Investors Look to the Future of AbbVie Post-Patent Protection for Humira
July 7, 2016
By Alex Keown, BioSpace.com Breaking News Staff
CHICAGO – Investors in AbbVie are getting a bit antsy looking down the road past a time when that company’s blockbuster rheumatoid arthritis (RA) drug Humira loses its patent protection later this year.
Humira has been responsible for the majority of the company’s revenue and will also face competition from biosimilars, including one under development from Amgen , the maker of another RA drug, Enbrel. In October 2015, Amgen announced positive Phase III results for ABP 501, a biosimilar to Humira (adalimumab) in patients with RA. The FDA is expected to review the drug for approval by Sept. 25, 2016.
On several occasions, AbbVie has suggested Humira will continue to be a strong driver of revenue, particularly as it is eventually approved for other uses. This morning, the company said it will present data from a Phase III trial using Humira to treat fingernail psoriasis. In its presentation, AbbVie said it will show Humira achieved at least a 75 percent improvement in moderate to severe fingernail psoriasis compared to patients receiving placebo.
Earlier this month Humira received FDA approval for the treatment of non-infectious intermediate, posterior and panuveitis, making it the first non-corticosteroid therapy available to adults dealing with the diagnosis. The European Commission also approved Humira in the European Union for the treatment of noninfectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, as well as in cases when corticosteroid treatment is inappropriate.
AbbVie will also certainly drive revenue from recent acquisitions, including newly acquired Imbruvica for treatment of chronic lymphocytic leukemia. Imbruvica generated $381 million in the first quarter of 2016 and has the potential to generate $3.6 billion annually, bidnessetc reported.
AbbVie also snapped up investigational cancer drug rovalpituzumab tesirine (Rova-T) in its acquisition of Stemcentrx. That drug could yield up to $5 billion in annual revenue, analysts have predicted. Stemcentrx also has four other drugs in clinical trials for various solid tumors, including triple-negative breast cancer, ovarian cancer and non-small cell lung cancer. It also has several compounds in preclinical studies, as well as a proprietary technology platform that uses stem cells to identify and screen tumor targets.
Another deal, worth about $500 million, was struck with CytomX Therapeutics to co-develop commercialize probody drug conjugates against CD71, also known as transferrin receptor 1 (TfR1).
AbbVie struck a deal with Belgium-based drugmaker argenx on a preclinical immuno-oncology drug targeting GARP, a protein believed to contribute to immuno-suppressive effects of T-cells. The drug, ARGX-115, is designed to selectively target tumor immune escape pathways in cancer patients.
Not only is AbbVie furthering its immunotherapy position with the argenx collaboration, but the company also struck a five-year agreement with the University of Chicago to improve the pace of discovery and advance medical research in oncology. Both organizations will initially work together to advance research in several areas of oncology, which include breast, lung, prostate, colorectal and hematological cancers.
AbbVie also maintains a robust pipeline, with more than 50 drugs in development for multiple cancers, autoimmune diseases, Alzheimer’s disease and hepatitis C. AbbVie also has other RA drugs in mid- and late-stage studies.
Shares of AbbVie are slightly up in early morning trading, hitting a high of $63.65 as of 9:38 a.m. In June, Morgan Stanley downgraded AbbVie’s stock from “overweight” to “equal weight” and cut its price target from $73 to $65. The investment firm cited concerns over the future of Humira.