How AbbVie Plans To Replace Humira

| About: AbbVie Inc. (ABBV)

Summary

Humira still makes up the bulk of AbbVie's revenue.

AbbVie has invested heavily in R&D, as a result a number of autoimmune medications are in development.

In a bold move, AbbVie is comparing its new medications to Humira to see if they are superior.

Background

AbbVie (NYSE:ABBV) is a large cap pharmaceutical company that was spun off from Abbott (NYSE:ABT) in 2013. With a market capitalization of 90 billion, AbbVie is one of the largest pharmaceutical companies in the world. The stock supplies a 4% dividend yield and trades at a relatively cheap multiple considering its sales growth of 15% last year. The main reason AbbVie trades so cheaply is the fear associated with its main product Humira. Last year, Humira had over $14 billion in sales and made up over 60% of AbbVie's total sales. Investors are rightfully nervous that when Humira loses patent protection, revenues will plummet. However, AbbVie is investing heavily in its pipeline to develop drugs that could be superior to Humira and eventually replace it as the dominant treatment for autoimmune disorders. AbbVie is going with the shotgun approach with four compounds in development. ABT-122, ABT-494, ABBV-247, and ALX-0061 are all in clinical trials to treat conditions similar to those that Humira is approved for.

ABT-122

ABT-122 works in a similar fashion as AbbVie's blockbuster Humira but with an added target. While Humira blocks TNF-alpha, ABT-122 blocks both TNF-alpha as well as IL-17. AbbVie feels this gives it an advantage and is designing its clinical trials appropriately. AbbVie is comparing ABT-122 directly to Humira for the treatment of psoriatic and rheumatoid arthritis. The trial for rheumatoid arthritis is complete and results should be coming out soon, while the psoriatic arthritis study should be completed within a couple of months. These results will be something to watch out for, if ABT-122 is shown to be superior to Humira, AbbVie will have another blockbuster on its hand.

ABBV-257

With ABBV-257, AbbVie is hedging its bets in case everything doesn't work out with ABT-122. ABBV-257 works in a similar fashion by blocking TNF-alpha and IL-17. It has just completed a phase I trial for patients with Rheumatoid arthritis in February of this year. Currently, there is no timeline for when a Phase II trial will be initiated. It will be interesting to watch how AbbVie progresses with ABBV-257, especially if ABT-122 presents excellent phase II data.

ABT-494

ABT-494 is the furthest along in AbbVie's pipeline, with multiple phase III trials ongoing. ABT-494 is being developed to treat patients that don't respond to TNF inhibitors. ABT-494 works by inhibiting JAK-1 and is taken orally which patients prefer. Phase II trials have been completed and were very positive. The first Phase II trial called BALANCE-1 compared ABT-494 to placebo to patients that had failed to respond to one or more TNF inhibitor. Over 70% of patients showed a 20% response and 44% of patients showed a 50% improvement. In a second Phase II study called BALANCE-2, AbbVie studied patients that had an inadequate response to methotrexate. In this study, 82% of patients had at least a 20% response rate and 50% of patients had a 50% response rate. These positive results led AbbVie to abandon its partnership with Galapagos in the advancement of filgotinib. Filgotinib is another JAK-1 inhibitor that had its own positive phase IIb results in the DARWIN trial. Gilead quickly jumped in to partner with Galapagos and is helping them advance to phase III trials. AbbVie has a number of phase III trials planned themselves for ABT-494, the two most consequential are the SELECT-NEXT and SELECT-COMPARE. In the SELECT-COMPARE trial, AbbVie is once again using Humira as the comparison drug, the trial should complete primary results in late 2017. The SELECT-NEXT trial compares ABT-494 to placebo on top of conventional disease modifying antirheumatics. This trial should also complete primary results in 2017.

ALX-0061

AbbVie paid 175 million to Ablynx (OTCPK:ABLYF) in 2013 to partner and co-promote ALX-0061. ALX-0061 is an anti-IL-6R nanobody that is given subcutaneously. The deal requires that Ablynx pay for the phase I and II trials, then if AbbVie decides it wants to continue, it will be responsible for funding all phase III trials. According to the agreement, AbbVie will have to decide if it wants to continue into phase III trials by the end of the year. There is a lot to like with regards to ALX-0061. First, it can be given only once a month which will be more manageable for patients. ALX-0061 also has shown to be extremely effective in an early rheumatoid arthritis study. The study showed 75% of patients scoring ACR50 or higher. The same study showed that the patients' arthritis didn't progress and the drug was well tolerated. Currently, ALX-0061 is in two phase IIb trials for rheumatoid arthritis and one phase IIb trial for systemic lupus erythematosus. The two trials for rheumatoid arthritis should be completed in the second half of this year and the lupus trial should be completed in 2018.

Conclusion

AbbVie claims that Humira biosimilars won't hit the market until 2022, so it has a considerable amount of time to advance these medications. With a strong pipeline in multiple therapeutic areas, I expect AbbVie's revenue will be much less reliant on Humira by then. Another aspect for investors to consider is that even when Humira's patent eventually lapses, revenues will not crater since it is a biologic, which are difficult and expensive to replicate. So while investors are right to be nervous about the percentage of sales that Humira contributes, AbbVie is making the proper investments to alleviate this concern when Humira's patent finally does expire.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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