More than a few biotechs, and most Big Pharmas, are exploring next-generation drug candidates in one of the hottest therapeutic areas: autoimmune conditions such as rheumatoid arthritis, psoriasis, and Crohn's disease. A crowded market for these large indications hasn't prevented newer drugs from receiving the regulatory green light in the U.S. and abroad, but in the short term, it's unlikely that any will unseat the towering giants in the space: Remicade, Enbrel, and Pharm Exec's Brand of the Year, Humira. These three drugs have combined sales exceeding the entire GDP of Afghanistan, and demand continues to mount, because for patients, they can mean the difference between a crippling disability and a relatively normal existence.
Johnson & Johnson/Merck's Remicade, administered by infusion, was the first anti-TNF to receive FDA approval—for acute moderate to severe Crohn's disease—while Amgen/Pfizer's Enbrel was the first to be approved for rheumatoid arthritis. Both approvals came in 1998. Abbott Laboratories' Humira didn't get approved until New Year's Eve 2002, but its product directors clearly made timely resolutions to celebrate. Abbott's bold promotional stewardship of the drug with respect to payers, patients, and evidence-driven medicine, combined with Humira's sheer clinical efficacy and success in gaining new indications where the others have not, are the reasons why Pharm Exec singled out Humira for brand leadership. Analysts are predicting that Humira's sales will surpass Lipitor's as the top-selling medicine ever, and there's a likelihood that even more indications will be added to the label. So Humira may not have been the first to market, but we think it was the best to market.Ten years after launch, Humira continues to grow. Last month, Abbott reported a global growth rate of 21.1 percent (19.3 percent in the U.S.) for Humira, with total sales at $7.9 billion ($3.4 billion in the U.S., and $4.5 billion internationally) in 2011. On the full-year 2011 earnings call, Abbott execs touted Humira's breadth of indications, strong long-term safety and outcomes data, as well as its strength in managed markets and a record of superior clinical efficacy. Responding to an analyst's question on new competitors, including the development of oral products, Abbott CEO Miles White noted that Humira "has seen competition" in the past, and has continued to succeed. The drug "continues to shine in its overall profile," he said.
Jeffrey Stewart, Abbott's vice president of U.S. proprietary pharmaceuticals, says the fundamental talents at Abbott revolve around anticipating the market, and then executing on strategy. "When you think about the three biggest indications—RA, psoriasis, and Crohn's—our indication set is the closest match to the market. RA and the rheumatological conditions remain the largest segment, but Crohn's and psoriasis are growing the fastest," says Stewart. Humira currently has six indications—RA, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's, and plaque psoriasis—and has plans for more. At JP Morgan's 30th Annual Healthcare Conference last month, Thomas Freyman, executive vice president, finance, and chief financial officer at Abbott, described Humira as a "cornerstone" of the proprietary pharma business, one he expects to provide "strong and sustainable growth" for the new pharmaceuticals division. (Abbott announced plans to split its drug and medical device products into two separate businesses, explained in further detail below.) Abbott is "evaluating Humira in a number of additional indications, which we expect to collectively generate significant incremental sales," said Freyman. Additionally, "low global penetration rates for biologics create a significant opportunity to drive longer-term sustainable growth ... we're focused on expanding the anti-TNF market, and the Humira patient base, as well as improving patient adherence," he said.
Indeed, an increased penetration of the anti-TNFs in global markets does represent an opportunity, says Barbara Ryan, managing director, Deutsche Bank Securities. "Humira is growing faster outside of the U.S.," she says. Stewart spotlights Brazil as "one of the fastest-growing areas for Humira ... It has become a very significant driver for us; the reimbursement rate is positive—the Abbott people down there are doing quite nicely with Humira," he says.
The most dramatic example of a global opportunity, according to Stewart, is in the psoriasis indication. "We're talking about penetration rates around 5 percent to 10 percent of the indicated patients with moderate-to-severe psoriasis; that's not market expansion or a new indication around mild psoriasis—we're not going for that—but it's amazing to think that there's another 80 percent to 90 percent, within the indication," says Stewart. Full market penetration may be a little unrealistic, given that the anti-TNF class has been around for over a decade, but "when you look at the new indications, and the relative penetration rate, it gives you a lot of cause for optimism," says Stewart.