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News Breaks
January 8, 2014
09:06 EDTSGEN, ABBVSeattle Genetics further expands ADC collaboration with AbbVie
Seattle Genetics (SGEN) announced that it has further expanded its antibody-drug conjugate collaboration with AbbVie (ABBV). Under the expanded deal, AbbVie will pay an upfront fee of $25M for additional rights to utilize Seattle Genetics’ ADC technology with AbbVie antibodies against oncology targets, including access to Seattle Genetics’ pyrrolobenzodiazepine dimer ADC technology and EC-mAb site-specific conjugation technology. In addition, Seattle Genetics could receive up to approximately $255M in potential license fees and milestone payments per target, upon achieving predetermined development and commercial objectives, as well as mid-to-high single-digit royalties on worldwide net sales of any resulting products.
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April 22, 2014
08:56 EDTABBVEnanta 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 16, 2014
08:34 EDTSGENPiper Jaffray tech and biopharma analysts hold analyst/industry conference call
Technical Analyst Johnson, along with BioPharma Analysts, discuss the recent downturn in the biotech and specialty pharmaceuticals industries on an Analyst/Industry conference call to be held on April 17 at 10 am.
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 EDTABBVEnanta 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 EDTABBVEnanta 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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April 9, 2014
11:43 EDTABBVGilead defended by analysts after recent pullback
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