AbbVie 2013 Annual Report Download - page 41

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AbbVie also has a number of next-generation programs underway to address immune-mediated
conditions, including the following.
• AbbVie’s studies of dual variable domain immunoglobulin (DVD-Ig) technology, which
represents an approach that can target multiple disease-causing antigens with a single biologic
agent, continue to progress. This proprietary technology could lead to next-generation biologic
treatments for complex conditions such as cancer or rheumatoid arthritis, where multiple
pathways are involved in the disease.
• AbbVie is collaborating with Biotest AG on an anti-CD4 biologic known as tregalizumab. The
compound is currently in Phase IIb clinical trials for rheumatoid arthritis and psoriasis.
• GLPG0634, a next-generation, oral Janus Kinase 1 (JAK1) inhibitor, is being developed with
Galapagos NV (Galapagos) in a collaboration entered into during the first quarter of 2012.
GLPG0634 is currently in Phase IIb development to treat rheumatoid arthritis and may be able
to address other autoimmune diseases. In January 2014, a Phase II study to evaluate GLPG0634
to treat Crohn’s disease was initiated.
• In September 2013, AbbVie entered into a global collaboration with Ablynx NV (Ablynx) to
develop and commercialize the anti-IL-6R Nanobody, ALX-0061, to treat inflammatory diseases
including rheumatoid arthritis and systemic lupus erythematosus. ALX-0061 is currently in
Phase II development for rheumatoid arthritis.
• In May 2013, AbbVie entered into a global collaboration with Alvine Pharmaceuticals, Inc. to
develop ALV003, a novel oral treatment for patients with celiac disease. ALV003 is currently in
Phase IIb development.
Virology
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. In December 2013 and January 2014, AbbVie disclosed
top-line results from all six of these registrational studies. AbbVie expects to complete regulatory
submissions in the United States and the European Union in the second quarter of 2014 and
anticipates commercialization in the United States before the end of 2014. AbbVie also initiated
Phase III development in Japan for HCV infection and expects to submit a regulatory application in
Japan in 2015.
AbbVie also recently initiated Phase II studies of its next-generation HCV program which includes
ABT-493, a potent protease inhibitor, and ABT-530, AbbVie’s new NS5A inhibitor.
Oncology
AbbVie is focused on the development of targeted treatments that inhibit tumor growth and improve
response to common cancer therapies. AbbVie’s later-stage 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 for multiple
myeloma. Two Phase III studies are ongoing with results expected in early 2015.
• Veliparib (ABT-888), 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
treatment of a variety of other solid tumors, including brain metastases from non-small-cell lung
cancer being treated with radiation therapy and non-small-cell lung cancer in combination with
chemotherapy. In January 2014, a Phase III clinical trial was initiated to evaluate the safety and
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