Best to Market - Pharmaceutical Executive


Best to Market

Pharmaceutical Executive

New Indications

Will Abbott be able to maintain double-digit growth for the next five or so years, until the patent expires? It's very doubtful that any new indication for Humira will be as lucrative as the RA, Crohn's, or psoriasis indications, but a couple new additions to the label means incremental growth. Stewart says six new indications are on the docket: hidrandenitis suppurativa (a fulminating inflammatory skin disease); uveitis (an eye inflammation that can lead to permanent vision loss); axial and peripheral spondyloarthropathies, or SpA (two indications covering a group of wide-ranging inflammatory diseases); ulcerative colitis (an inflammatory bowel disease); and pediatric Crohn's disease. The FDA is expected to weigh in on the ulcerative colitis indication this year, although "we wonder to what extent it's already being used off-label," says Ryan. Stewart says the new indications represent "a substantial opportunity for Humira, and [would] certainly provide a lot of relief for patients." Humira has "strong patent protection through early 2017 in the U.S., and early 2018 in Europe," and Abbott also holds "numerous process patents that extend well beyond that time frame," the company says.

In the meantime, other pharmas are scheming on Humira's market share. Stewart says he attended the American College of Rheumatology meeting last November, to hear about the new oral disease-modifying anti-rheumatic drugs (DMARDs), but he says the fact that eight or nine drugs are already on the market for RA makes for a difficult entrance. Pfizer's tofacitinib, an oral JAK inhibitor, is expected to gain approval late this year or in early 2013, but the label will most likely include only one indication—RA—initially, if it's approved at all, says Stewart. The drug is being tested for other conditions such as psoriasis and inflammatory bowel disease (the category to which Crohn's and ulcerative colitis belong). Stewart is cool on the oral JAK inhibitor class. "Our take is, the twice-a-day JAK inhibitor, they've basically revealed that they're not really bringing anything new to the table in terms of safety or efficacy," he says. "If you look at the data, the market has moved beyond ACR scores"—which measure change in RA symptoms—"and it's really focusing now on radiographic inhibition, and there's some interesting data" related to tofacitinib dosing and radiographic inhibition, says Stewart. FDA accepted Pfizer's filing for tofacitinib in December, so Abbott will observe the proceedings, but not with bated breath. "We're certainly watching this ... but we think it's a manageable competitive threat if it does come through," says Stewart.


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