Several factors are driving greater market-share estimates of products to treat rheumatoid arthritis (RA) and other conditions like ankylosing spondylitis, Crohn's disease, psoriasis and ulcerative colitis.
Biologics called TNF inhibitors underpin the sector's growth prospects. Johnson & Johnson/Merck's Remicade is the top-selling anti-TNF on the US market, with $3.3 billion in sales last year, a 4.3% increase over 2008, followed by Pfizer/Amgen's Enbrel and Abbott Labs/Eisai's Humira.
According to a forecast by EvaluatePharma, Humira will become the world's biggest product in 2012 with global sales of $8.3 billion and will retain its top spot until 2016, when sales could exceed $10 billion. Enbrel and Remicade will reach the no. 3 and no. 7 spots, the forecast notes.
What's driving the upbeat predictions? “Anti-TNFs have transformed the treatment of immunologic diseases like Crohn's disease and RA,” says a spokesman for J&J's Centocor Ortho Biotech.
In addition, their clinical utility is broad. Remicade has clinical utility across gastroenterology, rheumatology and dermatology. Since its approval in 1998 for the treatment of Crohn's, Remicade has achieved 15 FDA approvals and is hoping for a 16th, in pediatric ulcerative colitis.
And there's room for growth. “A significant number of patients [for whom the drugs are indicated] still have not been put on [anti-TNFs],” says Jeffrey Stewart, who heads Abbott's US Humira business.
Of the five marketed TNF inhibitors, Remicade is the only infusion product, while Humira and Enbrel are injectable, as are UCB's Cimzia and Simponi, which Centocor Ortho Biotech launched last year. “We're the only self-injectable TNF inhibitor in the category that works across the bones, skin and the gut,” says Stewart, referring to Humira's indications for RA, psoriasis and Crohn's. Enbrel is no approved for Crohn's.
The complexity of anti-TNFs dictates a multichannel marketing approach, adds Stewart. Humira has used both branded and non-branded communications, such as its disease-awareness website RA.com, to educate patients and professionals. In the past, the brand has also run television, although not currently.
“We've seen a very significant migration toward [patients] studying medications and looking up disease states online,” especially for complex biologics, Stewart notes.
Aside from Remicade, whose media spending rose sharply last year, it appears that many brands in the rheumatology space, including some of the small-molecule drugs, are also cutting back on expensive broadcast DTC, according to figures from SDI.
“The next big thing in RA will be some small molecules that are true disease-modifying agents,” says Ben Weintraub, PhD, director of research, Wolters Kluwer Pharma Solutions. The most promising of these is Pfizer's oral JAK-3 inhibitor CP 690,550, now in Phase III. JAK inhibitors are also being developed by Incyte and Rigel.
Human Genome Sciences (HGS) and GlaxoSmithKline expect to submit a regulatory filing this month for lupus drug Benlysta, which could become the first FDA-sanctioned lupus treatment in decades.
“We hope we'll get priority review of six months, and we're preparing the ramp-up of our sales and marketing efforts, so we'll be ready to launch [by year's end],” says Barry Labinger, EVP and chief commercial officer for HGS.
The anti-BLyS antibody met its primary endpoint after a year but not a secondary endpoint six months later, prompting Weintraub to give it a 60% chance of approval and a $1.6 billion forecast.
Amgen's rank ligand inhibitor Prolia, which is being developed primarily for osteoporosis, may also be a compelling drug to use in RA patients, says Weintraub. This is the third in a series of bi-monthly features examining different therapeutic categories. The next installment will be August's focus on metabolic products.