Why J&J's Stelara Launch Should Target Dermatologists First
Johnson & Johnson recently launched Stelara 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) inhibitor could put the "no more tears" back in J&J's future -- if successfully marketed to specialists, in particular dermatologists, as it is a novel and less cumbersome injectable than established biologics for psoriasis, the tumor necrosis factor-alpha inhibitors.
There is no cure for psoriasis, which affects upwards of 7.7 million Americans, according to the National Institute of Health. TNF-alpha inhibitors, which work to neutralize inflammatory protein messengers, currently dominate biological options for this skin disease, contributed 55 percent of the $2.5 billion psoriasis sales in 2008 across seven major markets (including the U.S. and Europe), according to market researcher Datamonitor.
An overactive immune system can also trigger high levels of IL-12 and IL-23, two proteins found in the red scaly skin patches characteristic of psoriatic plaques. Stelara (ustekinumab) is a novel monoclonal antibody that binds to IL-12 and IL-23, thereby slowing the overproduction of skin cells and the resultant inflammation (see image to left; click for a larger version).
The actual size of the psoriasis market is deceptive in terms of market size and sales potential. Epidemiological studies have shown that as patients age their risk of developing co-morbid autoimmune diseases, such as the GI disease Crohn's, rheumatoid arthritis, and psoriatic arthritis, increases, too.
Overlapping pathogenic pathways in autoimmune diseases have not been lost on the makers of the three major TNF-alpha blockers. Amgen, Abbott Labs, and J&J understand the dynamics of brand positioning. With diversified FDA-approved product labeling -- from the relatively uncommon spinal arthritic condition, called ankylosing spondylitis, to the more familiar psoriasis, psoriatic or rheumatoid arthritis -- the drug makers have successfully sold specialists (in particular, gastroenterologists and rheumatologists) on the clinical utility of prescribing TNF inhibitors across a range of prominent autoimmune diseases: Amgen reported a three percent increase in third-quarter sales of Enbrel (etanercept) to $924 million; Abbot said Humira (adalimumab) revenue in its third-quarter climbed 24 percent to $1.49 billion; and, J&J posted a 5.9 percent gain in Remicade (infliximab)sales of $1.04 billion!
Stelara, like all existing autoimmune-modifying biologics on the market, can increase the risk of opportunistic infections in those patients hosting latent viruses or bacterium. Nonetheless, given J&J's experience in working with opinion leaders in the field of systemic biologics, expectations run high for Stelara. Analyst Larry Biegelsen of Wells Fargo sees Stelara sales of $521 million in 2013.
In my opinion, this estimate could prove to be conservative. As intimated, with a still incomplete understanding of the numerous (and still to be identified) inflammatory cascades involved in the progression of psoriasis and co-morbid autoimmune diseases, there is an unmet need for effective long-term therapies that also do not grind down patient compliance.
Enbrel and Humira are currently opinion leaders' drugs of choice for patients in need of systemic therapies because they believe those two TNF blockers offer a superior balance of efficacy and safety, according to pharmaceutical think tank Decision Resources. However, Stelara's demonstrated advantages in the treatment of psoriatic plaques, if properly communicated, could help rocket sales from launch: superior efficacy compared to Enbrel, longer remission rates, and a convenient 12-week dosing interval (see figure at left; click for a larger version).
The average wholesale price of Stelara is $5,595.60 per 45mg/0.5 ml vial, according to CVS Caremark. This pricing is competitive with the average annual budgets expended on each of the three popular injectable TNF-alpha inhibitors.
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 more of their Stelara prescriptions would replace Humira as their preferred second-line systemic biologic agent (after Enbrel).
Dermatologists seem eager to try the drug. And, in comparison to a possible 100 (plus) injections with Enbrel, the superior efficacy and better patient compliance associated with Stelara could quickly flip-flop skin doctors' preference in time.
The new report also suggested that dermatologists are more readily moving patients from first-line topical corticosteroids to second-line conventional systemic agents and foregoing additional lines of topical treatment in the process. This is great news for Stelara, as J&J management projects dermatologists share of the global psoriasis market will more than double in size by 2013, from $2 billion to an estimated $4.4 billion (see figure at left; click for a larger version).
Stelara has a clear field to build a loyal doctor-patient base; most of the biologic compounds in late-stage development are perceived as "me-too" TNF-alpha inhibitors and Abbott Lab's IL- blocker briakinumab is unlikely to hit the market before 2011. Ergo, specialists have more than two years to gain clinical experience -- and improve their comfort level with the drug.
J&J just might have found the right medicine to clear up the irritating red rash in U.S. prescription drug revenue due to lost sales of the schizophrenia drug Risperdal oral and the seizure medicine Topamax (to generic competitors). First-mover advantages in this novel class of biologics combined with additional indications under development for Stelara -- including Crohn's disease (Phase 2b) and Psoriatic arthritis (late-stage trials) -- could fuel a new blockbuster ($1 billion +) immunology franchise for J&J.
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