Key Developments: AbbVie Inc (ABBV.K)

ABBV.K on New York Consolidated

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27 Apr 2015
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Latest Key Developments (Source: Significant Developments)

AbbVie Inc announces resents late-breaking, preliminary phase 3b data with viekirax + exviera in chronic hepatitis C patients with renal impairment
Saturday, 25 Apr 2015 10:00am EDT 

AbbVie Inc:Says new, preliminary safety and efficacy data from first cohort of its ongoing, Phase 3b RUBY-I study.Says RUBY-I is evaluating VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) with or without ribavirin (RBV) in treatment-na├»ve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage 4 or 5), including those on hemodialysis.Primary endpoint of study is percentage of patients achieving sustained virologic response at 12 weeks post-treatment (SVR(12)).Patients who reached post-treatment week four to date (n=10 of 20 enrolled) achieved 100 percent SVR(4 )(n=10/10).  Full Article

U.S. FDA grants priority review to AbbVie Inc for investigational, all-oral, interferon-free therapy for treatment of Genotype 4 Chronic Hepatitis C
Friday, 24 Apr 2015 12:45am EDT 

AbbVie Inc:Says FDA has accepted its New Drug Application (NDA) and granted priority review for company's, all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV).Says NDA is for treatment of adults with chronic genotype 4 (GT4) hepatitis C virus (HCV) infection.FDA granted priority review to AbbVie for the regimen based in part on data from the PEARL-I study, which was recently published online in The Lancet.Says FDA grants priority review designation to investigational therapies that treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.This designation shortens regulatory review period for non-new chemical entity NDAs from normal 10 months to six months.  Full Article

AbbVie raises FY 2015 EPS guidance
Thursday, 23 Apr 2015 07:53am EDT 

AbbVie Inc:Raises FY 2015 adjusted diluted earnings-per-share guidance to $4.10 - $4.30 from $4.05 - $4.25.FY 2015 EPS of $4.19 - Thomson Reuters I/B/E/S.  Full Article

AbbVie extends exchange offer to acquire Pharmacyclics, Inc
Friday, 17 Apr 2015 04:47pm EDT 

AbbVie Inc:Announced that it has extended the expiration of its exchange offer to acquire all of the outstanding shares of common stock of Pharmacyclics, Inc, on May 1.Says it also voluntarily withdrew its initial Notification and Report Form under the Hart-Scott-Rodino Antitrust Improvements Act in order to provide the FTC with additional time to review the proposed transaction.All other terms and conditions of the exchange offer remain unchanged.  Full Article

Ablynx initiates second of two phase IIb RA studies partnered with AbbVie
Tuesday, 7 Apr 2015 01:00am EDT 

Ablynx NV:Ablynx initiates second of two phase IIb RA studies with its anti-IL-6R nanobody, partnered with AbbVie.Announces that it has administered first dose in phase IIb study to evaluate efficacy and safety of its anti-IL-6r nanobody, ALX-0061.Study is expected to enroll 228 subjects in United States, Europe and South America.Top line results from two phase IIb studies in RA expected before end of 2016.  Full Article

AbbVie Inc lowers FY 2015 EPS outlook - Conference Call
Thursday, 5 Mar 2015 09:00am EST 

AbbVie Inc:Updates FY 2015 adjusted diluted earnings per share guidance to $4.05 to $4.25 per share.FY 2015 EPS of $4.39 - Thomson Reuters I/B/E/S.  Full Article

AbbVie Inc to acquire Pharmacyclics Inc
Wednesday, 4 Mar 2015 10:47pm EST 

AbbVie Inc and Pharmacyclics Inc:Announce definitive agreement under which AbbVie will acquire Pharmacyclics, and flagship asset Imbruvica (ibrutinib), an effective treatment for hematologic malignancies.Under terms of transaction, AbbVie will pay $261.25 per share comprised of a mix of cash and AbbVie equity.Transaction values Pharmacyclics at about $21 billion and was approved by boards of both companies.Aggregate consideration will consist of about 58 pct. cash and 42 pct. AbbVie common stock.Transaction is expected to close in mid-2015.  Full Article

AbbVie Inc increases quarterly dividend
Thursday, 19 Feb 2015 12:12pm EST 

AbbVie Inc:Says board increased the company's quarterly cash dividend by 4 pct from $0.49 per share to $0.51 per share.Says cash dividend is payable May 15, to stockholders of record at the close of business on April 15.  Full Article

Enanta Pharmaceuticals Inc announces AbbVie submits new drug application to Japanese Ministry of Health, Labour and Welfare for its Investigational, All-Oral, Treatment for Chronic Hepatitis C
Thursday, 12 Feb 2015 06:30am EST 

Enanta Pharmaceuticals Inc:Says that AbbVie has submitted New Drug Application (NDA) to Japanese Ministry of Health, Labour and Welfare (MHLW).Seeking approval for AbbVie's investigational, once-daily dosed, all-oral, ribavirin (RBV)-free and interferon (IFN)-free, 12-week, two direct-acting antiviral treatment consisting of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r).The submission is for treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.Paritaprevir is Enanta's lead protease inhibitor identified within ongoing Enanta-AbbVie collaboration and is one of the two direct-acting antivirals in treatment regimen.AbbVie is responsible for all development and commercialization activities for regimens that contain paritaprevir.AbbVie studied a two direct-acting antiviral regimen without RBV in Japan due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b.In Japan, abour 1.5 to 2 mln people are living with HCV.(1)Genotype 1 is the most common HCV genotype in Japan with 60 to 70 percent of patients infected and, of those, about 95 percent are infected with the GT1b sub-type.(2).AbbVie has previously said that they expect regulatory approval in Japan in second half of 2015.Upon commercialization regulatory approval in Japan, Enanta will be entitled to a $30 mln milestone payment from AbbVie.  Full Article

AbbVie Inc reaffirms FY 2015 EPS outlook
Friday, 30 Jan 2015 07:47am EST 

AbbVie Inc:Confirms FY 2015 adjusted diluted earnings-per-share guidance of $4.25 to $4.45, which reflects industry growth versus the prior year.FY 2015 EPS of $4.37 - Thomson Reuters I/B/E/S.  Full Article

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Drugmaker AbbVie's profit beats estimates on strong Humira sales

- U.S. drugmaker AbbVie Inc reported better-than-expected quarterly profit and revenue, driven by strong sales of its arthritis drug, Humira.

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