AbbVie 2013 Annual Report Download - page 42

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efficacy of Veliparib when added to carboplatin, a chemotherapy, in women with early-stage,
triple-negative breast cancer.
• ABT-199, a next-generation Bcl-2 inhibitor in development for chronic lymphocytic leukemia. In
January 2014, a Phase III evaluation was initiated in collaboration with AbbVie’s development
partner, Roche Holding AG. AbbVie anticipates results from this trial in early 2015. ABT-199 is
also being explored for use across a number of different hematologic cancers including
non-Hodgkin lymphoma, diffuse large b-cell lymphoma and acute myeloid leukemia.
• Other molecular targets are being explored with Antibody-Drug Conjugate approaches linking
anti-target antibodies with potent cytotoxic agents.
Renal Disease
AbbVie’s renal care pipeline includes atrasentan, for the treatment of diabetic CKD. In 2013, a
Phase III study was initiated to assess atrasentan, when added to standard of care, on progression of
kidney disease in patients with stage 2 to 4 CKD and type 2 diabetes. This global registrational study is
expected to be completed in 2017. Atrasentan will potentially be the first compound launched to treat
diabetic nephropathy by specifically targeting albuminuria and slowing the progression of CKD. AbbVie
is also investigating ABT-719, in Phase IIb development, for the treatment of acute kidney injury
associated with major cardiac surgeries.
Neurological Diseases
AbbVie has clinical studies underway on multiple compounds that target receptors in the brain that
help regulate mood, memory, and other neurological functions and conditions, including the following.
• AbbVie is collaborating with Biogen Idec to develop daclizumab for the treatment of the
relapsing remitting form of multiple sclerosis (MS), which is the most common form, and affects
nearly 85 percent of newly diagnosed MS patients. Daclizumab, an anti-CD25 monoclonal
antibody, is currently in Phase III development.
• AbbVie recently completed two Phase IIb studies of ABT-126, an Ȋ7-NNR modulator, in both
Alzheimer’s disease and cognitive deficits of schizophrenia. Based on the results of these studies,
AbbVie plans to focus its efforts on the schizophrenia indication.
• A levodopa-carbidopa intestinal gel for the treatment of Parkinson’s disease is under regulatory
review in the United States and a decision is expected before the end of 2014. This product is
sold under the name Duodopa outside the United States.
Women’s Health
AbbVie is developing a novel oral gonadotropin-releasing hormone (GnRH) antagonist, elagolix, under
a collaboration with Neurocrine Biosciences for the treatment of endometriosis-related pain and uterine
fibroids. A Phase III study in endometriosis began in mid-2012 and a Phase IIa study for uterine
fibroids was initiated in November 2011. In 2013, AbbVie initiated a second Phase III trial for
endometriosis and the study for uterine fibroids transitioned to Phase IIb.
Other
Given the numerous sources for potential future growth, no individual project is expected to be
material to cash flows or results of operations over the next five years. Factors considered included
R&D expenses projected to be incurred for the project over the next year relative to AbbVie’s total
R&D expenses as well as qualitative factors, such as marketplace perceptions and impact of a new
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