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AbbVie Advanced Its Mid- and Late-Stage Research Pipeline in 3Q15

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Jan. 22 2016, Updated 4:05 p.m. ET

Mid- and late-stage research pipeline

In 3Q15, AbbVie reported positive data and continued to advance its mid- and late-stage research for multiple assets, across immunology, oncology, neuroscience, hepatitis C (or HCV), and other franchises.

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Oncology drugs

AbbVie (ABBV) has a strong oncology research pipeline, involving drugs such as Imbruvica, Elotuzumab, Veliparib, and ABT-199 (or Venetoclax). Currently in Phase 3 clinical trials, Imbruvica is explored for several indications:

  • follicular lymphoma (or FL)
  • marginal zone lymphoma (or MZL)
  • diffuse large B-cell lymphoma (or DLBCL)
  • multiple myeloma (or MM)
  • chronic graft versus host disease
  • solid tumors such as pancreatic cancer, lung cancer, and breast cancer

If approved for these new indications, the drug could enable AbbVie to give tough competition to other companies in the oncology space such as Merck (MRK), Amgen (AMGN), and Celgene (CELG).

In addition to Imbruvica, to further penetrate in the $27 billion hematologic oncology market, AbbVie is currently testing Venetoclax in Phase 3 clinical trials for front-line chronic lymphocytic leukemia (or CLL) as well as for relapsed/refractory CLL. The company is also exploring elotuzumab in collaboration with Bristol-Myers Squibb, as a first-line treatment for multiple myeloma (or MM). AbbVie also has a strong pipeline of drugs, including Veliparib and ABT-414, for treating solid tumors.

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Immunology drugs

On September 25, 2015, AbbVie announced that its investigational selective JAK1 inhibitor, ABT-494, managed to meet its primary endpoints for rheumatoid arthritis (or RA) in patients who responded inadequately to prior methotrexate or tumor necrosis factor (or TNF) inhibitors therapy. Although the majority of leading RA drugs such as Humira, Remicade, and Enbrel are TNF inhibitors, they do not prove effective in 35% of US RA patients who belong to the most challenging, anti-TNF inadequate responders category.

If approved, based on high efficacy and once-daily dosing, ABT-494 could prove to be the best-in-class therapy for RA patients, including those that do not respond adequately to TF inhibitors. To learn how TNF inhibitors work, please refer to Humira Takes Top Spot for Rheumatoid Arthritis Drugs.

AbbVie is actively pushing ABT-494 in Phase 3 clinical trials and by 2019, it plans to launch the drug prior to the entry of any biosimilar in the RA segment. The company also plans to deploy its commercial infrastructure, currently being used for Humira for ABT-494 and other immunology assets in future years.

AbbVie expects that its immunology research pipeline will contribute about $8 billion revenues in 2024, with $4 billion revenues being contributed by ABT-494. ABT-494 will increasingly be used to treat patients who do not respond to Humira as well as those who fail to respond to future RA biosimilars. ABT-494 is also being explored as a treatment for Crohn’s disease.

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AbbVie is also developing ABT-122, based on the dual variable domain (or DVD) antibody platform for RA and psoriatic arthritis. ABT-122 is a combination of anti-TNF and interleukin-17 inhibitors (or anti-IL17), which are two proven treatment platforms in immunology. Additionally, the company is also exploring ALX-0061 for RA and ABT-981 for osteoarthritis.

Other research programs

AbbVie’s mid- and late-stage research pipeline also consists of investigational medicines for hepatitis C and uterine fibroids. The company is also exploring drugs targeting cystic fibrosis, Alzheimer’s disease, and various solid tumors in its early stage pipeline.

Instead of directly investing in AbbVie, you can gain diversified exposure to the company through the iShares S&P 500 Growth ETF (IVW). AbbVie accounts for about 0.6% of IVW’s total holdings.

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