AbbVie 2012 Annual Report Download - page 47

Virology
AbbVie has released positive Phase II and Phase IIb results from interferon-free studies for the
treatment of HCV. In October 2012, AbbVie initiated a comprehensive Phase III program for
genotype 1 HCV that involves combinations of ABT-450; a protease inhibitor for HCV infection;
ABT-333, a polymerase inhibitor; and ABT-267, a NS5A inhibitor.
Renal Disease
AbbVie’s renal care pipeline includes atrasentan, for the treatment of diabetic chronic kidney disease
(CKD). A Phase IIb study of atrasentan in patients with diabetic kidney disease, which began in June
2011, has been completed, with results to be presented in 2013. 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 surgeries.
In 2010, AbbVie entered into an agreement with Reata Pharmaceuticals Inc. (Reata) for ex-U.S. rights,
excluding certain Asian markets, to bardoxolone methyl, an investigational treatment for CKD. A
global Phase III clinical trial was initiated in June 2011. On October 17, 2012, Reata informed AbbVie
that it is discontinuing the Phase III clinical study. The discontinuation was based on a
recommendation from the study’s Independent Data Monitoring Committee regarding safety concerns
due to excess serious adverse events and mortality in the bardoxolone methyl arm. Reata and AbbVie
will closely examine the data from this study to determine whether there is an appropriate path forward
for the development of bardoxolone methyl in CKD or other indications.
Neuroscience and Pain
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 schizophrenia,
pain, Alzheimer’s disease, and multiple sclerosis (MS).
• AbbVie is collaborating with Biogen Idec to develop 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. Daclizumab, an anti-CD25 monoclonal antibody, is currently in
Phase III development.
• AbbVie is investigating ABT-126, an Ȋ7-NNR modulator, in both Alzheimer’s disease and
cognitive deficits of schizophrenia. Additional Phase IIb studies began in March 2012.
• The development of ABT-110 for the treatment of multiple pain indications has been suspended
based upon FDA class-wide feedback.
• A levodopa-carbidopa intestinal gel completed its Phase III program and AbbVie is pursuing
regulatory approval in the United States. This product is sold under the Duodopa name outside
the United States.
Oncology
AbbVie is focused on the development of targeted treatments that inhibit tumor growth and improve
response to common cancer therapies. AbbVie’s oncology pipeline includes the following.
• Elotuzumab, an anti-CD37 antibody for the treatment of multiple myeloma under a
collaboration with Bristol-Myers Squibb. Phase III development began in June 2011.
• Veliparib, a PARP-inhibitor. A Phase IIb study in BRCA-mutated breast cancer being treated
with chemotherapy was initiated in 2011. Veliparib is also in Phase II evaluation for the
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