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Just over a year ago – and buoyed by recent FDA approval – expectations for Pfizer's rheumatoid arthritis treatment Xeljanz (tofacitinib) were suitably high. The drug – an oral alternative to injectable biologic therapies with a comparative efficacy and safety profile – was widely expected to help spearhead Pfizer's post-Lipitor growth expectations.
Consensus expectations in November of last year pointed to full-year sales of around $315 million for Xeljanz in 2013. Based on its current quarterly run-rate, analysts now expect the franchise to generate revenue of about $123 million.
Failure of Xeljanz to gain approval in Europe (see ViewPoints: Key opinion leader casts doubt as to whether Pfizer's Xeljanz will ever secure European approval) is a contributing factor to this downgraded commercial outlook, but in the US market, Pfizer's product has simply not gained the anticipated traction among physicians, despite its oral availability.
This trend says as much about the entrenched competition – particularly AbbVie's Humira, Johnson & Johnson's Remicade and Amgen/Pfizer's Enbrel – as it does about Xeljanz. During Q3, these three biologics were the industry's biggest selling products, generating sales of $2.9 billion, $2.5 billion and $2.1 billion, respectively. In 2012, these three franchises delivered combined global sales of around $28 billion.
The sheer size of revenues generated within the autoimmune space is one reason why Xeljanz is still expected to achieve blockbuster status by 2017 (a similar outlook was referenced last week by one analyst towards Sanofi and Regeneron Pharmaceuticals' biologic sarilumab, which could achieve peak sales of around $1 billion despite being largely differentiated from existing competition). However, gaining market share at the expense of these long-established products has taken longer than anticipated.
Pfizer management has conceded that uptake of Xeljanz needs to increase if the product is to deliver on (presumably revised) expectations. The company initiated a US direct-to-consumer (DTC) marketing campaign at the beginning of the summer and hopes to gain approval for a revised label from the FDA in February to reflect Xeljanz's ability to inhibit progression of structural disease.
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FirstWord polled US-based rheumatologists in May to ascertain how physicians were utilising Xeljanz and this week's Physician Views poll partly acts as a follow-up. Specifically, this week's poll will ask US-based rheumatologists:
• To what percentage of rheumatoid arthritis patients they have now prescribed Xeljanz?
• Where they are typically using the drug in the treatment paradigm?
• How awareness of the drug has increased over the past 6 months?
• How significant a role the oral availability of Xeljanz holds in the eyes of patients?
• Whether potential new labelling for Xeljanz (possibly secured in February 2014) will impact usage?
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