Belated Stelara approval should be worth the wait

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Although FDA approval for Johnson & Johnson’s Stelara (ustekinumab) has arrived almost two years after the antibody was filed with the US regulator, it marks the most significant new product to treat psoriasis since Abbott Laboratories’ Humira was approved in this setting two years ago and maintains J&J’s impressive recent track record of delivering new drugs to the market.

The regulatory delay and some safety concerns have reduced forecast sales for Stelara yet with consensus analyst estimates of $950m by 2014 the product clearly still has blockbuster potential. As for Abbott, the approval for Stelara highlights the fact their antibody candidate in the same class, ABT-874 (briakinumab), which at one stage was expected to beat Stelara to the market, will now come a distant second with launch not likely until 2011, handing Stelara significant first mover advantage.

Unique selling points

J&J filed a BLA for Stelara with the FDA in December 2007 and although an advisory committee voted unanimously to approve the drug in June 2008, the FDA issued a complete response letter last December to address some issues with the proposed risk evaluation and mitigation strategy (REMS).

The immunosuppressant nature of the antibody, which targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), means that Stelara could increase the risk of serious infection and cancer for psoriasis patients. The FDA’s concerns over the monitoring of these side effects have now been addressed in the drug’s medication guide that forms an important part of the REMS.

These potential side effects aside, Stelara has some unique selling points which should help it carve out a decent share of the global psoriasis market, estimated by JP Morgan to be $3bn in 2010.

First up is Stelara’s dosing advantage, which only needs to be injected once every three months, whereas current treatments such as Humira, Wyeth’s Enbrel and J&J’s own Remicade require much more frequent administration of once a week or two times a month.

Second and just as important is Stelara’s proven efficacy record, which secured a major coup by coming out on top in a direct head-to-head trial with Enbrel (J&J's head-to-head gamble pays off, September 19, 2008).

Although consensus forecasts in 2014 have been reduced by 30% over the past 12 months, final FDA approval could remove any lingering doubts over the product and stimulate some upgrades depending on the initial uptake.

Abbott loses out

Following Abbott’s acquisition of Knoll in 2001, the healthcare giant has since been developing ABT-874, an antibody which also targets IL-12 and IL-23, for the treatment of psoriasis.

Back in 2004 analysts had predicted that ABT-874 could reach the market by 2007 with sales rapidly rising to almost $500m within three years of launch, archive consensus forecasts from EvaluatePharma reveal.

With Abbott yet to report any pivotal phase III data for ABT-874 and now guiding to a regulatory filing next year, the product’s entrance onto the market looks like arriving four years late, in 2011.

With a similar dosing frequency to current psoriasis treatments, the product will clearly have to deliver exceptional efficacy and safety data when the phase III data is finally revealed for ABT-874 to make any inroads into the market, especially now that Stelara has almost a two-year head start.

Consensus forecasts for ABT-874 of $392m by 2014 have already more than halved over the last 12 months from $874m. As such, approval for Stelara could cause further downgrades to these expectations for ABT-874.

Nevertheless, despite these significant downgrades the product still represents Abbott’s most valuable pipeline product with an NPV of $1.2bn. The largely disappointing developments from Abbott’s pipeline therefore points to another driving force behind their recent acquisition of Solvay’s pharma business (Abbott's buying spree continues with €4.5bn Solvay buy, September 28, 2009).

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