 2014 and 2015 estimates for the company clearly must increase, the analyst contended. Even if Sovaldi's sales are cut in half from their peak levels in 2015-2017, the stock should still rise, Skorney wrote. He kept a $103 price target and Outperform rating on the stock. Also upbeat on Gilead was Wells Fargo. The launch of Sovaldi was "as good as it gets," and Gilead's results were "outstanding," the firm contended. It kept an $87-$91 price target and Outperform rating on the stock. OTHERS TO WATCH: AbbVie (ABBV) is also developing a treatment for hepatitis C. PRICE ACTION: In morning trading, Gilead gained $2.11, or 2.9%, to $74.97, while AbbVie shares were down 0.6% to $49.71.
April 22, 2014
08:56 EDTENTA, ABBVEnanta announces ABT-450 NDA submission
Enanta (ENTA) announced that AbbVie (ABBV), Enanta’s collaboration partner for ABT-450, has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for an investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus infection. The three direct-acting antiviral regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. ABT-450 is the lead protease inhibitor developed through Enanta’s collaboration with AbbVie. The U.S. NDA filing triggers a $20M milestone payment to Enanta from AbbVie. AbbVie also plans to submit applications for regulatory approval of its regimen in the European Union in early May. Enanta is entitled to receive an additional $20M upon the first regulatory filing in the European Union for a regimen containing a collaboration compound.
08:49 EDTABBVAbbVie submits NDA to FDA for GT1 hepatitis C virus infection
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April 15, 2014
09:22 EDTABBVAbbVie initiates Phase III clinical trial of veliparib in lung cancer
AbbVie announced the initiation of a global Phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib or ABT-888, in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer. The trial will compare patients randomized to receive either the standard chemotherapies of carboplatin and paclitaxel with the addition of veliparib, versus patients receiving carboplatin and paclitaxel with the addition of placebo. The trial will recruit approximately 900 patients.
April 14, 2014
17:31 EDTABBVAbbVie stock could reach $55, Barron's says
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07:45 EDTABBVAbbVie defended at BMO Capital
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April 12, 2014
19:23 EDTABBV, ENTAEnanta reports detailed results from Turquoise ll study
Enanta Pharmaceuticals (ENTA) announced that detailed results from AbbVie’s (ABBV) pivotal phase 3 TURQUOISE-II study, will be presented as a late-breaking oral presentation at the International Liver Congress, ILC, which is the 49th Annual Meeting of the European Association for the Study of the Liver, EASL. Results from the TURQUOISE-II study were featured in the ILC press conference and were published on-line in the New England Journal of Medicine. The TURQUOISE-II study reports results from AbbVie’s investigational three direct-acting antiviral regimen containing ABT-450, Enanta’s lead protease inhibitor discovered through Enanta’s collaboration with AbbVie. The regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. TURQUOISE-II is a global, multi-center, randomized, open-label study evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with AbbVie's three direct-acting antiviral regimen with ribavirin, RBV, in adult patients with genotype 1, GT1, chronic hepatitis C virus, HCV, infection with compensated liver cirrhosis. Patients achieved sustained virologic response rates 12 weeks post-treatment, SVR12, of 91.8% and 95.9% in the 12-week and 24-week treatment arms, respectively. Patients in the study were either new to therapy or treatment-experienced, failed previous treatment with pegylated interferon and RBV.
April 11, 2014
05:27 EDTABBV, ENTAEnanta announces results for partner AbbVie's HCV studies
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05:24 EDTABBVAbbVie announces 96% sustained virologic response rates in HCV study
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