On March 26, AbbVie announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved its Skyrizi (risankizumab) for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults who haven’t responded to conventional therapies.
On March 26, AbbVie announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved its Skyrizi (risankizumab) for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults who haven’t responded to conventional therapies. This marks the first approval in what many expect to be two big drugs for AbbVie.
Skyrizi is part of a collaboration between AbbVie and Boehringer Ingelheim. On March 1, the European Medicine’s Agency’s Committee for Medicinal Products for Human Use (CHMP) gave the drug a positive recommendation. The data for the submission came from the companies’ Phase III psoriasis program that studied more than 2,000 patients with moderate to severe plaque psoriasis in four Phase III trials. The drug is also being evaluated by the U.S. Food and Drug Administration (FDA). The FDA has a target action date of April 25.
AbbVie is also likely to begin evaluating the drug for more indications, including for Crohn’s disease and ulcerative colitis. Sales predictions for the drug have it bringing in $1.74 billion in 2023.
“With this first global approval of Skyrizi, we are excited to bring a new treatment option to people living with psoriatic disease in Japan,” stated Michael Severino, vice chairman and president, AbbVie. “Skyrizi has the potential to improve the signs and symptoms of these chronic, immune-mediated diseases. We look forward to continuing to work with regulatory authorities to make this treatment available to more patients worldwide.”
The other big drug in AbbVie’s pipeline is upadacitinib. On December 20, 2018, AbbVie submitted a New Drug Application (NDA) to the FDA as well as a marketing authorization application (MAA) to the EMA. The FDA accepted the NDA on February 19 under Priority Review, with a regulatory decision expected in the third quarter.
Upadacitinib is an oral investigational JAK1-selective inhibitor to treat adults with moderate to severe rheumatoid arthritis. The NDA and MMA are built on data from the company’s SELECT Phase III rheumatoid arthritis program that studied more than 4,000 rheumatoid arthritis patients in five Phase III trials. The drug met all primary and ranked secondary endpoints.
Of course, AbbVie has the world’s best-selling rheumatoid arthritis drug, Humira. However, the drug is facing competition in Europe to biosimilars, and will likely have the same issue in the U.S. once various biosimilars that have already been approved made their way onto the market.
The problem is that Humira accounts for about 60 percent of AbbVie’s total revenue. If and when upadacitinib is approved, it is projected to bring in about $2.2 billion in 2023. One of the potential benefits of upadacitinib is it worked well in clinical trials in patients who didn’t respond to Humira and other similar drugs.
Investors and analysts believe Humira sales probably peaked last year, especially after sales dropped in the fourth quarter after it lost patent exclusivity. In the fourth quarter, international Humira sales dropped 14.8 percent from 2017, but in the U.S., sales rose 10.7 percent for the year to $13.7 billion. Until biosimilar competition makes its way to the U.S., it’s expected to continue to rise for the next couple years.
This fact has brought a fair amount of heat down on the company from critics of the industry and drug prices. At the February Senate Finance Committee hearing with seven pharmaceutical executives, AbbVie’s chief executive officer Richard Gonzalez found himself on the hot seat regarding Humira, even if some of the senator’s questions exposed a certain level of either naivete about how drug patents work or merely an opportunity for aggressive soundbites (or both).
Senator John Cornyn (R-Texas) went after AbbVie’s 136 patents that protect Humira exclusivity. He said, “I support drug companies recovering a profit based on their research and development of innovative drugs. But at some point, that patent has to end, that exclusivity has to end, to be able to get it at a much cheaper cost.”
Gonzalez responded, “That patent portfolio evolved as we discovered and learned new things about Humira.” For example, the primary patent, the composition-of-matter patent, expired in 2016. But as the company developed the drug for new diseases, it developed patent protection for those indications.
Recently, the United Food and Commercial Workers Local 1500 (UFCW Local 1500) filed a class action lawsuit against AbbVie for allegedly using a group of patents to maintain a monopoly on Humira. It alleges that AbbVie and several of its biosimilar competitors colluded to split the Humira market between the U.S. and Europe.
This is probably a more accurate and reasonable allegation than Senator Cornyn’s statement. Seven other drug manufacturers are co-defendants in the case, including Amgen, Samsung Bioepis, Mylan, Sandoz, Fresenius Kabi, Pfizer, and Momenta.
Amgen, Bioepsis, Mylan and Pfizer have already settled patent disputes with AbbVie over Humira. This complaint argues these settlements were “illegal market division agreements.”
The lawsuit uses the term “patent thickets,” a term that has made the biopharma industry uneasy. A biopharma intellectual property (IP) expert told Modern Healthcare “he is concerned that lawmakers are using the term too loosely without broader context for how multiple patents protect a company’s significant changes to a drug.”
Although the class action lawsuit is worrisome, investors, and probably AbbVie, have confidence in the company’s new drugs, continuing sales of Humira, and other drugs in the company’s portfolio. For example, Imbruvica, for leukemia, is still growing, with 2018 sales rising 39 percent to $3.6 billion. In addition, Venclexta, which was launched with Roche in 2016, has had slow sales, but are expected to speed up. And the company’s Orilissa is expected to hit $2 billion in annual sales by 2025. Orilissa is prescribed to treat pain from endometriosis.
