AbbVie 2014 Annual Report Download - page 42

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• AbbVie is collaborating with Biotest AG on an anti-CD4 biologic known as tregalizumab. The
compound is currently in Phase 2b clinical trials for rheumatoid arthritis and psoriasis.
• Filgotinib (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. Filgotinib
is currently in Phase 2b development to treat rheumatoid arthritis and may be able to address other
autoimmune diseases. In January 2014, a Phase 2 study to evaluate Filgotinib to treat Crohn’s
disease was initiated.
• ABT-494, AbbVie’s JAK-1 selective inhibitor, is currently in Phase 2b.
• 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 2
development for rheumatoid arthritis.
• In May 2013, AbbVie entered into a global collaboration with Alvine Pharmaceuticals, Inc. (Alvine) to
develop ALV003, a novel oral treatment for patients with celiac disease. ALV003 is currently in
Phase 2b development.
Virology/Liver Disease
On December 19, 2014, the U.S. Food and Drug Administration (FDA) approved AbbVie’s VIEKIRA PAK,
an all-oral interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with
chronic genotype 1 HCV infection, including those with compensated cirrhosis. On January 16, 2015, AbbVie
announced that the European Commission granted marketing authorizations for its all-oral, short-course,
interferon-free treatment VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets).
The treatment has been approved with or without RBV for patients with genotype 1 chronic HCV infection,
including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy
and liver transplant recipients. Additionally, VIEKIRAX has been approved for use with RBV in genotype 4
chronic HCV patients. AbbVie’s HCV combination is also in Phase 3 development in Japan. AbbVie submitted
its regulatory application in Japan in 2015.
AbbVie is also currently conducting Phase 2 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 is an anti-SLAM7 antibody for the treatment of multiple myeloma under a collaboration
with Bristol-Myers Squibb (BMS). Phase 3 development began in June 2011 for multiple myeloma. In
2014, AbbVie and BMS announced that the FDA granted elotuzumab Breakthrough Therapy
Designation for use in combination with lenalidomide and dexamethoasone for the treatment of
multiple myeloma in patients who have received one or more prior therapies. Two Phase 3 studies
are ongoing with results expected in 2015.
• Veliparib (ABT-888), a PARP-inhibitor, is in a Phase 3 study in BRCA-mutated breast cancer being
treated with chemotherapy initiated in 2014. Veliparib is also in Phase 2 evaluation for the
treatment of a variety of other solid tumors. In 2014, AbbVie announced the initiation of four
separate Phase 3 clinical trials evaluating the safety and efficacy of veliparib, in combination with
chemotherapy in patients with previously untreated locally advanced or metastatic squamous
non-small cell lung cancer (NSCLC) and a separate study in patients with nonsquamous NSCLC, as a
neoadjuvant therapy, when added to carboplatin, prior to surgery in women with early-stage, triple
36 2014 Form 10-K