According to this statement from the FDA, about 620,000 Americans suffer from ulcerative colitis, a chronic inflammatory bowel disease. The string of recent FDA approvals of existing rheumatoid arthritis medications for ulcerative colitis has the drug majors clawing at each other for a spot at the top.
While trying to sort out who was selling how much of what, I found the space horribly cluttered and confusing. Here's an organized look at existing players and fresh upstarts all fighting to be the King of Colitis.
A Brief History of Remicade's Tangled Web
Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Remicade is the company's biggest seller, and eighth overall in the U.S. with $3.79 billion in sales over the past four quarters. Unfortunately for J&J, sales of the treatment are shared with Merck (NYSE:MRK) due to a tangled web of acquisitions and marketing partnerships.
Schering-Plough originally signed a contract with J&J to market Remicade. J&J argued that a provision of the agreement stated that in the event of a merger or acquisition, all rights to Remicade would belong to J&J. Merck argued that "its acquisition was structured in a way that sidestepped that clause by listing Schering-Plough as the official purchaser in a reverse merger."
In April, 2011, Merck and J&J settled out of court. The settlement stated that Merck would retain exclusive rights to sales of Remicade in Europe, Russia, and Turkey. J&J retained exclusive rights in the U.S. In the rest of the world, Merck and J&J would split profits from sales of the drug down the middle.
Also involved in the Schering-Plough, Merck, and J&J triangle is Simponi, a subcutaneously administered drug previously approved for rheumatoid arthritis. Last week, the FDA approved Simponi for treatment of moderate to severe ulcerative colitis in adult patients. Unlike Remicade, which must be administered intravenously, Simponi treatments involve a simple subcutaneous injection once every four weeks.
Year on year, J&J's portion of Remicade sales were up 5.2% from $1.521 billion in Q1 2012 to $1.6 billion in Q1 2013. Simponi sales reached $237 million in Q1 2013, but will undoubtedly increase now that it is approved for treatment of ulcerative colitis. Merck reported Remicade sales of $549 million for Q1 2013, an increase of 6% year on year. Merck's portion of Simponi sales were about $108 million for the quarter.
Not So Lonely at the Top
Both Remicade and Simponi will be competing with Abbott Laboratories' (NYSE:ABT) spin off AbbVie's (NYSE:ABBV) ulcerative colitis drug, Humira. Already a blockbuster for rheumatoid arthritis, the FDA approved Humira for ulcerative colitis in September 2012. Like Simponi, Humira is also administered subcutaneously every two weeks after initiating treatment with the drug.
Humira was the top selling drug in 2012 with about $9.3 billion in sales. AbbVie reported worldwide sales of Humira at $2.244 billion for Q1 2013, up 16% year on year. Humira comprised 52% of the company's net sales for the quarter.
Before you go buying up AbbVie shares on the strength of Humira, remember that its patent protection expires in 2016. Humira has filed a petition with the FDA that might effectively bar biosimilars from entry using some bizarre logic. Generics will find Humira difficult to produce because it is manufactured in living cells, but with a prize this big they won't stop trying.
A New Approach
The FDA approved Pfizer's (NYSE:PFE) Xeljanz in September 2012 for rheumatoid arthritis, and gunning for ulcerative colitis approval as well. Unlike Remicade, Simponi, and Humira, Pfizer's Xeljanz is a pill taken orally. The differences don't stop there. Xeljanz operates within cells to inhibit the function of cytokines -- molecules with functions similar to hormones -- like tumor necrosis factor (TNF). Remicade, Simponi, and Humira work outside of cells by binding to TNF and limiting its function.
The FDA has already approved Xeljanz for treatment of rheumatoid arthritis in the U.S., but the drug isn't having the same luck in Europe. Last month, The Committee for Medicinal Products for Human Use advised the European Medicines Agency not to approve Xeljanz. The advisory board claims that the treatment isn't effective enough and therefore shouldn't be approved.
Some Room at the Top for Everyone
When the FDA announced its approval of Humira for treatment of ulcerative colitis, Division of Gastroenterology and Inborn Errors Products Director Donna Griebel, M.D., stated that "each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual's needs." Since different patients respond to different treatments, it is unlikely that any single drug will completely dominate the growing ulcerative colitis market.
Q1 2013 Sales
FDA Approval for Ulcerative Colitis
Remicade -- J&J
Remicade -- Merck
Simponi -- J&J
Simponi -- Merck
Humira -- AbbVie
Xeljanz -- Pfizer
The estimated 700,000 Americans, and millions worldwide, suffering from ulcerative colitis will most likely have several options to treat the affliction. Assuming Pfizer's Xeljanz is approved for ulcerative colitis, patients will soon have the option of a pill, subcutaneous injection, and/or IV treatments. It looks like the battle for the top spot will be exciting and unpredictable for years to come.