AbbVie 2012 Annual Report Download - page 48

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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.
• ABT-199, a next-generation Bcl-2 inhibitor in development for chronic lymphocytic leukemia is
expected to start Phase III evaluation in 2013.
• Other molecular targets are being explored with Antibody-Drug Conjugate approaches linking
anti-target antibodies with potent cytotoxic agents.
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.
Immunology
AbbVie is developing several additional indications for HUMIRA and has a number of next-generation
programs underway to address immune-mediated conditions, including the following.
• Dual variable domain immunoglobulin (DVD-Ig) technology, which represents an approach that
can target multiple disease-causing antigens with a single biologic agent. 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 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 the fourth quarter of 2011, AbbVie entered into a collaboration with Reata for the joint
development and commercialization of second-generation, oral antioxidant inflammation
modulators.
Additional Indications and Formulations
AbbVie continues to dedicate R&D efforts to expanding indications for HUMIRA, including in the
fields of rheumatology (peripheral spondyloarthritis, axial spondyloarthritis and pediatric enthesitis
related arthritis), gastroenterology (pediatric Crohn’s disease and pediatric ulcerative colitis),
dermatology (pediatric psoriasis and hidradenitis suppurativa), and ophthalmology (uveitis). Phase III
trials are ongoing in preparation for regulatory applications for: uveitis in the United States and the
European Union; peripheral and axial spondyloarthritis in the United States; peripheral
spondyloarthritis in the European Union and hidradenitis suppurativa in the United States and the
European Union. The following registrations and approvals have occurred since January 1, 2011.
• European Union approval for pediatric Crohn’s disease was obtained in November 2012.
• For ulcerative colitis, European Union approval was obtained in April 2012 and approval in the
United States was obtained in September 2012.
• For axial spondyloarthritis, approval in the European Union was obtained in July 2012. The
registration submission was made in the United States in November 2012.
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