February 26, 2015

AbbVie's Ongoing Research in Neuroscience and Oncology will be Featured at the 2015 American Academy of Neurology Annual Meeting

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Fifteen Accepted Abstracts Include New Data From:
- A Phase 1 Study of Investigational Treatment ABT-414 in Patients with Glioblastoma Multiforme, an Aggressive and Often Fatal Type of Brain Cancer
- Studies of FDA Approved DUOPA™ in Patients with Advanced Parkinson's Disease
- The Phase 3 DECIDE Study of Investigational Treatment ZINBRYTA™ (daclizumab High-Yield Process) in Patients with Relapsing Remitting Multiple Sclerosis

NORTH CHICAGO, Ill., Feb. 26, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that 15 abstracts of studies in its neuroscience and oncology development programs have been accepted for presentation during the 67th American Academy of Neurology annual meeting in Washington, D.C., from April 18-25. The accepted abstracts feature results from studies evaluating AbbVie's FDA-approved product, DUOPA, in addition to investigational treatments in AbbVie's pipeline. Presentations will include Phase 1 results from a study of ABT-414 in patients with glioblastoma multiforme, Phase 3 data for ZINBRYTA™ (daclizumab high-yield process), which is being developed jointly with Biogen Idec, in relapsing remitting multiple sclerosis, and results from a study of DUOPA (carbidopa and levodopa) enteral suspension in advanced Parkinson's disease.

"The data to be presented at AAN demonstrate the depth and breadth of AbbVie's ongoing commitment to research innovative ways to address devastating neurodegenerative diseases like multiple sclerosis, as well as primary brain cancers," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Our rapidly advancing oncology and neuroscience research is an important part of AbbVie's dedication to developing therapies that have the potential to provide a remarkable impact on patients' lives."

Meeting abstracts are available at http://www.abstracts2view.com/aan/.

Presentations of Investigational Assets:

ABT-414

  • A Phase 1 Study Evaluating ABT-414 with Temozolomide (TMZ) or Concurrent Radiotherapy (RT) and TMZ in Glioblastoma (GBM); Lassman, A., et al.; Abstract S43.006; Platform Presentation; Thursday, April 23, 2015; 2:15-2:30 p.m. EDT

ZINBRYTA (daclizumab high-yield process)

  • Daclizumab high yield process (DAC HYP) has no effect on activity of the cytochrome P450 (CYP) enzymes: results of a drug cocktail interaction study in subjects with multiple sclerosis; Tran JQ., et al.; Abstract P1.148; Poster Session; Monday, April 20, 2015; 2-6:30 p.m. EDT
  • Early, Sustained and Reversible Pharmacodynamic Effects of DAC HYP in MS Supports Mechanism of Action via Modulation of the IL-2 pathway; Amaravadi, L., et al.; Abstract P1.149; Poster Session; Monday, April 20, 2015; 2-6:30 p.m. EDT
  • Evaluation of Immunogenicity in Patients with Multiple Sclerosis Treated with daclizumab HYP; Amaravadi, L., et al.; Abstract P1.147; Poster Session; Monday, April 20, 2015; 2-6:30 p.m. EST
  • Daclizumab HYP Versus Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis: Primary Results of the DECIDE Study; Kappos, L., et al.; Abstract S4.003; Platform Presentation; Tuesday, April 21, 2015; 1:30-1:45 p.m. EDT
  • Pharmacokinetics of Daclizumab High-Yield Process (DAC HYP) with Repeated Administration of the Clinical Subcutaneous Regimen in Subjects With Relapsing-Remitting Multiple Sclerosis; Tran, J., et al.; Abstract P3.257; Poster Session; Tuesday, April 21, 2015; 2-6:30 p.m. EDT
  • Daclizumab HYP versus Interferon ß-1a across Patient Demographic and Disease Activity Subgroups in the DECIDE Phase 3 Study; Wiendl, H., et al.; Abstract P4.007; Poster Session; Wednesday, April 22, 2015; 7:30 a.m.-12 p.m. EDT
  • Treatment with Daclizumab HYP Improved Disease-Specific Patient-Reported Outcomes Versus Interferon Beta-1a in Multiple Sclerosis in the Phase 3 DECIDE Trial; Liu, Y., et al.; Abstract P7.209; Poster Session; Thursday, April 23, 2015; 2-6:30 p.m. EDT
  • Long-term Safety of Daclizumab HYP in Patients with Relapsing-Remitting Multiple Sclerosis: 3-4 year Results from the SELECTED Extension Study; Gold, R., et al.; Abstract P7.225; Poster Session; Thursday, April 23, 2015; 2-6:30 p.m. EDT
  • Long-term Efficacy of Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis: 3 Year Results from the SELECTED Extension Study; Radue, E-W., et al.; Abstract P7.226; Poster Session; Thursday, April 23, 2015; 2-6:30 p.m. EDT
  • Safety and Tolerability Results From the DECIDE Study: A Phase 3 Active-Comparator Study of Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis; Selmaj, K., et al.; Abstract P7.230; Poster Session; Thursday, April 23, 2015; 2-6:30 p.m. EDT
  • Daclizumab HYP Reduced Brain MRI Lesion Activity Compared With Interferon Beta-1a: Results from the DECIDE Study; Rose, J., et al.; Abstract P7.252; Poster Session; Thursday, April 23, 2015; 2-6:30 p.m. EDT

Presentations for FDA Approved Product:

DUOPA (carbidopa and levodopa) enteral suspension

  • Global Long-term Registry on Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson's Disease in routine Care (GLORIA) – Interim Results on Non-motor Symptoms; Antonini, A., et al.; "Data Blitz" Presentation #I3-3B; Sunday, April 19, 2015, 10:30-10:35 a.m. EDT; Abstract P3.004; Tuesday, April 21, 2015; 2-6:30 p.m. EDT
  • Global Long-term Registry on Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson's Disease in Routine Care (GLORIA) – Interim Results in a Subgroup of Patients with Dyskinesia at Baseline; Antonini, A., et al.; Abstract P1.192; Poster Session; Monday, April 20, 2015; 2-6:30 p.m. EDT
  • Interim Results of a Phase 3b Study Assessing the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease; Dubow, J., et al.; Abstract P6.041; Poster Session; Thursday, April 23, 2015; 7:30 a.m.-12 p.m. EDT

About DUOPA (carbidopa and levodopa) enteral suspension
DUOPA is a new approach to the administration of carbidopa and levodopa for the treatment of motor fluctuations for people with advanced Parkinson's disease. DUOPA was reviewed and approved by the FDA as a combination product with use of the CADD Legacy 1400 pump.

DUOPA (carbidopa and levodopa) enteral suspension is a prescription medicine used for treatment of advanced Parkinson's disease. DUOPA contains two medicines: carbidopa and levodopa.

DUOPA is given over a period of 16 hours by a pump through a tube that requires a small hole (stoma) into the stomach. Before the procedure, a discussion with a healthcare provider about any previous procedures or problems with the abdomen area is required. Risks of the procedure may result in blockage of the stomach or intestine, stopping of movement through the intestine, infection, inflammation of the pancreas, stomach pain, gas, stomach and intestinal ulcers or bleeding, nausea, blocking of the tube, or other serious outcomes that may lead to surgery or be fatal.

DUOPA should not be taken by people who are currently taking or have recently taken (within 2 weeks) a medicine called a nonselective monoamine oxidase (MAO) inhibitor. Serious side effects of medicines that contain carbidopa and levodopa, including DUOPA, include sleepiness or suddenly falling asleep without warning during daily activities. Patients should not drive or operate heavy machinery until they are sure how DUOPA affects them. Some patients taking Parkinson's disease medications, including DUOPA, can experience low blood pressure; fast, irregular heartbeat or chest pain; dizziness or fainting; hallucinations or confusion; intense urges they are unable to control, including the urge to gamble, spend money, or overeat; increased sexual urges; and other intense urges. DUOPA can cause or worsen depression. Patients should be counseled to report symptoms of depression or thoughts of suicide. Suddenly stopping DUOPA or rapid dose reduction can result in fever and confusion. Taper dose and monitor patients for fever, confusion, or severe muscle stiffness. Progressive weakness or loss of sensation in the fingers or feet may occur. People with Parkinson's disease have a greater risk of melanoma than the general population and should be monitored while on DUOPA. Worsening of glaucoma may occur. The most common adverse reactions (>7% and greater than carbidopa and levodopa immediate release) were complication of device insertion, nausea, constipation, incision site erythema, dyskinesia, depression, post procedural discharge, peripheral edema, hypertension, upper respiratory tract infection, oropharyngeal pain, atelectasis, confusional state, anxiety, dizziness, and hiatal hernia.

Full Prescribing Information, including the Medication Guide can be found at www.rxabbvie.com.

Carbidopa and levodopa enteral suspension is marketed by AbbVie as DUODOPA® outside the United States.

About ABT-414
ABT-414 is an investigational anti-EGFR (epidermal growth factor receptor) monoclonal antibody drug conjugate (ADC) being evaluated for the treatment of patients with various cancer and tumor types. Developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics, ABT-414 is currently being investigated for the treatment of glioblastoma multiforme, a common and aggressive malignant primary brain tumor. ABT-414 is also in clinical trials for the treatment of patients with squamous cell tumors, including non-small cell lung cancer. ABT-414 is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

About ZINBRYTA (Daclizumab High-Yield Process)
ZINBRYTA (daclizumab high-yield process) is an investigational drug and is a new form of humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is expressed at high levels on T-cells that become abnormally activated in MS. ZINBRYTA is thought to modulate IL-2 signaling without causing general immune cell depletion. ZINBRYTA is believed to work by decreasing abnormally-activated T-cells and pro-inflammatory lymphoid tissue inducer cells, and increasing CD56bright natural killer (NK) cells, important cells that help regulate the immune system.

ZINBRYTA is an investigational compound and its efficacy and safety for the treatment of relapsing remitting multiple sclerosis has not been established by the FDA or any other health authority.

AbbVie and Biogen Idec are jointly developing ZINBRYTA.

About AbbVie
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. AbbVie employs more than 26,000 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.

 

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SOURCE AbbVie

Contact(s)


Media
David Freundel
david.freundel@abbvie.com
(847) 937-4522
Gentry Lassiter
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(847) 935-5591

Investors
Liz Shea
liz.shea@abbvie.com
(847) 935-2211