Innovations in immunology
In addition to expanding the label of its blockbuster therapy Humira, AbbVie is also focused on developing innovative immunology drugs, ABT-494, ABT-122, and ABLX-0061.
Enhancements to Humira
AbbVie (ABBV) has been actively expanding Humira’s label and expects to earn annual revenues worth $18 billion from the sales of the drug in 2020. On September 10, 2015, Humira was approved by the FDA for the treatment of hidradenitis suppurativa (or HS). The drug has been already approved for HS by the European Medicines Agency (or EMA) in June 2015. Humira is also being currently reviewed by the FDA and EMA as a treatment for uveitis, with regulatory outcomes expected in second half of 2016.
In 2015, AbbVie developed a new formulation for Humira to reduce the injection site pain for the patients as well as the dosage volume required for every injection. This new formulation has been approved in the US and Europe. The company is also seeking approvals from the regulatory bodies for launching an improved version of the Humira Pen device for injecting the drug.
These innovations are expected to enable Humira to continue being strong competition for immunology drugs such as Johnson & Johnson’s (JNJ) Remicade (through subsidiary Janssen Biotech) and Amgen’s (AMGN) Enbrel.
On January 8, 2016, the company announced the initiation of its Phase 3 clinical trial program for ABT-494, a JAK1 inhibitor therapy, targeted at treating rheumatoid arthritis (or RA) patients. ABT-494 can prove to be a promising investigational therapy, especially for difficult-to-treat RA patients who respond inadequately to TNF-inhibiting therapy.
The drug was able to meet its primary goal in the Phase 2 clinical trials when tested in a patient population with difficult-to-treat RA. AbbVie expects to launch this drug in 2019. ABT-494 is also expected to face competition from another JAK1 inhibitor therapy, Eli Lilly’s (LLY) investigational drug baricitinib. To learn how TNF-inhibiting drugs work, please refer to Humira Takes Top Spot for Rheumatoid Arthritis Drugs.
ABT-122 and ABLX-0061
Both ABT-122 and ABLX-0061 molecules are currently in mid-stage clinical trials. AbbVie expects to release data for ABT-122 in mid-2016 while the data for ABLX-0061 is expected by the end of 2016. To learn more about these research programs, please refer to AbbVie Advanced Its Mid- and Late-Stage Research Pipeline in 3Q15.
If these new immunology drugs prove to be successful in the clinical trials, AbbVie should continue to be a strong immunology player, despite Humira’s impending patent expiry in December 2016. It should also have a positive impact on share prices of the iShares Russell 1000 ETF (IWB). AbbVie accounts for 0.47% of IWB’s total holdings.