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AbbVie will present late-breaking studies on two investigational treatments for moderately to severely active Crohn's disease during the Clinical Science: Late-Breaking Abstract Plenary Session on Tuesday, May 9. The late-breaking research includes a Phase 2 study that evaluates the safety and efficacy of multiple dosing regimens of upadacitinib as induction therapy in patients with moderately to severely active Crohn's disease after 16 weeks of treatment. The majority of these patients had failed two or more biologics. Upadacitinib is an investigational oral JAK1-selective inhibitor, which targets an inflammatory pathway that plays an important role in Crohn's disease and several other chronic immune-mediated conditions. AbbVie will also present a Phase 2, open-label maintenance therapy study that evaluates clinical and endoscopic remission, and clinical and endoscopic response of risankizumab at one year in patients with moderately to severely active Crohn's disease. Risankizumab selectively blocks interleukin-23 (IL-23), a key signaling agent that has been linked to a number of chronic immune-mediated diseases. Risankizumab is an investigational treatment that is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally. Additionally, AbbVie will present new HUMIRA analyses, including an evaluation of patients with ulcerative colitis treated in a clinical practice setting, an evaluation of the long-term safety of HUMIRA in patients with moderately to severely active Crohn's disease, and an evaluation of the efficacy of HUMIRA in anti-tumor necrosis factor-naïve pediatric patients with Crohn's disease. HUMIRA is one of the most comprehensively studied biologics available for immune-mediated diseases and is supported by more than 14 years of clinical trial experience in inflammatory bowel disease (Crohn's disease and ulcerative colitis).1 Data from AbbVie's hepatitis C virus (HCV) clinical development program will be presented in six presentations throughout the meeting. These studies provide primary and integrated analysis of treatment with its investigational, once-daily, ribavirin-free, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) in patients across all major genotypes (GT1-6). The results investigate the potential of G/P in patients with specific treatment challenges and explore a virologic cure* in as little as 8 weeks of treatment for HCV patients without cirrhosis and those new to treatment, who make up the majority of HCV patients. The new drug application (NDA) for G/P has been accepted by the U.S. Food and Drug Administration (FDA) with priority review designation and is currently under review. G/P is an investigational regimen and its safety and efficacy has not been established. *Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. Abstracts are available here. About HUMIRA in the U.S. Uses2 HUMIRA is a prescription medicine used: Important Safety Information2 HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy, even if their TB test was negative. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, as these infections may happen or become more severe if people use HUMIRA. People should tell their doctor if they have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores. For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated. Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA. Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea. HUMIRA is given by injection under the skin. The benefits and risks of HUMIRA should be carefully considered before starting therapy. Please click here for the Full Prescribing Information and Medication Guide. About AbbVie's HCV Clinical Development Program AbbVie's glecaprevir/pibrentasvir (G/P) clinical development program was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing treatment areas of continued unmet need. G/P is an investigational, pan-genotypic regimen being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA)**, who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis. G/P is a once-daily regimen that combines two distinct antiviral agents. G/P is a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets. Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. *Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.  **Patients who are treatment-naive or had prior treatment experience with IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN). About AbbVie AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn. Forward-Looking Statements  Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2016 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 1 Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology. 2006;130(2):323-333.  2 HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/abbvie-demonstrates-leadership-in-gastroenterology-and-hepatology-with-new-data-and-late-breaking-studies-to-be-presented-at-digestive-disease-week-300451228.html


News Article | May 5, 2017
Site: www.prnewswire.com

NORTH CHICAGO, Ill., May 5, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the UBS Global Healthcare Conference on Monday, May 22, 2017. Richard A. Gonzalez, chairman of the board and chief executive officer, will present at 7 a.m. Central time. A live audio webcast of the presentation will be accessible through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.


News Article | February 15, 2017
Site: www.prnewswire.com

NORTH CHICAGO, Ill., Feb. 15, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the Cowen and Company 37th Annual Health Care Conference on Wednesday, March 8, 2017. William Chase, executive vice president and chief financial officer, will present at 8:20 a.m. Central time....


ABT-384 is a potent, selective inhibitor of 11-beta-hydroxysteroid dehydrogenase type 1 (HSD-1). One milligram of ABT-384 daily fully inhibited hepatic HSD-1. Establishing the dose that fully inhibits central nervous system (CNS) HSD-1 would enable definitive clinical studies in potential CNS indications. [9,11,12,12-(2)H4] cortisol (D4 cortisol), a stable labeled tracer, was used to characterize HSD-1 inhibition by ABT-384. D4 cortisol and its products were measured in the plasma and cerebrospinal fluid (CSF) of healthy male volunteers during D4 cortisol infusions, for up to 40 h after five daily doses of 1-50 mg ABT-384. Similar procedures were conducted in control subjects who received no ABT-384. Peripheral HSD-1 inhibition was calculated from plasma levels of D4 cortisol and its products. CNS HSD-1 inhibition was characterized from plasma and CSF levels of D4 cortisol and its products. ABT-384 regimens ≥2 mg daily maintained peripheral HSD-1 inhibition ≥88%. ABT-384 1 mg daily maintained peripheral HSD-1 inhibition ≥81%. No CNS formation of D3 cortisol (the mass-labeled product of HSD-1) was detected following ABT-384 ≥2 mg daily, indicating full CNS HSD-1 inhibition by these regimens. Partial CNS HSD-1 inhibition was associated with 1 mg ABT-384 daily. CNS HSD-1 inhibition was characterized by strong hysteresis and increased with maximum post-dose plasma concentration of ABT-384 and its active metabolites. ABT-384 has a wide potential therapeutic window for potential indications including Alzheimer's disease and major depressive disorder. Stable labeled substrates may be viable tools for measuring CNS effect during new drug development for other enzyme targets.


The instant invention relates to modulated lysine variant species compositions comprising a protein, e.g., an antibody, or antigen-binding portion thereof, and methods, e.g., cell culture and/or protein purification methods, for producing such modulated lysine variant species compositions. Methods for using such compositions to treat a disorder, e.g., a disorder in which TNF is detrimental, are also provided.


Disclosed herein are methods of purifying proteins using ultrafiltration and diafiltration processes.


News Article | February 16, 2017
Site: www.prnewswire.com

NORTH CHICAGO, Ill., Feb. 16, 2017 /PRNewswire/ -- The board of directors of AbbVie Inc. (NYSE: ABBV) declared a quarterly cash dividend of $0.64 per share.  The cash dividend is payable May 15, 2017 to stockholders of record at the close of business on April 13, 2017. Since the c...


NORTH CHICAGO, Ill., Feb. 27, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for a shorter,...


News Article | February 17, 2017
Site: www.prnewswire.com

NORTH CHICAGO, Ill., Feb. 17, 2017 /PRNewswire/ -- The board of directors of AbbVie Inc. (NYSE: ABBV) has authorized a $5 billion increase to AbbVie's existing stock repurchase program. Purchases may be made from time to time in management's discretion. The stock repurchase...


News Article | February 17, 2017
Site: www.prnewswire.co.uk

The board of directors of AbbVie Inc. (NYSE: ABBV) has authorized a $5 billion increase to AbbVie's existing stock repurchase program. Purchases may be made from time to time in management's discretion. The stock repurchase authorization permits shares to be repurchased in open market or private transactions, has no time limit and may be discontinued at any time. AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs approximately 30,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page. This is a disclosure announcement from PR Newswire.

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