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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.


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 19, 2017
Site: www.prnewswire.com

NORTH CHICAGO, Ill., May 19, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the Jefferies 2017 Global Healthcare Conference on Thursday, June 8, 2017. Bill Chase, executive vice president and chief financial officer, will present at 1:30 p.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.


Additionally, researchers will present data from studies evaluating venetoclax, a BCL-2 inhibitor developed by AbbVie and Genentech, a member of the Roche Group, for investigational uses across multiple hematologic malignancies; ibrutinib, an inhibitor of Bruton's tyrosine kinase (BTK), across multiple hematologic malignancies and chronic graft versus host disease (cGVHD); rovalpituzumab tesirine (Rova-T), an investigational ADC targeting delta-like protein 3 (DLL3)-expressing tumors in small cell lung cancer (SCLC); veliparib, an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor, across multiple solid tumors; elotuzumab, an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein; and other early-stage investigational compounds. AbbVie will also share early-stage research from its oncology pipeline. AbbVie is utilizing technologies and new approaches to help advance cancer therapies that may become foundational to the next generation of cancer treatments. "AbbVie's data presentations at this year's ASCO meeting reinforce our diverse and comprehensive oncology pipeline, focused on bringing new medicines to patients, especially in areas where few options exist in cancer," said Tom Hudson, M.D., vice president of oncology discovery and early development, AbbVie. "By combining our deep knowledge in core areas of biology with cutting-edge technologies, and working together with our partners including scientists, industry peers and patients, we aim to discover and develop medicines that will drive transformational improvements in cancer treatment." The ASCO 2017 Annual Meeting abstracts are available at http://am.asco.org/abstracts. About IMBRUVICA® (ibrutinib) in the U.S. IMBRUVICA is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.5,6 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.5 IMBRUVICA is FDA-approved in five distinct patient populations: CLL, SLL, WM, along with previously-treated MCL and MZL. Accelerated approval was granted for the MCL and MZL indication based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.5 IMBRUVICA was one of the first medicines to receive U.S. Food and Drug Administration (FDA) approval via the new Breakthrough Therapy Designation pathway. IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry with nearly 30 company-sponsored trials underway, 14 of which are in Phase 3. In addition, there are approximately 100 investigator-sponsored trials and external collaborations that are ongoing and active around the world. To date, more than 65,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials. Patient Access to IMBRUVICA AbbVie and Janssen strive to make access to IMBRUVICA easy by helping patients in the U.S. understand their insurance benefits for IMBRUVICA. The YOU&i™ Support Program is a program that includes information on access and affordability support options, nurse call support and resources for patients being treated with IMBRUVICA. Hemorrhage - Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA®. The mechanism for the bleeding events is not well understood. IMBRUVICA® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding. Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and postsurgery depending upon the type of surgery and the risk of bleeding. Infections - Fatal and nonfatal infections have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA®. Evaluate patients for fever and infections and treat appropriately. Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 13% to 29%), thrombocytopenia (range, 5% to 17%), and anemia (range, 0% to 13%) based on laboratory measurements occurred in patients treated with single agent IMBRUVICA®. Monitor complete blood counts monthly. Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6% to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (eg, palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. Atrial fibrillation should be managed appropriately and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines. Hypertension - Hypertension (range, 6% to 17%) has occurred in patients treated with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new-onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA®. Adjust existing antihypertensive medications and/or initiate antihypertensive treatment as appropriate. Second Primary Malignancies - Other malignancies (range, 3% to 16%) including non-skin carcinomas (range, 1% to 4%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 2% to 13%). Tumor Lysis Syndrome - Tumor lysis syndrome has been infrequently reported with IMBRUVICA® therapy. Assess the baseline risk (eg, high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate. Embryo-Fetal Toxicity - Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period. The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia* (61%), thrombocytopenia* (62%), diarrhea (43%), anemia* (41%), musculoskeletal pain (30%), rash (30%), nausea (29%), bruising (30%), fatigue (29%), hemorrhage (22%), and pyrexia (21%). * Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased). The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MCL patients were pneumonia (7%), abdominal pain (5%), atrial fibrillation (5%), diarrhea (5%), fatigue (5%), and skin infections (5%). The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MZL patients were pneumonia (10%), fatigue (6%), diarrhea (5%), rash (5%), and hypertension (5%). Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9% (WM [6%] and MZL [13%]) of patients discontinued due to adverse reactions. Most common adverse reactions leading to discontinuation were pneumonia, hemorrhage, atrial fibrillation, rash, and neutropenia (1% each) in CLL/SLL patients and subdural hematoma (1.8%) in MCL patients. The most common adverse reactions leading to discontinuation were interstitial lung disease, diarrhea, and rash (1.6% each) in WM and MZL patients. CYP3A Inhibitors - Avoid coadministration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose. Hepatic Impairment - Avoid use in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA® dose. About VENCLEXTA™ (venetoclax) in the U.S. Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor developed by AbbVie and Genentech, a member of the Roche Group, indicated in the U.S. for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. There is an ongoing study to find out how Venclexta works over a longer period of time. It is not known if Venclexta is safe and effective in children. Venclexta targets a specific protein in the body called BCL-2. When you have CLL, BCL-2 may build up and prevent cancer cells from self-destructing naturally. Venclexta targets BCL-2 in order to help restore the process of apoptosis. Through apoptosis, your body allows cancer cells and normal cells to self-destruct. AbbVie and Genentech are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory and first-line CLL, along with early phase studies in several cancers. Venetoclax is under evaluation by health authorities in multiple countries, and is currently approved in more than 10 nations, including the U.S. The full U.S. prescribing information for Venclexta can be found here. Patient Assistance Program For those who qualify, AbbVie and Genentech offer patient assistance programs for people taking Venclexta in the U.S. VENCLEXTA™ (venetoclax) U.S. Use and Important Safety Information Use What is VENCLEXTA™ (venetoclax)? VENCLEXTA™ (venetoclax) is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior treatment. VENCLEXTA was approved based on response rate. There is an ongoing study to find out how VENCLEXTA works over a longer period of time. It is not known if VENCLEXTA is safe and effective in children. Important Safety Information What is the most important information I should know about VENCLEXTA? VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your doctor will do tests for TLS. It is important to keep your appointments for blood tests. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Tell your doctor right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Drink plenty of water when taking VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Who should not take VENCLEXTA? Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased. What should I tell my doctor before taking VENCLEXTA? Before taking VENCLEXTA, tell your doctor about all of your medical conditions, including if you: What should I avoid while taking VENCLEXTA? You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood. What are the possible side effects of VENCLEXTA? VENCLEXTA can cause serious side effects, including: The most common side effects of VENCLEXTA include low white blood cell count, diarrhea, nausea, low red blood cell count, upper respiratory tract infection, low platelet count, and feeling tired. VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your doctor if you have concerns about fertility. These are not all the possible side effects of VENCLEXTA. Tell your doctor if you have any side effect that bothers you or that does not go away. About Empliciti™ (elotuzumab) in the U.S. Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.7 Empliciti has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity. On November 30, 2015, the U.S. Food and Drug Administration (FDA) approved Empliciti in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received one to three prior therapies. The safety and efficacy of Empliciti is still being evaluated by other health authorities. Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities. EMPLICITI™ (elotuzumab) is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone in people who have received one to three prior treatments for their multiple myeloma. It is not known if EMPLICITI is safe and effective in children. EMPLICITI is used in combination with REVLIMID and dexamethasone. It is important to remember that the safety information for these medications also applies to EMPLICITI combination therapy. Before you receive EMPLICITI, tell your healthcare provider about all of your medical conditions, including if you: Serious side effects that can occur with EMPLICITI treatment are: The most common side effects of EMPLICITI include: These are not all of the possible side effects of EMPLICITI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please read Patient Information in the full Prescribing Information. About Depatuxizumab Mafodotin Depatuxizumab mafodotin, previously known as ABT-414, is an investigational antibody-drug-conjugate (ADC) being developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics.8 Depatuxizumab mafodotin is a biomarker-driven therapy that binds to an epitope that is exposed on tumor cells with epidermal growth factor receptor (EGFR) amplification and delivers a potent cytotoxin, a substance toxic to cells, that is released inside the tumor cell. It is being evaluated for EGFR-amplified newly diagnosed or recurrent glioblastoma (GBM), an aggressive malignant brain tumor.9 In 2014, the U.S. Food and Drug Administration (FDA) and the European Commission (EC) granted depatuxizumab mafodotin Orphan Drug Designation (ODD) for the treatment of GBM and glioma in adults, respectively.10,11 In 2016, the FDA granted depatuxizumab mafodotin Rare Pediatric Disease Designation for the treatment of diffuse intrinsic pontine glioma (DIPG), a type of pediatric brain tumor.12 Depatuxizumab mafodotin is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority. About Rovalpituzumab Tesirine (Rova-T) Rovalpituzumab tesirine (Rova-T) is an investigational antibody-drug conjugate (ADC) targeting delta-like protein 3 (DLL3), which is expressed in about 80 percent of small cell lung cancer (SCLC) patient tumors. It is prevalent on SCLC tumor cells, but not present in healthy tissue.13 Rova-T combines a targeted antibody with a cytotoxic agent to deliver a substance toxic to cells directly to the DLL3-expressing cancer cells. Rova-T is under investigation for the treatment of SCLC. An open-label, single-arm Phase 2 trial is under way to evaluate Rova-T in the third-line setting in relapsed or refractory DLL3-expressing SCLC.14 Two randomized Phase 3 trials have been initiated in the second-line and first-line maintenance setting. Additional studies are underway in multiple neuroendocrine tumor types, metastatic melanoma, and glioblastoma (GBM).15 Rova-T is an investigational compound and its efficacy and safety have not been established by the U.S. Food and Drug Administration (FDA) or any other health authority. About Veliparib Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types.16,17 PARP is a naturally-occurring enzyme in the body that repairs damage to DNA in cells. While this repair is a useful process to maintain the integrity of healthy cells, the same process may also help repair DNA in cancer cells, causing them to survive.18 Discovered and developed by AbbVie researchers, veliparib is being studied in combination with chemotherapy or radiation to help determine whether it can improve the survival outcome of common DNA-damaging therapies, such as chemotherapy or radiation, compared to platinum chemotherapy regimens alone.16 Veliparib is currently being studied in more than a dozen cancers, including in Phase 3 studies in advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), ovarian cancer and BRCA1/2 breast cancer.19 Veliparib is an investigational medicine and its efficacy and safety have not been established by the U.S. Food and Drug Administration (FDA) or any other health authority. About ABBV-221, ABBV-399 and ABT-348 ABBV-221 is an investigational epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC) being studied in an open-label, dose escalation Phase 1 clinical trial for the treatment of EGFR-expressing solid tumors in participants with advanced solid tumors likely to exhibit elevated levels of EGFR.20 ABBV-399 is an investigational c-Met targeted ADC being studied in an open-label Phase 1 clinical trial evaluating its safety, pharmacokinetics (PK) and preliminary efficacy in patients with solid tumors.21,22 ABT-348 is an investigational novel kinase inhibitor targeting the aurora, vascular endothelial growth factor receptor/platelet-derived growth factor receptor, and Src kinase families and is being studied in a Phase 2 clinical trial of patients with CDKN2A deficient solid tumors.23,24 These are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration (FDA) or any other health authority. About AbbVie in Oncology AbbVie is striving to outsmart cancer by working with scientists, physicians, industry peers, patient advocacy groups and most importantly patients, to discover, develop and provide new therapies that may have a remarkable impact on the lives of people around the world affected by cancer. Our goal is to provide medicines that make a transformational improvement in cancer treatment and outcomes for cancer patients. By exploring and investing in new pathways, technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers. We are also exploring solutions to help patients obtain access to our cancer medicines. With the acquisition of Pharmacyclics in 2015 and Stemcentrx in 2016, and through several collaborations, AbbVie's oncology portfolio consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in nearly 200 clinical trials in 20 different tumor types. For more information about AbbVie Oncology, please visit http://abbvieoncology.com. About Pharmacyclics, An AbbVie Company Pharmacyclics LLC, a wholly-owned subsidiary of AbbVie (NYSE: ABBV), is focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune-mediated diseases. Pharmacyclics' mission is to develop and commercialize novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical needs. Pharmacyclics markets IMBRUVICA and has two product candidates in clinical development and several preclinical molecules in lead optimization. Pharmacyclics is committed to high standards of ethics, scientific rigor and operational efficiency as it moves each of these programs toward commercialization. To learn more, please visit www.pharmacyclics.com. 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. AbbVie 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," of AbbVie's 2015 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 Ostrom QT, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 2009–2013. Neuro Oncol. 2016;18:v1-v75. 2 Visser O, et al. Survival of adults with primary malignant brain tumours in Europe; Results of the EUROCARE-5 study. Eur J Cancer. 2015 [Epub ahead of print]. 3 Brennan CW, et al. The somatic genomic landscape of glioblastoma. Cell. 2013;155:462-477. 4 Yoshimoto K, et al. Development of a real-time RT-PCR assay for detecting EGFRvIII in glioblastoma samples. Clin Cancer Res. 2008;14:488-493. 5 IMBRUVICA US Prescribing Information, January 2017. 6 Genetics Home Reference (2017). Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed March 2017. 7 Empliciti [Package Insert]. Princeton, N.J.: Bristol-Myers Squibb Company. 8 Van den Bent M, et al. ACTR-07. Efficacy of a novel antibody-drug conjugate (ADC), ABT-414, as monotherapy in epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM). Neuro Oncol. 2016; 18. 9 Omuro A, et al. Glioblastoma and other malignant gliomas: A clinical review. JAMA. 2013;310(17):1842-1850. 10 AbbVie Inc. ABT-414 Sponsor Briefing Document. Pediatric Oncology Subcommittee. November 19, 2015. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM472970.pdf. Accessed March 2017. 11 U.S. Food and Drug Administration (2014). Orphan Drug Designations and Approvals. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=433214. Accessed March 2017. 12 Warren KE, et al. Diffuse intrinsic pontine glioma: poised for progress. Front Oncol. 2012;2:205. 13 Saunders LR, et al. A DLL3-targeted antibody-drug conjugate eradicates high-grade pulmonary neuroendocrine tumor-initiating cells in vivo. Sci Transl Med. 2015;7(302):1-13. 14 ClinicalTrials.gov (2017). NCT02674568: Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY). https://clinicaltrials.gov/ct2/show/NCT02674568?term=NCT02674568&rank=1. Accessed March 2017. 15 ClinicalTrials.gov (2017). Search Results: Rovalpituzumab Tesirine. https://clinicaltrials.gov/ct2/results?term=Rovalpituzumab+Tesirine+&Search=Search. Accessed March 2017. 16 Palma JP, et al. ABT-888 confers broad in vivo activity in combination with temozolomide in diverse tumors. Clin Cancer Res. 2009;15(23):7277-7290. 17 Anders CK, et al. Poly (ADP-Ribose) polymerase inhibition: "targeted" therapy for triple-negative breast cancer. Clin Cancer Res. 2010;16(19):4702-4710. 18 Plummer ER, et al. Targeting Poly (ADP-Ribose) Polymerase: A Two-Armed Strategy for Cancer Therapy. Clin Cancer Res. 2007;13(21): 6252-6256. 19 ClinicalTrials.gov (2017). Results: Veliparib: Open Studies. https://clinicaltrials.gov/ct2/results?term=veliparib&recr=Open. Accessed March 2017. 20 Calvo, et al. Preliminary Results from a Phase 1 Study of the Antibody-Drug Conjugate ABBV-221 in Patients with Solid Tumors Likely to Express EGFR. Abstract 2510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT. 21 Angevin, et al. Phase I Study of ABBV-399, a c-Met Antibody-Drug Conjugate (ADC), as Monotherapy and in Combination with Erlotinib in Patients (Pts) with Non-Small Cell Lung Cancer (NSCLC). Abstract 2509; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT. 22 Awad, et al. Impact of MET Inhibitors on Survival Among Patients (Pts) with MET Exon 14 Mutant (METdel14) Non-Small Cell Lung Cancer (NSCLC). Abstract 8511; Clinical Science Symposium; Sunday, June 4, 2017; 8:00 a.m.-9:30 a.m. CDT. 23 Maitland, et al. Pharmaco-kinetics/dynamics (PK/PD) Evaluation and Individual Patient Cross-Over Studies with Growth Trajectory Assessment to Adaptively Develop Ilorasertib. Abstract 2563; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT. 24 ClinicalTrials.gov (2017). NCT02478320: Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors. https://clinicaltrials.gov/ct2/show/NCT02478320. Accessed May 2017. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/abbvie-to-present-latest-clinical-study-results-in-hematology-and-solid-tumor-research-at-the-53rd-american-society-of-clinical-oncology-asco-annual-meeting-300459531.html


About Endometriosis Endometriosis occurs when tissue similar to that normally found in the uterus begins to grow outside of the uterus, leading to long-term pelvic pain (during or between periods), pain with intercourse and other painful symptoms.1,2 These growths are called lesions and can occur on the ovaries, the fallopian tubes, or other areas near the uterus, such as the bowel or bladder.1,3 There is no cure for endometriosis,4 and the associated pain is currently managed with oral contraceptives, progestins, danazol, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and GnRH agonists, many of which are not specifically indicated for the treatment of endometriosis.5 In more extensive cases, surgical interventions (e.g., laparotomy or laparoscopy) are often pursued, and may not be curative for all individuals.5 About Elagolix Elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, is an orally administered, short-acting molecule that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy. Elagolix is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis. To date, elagolix has been studied in over 40 clinical trials totaling more than 3,000 subjects. AbbVie plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) for endometriosis in 2017. Phase 3 trials of elagolix for the management of uterine fibroids are ongoing. 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 2015 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 The American College of Obstetricians and Gynecologists. ACOG Education Pamphlet AP013: Endometriosis. Washington, DC: September 2008. ISSN 1074-8601. 2 Mayo Clinic. Diseases and Symptoms: Endometriosis Fact Sheet. http://www.mayoclinic.org/diseases-conditions/endometriosis/basics/symptoms/con-20013968. Accessed February 1, 2016.  3 MM, Silverberg K, Olive DL. Endometriosis and Adenomyosis. IN: Copeland LJ, Jarrell JF, eds. Textbook of Gynecology. 2nd ed. Philadelphia, PA: WB Saunders; 2000:687-722.  4 Nnoaham KE, Hummelshoj L., Webster P, d'Hooghe T, de Cicco Nardone,F, de Cicco Nardone C, Jenkinson C, Kennedy SH, Zondervan KT, World Endometriosis Research Foundation Global Study of Women's Health, consortium.  Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertility and Sterility. 2011:96:366-373. 5 Giudice LC. Clinical practice: Endometriosis. New England Journal of Medicine. 2010;362:2389–2398. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/abbvie-presents-pivotal-phase-3-data-on-investigational-treatment-elagolix-at-the-world-congress-on-endometriosis-300458986.html


About Endometriosis Endometriosis occurs when tissue similar to that normally found in the uterus begins to grow outside of the uterus, leading to long-term pelvic pain (during or between periods), pain with intercourse and other painful symptoms.1,2 These growths are called lesions and can occur on the ovaries, the fallopian tubes, or other areas near the uterus, such as the bowel or bladder.1,3 There is no cure for endometriosis,4 and the associated pain is currently managed with oral contraceptives, progestins, danazol, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and GnRH agonists, many of which are not specifically indicated for the treatment of endometriosis.5 In more extensive cases, surgical interventions (e.g., laparotomy or laparoscopy) are often pursued, and may not be curative for all individuals.5 About Elagolix Elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, is an orally administered, short-acting molecule that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy. Elagolix is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis. To date, elagolix has been studied in over 40 clinical trials totaling more than 3,000 subjects. AbbVie plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) for endometriosis in 2017. Phase 3 trials of elagolix for the management of uterine fibroids are ongoing. 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 2015 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 The American College of Obstetricians and Gynecologists. ACOG Education Pamphlet AP013: Endometriosis. Washington, DC: September 2008. ISSN 1074-8601. 2 Mayo Clinic. Diseases and Symptoms: Endometriosis Fact Sheet. http://www.mayoclinic.org/diseases-conditions/endometriosis/basics/symptoms/con-20013968. Accessed February 1, 2016.  3 MM, Silverberg K, Olive DL. Endometriosis and Adenomyosis. IN: Copeland LJ, Jarrell JF, eds. Textbook of Gynecology. 2nd ed. Philadelphia, PA: WB Saunders; 2000:687-722.  4 Nnoaham KE, Hummelshoj L., Webster P, d'Hooghe T, de Cicco Nardone,F, de Cicco Nardone C, Jenkinson C, Kennedy SH, Zondervan KT, World Endometriosis Research Foundation Global Study of Women's Health, consortium.  Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertility and Sterility. 2011:96:366-373. 5 Giudice LC. Clinical practice: Endometriosis. New England Journal of Medicine. 2010;362:2389–2398. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/abbvie-presents-pivotal-phase-3-data-on-investigational-treatment-elagolix-at-the-world-congress-on-endometriosis-300458986.html


Jarvis M.F.,AbbVie | Williams M.,Northwestern University
Trends in Pharmacological Sciences | Year: 2016

Concerns regarding the reliability of biomedical research outcomes were precipitated by two independent reports from the pharmaceutical industry that documented a lack of reproducibility in preclinical research in the areas of oncology, endocrinology, and hematology. Given their potential impact on public health, these concerns have been extensively covered in the media. Assessing the magnitude and scope of irreproducibility is limited by the anecdotal nature of the initial reports and a lack of quantitative data on specific failures to reproduce published research. Nevertheless, remediation activities have focused on needed enhancements in transparency and consistency in the reporting of experimental methodologies and results. While such initiatives can effectively bridge knowledge gaps and facilitate best practices across established and emerging research disciplines and therapeutic areas, concerns remain on how these improve on the historical process of independent replication in validating research findings and their potential to inhibit scientific innovation. © 2015 Elsevier Ltd. All rights reserved.


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.

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