Remicade (infliximab), a biologic drug for the treatment of rheumatoid arthritis and other autoimmune diseases, remains the top growth driver for Johnson & Johnson (JNJ). Positioning two new biological entrants approved in 2009 for similar commercial successes will be challenging, and require branding strategies that avoid cannibalizing sales of its flagship drug.Remicade is in a class of biologics that inhibit circulating inflammatory proteins, called tumor necrosis factor (TNF). In total, Remicade is approved for 15 immune-mediated inflammatory conditions in the U.S. alone, including recent approvals for pediatric Crohn's, chronic severe plaque psoriasis and psoriatic arthritis. It contributes 19 percent to total pharmaceutical product revenues.
Despite increased competition -- expanded (labeling) indications from other TNF blockers and the launch of new disease-modifying agents -- Remicade sales increased 14.8 percent to $4.3 billion in 2009, with growth driven by new clinical data, expanded labeling, and overall market growth (actual gains adjusted for price hikes is unknown).
J&J subsidiary Centocor Ortho Biotech won approval from the FDA in April 2009 to market its second anti-TNF drug Simponi (golimumab) for the treatment of rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis. A multiple approval launch is a first among TNF blockers, which all had follow-on, gradual labeling strategies.
Simponi is the fourth TNF inhibitor to reach the market, with efficacy and safety in line with the other anti-TNFs. The one major differentiating factor is administration, as trained patients may self-inject just once monthly. Surveyed doctors said -- at least initially -- they planned to limit prescription starts to anti-TNF treatment failures, although price would not be a limiting factor: Average wholesale cost (as of 9/09) for Simponi was $1,890 per month, compared to about $1,980 and $1,904 per month for Amgen's Enbrel (etanercept) and Abbott's Humira (adalimumab).
Simponi is unlikely to threaten the Remicade brand. Given its labeling, JNJ will initially market Simponi in subgroups of patients with multiple conditions -- over time up to 30 percent of patients with psoriasis develop arthritis. Longer-term, successful switching strategies will need to demonstrate cost-effectiveness and superior efficacy -- as shown in head-to-head trials -- against other ant-TNFs.
Specialists and primary care providers agree slowing the progression of structural damage (such as joint damage) and improving physical function -- signs and symptoms -- are key goals in the treatment of RA. Word on the street is that rheumatologists have been slow to embrace Simponi, believing that "neither Simponi nor any other RA biologic have the same effect as Enbrel in inhibiting/slowing structural damage progression." JNJ obviously needs to do a better job in communicating that Simponi has demonstrated efficacy, as witnessed in RA patients who were previously treated with other ant-TNF agents, including Enbrel.
In contrast, dermatologists seem eager to try Stelara (ustekinumab), recently launched for the treatment of adult patients with moderate to severe plaque psoriasis. Although Stelara is entering a crowded treatment room for psoriasis, this first-in-class interleukin (IL) offers significant advantages over TNF inhibitors, including superior efficacy (ACCEPT Trial) and a convenient 12-week dosing cycle.
In the psoriasis markets, Remicade is not the competition. Decision Resources, in a Treatment Algorithms in Psoriasis report, opines that Stelara will change the prescribing habits of dermatologists and help to grow the entire market for systemic biologic agents. Humira has the most to lose among the dermatologists polled in the survey, as most of them indicated that Stelara prescriptions would replace Humira as their preferred second-line systemic biologic agent (after Enbrel).
As patients cycle through anti-TNF therapies and the failure pools increase, there is ample room for Simponi and Stelara to grow prescription share in their respective markets without cannibalizing Remicade sales. As the two drugs expand their labeling to address unmet needs in other markets, their orbits will eventually collide with each other and with Remicade. In fact, (in my opinion) by 2018 both drugs will challenge Remicade's position http://umm.edu/health/medical/reports/articles/psoriasis as a preferred psoriasis medicines agent in immune-mediated inflammatory conditions, from RA to Crohn's and ulcerative colitis, due to their more convenient dosing schedules and established efficacy -- the same year, of course, Remicade loses patent protection.
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