AbbVie 2014 Annual Report Download - page 43

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negative breast cancer and in patients with human epidermal growth factor receptor 2-(HER2)
negative metastatic or locally-advanced breast cancer, containing BRCA1 and/or BRCA2 gene
mutations, when added to carboplatin and paclitaxel.
• Venetoclax (ABT-199), a next-generation Bcl-2 inhibitor, is in development for patients with relapsed/
refractory chronic lymphocytic leukemia. In 2014, two Phase 3 studies in chronic lymphocytic
leukemia (CLL) were initiated in collaboration with AbbVie’s development partner, Roche Holding AG.
AbbVie also completed enrollment in a single arm study evaluating venetoclax in patients with
relapsed/refractory CLL harboring the 17p deletion mutation, a negative prognostic factor. AbbVie
anticipates results from this study in 2015. Venetoclax 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. In 2014, the European Medicines Agency (EMA)
and the FDA granted orphan drug designation to AbbVie’s investigational compound ABT-414, an
anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety
and efficacy in patients with glioblastoma multiforme, the most common and most aggressive type
of malignant primary brain tumor.
• In 2014, AbbVie in-licensed duvelisib, a dual acting PI3 kinase inhibitor currently under investigation
for use in a variety of hematological malignancies, from Infinity. Duvelisib is also under investigation
for use in indolent non-Hodgkins lymphoma and for use in CLL.
Renal Disease
AbbVie’s renal care pipeline includes atrasentan, for the prevention of progression of diabetic CKD. In
2013, a Phase 3 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 2018. Atrasentan will potentially be the first compound launched to treat
diabetic nephropathy by specifically targeting albuminuria and slowing the progression of CKD. AbbVie was
previously investigating ABT-719, for the treatment of acute kidney injury associated with major cardiac and
vascular surgeries. In 2014, AbbVie completed its Phase 2b study and, based on the results of that study,
decided not to continue development of ABT-719.
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 ZINBRYTA (daclizumab) for the treatment of the
relapsing/remitting form of MS, which is the most common form, and affects nearly 85 percent of
newly diagnosed MS patients. The Phase 3 study for ZINBRYTA (daclizumab), an anti-CD25
monoclonal antibody, was successfully completed in 2014. AbbVie is in the process of working with
Biogen Idec to complete its global regulatory applications for ZINBRYTA (daclizumab) which are
expected to be submitted in the first half of 2015.
• On January 12, 2015, AbbVie announced that the FDA approved Duopa, a levodopa-carbidopa
intestinal gel for the treatment of Parkinson’s disease. Duopa is administered using a small, portable
infusion pump that delivers levodopa and carbidopa directly into the small intestine for 16
continuous hours via a procedurally-placed tube. This product is sold under the name Duodopa
outside the United States.
2014 Form 10-K 37